Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack's first commercial product, ONIVYDE™ (irinotecan liposome injection), was approved by the U.S. FDA on October 22, 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry.

The primary responsibility of this position will be: assisting in the development, management and continuous improvement of the GCP, GCLP and GLP Quality Systems; conducting and/or assisting with preparing Contract auditors to perform a wide array of quality audits in order to assure that all aspects of clinical trials and non-clinical studies conducted are being executed in compliance with applicable US FDA 21CFR Part 11, 50, 54, 56, 312, 314 and Good Laboratory Practice Part 58, ICH GCP Guidelines, and other government and/or country specific regulations; assisting in the development and/or revision of departmental (Clinical QA) policies and procedures (SOPs).

Job Responsibilities:

• Conduct compliance audits and/or assist in the preparation of Contract Auditors for the following types of audits: Clinical Investigator Sites, External CROs/Vendors, Laboratories (clinical and non-clinical), Internal Systems, Trial Master Files
• Perform document review and/or audits of: protocols, protocol amendments, investigator brochures, clinical/non-clinical study reports, annual reports, regulatory submission documents (IND, NDA, sNDA), informed consent forms
• Advise clinical and pre-clinical development (toxicology, pharmacology and pharmacokinetics) projects and teams as compliance issues arise in day-to-day operations
• Review and assess audit reports and responses/proposed CAPAs from both internal customers as well as 3rd Party contractors
• Create and revise departmental SOPs and policies in support of QA-GCP/GCLP/GLP activities
• Participate and lead in companywide quality improvement projects

Requirements:

• Bachelor’s and/or Master’s degree in an appropriate discipline
• At least 3-5 years’ experience in clinical quality assurance (preferably as a GCP or GLP auditor)
• Direct experience in conducting and/or leading the following types of audits: Clinical Investigator Sites, External CROs/Vendors, Laboratories (clinical and non-clinical), Internal Systems, Trial Master Files and GCP Documentation (clinical study reports, investigator brochures, annual reports, PSURs, INDs, NDAs)
• A solid understanding of  US and  ICH-GCP Regulations and guidelines for the conduct of clinical trials and non-clinical studies
• Excellent written and oral communication skills, with exceptional organization and multitasking ability
• Demonstrated ability to work and achieve consensus in a team environment as well as completing projects with minimal oversight
• Knowledge and experience of Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP) and Good Pharmacovigilance Practice (GPV) is a plus
• Passion for fighting cancer

Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open on our Emerging Technologies operational team.

Aseptic Manufacturing Associate/Manufacturing Project Specialist-Portsmouth, NH

Responsibilities:

As part of the Emerging Technologies operational team this is a unique opportunity for an experienced and capable Aseptic manufacturing associate to be involved with the new manufacturing activities that encompass cell therapy at the Lonza site in Portsmouth, NH.  The preferred candidate will have the following background:

• Must have experience and      knowledge of aseptic production processes and be a source of technical      expertise.  3+ years of experience in Aseptic Drug Product Filling      (for example - vials, syringes, otic/ophthalmic      containers) experience is required.  Finish experience with drug      product primary container visual inspection (automated, semi-automated and      manual) is preferred.
• Significant manufacturing      experience.
• High School Diploma is      required. Certification, Associates or Bachelor's Degree in a      science/technology related discipline is preferred. 
• Experience with      independently writing and executing SOPs and associated batch record      documentation; experience with technical writing preferred.
• Strong knowledge and      adherence to cGMP compliant processing (At least 4 years’ experience)
• Demonstrated support to      change control process, work order generation, deviation investigation and      management
• Proven logic and decision      making abilities.  Including real-time decision making on process      events based on knowledge of defined SOPs & policies.
• Able to provide      manufacturing insight into the review of more complex decisions with      supervisor and support departments, plus provide input to management on      scheduling or process issues based technical, process & equipment      experience.
• Able to multi-task on      equipment preparation and operations to ensure area stays on schedule
• Where required work      unsupervised.  For example perform shift exchanges independently
• Offers suggestions for      improvement, implements where appropriate and is keen to develop self with      respect to technical knowledge of operations and technologies
• Ability to manage multiple      priorities and coordinate between departments for multiple parallel      activities.
• Able to troubleshoot      equipment; non-routine as well as routine troubleshooting
• Ability to communicate manufacturing      operations perspective effectively to management, support department and      customers.
• Strong mechanical aptitude preferred.
• Ability to work collaboratively in a project      and cross-functional team environment

The Aseptic Manufacturing Associate will initailly focus on supporting the equipment & operational readiness of the cell therapy project, with the intent of assuring that Manufacturing & the customer is provided with a facility that matches their requirements of quality, operability & consistency.  Through the course of the project (construction, commissioning and validatation) responsibilities may also include but will not be limited to;

• Review the design of the facility & equipment and provide support to FATs, SATs & validation
• Supporting training with repsect to Cell Therapy operations. (particular emphasis on aseptic filling)
• Provide guidance and trouble shooting input during the commissioning, validation & start-up effort.
• Support the generation of SOP's and batch records for the Cell Therapy project. (particular emphasis on aseptic filling)
• Support the ordering and set-up for new small equipment required to run the area, including ensuring proper documentation is in place
• Support activities associated with setting the area up for GMP operation, and that the transition from project to GMP operation is planned for and transitioned smoothly.  This will include placing systems and procedures from current operations in place prior to start up.
• During the project phase this position will have a schedule of Monday to Friday 8:00am to 4:30pm.
• Post project completion this role will transition into a traditional manufacturing schedule.
• Potential opportunity for short term international assignment at a sister site to support the business and enhance training

Quality should be the responsibility of all persons involved in Manufacturing.  Adherence to cGMPs is required at all times.  All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc).

All personnel should practice good personal hygiene and health habits.

An Equal Opportunity Employer

      M/F/Disability/Veterans

Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open on our Operations team.

Manufacturing Associate-Portsmouth, NH

Job Responsibilities:

The associate role is responsible for the manufacture of therapeutic proteins under cGMP (current good manufacturing practice) conditions. The exact duties and responsibilities can vary by area which can be Upstream (Fermentation or Media Prep) or Downstream (Purification or Buffer Prep). Candidates may be offered a position in any one of these areas. Work areas are dynamic in that associates are required to participate in a number of different activities within production areas.

Our ideal candidate must have a strong set of core values and a dedication to quality. As a Lonza Biologics Manufacturing Associate the highest levels of integrity are expected, an openness to learn and ability to work as part of a team are crucial. As part of our team the Manufacturing Associate will undergo a structured training regimen which will prepare them the duties and daily responsibilities listed below. Our training will prepare the candidate to be competent with the technical aspect of our job but in order for a manufacturing associate to be successful they will need a strong attention to detail, positive attitude, and most importantly a safe work habit.           

General Duties (All areas):

• Learns and performs      well-defined procedures.
• Proactively stay up to date      on training.
• Perform      basic laboratory tasks (pH, Conductivity, sampling etc…)
• Demonstrate      aseptic technique in the handling of product/ materials (work in biosafety      cabinets, laminar flow hoods, use of sterile filtration and pipetting).
• Perform      routine sanitation tasks to maintain facility standards.
• Become 100%      trained on routine tank preparation activities such as cleaning CIP (Clean      in Place), sterilization SIP (Steam in Place) and sterile filling      procedures.
• Attain a      basic understanding of cGMP’s and compliance in a GMP manufacturing      setting performing both supervised and unsupervised tasks.
• Meticulous      completion of paper and electronic documentation requiring attention to      detail.

Equipment Expertise

Upstream Areas (Fermentation and Media Prep):

• Equipment      monitoring for vessel control parameters (Fermentation), temperatures and      pressures.
• Perform routine sampling      using aseptic sampling devices and submission of samples.
• Routine cell counting using      slides and/or automated cell counters (Fermentation).
• Routine use of sample      analyzers to measure in process attributes (metabolites, osmolality,      conductivity, pH).
• Operation of bench top      centrifuges, water baths.
• Large and small scale      filtration.
• Large and small scale      solution prep (Media Prep).
• Standardization of dissolved      oxygen and pH probes (Fermentation).
• Filter integrity testing.
• Use of autoclave (Media      Prep).

Downstream Areas (Purification and Buffer Prep):

• Perform routine sampling using aseptic      sampling devices and submission of samples.
• Operation of Chromatography Equipment (column      packing, testing and operation) (Purification).
• Operation of Ultrafiltration and Diafiltration      Equipment (Purification).
• Operation of UV meters, probes and      spectrophotometers (Purification).
• Viral Filtration (Purification).
• Filter integrity testing.
• Use of Autoclave.

Technical Process Expertise

All Areas:

• Exhibit basic understanding of critical      process parameters and operational parameters.
• Systems & cGMP Expertise
• Regular use of Standard      Operating Procedures, logbooks and Batch records.
• Ability to write clearly and concisely.
• General understanding of the batch record      review process.
• Ability to be trained in Lonza’s sample      submission and management system.
• Operating knowledge of Lonza’s Computerized      Control Systems (DeltaV or DCS).
• Able to accurately enter activity completion      data using scheduling software (ASPEN).

• General understanding of the document change      system.  Initiate simple Document      Change Forms, with supervision.
• General understanding of the deviation system      (Trackwise).
• Ability to be trained to locate and order      materials in SAP.
• Ability to order logbooks and supplies. 

Upstream Areas:

• Basic      understanding of cell growth.
• Helium      testing and determination of leak locations.
• Understanding      principles behind steam sterilization (SIP).
• Passage      of cell cultures (T flask, roller bottles, spinner flasks).
• Use      of process trends to assist in trouble shooting.
• Operation      and principles of harvest equipment (large scale centrifugation and      concentration).

Downstream Areas:

• Theory      of chromatographic techniques (affinity, cation/anion exchange,      hydrophobic interaction).
• HETP      calculations.
• Understanding      what conditions can adversely affect a column resin bed.
• NWP      calculations.
• Final      fill of product (in bags or bottles).

Problem Analysis / Decision Making

• Basic decision making, knows when to seek help      and who to contact.
• Able to identify situations which may require      escalation to supervisor (Deviations, Alarms).

 Planning/Communication

• Organizes & plans assigned daily      activities to ensure timely completion of assignments.
• Documents all work methodically as it occurs.
• Proactively seeks training and knowledge to      increase understanding of role.
• Ability to communicate interdepartmentally.
• Ability to read the production schedule and      gather the necessary batch records and dispensings. 

 Supervision Received

• Reports to Supervisor.
• Receives daily supervision on routine work and      detailed instructions on new assignments.

 ALL LONZA BIOLOGICS EMPLOYEES HAVE THE FOLLOWING RESPONSIBILITIES:

• Quality should be the responsibility of all      persons involved in Manufacturing.       Adherence to cGMPs is required at all times during the manufacture      of Active Pharmaceutical Intermediates (product).
• All personnel are responsible for notifying      responsible management in a timely manner of regulatory inspections,      serious GMP deficiencies, product defects and related actions (e.g. quality      related complaints, recalls, regulatory actions, etc)
• All personnel should practice good sanitation      and health habit.

Qualifications:

3+ year’s relevant experience in Manufacturing or other structured work environment that includes following written procedures and recording information.  

High School Diploma is required.

Certification, Associates or Bachelor's Degree in science related discipline is preferred.

• Working in a safe manner is an      expectation and safety training must be up to date.  Suite and area safety inspections are      expected from all Associates with communication to supervisor and      appropriate follow-up on any safety issues.
• Associates will be required to      work a rotating 12 hr shift determined by the specific production being      performed with overtime as required.
• Constructive proactive      communication is expected.
• Familiarity with use of computers      - Word, Excel, Outlook or equivalent.
• Ability to read and follow      technical instructions in English.
• Ability to comply with detailed      procedures.
• Ability to perform math with      assistance of calculator.
• Positive team oriented attitude.
• Excellent work record (includes      tardiness and absenteeism record).
• Minimal error rate with high      attention to detail
• Employees are expected to      frequently lift/push/pull/carry 12kg (~26lbs). On an occasional basis      employees may be required to lift/push/pull/carry up to 50lbs.  Use of mechanical aids (carts, lifts,      hoists, etc.) are provided and are required to be used when the weight      exceed 50lbs.
• Other physical job requirements      include the ability to gown and wear clean room attire as well as any      required protective equipment up to and including safety shoes and safety      glasses. Gowning requires wearing a single piece suit with snaps at the      ankle.
• Employees are required to continuously climb stairs and      occasionally climb ladders.
• Employees must be of health standard to enable them to      work in clean room environment per Lonza Sickness Policy.

An Equal Opportunity Employer

      M/F/Disability/Veterans

Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

Lonza Portsmouth, has significant expertise in the field of mammalian cell culture and cGMP custom manufacturing and is active in the large-scale production of biopharmaceuticals. Concretely, Portsmouth is a custom manufacturer of therapeutic monoclonal antibodies and recombinant proteins using mammalian cell culture for mammalian biopharmaceutical. The facility has been in cGMP manufacture since 1996 and is dedicated to meeting the needs of our customers. The setup and performance of projects teams with experts from Lonza and our customers working together is unmatched in the industry.  We currently have a position open in our Deviations Department.

Deviation Investigation Writer, Level 2-Portsmouth, NH

Summary:

Independently responsible for the efficient and thorough investigation of process deviations (that occur in manufacturing; cell culture and purification, engineering, controls, metrology, and QC), determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents. The position requires working with minimal supervision to manage assigned investigations from initiation to completion.

Job Responsibilities:

• As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations.
• Prepares and analyzes manufacturing and laboratory analytical historical data, and uses methodical root-cause analysis tools to determine root causes and effectively documents the root cause.
• Properly assess the manufacturing or analytical environment and independently conceives and documents appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using analytical tools.
• The individual in the position provides technical expertise to the site on thorough and complete deviation investigations.
• Works independently to comply with procedure driven guidelines relating to Deviation investigations.   
• Demonstrates strong technical skills; and solves complex problems.
• Ensures that deadlines are maintained and monitors the need for extensions in order to maintain compliance in this area.  

Qualifications:

• BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience 3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including: QA, QC, Validation, Manufacturing, or process engineering.
• Good deductive and inductive critical thinking skills required.
• Advanced writing skills required.
• Candidate must possess strong interpersonal, written, and verbal communication skills.
• Incumbent must be able to interface positively with Regulatory Agencies, customers, and company departments.
• Able to lead cross functional teams and ensure alignment and agreement on documented findings.
• Strong time management skills and an ability to multitask in a face paced environment. 
• Good knowledge of MS Office programs, including Word and Excel, and TrackWise

An Equal Opportunity Employer

      M/F/Disability/Veterans

Please take virtual tour of the Portsmouth, NH site. Click here http://lonzavirtualtours.com/

KEW Group is a Personalized Oncology & Precision medicine company in Cambridge, MA, a vibrant center for medical and biotech innovation. We use a multidisciplinary approach to support decision‐making in cancer care. The KEW MDx laboratory generates tumor specific genetic information using next generation DNA sequencing, which is then combined with the most current knowledge of disease and therapeutics. Together, these enable the delivery of optimal treatment strategies tailored to each cancer patient.

We are looking to expand our bioinformatics team with motivated, experienced professionals who are excited about having an impact on cancer care. You’ll be working in a fast‐paced, dynamic and results‐oriented startup environment.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

- Develop, enhance and automate analysis of DNA sequencing data. Assess accuracy, precision, sensitivity, specificity and robustness.

- Work with clinical analytics team to annotate variants and generate content to be used in the generation of clinical reports.

- Work with clinical operations team within the CLIA-certified laboratory environment, to provide robust, reliable variant calls and ensure high quality data generation while complying with interoperability, security and privacy requirements.

SKILLS AND ABILITIES REQUIRED:

- MS or PhD in bioinformatics or computational biology and 2 years of experience in academia or industry.

- Knowledge and understanding of algorithms, data structures, and scientific programming.

- Experience working with next generation sequencing data including common NGS tools such as BWA, GATK, Samtools, Picard, TopHat, and Cufflinks as well as development of novel tools.

- Experience in a Unix/Linux environment.

- Deep knowledge of at least one “compiled” programming language, such as Go, C/C++, or Java.

- Proficiency in scripting languages such as Shell, Perl, or Python.

- Experience in high performance computing, clusters and cloud computing.

The following skills are considered as a plus:

- Knowledge of applied statistics.

- Knowledge and experience of relational database concepts and SQL.

- Experience  with  common bioinformatics databases and genome browsers (Ensembl,  GenBank, RefSeq, dbSNP, UCSC, etc.)

- Experience with LIMS/lab automation.

KEW Group Inc. is committed to providing and promoting equal opportunities in our work environment. We support a workplace environment which is free from unlawful discrimination, and which enhances and celebrates the diversity of its workforce. KEW Group Inc. follows all federal and state laws as outlined and enforced under the United States Equal Opportunity Commission as well as the Massachusetts Commission against discrimination.

General Scope and Summary

SAGE Therapeutics has an exciting opportunity available for a creative, resourceful, innovative recruiter who will be responsible for full-cycle recruiting. Must be able to successfully partner with all levels of management, exhibit strong organizational and problem solving skills, and deliver a world class experience to each potential candidate and hiring manager.

Note: This is an onsite recruiting position in a fast paced, high energy environment

Roles and Responsibilities

• Partner closely with hiring managers in order to successfully develop current and forecasted hiring needs and strategies
• Establish recruitment and selection processes, consider internal variables, EEO and diversity compliance, and budgetary considerations to ensure departmental and organization needs are met in a timely and efficient manner
• Phone screen and assess candidates presented to hiring managers for competence, background and skills, as well as overall ability to thrive in the organization
• Schedule and participate in on-site Interviews, evaluate and recommend qualified candidates for all positions, and initiate the offer approval process
• Assist in structuring and negotiating appropriate relocation packages as necessary. Arrange and coordinate all relocation activities
• Perform reference checks, formulate and extend offers
• Effectively manage and prioritize multiple requisitions based on business needs
• Maintain communication with recruiting partners and proactively communicate with managers and supervisors as to the status of the recruitment process
• Work with our partner vendors to ensure full utilization of their products and services to maximize SAGE’s effectiveness in meeting its talent acquisition objectives
• Utilize, update, and maintain applicant tracking system

• Track recruitment performance metrics and reporting

• Assist with other duties as assigned including special projects related to talent acquisition
• Ensure understanding of the SAGE’s mission and business goals to effectively identify the right talent that will contribute to and embrace SAGE’s culture and values.

Required Skills

• Experience successfully sourcing candidates in the biotech or pharmaceutical industry is required.
• Demonstrated skills in working with in-house HR business partners to manage sourcing for multiple positions
• Proven knowledge and application of laws and regulations especially as they relate to the sourcing and recruitment process
• Exceptional interpersonal skills are a must. The successful candidate has experience developing important relationships with key stakeholders, has good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations
• Strong team player that has a customer service approach and is solution oriented
• The ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors
• Excellent project management and planning skills, paying high attention to details
• Ability to demonstrate flexible and efficient time management and to appropriately prioritize workload based upon organization and department needs
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
• Excitement about the vision and mission of Sage

Required Experience

• Bachelor’s Degree required
• 3-5 years recruiting experience in Biotech or Pharmaceutical Industry

ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Summary:
Senior Medical Science Liaisons (SMSLs) are field-based, experienced, highly trained professionals with strong clinical and/or scientific backgrounds and excellent communication skills. They represent the Medical Affairs organization to the broad medical/scientific community.  SMSLs are responsible for developing and maintaining peer-to-peer relationships with opinion leaders (OLs) within their regions.  They will also recognize new OL relationship opportunities and engage appropriately.

Responsibilities:

• Develop and track OL engagement plans – identify, develop, and maintain long-term collaborative relationships with OLs within assigned region. Participate in medical & scientific exchanges with the medical/scientific community. Share key learnings from real-world OL scientific exchanges in the interest of continuous MSL team improvement.
• Respond to and document unsolicited requests for information on company products and pipeline. Provide clinical/scientific information, as requested, to local payers and formulary decision makers to ensure patient access and support reimbursement. Serve as resource to MSL team for best practices in conveying requested scientific information.
• Facilitate company sponsored and investigator sponsored trials (ISTs). Anticipate and understand the needs of internal stakeholders by updating medical/clinical teams with frequent feedback/insights from interactions with OLs and investigators.  Facilitate investigator interactions with Medical Directors. 
• Provide medical/scientific presentations to internal and external groups. Assist in the development and provision of clinical/scientific input and training to internal functions within regulatory guidelines.
• Identify and nominate members of the Ariad Promotional Speakers’ Bureau and ensure they are updated on new clinical data and findings.
• Support advisory board meetings and investigator meetings. Proactively provide support for content development and delivery of clinical presentations.
• Represent the company at medical meetings through Medical Affairs’ Scientific Booth coverage and other related activities. Assist in development of MSL plans for poster/podium coverage and debrief reporting.
• Adhere to corporate SOPs and ensure vigilant compliance with relevant legal and regulatory guidelines governing scientific interactions with physicians and healthcare professionals across all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information.
• Maintain clinical, scientific, and technical expertise in relevant product and disease state areas. Lead initiatives for ensuring MSL team stays abreast of relevant cutting-edge knowledge.
• Play leadership role on department committees as delegated by MSL leadership.
• Embrace and demonstrate the Ariad Corporate Values.
• Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
• Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Qualifications:

• An advanced clinical degree (e.g. PharmD, PhD, or MD – other doctoral degrees may be considered) is preferred; non-terminally degreed candidates with exceptional field and/or clinical pharmaceutical experience may also be considered.
• A minimum of 5 years of Clinical/research experience in the area of hematology and/or oncology strongly preferred.
• Previous pharmaceutical/MSL experience required.
• Flexibility, diplomacy, and ability to manage expectations.
• Problem solving and entrepreneurial skills.
• Ability to travel frequently with overnight stays (e.g., OL visits, internal Ariad meetings, medical meetings and congresses, and training meetings)
• Strong commitment to business ethics.
• Understanding of, and experience with, regulatory framework applicable to interactions with health care providers (HCPs), payers, advocacy and other business partners.

Submitting a resume online at a job site could cause valuable screening information to be missed.

Click here to apply:
http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=604&company_id=16419&jobboardid=306

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. bluebird bio seeks an outstanding scientist to join and catalyze the newly formed Process Research Development Team.  The focus of this group is to assist in the seamless transition of programs from Research to Process Development.  The candidate’s primary responsibilities will be to develop and scale-up mRNA production processes, support analytical development of mRNA, and perform internal and external technology transfers.  We seek candidates with proven ability to successfully work independently and collaboratively across functions to achieve optimized project plans, with the ultimate goal to deliver therapies that transform the lives of patients.

About the role:

• Planning and execution of mRNA production and purification development activities appropriate for GMP manufacturing.
• Screening, optimization and scale-up of enzymatic reactions, chromatographic separations (e.g. affinity, IEx, HIC, SEC), and filtration processes including microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration.
• Support technology transfer to manufacturing by generating development reports, reviewing master batch records, and providing technical support.
• Develop analytical methods for the evaluation of drug substance or process intermediates utilizing SEC, CGE, RP-HPLC, LC/MS, and restriction mapping.
• Assist in qualification of robust molecular and cell-based assays for support of in-process controls and final product release testing.
• Support studies for process improvements and advancements.
• Assist in the technical review of supporting documents, reports, and change controls, including CMC sections for regulatory filings.

About you:

• BS with 5+ years of directly related experience or MS with 3+ years of directly related experience.  Degree emphasis in Molecular Biology, Biochemistry, Chemical Engineering, Bioengineering, Molecular Medicine, Genetics or related field preferred.
• This position requires conducting laboratory experiments, excellent documentation review and writing skills, and the flexibility to work on multiple projects as needed.
• An in-depth understanding of purification of biologics, specifically mRNA, including process scale-up, scale-down, and tech transfer. A proven track record of purifying multiple drug modalities is strongly preferred.
• Understanding of nucleic acid chemistry, enzymatic and chemical reactions, PCR, plasmid processing, and standard analytical techniques for macromolecules.
• Working knowledge of ÄKTA systems and UNICORN control software, proficiency strongly preferred.
• Experience with high-throughput process development techniques and statistical design of experiments (DoE) strongly preferred.
• Understanding of requirements for development of biologics including requirements for product comparability.
• Experience in working with vendors.
• Track record of completing deliverables within specified timelines.
• Knowledge of GMP/ICH/FDA regulations strongly preferred.
• Ability to execute, document, and follow-through projects to completion. documentation.
• Independently motivated, detail oriented and good problem solving ability
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Excellent communication skills and ability to influence across multiple functions.
• Willingness to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

With our clients expanding biologics pipeline, the process development department is looking to add additional talent to their innovative team.  This position will support all operations in the LSPD lab in all aspects of monoclonal antibody processing, from cell thaw to formulation.   This includes assisting with the passaging of cells and operation of bioreactors up to 250L scale as well as the set up and operation of the downstream unit.
Required Knowledge, Skills and Attributes:
• BS with 1 year of purification / characterization experience
• Knowledge of clarification and purification technologies (Downstream)
• Experience with AKTA skids
• Experience with Unicorn Software a PLUS
• Experience packing 5mm to 30cm columns
• Amazing organizational and communication skills
About StratAcuity
Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

CLIENT:: Biotech Company

The Epigenetics Group is seeking a scientist who is passionate about leveraging computational biology to create life-changing therapies for patients with degenerative diseases. You will work within Epigenetics and collaboratively with other company discovery, translational and clinical scientists to design experiments that probe multiple ‘omic dimensions (e.g., transcriptome, proteome, genome, epigenome), to use creative analytical approaches to reveal drug targets and biomarkers, and to generate insights into mechanisms of action. You will become expert in the interrogation of bench- and patient-derived high-throughput data sets to produce new insights into fundamental biology and to further the development of effective therapies.

• Experience and strong proficiency in the analysis and integration of multiple ‘omic data sets 
• Familiarity with high-throughput platforms for analysis of: coding and non-coding transcriptomes; DNA, histone, and protein methylation; chromatin conformation; protein/RNA/DNA interactions; and/or genomics, epigenomics, or metabolomics. 
• A track record of working collaboratively with teams involved in large-scale data processing and analysis architectures, balancing publicly available toolsets and datasets with targeted internal code development and experimentation. 
• A demonstrated understanding of the use of visual information techniques to effectively communicate the essence of complex biological results. 
• Knowledge of modern object-oriented and statistical programming techniques, and languages (e.g., R, Python, MATLAB, Java, C/C++, sh). 
• Knowledge of current NGS analysis algorithms and toolsets (e.g., STAR, Trinity, Tuxedo, HOMER, MACS, GATK, Galaxy), and comfort using local and cloud-based UNIX compute environments. 
• A strong background in statistics and/or machine learning, and knowledge of modern pathway discovery and network analysis techniques. 
• A strong record of collaboration with cross-functional, multidisciplinary teams. 
• Highly self-motivated with excellent organizational, oral and written communication skills. 

Education:
A B.S. plus five years experience, or an M.S. plus three years experience in life science research, with a degree in cell biology, molecular genetics or a related discipline (background flexible). Industry experience a plus. 

Candidates with PhD's may also be considered. 
• Experimental design, implementation and interpretation skills 
• Communication skills 
• Creative/innovative/problem-solving 
• Adaptable/flexible/agile/team-oriented

Seeking scientists who are passionate about developing & communicating new ways to extract biological insights from data, leading to better medicines for patients.

This role involves working closely with leading pharmaceutical companies, helping to facilitate the development of new medicines for serious diseases including neurodegeneration and cancer. The ideal candidate would have experience in two or more of the following areas:

Neurodegeneration, CNS Diseases, and Neuroscience

Expertise in CNS diseases such as Alzheimer’s, Parkinson’s, Huntington’s Disease, Multiple Sclerosis, ALS, or others, as well as the cellular and molecular mechanisms underlying neuronal development, function, and/or pathogenesis.

Computational Biology

Experience analyzing human data (including gene expression, SNPs, exome and whole genome sequencing, RNA-Seq, and proteomic data), using computational methods to help facilitate the development of new medicines for patients with a variety of serious diseases.

Next Generation Sequencing (NGS)

Expertise across the entire NGS pipeline including data QC, alignment and variant calling; pipeline implementation; and biological interpretation of the results. Experience applying approaches for CNV and structural variant / fusion detection. Ability to clearly communicate the process for each of these analyses, and weigh the applicability of differing tools and approaches.

Machine Learning / Statistics (with Biological Applications)

Expertise in machine learning and statistical modeling with experience applying these approaches to biological data. Ability to develop and apply cutting-edge methods, and ability to clearly communicate the biological context and implications of the analyses to scientists with a range of expertise.

Oncology

Expertise in disease biology and data analysis for cancer research.

Pathway Biology

Performing detailed mechanistic analysis of biological signaling pathways, using quantitative approaches.

Responsibilities

● Interpret data from a biological and clinical perspective

● Collaborate with colleagues to solve complex computational research problems

● Present scientific material (written and oral) to diverse audiences

● Analyze data such as gene expression, SNPs, NGS (RNA-Seq, exome, and whole genome sequencing), proteomic data, and clinical metadata

● Develop innovative analysis methods and algorithms to identify biological insights

Minimum Qualifications

● PhD in Computational Biology, Neuroscience, or a related field (i.e., Biology, Engineering, Computer Science, Mathematics, Bioinformatics, Statistics) or 5+ years of work experience at a leading computational biology focused institution

● Proven ability to work independently as well as contribute to larger initiatives

● Effective English communication skills (both written and oral)

● Proficient in at least one of R, Python, MATLAB, or a similar language

● An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

Preferred Qualifications (in addition to those noted above)

● Postdoctoral experience in a top lab focusing on computational biology and/or neuroscience

● Broad and deep understanding of genetics, proteomics, and/or genomics as documented by a strong publication record in high-impact journals

● Strong experience in scientific communication, excellent writing and presentation skills

● Demonstrated experience developing novel algorithms to address complex scientific problems

● Extensive experience working in R

● Hands-on experience with samtools, IGV, GATK, bwa or similar, RSEM or similar

● Experience applying machine learning approaches to analysis of heterogeneous clinical and pre-clinical data

Our client, an academic leader, is seeking a talented and experienced Senior Alliance & Program Manager to join their team growing. If you are a high caliber individual with in depth experience of drug discovery and development timelines, this is a unique not to be missed opportunity to work as a liaison between faculty and industry partners. 

The ideal candidate for this role will possess excellent communication skills, both written and verbal, as well as have the ability to maintain, update and communicate project timelines.  Someone with previous experience working with external groups, either sponsors of research awards or partner organizations, would transition very well into this role.  Collaborating with leadership and team members, and actively problem solving are critical responsibilities so a can-do attitude and business development experience is key for success in this role. Our client is looking for an individual that can evolve their strategic vision and plan for partnerships and constantly create new opportunities for engagement and growth.

 Requirements:

·         Highly entrepreneurial spirit possessing a results driven approach

·         5 years of relevant experience in alliance management, project management, or business development

·         In depth understanding of drug discovery and development process and milestones

·         PHD in biological sciences

 About StratAcuity

Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

• The Associate Director of the PIO (Product & Industrial Operations) Project Management Office (PMO) provides strategic, technical, process and operational leadership in the area of project management and external operations (partner collaborations) to multiple teams and functions across PIO and with other vaccine business unit (VBU) functions.
• This position (1) establishes and leads global, multi-disciplinary project management teams thereby ensuring the successful attainment of program deliverables and partner collaboration objectives); (2) leads the development and implementation of appropriate alliance management methodologies and systems; (3) leads the development and implementation of project management standards and best practices within PIO.
• This position works closely with the Senior Director, Strategic Planning & External Operations, and other PIO function heads to provide leadership in defining the operational strategy for product development/commercialization and PIO external collaborations. 
• This position will also collaborate with other functions within VBU (Regulatory, Clinical, Quality) and within broader Takeda (Global Manufacturing & Supply) to identify synergies and appropriate linkages between PIO objectives, partner capabilities and best practice solutions. In addition, the Associate Director will work closely with the Director of External Operations and Early Development to ensure appropriate tools and processes are developed to support PIO’s partnering goals.

• Lead high impact projects to advance our internal pipeline to registration, support securing new assets, establish strategic collaborations with partners and support life cycle management activities.
• Provide strong leadership to enable the team to deliver program and process management expertise and support the building of VBU’s external operations capability.
• Act as the single point of contact with strategic partners and manage these collaborations including setting up and managing joint steering committees, performance tracking KPIs, budgets, quality councils and contracts.
• Establish and manage the process for the collection, synthesis and dissemination of information within the VBU and with strategic partners. Ensure the integration of internal work streams and external objectives/deliverables.
• Identify and leverage partner strengths to maximize the value of our collaborations.
• Translate complex global activities into working processes for regional contributors to global programs; assess process gaps across regions for global programs.
• Lead the strategic definition, creation, documentation and maintenance of project management standards, processes and tools and develop and promote the use of PMO best practices across PIO.
• Define alignment opportunities with other PMO groups; identify process alignments, common milestones, resourcing needs, and systems support for aligned organizational objectives.

• Demonstrate strategic thought and resource planning to support multi-geographic programs and personnel.
• Drive the rigor with which we manage programs through the use of both project management best practices and technical program development via the appropriate application of Quality by Design (QbD).
• Ensure that PIO tactical execution and related budget plans are developed and maintained and that information is effectively utilized by the PIO leadership team.
• Identify issues and obstacles that could impact the timely completion of PIO deliverables and resolve them with team members and/or the relevant functional management.
• Identify and communicate opportunities for change; plans for team to meet new challenges.

Qualifications

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

• Bachelor’s degree in science or business-related field.
• Minimum 10 years of project management experience within the pharmaceutical industry in the area of CMC or research and development .
• Experience implementing systems and processes for support of cross-functional activities.
• Demonstrated ability to clearly and concisely communicate/present key information to senior management.
• Demonstrated ability to build consensus and drive resolution of issues while maintaining positive working relationships across functions. 

• Demonstrated leadership skills managing matrix teams, influencing outcomes and key project decisions.
• Experience establishing and managing global teams across geographic regions.
• Experience with Quality by Design (QbD). 

• Ability to assess business needs and apply process and systems-based solutionsand take initiatives from concept to completion.
• Ability to work across geographic areas with sensitivity to cultural differences.
• Ability to establish and articulate processes which impact cross-functionally.
• Ability to recognize problems before they occur, to appropriately raise issues to management, to bring an insightful approach to problem solving, and to communicate issues to stakeholders in a mature, professional manner.
• Proficiency using Microsoft Word, Excel, PowerPoint and Project .
• Problem solving – ability to think through problems and propose solutions to complex problems.
• Strategic thinking – ability to approach specific issues/problems with understanding of the larger context.
• Strong communication skills – written and verbal.
• Strong organizational skills.
• Negotiation and strong persuasive abilities.
• Excellent collaboration and cross-functional team building skills.
• Management skills – ability to handle a variety of diverse tasks simultaneously while achieving deadlines.
• Presentation – ability to present information in a clear and concise manner.
• Ability to drive decision-making within a cross-functional and cross-cultural, global team structure.
• Ability to develop, articulate and establish processes which impact cross-functionally.
• Demonstrate a high degree of self-awareness, self-motivation, initiative, and attention to detail.

•    Project Management Professional certification with PMI desired.

• Ability to travel to various meetings or client sites, including overnight trips.
• International travel is likely.
• Travel requirements estimated between 25-50%

Education & Experience Requirements:
* High School diploma or equivalent required; Bachelor's degree preferred
* 4+ years administrative experience in a fast-paced professional environment
* Knowledge of proper English usage, grammar, vocabulary, spelling

Key Skills, Abilities, and Competencies:
* Ability to operate a personal computer and related software
* Advanced MS Office skills:
* Word: Forms, Mail Merge, Index and Tables
* Excel: Forms, Formulas, Functions, Pivot Tables, Graphs
* PowerPoint: Graphics, Animation
* Ability to use a personal computer to accurately type a minimum of 50 words per minute
* Ability to operate general office equipment
* Ability to prioritize and perform multiple tasks in a fast-paced, collaborative team environment
* Ability to interact appropriately with senior management on a regular basis
* Solid verbal and written communication skills
* Solid organizational skills; ability to organize and maintain accurate, orderly files and records
* Strong attention to detail; ability to accurately proofread documents
* Ability to maintain confidentiality
* Knowledge of proper English usage, grammar, vocabulary, spelling
* Strong customer-service orientation

Other Job Requirements:
* Ability to hear and speak to employees/management and outside business associates on the phone and in person
* Ability to sit for long hours at a time
* Ability to see the letters and numbers on a personal computer screen and on memoranda, reports and other documents (near vision)
* Requires moderate right and left hand coordination for the use of the personal computer
* Ability to maintain a professional image / demeanor

About Shire:
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Application URL:http://www.aplitrak.com/?adid=c21vdXNzZWF1LjIzMDEzLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The Process Technician will be responsible for the execution of Cell Culture, Media preparation and glasswash activities in a multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and development drug substance. Successful candidates will be flexible and adaptable, willing to work in a fast-paced, dynamic environment.

Responsibilities
* Set-up and execution of cGMP unit operations with a focus on Cell Culture (Flasks, biowaves and bioreactors up to 6000L), harvest (centrifugation, depth filtration, microfiltration) media preparation and glasswash . Includes cleaning and sanitization of the facility and equipment (CIP, SIP, COP, autoclaving, depyrogenation, etc).
* Accurately follow oral, written and electronic instructions in the production area and document daily operations in GMP batch records and logs.
* Operate manual and automated equipment. Individuals will be expected to learn and work with enterprise system such as LabWare LIMS and SAP.
* Support implementation of new technology for process execution and/or analysis. May be responsible for authoring and revising cGMP documents including batch records and SOPs.
* Responsible for data entry and real time process monitoring.
* Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.

Qualifications
* Associates Degree with 2+ years of experience, or an equivalent combination of education and experience is required.
* Experience working in a federally regulated environment is strongly preferred.
* Familiarity and experience with biotech cell culture, protein purification and/or support operations (such as solution preparation and/or operation of autoclave/depyrogenation ovens) preferred.
* Previous experience with manufacturing-scale bioreactors or harvest (centrifugation, depthfiltrations, microfiltration) a plus.
* Basic computer skills are required.
* Experience working in a federally regulated environment is strongly preferred.
* Strong oral and written communications skills are desired.

PHYSICAL/MENTAL REQUIREMENTS
Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs. Must be able to lift ~50 pounds.

EEO & Employment Eligibility
* Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Application URL: http://www.aplitrak.com/?adid=SmltLlRhdm9saWVyaS42MzA1MS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

OVERALL RESPONSIBILITY
We are looking for a highly motivated and talented candidate to join us on an exciting method-development project between the Broad Technology Labs (BTL) and Raul Mostoslavsky's group at Harvard Medical School. The project is aimed at the development of a novel technology for simultaneous mapping the genome-wide localization of multiple DNA-associated proteins, followed by the application of this method to study chromatin regulation mechanisms in eukaryotic cells.

The project involves molecular biology, epigenomics and computational analyses of genomic data. Our groups provide a superb scientific setting: the successful candidate will be a member of a multi-disciplinary team of scientists in a fast-paced, cutting-edge environment spanning several institutions, including the Broad Institute and Harvard Medical School. The individual will interact and collaborate closely with other scientists including biologists, chemists, engineers and computational biologists.

MINIMUM QUALIFICATIONS
- Ph.D. in Biology or a related discipline.
- Experience in molecular biology techniques, preferable epigenetic and genomic.
- Excellent oral and written English communication skills required.
- Must demonstrate outstanding personal initiative and the ability to work effectively as part of a team.

EOE / Minorities / Females / Protected Veterans / Disabilities

To apply for this position, please CLICK HERE

Primary Duties
The Head of Strategic Sourcing will drive Shire R&D's overall sourcing program and the development of future vision regarding utilization of external vendors to achieve optimal flexibility and cost effectiveness in the development of our pipeline. This individual will partner with the SVP R&D Operations to provide sourcing leadership to the Global R&D team, establish/maintain the strategic direction and ensure cross-functional consistency. Providing the overall strategic 'steer' for R&D sourcing, the Head of Strategic Sourcing will lead a global R&D cross-functional team comprised of members from each of the key functions (Research/Non-clinical, Clinical, Regulatory, Medical Affairs, PVRM, Process Development and R&D QA & Compliance) that will collaborate to manage the sourcing network and ensure that functional activities are aligned.

The Head of Strategic Sourcing will drive the development and maintenance of common processes and standards for sourcing and managing vendors across R&D. This individual will liaise with key cross-functional suppliers to ensure success of the partnerships, report and communicate various aspects of overall vendor performance to SVP R&D Ops and the R&D Leadership Team. Will be effective at interfacing with Procurement to define and implement clear roles and responsibilities in the strategic sourcing and interfacing with vendors.

Responsibilities:
40% Sourcing Strategy
* Set strategic direction for the cross-functional sourcing program
* Work with R&D Leadership Team and business stakeholders to maintain and continuously evolve the strategic sourcing program across the globe for R&D
* Identify and implement additional opportunities to bundle services and maximize value of sourced spend
* Monitor external environment; identify trends / new operating models and evaluate suitability for consideration at Shire

20% Sourcing Team and Organizational Leadership
* Matrix leadership of a cross-functional sourcing team comprised of members from each of the key functions
* Identify sourcing best practices and collaborate with the cross-functional team to ensure practices are applied across R&D
* Direct line management of a small team dedicated to strategic sourcing (2-3 individuals)

25% Vendor Relationship and Performance Management / Functional Relationship Management
* Develop and maintain common standards and processes for managing vendor performance and relationships under different models
* Liaise with key cross-functional suppliers to ensure overall success of the partnerships
* Coordinate and conduct ongoing review meetings with key external partners regarding vendor performance, relationship management and best practices sharing
* Serve as key point of contact for mitigation of any issues/concerns from functional stakeholders and internal customers
* Act as a the senior point of escalation for cross-functional issue resolution
* Report and communicate various aspects of overall vendor performance to SVP R&D Ops and the R&D Leadership Team

15% Member of R&D Operations Leadership Team and Other departmental / R&D initiatives as required
* Serves as a member of the Shire R&D Operations Leadership Team to influence the overall operations, administration and future direction and strategy of Shire R&D Operations
* Leadership and management of additional R&D and Departmental initiatives and projects. For example, R&D space planning oversight and management of the R&D IT Portfolio

Education and Experience Requirements:
* Bachelors Degree required, preferably in a scientific field; MBA or other advanced degree preferred
* Minimum of 7-10 years R&D operations / sourcing / vendor management experience
* Education, experience and documented results in R&D operations and/or sourcing
* Experience in problem solving, negotiations, presentation and collaborative team-building within a matrix required

Other Job Requirements:
* Some travel required, including international travel

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjMzMDI4LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Duties:
Set-up and lead cross-functional R&D early assessment and due diligence Teams to evaluate Business Development opportunities (including M&As, licensing and divestments). Ensure the delivery of high quality assessments within business defined timelines enabling informed business decisions in support of the One Shire strategy. Serve as a member of the R&D Operations leadership team to influence the overall operations, administration and future direction and strategy of Shire R&D Operations.

Responsibilities:
65% Setting-up and leading R&D due diligence and technical assessment teams. Key responsibilities within this are:
* Liaise with R&D functional line heads and Corporate Due Diligence Lead to identify and recruit R&D Due Diligence and Technical Assessment Team members.
* Establish R&D Team and ensure efficient knowledge transfer from Early Assessment.
* Act as primary contact within R&D for Corporate Due Diligence Team and facilitate cross-functional alignment between R&D and other key functions such as Commercial Assessment, Global Supply Chain and CMC.
* Define and communicate R&D Team objectives, project scope and timelines.
* Lead integrated R&D Due Diligence assessment ensuring efficient execution of the R&D due diligence process, co-ordination of activities across R&D and efficient interactions with the Corporate Due Diligence team.
* Develop R&D Team recommendations; ensure the appropriate coordination of, and the preparation and presentation of, assessment outputs to decision making bodies. Outputs should include technical assessment documents and supporting slide decks; integrated development plan; top line risks and opportunities of potential products.
* Ensure RDLT alignment with the R&D Team recommendation and ensure the R&D recommendation is incorporated in all communications for example to Pipeline Committee, STC and Executive Committee.
* Captures lessons learned and drives continuous improvement of the R&D technical assessment process.

20% Setting-up and leading R&D early assessment teams. Key responsibilities within this are:
* Liaise with R&D functional line heads and Business Development lead to identify and recruit R&D early assessment team members.
* Lead integrated R&D early assessment ensuring efficient execution of the R&D early assessment process, co-ordination of activities across R&D and efficient interactions with the Corporate Business Development team by, for example, participating in triage discussions.
* Develop R&D Team recommendation, ensure the appropriate coordination of and the preparation and presentation of assessment outputs to decision making bodies, ensure RDLT alignment with the recommendations, ensure the R&D recommendation is incorporated in all communications for example to Pipeline Committee.

15%Member of R&D Operations Leadership Team and Other departmental / R&D initiatives as required:
* Serves as a member of the Shire R&D Operations Leadership Team to influence the overall operations, administration and future direction and strategy of Shire R&D Operations
* Leadership and management of additional R&D and Departmental initiatives and projects.

Education and Experience Requirements:
* Scientific Degree (M.Sc. or Ph.D.) required
* 12 years plus experience in drug discovery and development (Required)
* MBA or proven business experience (Preferred)

Other Job Requirements:
* International travel likely - occasionally at short notice
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.
Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjU5NTQ5LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Role:
The Business Analyst collaborates with the commercial business teams (sales, marketing, patient services, and associated commercial operations) and other IT teams tanalyze and design innovative solutions that are aligned with long-term strategic plans.

The Business Analyst analyzes the Shire commercial organization's need, assesses and documents its processes and systems, and helps define the business model and its integration with technology. The Business Analyst leverages appropriate cross-functional expertise from the service management group, architecture, business experts and IT leadership to develop accurate cost, resource and time estimates for both initial development and ongoing support for a proposed solution.

The Business Analyst gains and maintains business process knowledge as it pertains to IT applications within the scope of the Shire commercial business. Also to be able to partner and advise the business on IT improvements, options and risks.

The Business Analyst is a key member of the business partnering team, and is a focal point of customer engagement for initiatives as assigned by the head of commercial IT and commercial IT business partners.

Responsibilities:
50 - 70%:
Plan and Build:
* In collaboration with the business and other IT teams, analyze and design innovative solutions that are aligned with commercial IT's long-term strategy
* Document and analyze business inputs, model the business domain (using process diagrams, flowcharts, and data models) and explore behavior models (use case, user experience design, storyboards, wireframes, user profiles and user stories)
* Perform gap analysis, conduct feasibility studies and verify and confirm requirements
* Help commercial stakeholders select the solution that best fits their requirements by using assessment tools, evaluating alternate solutions, determining quality assurance mechanisms, and crafting and assessing an RFP
* Manage issues, risks and requirements; resolve conflicts; gain approval through governance processes and track requirements through to business case approval
* Ensure that applications and systems are in compliance with current and emerging regulations, including but not limited to those defined by cGMP's, FDA regulations (21 CFR Part 11), EMEA regulations (Annex 11), Sarbanes-Oxley and HIPAA

20 - 30%:
Run:
* Provide budgeting and forecasting data for projects transitioning to long term support or enhancements to existing systems and license requirements and projects in association with commercial stakeholders and commercial IT team members
* Provide input and recommendations on system support resource needs

10 - 20%:
Strategic Partnering:
* Work with stakeholders to help them understand their requirements within the scope of a project
* Elicit requirements via brainstorming, analyzing documents, running focus groups, collecting input via surveys and questionnaires, analyzing system interfaces, interviewing stakeholders and subject matter experts, observing real-time activities and work environment, facilitating requirements workshops, or reverse engineering existing systems

Education & Experience Requirements:
* Bachelor's degree in information technology, computer science, engineering, marketing and/or business administration (required)
* More than 3 years relevant IT/business experience, including project scoping, analysis, and documentation of business and technical requirements (required)
* Experience in the Pharmaceuticals or Life Sciences industry (preferred)
* Experience consulting or working in complex, global matrix organization (preferred)
* Experience or certification in ITIL service management framework (preferred)

Key Skills, Abilities, and Competencies:
Shire Leadership Behaviors
* Positive-inspires a passion for growth, challenge and innovation
* Accountable-takes responsibility and fulfills commitments
* Results Driven-generates breakthrough solutions to critical issues
* An Excellent Manager of Self and Others-develops high performance in self, individuals and teams

IT Competencies
* Relationship Management - creates relationships, builds trust and partners with internal and external stakeholders, using a consultative approach to negotiate and confront conflict positively; conveys information in a way that is understood and actionable
* Strategy & Innovation - balances the people, process and technology components that comprise strategic solutions, knowing where technology is going and providing stakeholders with a long-term view while questioning assumptions and imagining future possibilities
* Technical & Digital Literacy - understands technology fundamentals to support cloud computing, social and mobile solutions, data analytics and digital solutions
* Unified Mindset - promotes sharing of information and resources and avoids a silo mentality by taking an overall IT perspective when making decisions

Commercial Technology Skills & Competencies
* Good understanding of how business works and various commercial models in the biotech / life sciences industry
* Knowledge of systems and processes related to several of the following commercial operation applications and systems:
* Customer Relationship Management (Veeva / salesforce.com)
* Master Data Management (Informatica)
* Digital Promotion Platforms (FICO, Epsilon, Exact Target)
* Web content and SEO
* Commercial Data Warehousing
* Commercial Data Analytics (qlikview and business objects)
* Sales Reporting
* Incentive Compensation, Targeting and Alignment, Sales Roster, etc
* Familiar with commercial data sources (IMS for retail, SPP for specialty) and how data is used to run a pharmaceutical business. (preferred)
* Knowledge or background in working with patient services call centers (preferred)
* Project management mindset

Other Job Requirements:
Domestic travel; limited possible international travel.

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.
Application URL:http://www.aplitrak.com/?adid=anN0Z2VvcmdlLjE2NDQyLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Role
* Ensure comprehensive review of all types of bioanalytical documentation, such as protocols, SOPs, test methods, data, and reports, including QC and verification of all references and source data, through collaboration with BBD staff, to achieve the highest quality from technical and compliance perspectives
* Responsible for QC review of BBD documentation in accordance with agency requirements and company standards
* Ensure regular, on-going communication with BBD, Regulatory Submissions, and Compliance colleagues to prioritize review of documentation to meet project timelines
* Responsible for tracking latest regulatory guidance and white papers regarding all bioanalytical assays and facilitate the implementation of these new requirements within BBD by effective communication and gate-keeping the related SOPs, validation and sample analysis reports and other documentation
* Responsible for archival and retrieval of BBD documents including memos, development, validation, and sample analysis reports and maintenance of BBD SharePoint and server sites
* Assist in writing of regulatory submission documents and key scientific publications

Responsibilities
* 40% Review of all regulated study documentation generated by Shire's BBD group, including test methods, forms, SOPs, protocols, assay results and reports to ensure they are in compliance with applicable GLP, CLIA, GCP, FDA and other global regulatory requirements, as appropriate
* 20% Responsible for tracking latest regulatory guidance and white papers regarding all bioanalytical assays and facilitate the implementation of these new requirements within BBD by effective communication and gate-keeping the related SOPs, validation and sample analysis reports and other documentation
* 10% Ensure alignment of Shire internal Compliance/Quality Assurance Units and BBD group as BBD group's primary contact
* 10% Organize, review and archive, as appropriate, other BBD laboratory documentation, such as clinical laboratory solution forms, critical reagent forms, study binders, memos and maintenance of BBD SharePoint and server sites
* 10% Document/categorize frequently occurring QC/QA errors and develop and deliver group training to mitigate future recurrence. Develop basic metrics to assess whether errors are reduced over time
* 10% Assist in writing of regulatory submission documents and key scientific publications

Education & Experience Requirements
* Requires BS/MS or higher in a relevant scientific discipline and 10+ years industry experience in the pharmaceutical/biotech industry and/or CRO. At least 5 years QC or QA experience in a regulated laboratory with sound knowledge of relevant regulatory guidelines (e.g., GLP, CLIA, FDA) addressing bioanalytical and biomarker support for both nonclinical and clinical studies and associated activities.

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.
Application URL:http://www.aplitrak.com/?adid=amVucy41ODI2MS4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ