Our client is seeking a GMP Quality Assurance Associate to perform quality compliance activities in support of commercial drug manufacturing (including secondary packaging and labeling activities).  In this position you will review manufacturing batch records including analytical and microbiological testing, CMO related external deviations and all supporting documentation, ensuring timely disposition of commercial drug product.  In addition you will compile batch record review comments for CMO resolution and trending, as well as enter deviations (Change Controls and CAPAs) into Trackwise.  You will also assist with dispositioning product, reviewing and approving incoming receipt inspection reports and assisting with deviations on temperature excursions during shipment of API and Drug Product.

This position requires a BS degree with a minimum of three years prior experience in a GMP Quality Assurance/Compliance position.  Prior experience with CFR and ICH Guidelines, knowledge of manufacturing techniques and terminology, experience interacting with CMOs, and familiarity with EU GMPs is required.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has five targeted therapeutic oncology candidates in clinical development.

Job Responsibilities:

This position is responsible for GxP (GMP, GCP, GLP, GCLP) supplier quality assurance.  In this role the employee will be responsible for evaluating suppliers, contract test labs, contract manufacturing organizations (CMO), and contract research organizations (CRO), from a quality perspective.  This will include the coordination of supplier self-assessments, assessments of supplier usage conducted internally, as well as coordination and conduct of supplier audits.  This individual will also conduct internal audits.

- Lead the QA team in evaluating GxP suppliers

- Coordination of the send out and reconciliation of supplier self-assessments

- Coordination of internal information regarding the current & future use of Suppliers

- Coordinate & schedule Supplier Audits

- Conduct Compliance audits (Suppliers of GMP and GCP services, Internal System)

- Assist with the management of Quality Systems

- Reassess and revise program SOPs as required

- Assist with the management of supplier quality agreements

Requirements:

- BS degree or higher (preferably in Biology or Chemistry)
- Minimum 5+ years QA GMP experience in the pharmaceutical/ biotechnology industry

- Excellent written and oral communication with exceptional organizational skills

- Demonstrated ability to work in a team environment and manage projects independently

- Direct QA Experience with Supplier Management Programs

- 3+ Years of GMP Supplier Audit Experience

- 3+ Years of supporting GMP Internal Audits     

If you are interested in a great opportunity with a fantastic company, please click the link below to apply!

http://hire.jobvite.com/j/?cj=o6w6Wfwo&s=Mass_Biotech_Council

Job Description

Located in Boston, Dana Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

The Technology Transfer Specialist will play an important role in Dana-Farber Cancer Institute's (DFCI) Office of Research and Technology Ventures (ORTV). ORTV is the technology transfer office of (DFCI) and is responsible for managing and licensing intellectual property and establishing research relationships with industrial partners. The Technology Transfer Specialist will be an active member of the ORTV team and will have daily interactions with DFCI faculty.
Required responsibilities for this position are:
drafting, negotiating and finalizing inbound and outbound academic and non-profit Material Transfer Agreements. Drafting, negotiating and finalizing Confidentiality Agreements. Providing MTA and CDA status updates to ORTV, DFCI investigators and third parties. Manage Federal compliance reporting for DFCI inventions funded by grants from the Federal government and non-profit foundations.
Other responsibilities may include management of new DFCI invention disclosures and efficient and accurate handling and routing of invention disclosures to the appropriate parties for review and entry into the ORTV invention database. Maintaining ORTV's intellectual property and contracts database including all aspects of database management. Providing patent and contract status updates for ORTV, DFCI investigators and third parties.

Job Qualifications
Bachelor's Degree is required with a preferred concentration in biology. Five years of full-time paralegal experience or significant research experience would be a highly desired. Experience in academic research strongly preferred and previous experience with technology transfer activities is a very strong plus. General administrative work experience is required.

Schedule
Full Time, 40 hours weekly
Dana-Farber Cancer Institute is an Affirmation Action/Equal Opportunity Employer - committed to diversity and inclusion in our workforce.

For more information, please contact Gary Sclar, Office of Research and Technology Ventures, gary_sclar@dfci.harvard.edu

Our client is seeking a QC Analyst with experience supporting a bioanalytical lab and hands-on experience in the following molecular biology techniques: DNA and RNA preparation, Southern and Northern Blots, PCR/qPCR. Additional required experience includes SDS-PAGE/IEF/Western Blot, ELISA and HPLC. The ideal candidate must have a BS in chemistry or biochemistry with a minimum of two years related industry experience.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

Position Summary:

Candidate will contribute to the Discovery Pharmaceutics goals by supporting internal drug discovery projects. Candidate will be able to design and execute solubility, stability and preformulation studies and interpret the data generated by these studies. Candidate will also contribute to the physicochemical and solid state characterization of new chemical entities from various discovery projects. Candidate will perform HPLC achiral/chiral method development, LC/MS, and MSn analysis. Responsibility extends to troubleshooting difficult experiments. Candidate will support senior members in the group on project related tasks and novel delivery technology activities.

Minimum Basic Qualifications:

• BS in chemistry or related field
• Knowledge of pharmaceutical science, analytical and organic chemistry
• Employee can understand instructions given to him/her within his/her area of expertise and has the ability to independently solve problems within discipline.
• Employee will be aware of activities relevant to his/her expertise and project(s) that exist outside of the home department.
• Demonstrated ability to write and communicate scientific data effectively
• Ability to work in a chemistry laboratory in compliance with safety regulations

Preferred Qualifications and Experience:

• BS in chemistry or related field plus 3-8 years of related industry experience; MS in Chemistry, Pharmaceutical Sciences or related field plus 2-5 years of related industry experience
• Knowledge of pre-formulation, potency, chemical and formulation stability, and solubility
• Knowledge of solution/solid phase organic synthesis
• Knowledge of Empower and data integration
• Knowledge of SOPs
• Experience with achiral/chiral HPLC method development
• Experience with LC/MS and MSn analysis for structure elucidation and impurity characterization
• Experience with the design and execution of preformulation/formulation stability studies
• Working knowledge of methods and instrumentation associated with analyses of oral and parenteral dosage forms (i.e. DSC, TGA, Dissolution, DVS, XRPD, HPLC, pH, Osmolality)
• Experience/Know-how of technologies for solubility enhancement of poorly soluble candidates for oral and parenteral administration

Competencies:

• Knowledge of computer software necessary for the analysis of scientific data and report writing (i.e. Excel, Slimstat, Microsoft Word, related equipment software)
• Effective communication skills
• Ability to work on multiple projects and meet timelines
• Ability to work independently
• Demonstrates genuine desire and an effectiveness to work co-operatively with others in a team environment
• Results oriented and pays attention to details
• Flexible and open to learning new methods and techniques

Work Environment:

• Laboratory and office
• Exposure to chemicals
• Exposure to noise levels with various laboratory equipment

Physical Demands:

• Light lifting of laboratory equipment and supplies

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Here

Supplier Relationship Excellence Sr. Manager 

 (Single-Use & Disposables Manufacturing) 

• The SRE (Supplier Relationship Excellence) Senior Manager will be responsible to work with key suppliers with a primary objective to improve quality and reliability by reducing variability in our operations utilizing Operational Excellence tools and principles.
• Will act as a Credible Leader, Change Agent, Program Ambassador
• Articulates technical knowledge to be able to understand issues and translate them to the rest of the team and organization
• Articulates vision and identifies strategic objectives partnering with the Executive Sponsor and Supplier
• Will maintain balance between strategic and operational initiatives
• Understands impact of quality and application of materials across the enterprise
• Communicates effectively across the network and with suppliers
• Leverages OpEx tools and resources to institutionalize continuous improvement mindset
• Delivers on objectives
• Ensure communication effectiveness to SRE functional team leads, executive sponsors and supplier
• Lead cross-functional teams with clear accountability for results and ensure the quality, cost, and delivery of products are consistently met, as well as lead issue resolution, problem solving, and serving as an escalation agent.
• Ensure metrics in place to measure, track and communicate the performance of the supplier sites, and lead external or internal operating review meetings.
• Drive continuous improvement at supplier sites by building robust business processes and relationships with suppliers
• Work closely with internal quality, supply chain and process development organizations to ensure supplier sites are monitored and corrective actions are implemented in a timely fashion.
• Execute against deliverables for risk management, operations excellence and other Operations initiatives.
• Domestic and International travel average up to 20%

 Basic Qualifications:

 • Doctorate degree & 2 years of directly related experience OR
• Master’s degree & 6 years of directly related experience OR
• Bachelor’s degree or & 8 years of directly related experience

 Preferred Qualifications:

 • Bachelor's degree in the Life Sciences or Engineering or MBA
• Specific knowledge of flexible manufacturing materials (disposables & single use components)
• 5 + years of experience in manufacturing environment
• 2 + years of experience working with external parties, and/or leading cross-functional teams for clinical and/or commercial products.
• 3 + years in role requiring knowledge of cGMPs, FDA and international regulatory guidelines and validation principles.
• 2 + years of project management experience leading multi-functional and multi-location teams. 

Interested candidates please email resume to smaguire@amgen.com

Infinity is seeking a motivated individual to lead the clinical pharmacology function for its small molecule drug candidates.  He/she will be responsible for all aspects of clinical pharmacology relating to the development of drug candidates and for working with colleagues from clinical and nonclinical disciplines to ensure innovative clinical strategy, model- based drug development, optimal use of all available information, optimal dose selection and delivery of clinical pharmacology studies.  This individual will be an active member of Infinity’s Research and Development Team and responsible for establishing and maintaining strong relationships with nonclinical pharmacology, chemistry, pharmaceutical development, toxicology and clinical development groups to ensure program goals are achieved. 

Responsibilities include:

• Development and execution of the Clinical Pharmacology strategy for a given program(s) from candidate selection through registration.
• Plan, design and oversee clinical pharmacology development plans on assigned programs and represent the function on Product Development Teams.
• Contribute to the planning of studies that generate PK-PD data and lead the integration of analyses involving PK, PD, patient      characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.
• Accountable and responsible for the design, analysis and interpretation of clinical PK and PD data and accountable for ensuring appropriate PK-PD analyses are conducted, including population PK, PK-PD modeling and simulation, throughout all stages of drug development.  
• Lead or participate in clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings, NDA/MAA.  Participate or take a lead role in writing and reviewing clinical pharmacology queries from regulatory agencies.
• Provide clinical pharmacology expertise to Discovery and Pharmaceutical Development as appropriate through collaborating with internal team members to define and generate in vitro and in vivo data to support clinical pharmacology studies. 

Requirements:

• PharmD, PhD or MD/PhD  with 7+ years of industry experience in      an area relevant to clinical pharmacology
• Demonstrated accomplishments in experimental design, regulatory considerations and clinical execution of clinical PK/PD studies
• Strong data analysis skills and an in-depth knowledge of pharmacokinetic and pharmacodynamic principles, including their      application in clinical research and drug development. 
• Comprehensive understanding of clinical regulatory requirements and knowledgeable in ICH and GCP guidelines
• Ability to produce and present quality scientific presentations at internal or external meetings.
• Excellent verbal and written communication and presentation skills
• Demonstrated ability to work effectively in a matrix,  team environment, manage multiple priorities and exercise sound judgment
• Title will be commensurate based on experience

 To apply please visit our website: http://www.infi.com/careers-opportunities.asp

Smart Biotech Solutions specializes in placing candidates in the biotechnology, pharmaceutical and medical device industries. Our pledge is to provide top quality service to our candidates in an honest, efficient, results driven manner.

We have a number of clients looking for permanent employees and professional consultants in and around the Boston area.

We are always interested in speaking with people who are looking to make the next step in their career. Candidates with Clinical and Regulatory experience in biotechnology, pharmaceutical and medical device industries are encouraged to contact a Smart Staffing employee.

Current Roles include:

Consultant Roles:

• Regulatory Strategy CMC
• Manager of Regulatory Affairs
• Regulatory Affairs Associate

Permanent Positions:

• Regulatory Affairs Associate
• Director of Regulatory Affairs

For more information submit a copy of your resume and a Smart Staffing employee will schedule a time to speak with you ASAP.

Constellation Pharmaceuticals is committed to developing cutting edge therapies based on our understanding of how epigenetic mechanisms impact important cellular processes, including transcription, replication and DNA repair in the areas of oncology and inflammation. We are seeking a detail-oriented Research Assistant with a background in tissue cell culture to support drug discovery in a highly collaborative, goal-oriented and fast-moving environment. This position requires excellent time management and communication skills, along with strong customer service skills and a “can-do” attitude.

Responsibilities:

The main responsibility is mammalian cell culture. The Research Assistant will manage and maintain all cells lines to support drug discovery activities in the Biology Department and across the organization. Other responsibilities include maintaining high functioning tissue culture rooms, time sensitive and large volume media preparation, day to day management of equipment and lab consumables related to a busy tissue culture operation. He/she will also assist molecular cloning experiments and protein characterization.

Requirements:

• Bachelor’s Degree in biology or relevant fields with cell culture experience.
• Expertise in mammalian cell culture is required.
• Must have strong communication skills and be capable of working in a broader team providing superior customer service.
• Postgraduate laboratory experience preferred.
• Experience with molecular biology techniques will also be preferred.  JOB CODE - RA-HH 

  Constellation Pharmaceuticals is an Equal Opportunity Employer and a participant in E-Verify, and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.

  If you are interested in joining Constellation’s team please submit your resume to the following address: careers@constellationpharma.com

Smart Biotech Solutions specializes in placing candidates in the biotechnology, pharmaceutical and medical device industries. Our pledge is to provide top quality service to our candidates in an honest, efficient, results driven manner.

We have a number of clients looking for permanent employees and professional consultants in and around the Boston area.

• We have an immediate need for a Packaging Engineer / Project manager at one of Medical Device clients. This position will consist of writing and data analysis, but no “hands on engineering”  as the process will be mostly out sourced. The appropriate candidate must have the technical knowledge to understand the process and previous experience managing the actual process with CMOs

• Candidate will be responsible for managing all aspects of design, development, testing and validation of packages and packaging systems for the Company's medical device products. Responsible for packaging equipment selection, procurement, buy-off, installation, troubleshooting and qualification.

• Knowledge of Packaging - packaging costs, distribution environment, sterile delivery techniques, Design of Experiments (DOE), and Failure Mode Effects Analysis (FMEA)

•  Must be able to travel up to 10% of the time; both domestic and International travel may be required. Typical work related travel assignments range 2-5 days, and as such overnight, out-of-town stays are required

For more information submit a copy of your resume and a Smart Biotech Solutions employee will schedule a time to speak with you ASAP.

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. Job Description

Summary

ARIAD Pharmaceuticals Inc. is seeking an independent and highly motivated associate scientist with a strong background in tissue culture, molecular biology and protein biochemistry to join our small molecule oncology drug discovery team.  The successful candidate will play an important role in expanding ARIAD’s capability and platform in structural chemistry and structure-based drug design and will join an interdisciplinary research group encompassing biophysical chemistry, structural chemistry (X-ray and NMR), computational chemistry and cheminformatics to support our internal drug discovery efforts.

Duties and Responsibilities

• Protein expression and production in baculovirus, mammalian and bacterial cells
• Make protein expression constructs in various protein expressing systems
• Purify and characterize protein in sufficient quantities for structural and biophysical studies
• 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

• Strong commitment to business ethics

Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners 

Experience and Requirement

• B. S. or M.S. degree in life science related fields
• At least two years of lab experience
• Experience in cellular culture of bacteria, insect and mammalian cells
• Experience in molecular cloning
• Experience in protein purification and characterization
• Good communication and teamwork skills
• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners

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

How to apply:

http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=245&company_id=16419&jobboardid=306

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. Job Description

Summary

This position will report to the Director of Global Medical Communications within the Global Medical Affairs department at ARIAD pharmaceuticals Inc. This is a strategic position supporting internal and external ARIAD customers. The individual will primarily be responsible for preparation and accuracy review of content for ARIAD’s proprietary compounds for internal and external audiences. Prior experience in Medical Communications is essential; oncology experience is preferred.

Responsibilities

• Oversee and manage all aspects of content management for Global Medical Communications, including budget planning and forecasting, vendor relations, and projects
• Preparation of content for Global Medical Communications projects including, but not limited to, advisory boards, steering committee and investigator meetings, field resource tools and training materials
• Preparation and review of content for other Medical Affairs departments including Medical Science Liaisons (MSLs), Medical Information, Outreach and Advocacy, and Health Economics and Outcomes Research (examples include slide decks, dossiers, and training materials)
• Serve as the medical reviewer on cross-functional teams to ensure the medical accuracy and approve the content of marketing and promotional materials, as well as scientific publications and MSL materials
• Maintain and update the scientific platforms for ARIAD proprietary compounds
• Provide strategic oversight and direction for ARIAD Knowledge Services, which incorporates the eLibrary, including regular review of processes and technology to promote sharing of information across the organization
• Critically evaluate the published medical and scientific literature related to ARIAD products and competitive products
• Provide regular updates on the competitive landscape and robust literature searches for medical affairs colleagues, as well as Clinical Research and Development departments such as safety, clinical and medical
• Oversee the distribution of literature search notification alerts to internal stakeholders, including communication of real-time news on publications relevant to ARIAD’s proprietary compounds
• Represent Global Medical Affairs at congresses and major meetings, as required
• Manage other Medical Communications personnel, as needed
• Assist the Director of Medical Communications with managing resources and priorities within and across the department, which includes publications, medical information, MSL training and content management
• Ensure compliance with all applicable laws, regulations and guidelines
• Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Requirements

• Advanced degree (PhD or PharmD) in a scientific discipline or equivalent
• 5 years or more of direct pharmaceutical industry experience in Medical Communications and Medical Affairs is essential
• Oncology experience strongly preferred
• Excellent ability to interpret and present medical, scientific and clinical trial data
• Experience with literature management applications that integrate with scientific/medical bibliographic databases and a literature document repository (eg, QUOSA) preferred
• Proficiency with standard software including Microsoft Office, PubMed, EMBASE, Endnote
• Excellent attention to detail and problem solving skills
• Initiative and ability to manage multiple assignments and maintain high level of productivity with minimal supervision
• Excellent interpersonal, verbal, and written communication skills
• Willingness and ability to travel
• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with health care professionals (HCPs), payers, advocacy and other business partners
• Understanding of, and experience with, regulatory framework applicable to interactions with 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=250&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.

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. Job Description

Summary

Experienced toxicologist to serve as the corporate scientific and strategic expert in the design, implementation and interpretation of nonclinical safety assessment studies that meet worldwide regulatory expectations and requirements supporting global clinical development and commercialization of novel small molecule oncology drugs. This position is also responsible forpreparing toxicology-related documents for internal or potential collaborator information and for global regulatory submissions as well as interacting with global regulatory agents on matters related to nonclinical safety assessment.

Duties and Responsibilities

• Designs, implements and interprets nonclinical safety assessment programs for new chemical entities that meet world-wide regulatory requirements that support the initiation of clinical development programs through the license application/marketing approval phase.
• Monitors outsourced studies, provides input to draft study reports and approves study reports prior to finalization by the Test Facility.
• Prepares nonclinical safety sections (safety pharmacology, general toxicology, reproduction toxicology, genetic toxicology, special toxicology) in regulatory documents: INDs, IMPDs, CTD, NDA
• Actively participates in a cross functional program team environment to meet corporate objectives related to bringing new chemical entities to the clinic and market.
• Interacts with global regulatory agencies, as necessary, to clarify, reconcile or rectify any raised nonclinical safety assessment questions or concerns related to submitted documents.
• Interacts with potential outside collaborators on topics of nonclinical safety assessment.
• Serves as company’s internal “subject matter expert” in the area of nonclinical safety assessment. Provides guidance in the design of in- house non clinical toxicology studies.
• Recommends and supports the setting of first-in-human dose regimens and toxicologic scientific rationales for clinical protocols.
• Works closely with the drug metabolism department in areas of joint interest, e.g,  Pharmacokinetics  in toxicological species, exposure of drug and metabolites in preclinical species.
• 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.

Requirements

• Ph.D in Toxicology, Pharmacology, Pathology or other relevant scientific area.
• Minimum of 10 - 12 years of experience with a pharmaceutical company in the design, planning, conduct, monitoring and reporting for a broad range of nonclinical safety assessment studies.
• Direct experience interacting with regulatory agencies regarding topics related to nonclinical safety assessment of new drug products.
• Demonstrated expertise in safety assessment of small molecule oncology drugs desirable.
• Familiarity with GLP regulations and regulatory guidelines for the nonclinical safety testing of pharmaceutical/biopharmaceutical products.
• Demonstrated expertise in compilation and integration of nonclinical drug safety information into various regulatory submission documents.
• Board Certification in Toxicology desirable but not required.
• Excellent written and oral communication skills required.
• Demonstrated management and leadership skills
• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with 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=213&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.

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. Job Description

Summary

The Manager/Senior Manager, Medical Communications will be responsible for Knowledge Services, which involves development and provision of library and scientific/medical information services in support of ARIAD’s proprietary compounds.  This is a strategic service oriented position supporting internal customers across the ARIAD organization.  Core responsibilities include overseeing an integrated process for company-wide access to medical/scientific literature, managing corporate subscriptions to journals and other content sources, searching literature databases, acquiring articles and maintaining a searchable, copyright compliant electronic central repository of publications (eLibrary) that is readily accessible to ARIAD personnel.  Additional responsibilities include maintaining a reference manager database and providing training to ARIAD personnel as appropriate, as well as communication of real-time news content relevant to ARIAD’s proprietary compounds.  Prior experience providing library and information services within the biotechnology or pharmaceutical sector is essential; oncology experience is preferred.

Responsibilities

• Oversee and manage all aspects of Knowledge Services including budget planning and forecasting, vendor relations, and projects
• Maintain and expand the existing eLibrary of scientific articles and conference material, including implementing a new platform (eg, QUOSA)
• Create, maintain, and refine an integrated workflow connecting ARIAD end-users to the medical/scientific literature
• Create and maintain the department’s reference manager (Endnote)
• Assess, maintain and manage corporate journal subscriptions. Make decisions/recommendations on spending in this area.
• Conduct literature research, including critical evaluation of the published medical and scientific literature related to ARIAD products and competitive products
• Create and distribute literature search notification alerts to internal stakeholders, including communication of real-time news on publications relevant to ARIAD’s proprietary compounds
• Manage annual business licenses, oversee copyright permissions, and promote a culture of copyright compliance
• Conduct ongoing outreach to other functional groups to determine needs for additional knowledge services and to promote the sharing of information across the organization
• Research, assess and implement new technologies in collaboration with Information Services to develop and promote a knowledge culture within the company, as appropriate
• Market services and resources, and provide training to ARIAD employees on the eLibrary and Endnote, as appropriate
• Promote a knowledge culture within the company where information is shared across the organization
• Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization
• 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

• 3 to 5 years of experience delivering integrated information support in an academic or life science organization (industry preferred)
• Undergraduate degree in a health science discipline is required
• Masters of Library Science (MLS) from an ALA-accredited library school or equivalent experience preferred
• Experience with literature management applications that integrate with scientific/medical bibliographic databases and a literature document repository (eg, QUOSA) preferred
• Familiarity with a variety of Library/Health Science Services concepts, practices, and procedures within the pharmaceutical industry
• Knowledge of the sources, services and tools essential to provision of scientific, clinical, and industry information and intelligence
• Proficiency with standard software including Microsoft Office, PubMed, EMBASE, Endnote
• Strong service orientation and demonstrated ability to solve customers’ problems and improve processes
• Experience with maintaining electronic subscriptions (individual periodicals and aggregated content services)
• Able to perform a variety of tasks within a team environment, relying on extensive experience and independent judgment to plan and accomplish goals
• Self-motivated and reliable, with ability to follow and establish processes and where a wide degree of creativity and latitude is expected
• Excellent interpersonal, verbal, and written communication skills
• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with 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=251&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.

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. Job Description

Position Overview

ARIAD Pharmaceuticals, Inc. is a growing biotech company exploring targeted therapies for cancer. The Company seeks a Medical Director – Oncology who is highly motivated and who desires an opportunity to make key contributions to the medical research department.  The responsibilities include the following. The carrying out of the job responsibilities below may entail focus on a subset of this description at any point in time.

• Close interaction with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration.
• Program development, including working cross-functionally with all of the disciplines necessary for successful drug development:  manufacturing, quality assurance, regulatory, marketing, legal, biostatistics and data management, and clinical operations.
• Protocol development, including writing protocols, reviewing them, writing or editing informed consent forms, and working closely with data management in constructing CRF and supporting materials.
• Directing protocol implementation, including site identification and communication, attendance at investigators meetings, correspondence with sites including IRBs, and interaction with operations teams.
• Clinical trial monitoring, including the oversight of all aspects of trial conduct and safety, contact with patients, with investigators, and with site and study staff.
• Support of data analysis and assembly, including clinical study report writing, and to contribute to the preparation of abstracts, presentations, and manuscripts.
• Marketing support, through the communication of medical issues to the commercial group, and by helping to formulate medical opportunities for the marketing team.
• Close interaction with the regulatory department, taking part in IND submissions, IB authorship and updating, and communication with US and international regulatory agencies.
• 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.

In summary, responsibilities center on the ability to provide medical expertise to the entire team in a variety of settings ranging from the preparation of and editing of documents to offering strategic guidance in the matter of trial choice and design. Reports to Vice President, Clinical Research and Development.

Position Requirements :

• Effective oral and written communication skills are required, as are excellent interpersonal skills with demonstrated ability to work with a team.
• Demonstrated independence, initiative and the ability to thrive in a fast-paced environment.
• Travel time is approximately 10% including visits to investigative sites and attendance at major oncology meetings.
• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

Position Qualifications:

• MD or MD/PhD with subspecialty training in oncology or hematology.
• Previous industry experience is preferred; outstanding academic achievement in a related field will be considered.

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=238&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.

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. Job Description

Summary:

This position will be responsible for providing data management expertise while working within Electronic Data Capture (EDC) environment for ongoing clinical trials. The successful candidate will also provide support in protocol review, form design and specifications for newly conceived trials working in EDC. The ideal candidate will have experience reviewing data for oncology clinical trials.

Duties and Responsibilities:

Lead DM for assigned projects:

• Serve as DM representative at study team meetings
• Manage assigned study timelines and ensure timelines are met

Mentor junior members of clinical data management team

Provide data management support for ongoing EDC trial:

• Review of electronic case report forms (eCRFs) for completeness, content and database considerations

• Generate queries based on manual review specifications
• Perform data review for quality issues and general data trends
• Perform reconciliation activities using data from external vendors
• Manage new user account access process in EDC environment
• Understand/follow and create Data Management Plans (DMP)
• Generate metric reports to track and report data status

Participate in data management activities in support of new clinical trials:

• Provide input into study protocols from a data management perspective
• Participate in eCRF and database design
• Define edit check specifications
• Develop UAT test plans and participate in user acceptance testing (UAT)

• Develop trial specific guidelines as specified (DMP, eCCGs)
• Understand and follow SOPs

• 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.

Experiences Desired:

• B.S. (or equivalent degree) and 4 years of relevant work experience in clinical data management in the pharmaceutical/biotechnology industry
• Knowledge of global standards related to data management activities (CRF design, database design and standards)
• Knowledge of related regulations, GCP and Good Clinical Data Management Practices
• Knowledge of medical terminology with expertise in oncology preferred
• Knowledge of coding dictionaries (MedDRA, WHO drug)
• Excellent written, verbal and organizational skills
• Must be detail oriented and have strong prioritization skills
• Ability to handle multiple projects and stressful situations
• 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.

Technical Skills:

• Knowledge of Electronic Data Capture (EDC-related tools and processes) preferably Medidata’s Rave.
• Data Management systems
• Proficient Computer Skills including MS office products
• Knowledge of database design and database concepts

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=253&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.

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. Job Description

Key Responsibilities

• Perform clinical assessment of SAE cases reported from clinical trials; perform Sponsor causality assessment; determine regulatory reportability
• Work closely with Drug Safety and PVG staff in the proper gathering, evaluation, medical assessment and follow-up of individual case safety reports
• Identify and analyze possible trends and concerns with company products including the identification and evaluation of safety signals through the assessment of single case safety reports, aggregate trend analyses and review of relevant literature for safety information pertinent to product safety
• Perform review of adverse event, medical history and concomitant medication coding into WHO-Drug and MedDRA codes
• Prepare/review aggregate safety reports for submission to domestic and international regulatory authorities
• Contribute to and support development of evolving risk management plans
• Prepare and maintain summary analyses of safety data on key events from all available sources including the literature
• Accurately identify safety issues that require further evaluation and
• Effectively collaborate with interdisciplinary team in the evaluation and management of safety issues during clinical development
• Contribute to and support safety sections clinical investigator brochures, risk profiles, protocols, and regulatory reports (e.g. Annual IND report; 6-monthly line-listings; EU Annual Safety Report)
• 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:

• Medical physician with a minimum of 2 years experience in the pharmaceutical, biotech, or contract research organization in Pharmacovigilance & Drug Safety or Pharmacoepidemiology.
• Minimum of 1 year clinical experience in academic or private practice including hospital based setting.
• Advanced knowledge in pre and post-marketing, US and international, safety regulations
• Ability to formulate and lead and investigative plan as well as develop sound risk assessment
• Advanced ability to analyze and interpret clinical data
• Strong analytical skills
• Ability to influence others (cross-functionally and within the function) to create a positive working environment
• Ability to work under pressure and dependably deliver high quality results in a timely manner
• Experience in developing, executing RiskMaps/ Risk Management Plans
• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with 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=244&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.

PLEASE CLICK HERE TO APPLY:

https://home.eease.adp.com/recruit/?id=3881411

Position Summary 

This position will involve training and work in every aspect of the Finish Operations (Inspection/Labeling/Packaging) department including: Inspection, Labeling, and Packaging of pharmaceutical products under the guidance of an Inspection/Labeling/Packaging Lead Technician, and/or Supervisor. Perform simple manufacturing tasks. Familiarity with, and the ability to follow established Standard Operating Procedures (SOPs), Master Batch Records, and adhere consistently to current Good Manufacturing Practices (cGMPs). Follow all Pharmalucence policies relating to job safety. Must be able to function independently. Operate, trouble shoot, and maintain manufacturing equipment. Maintain manufacturing records.

Position Responsibilities 

• Capable of independently performing Visual Inspection, Labeling, and Packaging of liquids, suspensions, and lyophilized pharmaceutical products in vials
• Ability to visually inspect small print/printed labels
• Labeling and package assembly operations: set-up, clean-up
• Data entry of batch documentation
• Perform and Oversee accountability and inventory transactions
• Complies with all safety-related procedures and practices, personally and in area
• Complete all necessary paperwork to conform to Federal Regulations and FDA
• Required to report variance or deviation from standard procedures to department management
• Manage stock materials consumed by the department
• Control area appearances 

Education and Experience Required 

• A biotechnology certificate and 1-3 years of pharmaceutical manufacturing in a cGMP/FDA regulated environment;
• Or a high school diploma or equivalent and 2-8 years of pharmaceutical manufacturing in a cGMP/FDA regulated environment

 Skills/Special License(s) Required 

• Good math skills
• Read, write and follow written and verbal instructions/procedures in English
• Ability to work independently or in a group setting
• Current Good Manufacturing Practices training

PLEASE CLICK HERE TO APPLY:

https://home.eease.adp.com/recruit/?id=3881411

• Are you ready to be an integral GCP leader in getting not just one but severalbreak-through, “game changing” drugs approved within the next few years?
• Do you want to work for a pharmaceutical company ranked as one of the best places to work in the entire US?
• Do you like the idea of working with some of the most passionate people in the biopharma industry…the best and brightest?
• If so...you owe it to yourself to read on then give us a call!  No excuses…THIS IS YOUR TIME TO SHINE!  Our client is ready to do what it takes to recruit and hire the best people for their programs.  Comprehensive relocation provided plus a terrific compensation & benefits package!

We seek an extraordinary Associate Director of GCP Quality to join a remarkably strong Quality Compliance Management organization in the Boston area. In this high profile position, the qualified candidate will be leading a professional Quality Assurance team to oversee external and internal clinical programs in accordance to Good Clinical Practices GCP, FDA regulations and industry standards.  Additionally, this leader will personally guide an internal team, managing and tracking a multitude of GCP related projects in accordance with specific timelines.  

Top Line Responsibilities:

• Develop, implement and manage a wide variety of resources from staffing and budgeting related to the GCP Quality Compliance efforts.
• Expert knowledge relating to the principles and application of quality and regulatory compliance associated to GCP regulated initiatives. 
• Organizing and inspire internal teams towards group goals and programs, while fostering team harmony.
• Use especially strong communication skills across all levels of the organization with the aptitude to manage, listen and form consensus on important decisions.
• Leverage your past GCP experiences/work history to positively managing projects/teams of noteworthy scope and challenge, (while achieving deadlines in a high quality fashion).
• Actively aware and ‘up to speed’ on the latest GCP Quality systems and system management within biopharma (IE GCP trends, standards and methodologies) – pass knowledge on to team and others within the organization.
• Cohesively partner with related management teams and internal groups to design team and group goals and timelines.
• Using strong presentation attributes be comfortable speaking and presenting imperative information to all levels of a company in a logical and open minded fashion; ranging junior level scientists to executive team.
• Develop, implement and manage a variety of systems to monitor global GCP standard operating procedures, methods and practices.
• Create and implement programs that ensure service providers, procedures, internal personnel, facilities, are consistently ready to meet regulatory requirements. 

Education & Experience & Personal Attributes

• BS or MS in a corresponding scientific field related to GCP Quality Compliance efforts
• 7 – 10 years of industry experience in focused GCP effort(s) including significant time within a GCP role where Quality Management was a primary focus/key deliverable (including people management)
• Based upon extensive past experiences in GCP Quality, proactively provide advice, viewpoints and feedback across internal departments associated with quality initiatives. 
• Proven to be astute in developing, overseeing, reporting and critiquing important GCP external service partners, internal GCP quality systems and programs, GCP elements related to regulatory inspections, all responsibilities associated with internal QA unit in cooperation with other internal departments sharing in corporate quality initiatives.  You drive excellence.
• Excellent organizational and reporting abilities related to GCP deliverables (ie compliance metrics, budgeting, personnel management)
• Hire, train and develop internal team to optimal performance with excellent interpersonal skills to work across organizations, advancing the objectives of the quality compliance organization and GCP related matters.
• Ability and interest to travel through the US and internationally up to 20%

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

• Are you ready to be an integral GLP leader in getting not just one but several break-through,“game changing” drugs approved within the next few years?
• Do you want to work for a pharmaceutical company ranked as one of the best places to work in the entire US?
• Do you like the idea working along side some of the most passionate people in the biopharma industry…the best and brightest?

If so...you owe it to yourself to read on then give us a call!  No excuses…THIS IS YOUR TIME TO SHINE! Our client is ready to do what it takes to recruit and hire the best people for their programs. Comprehensive relocation provided plus a terrific compensation & benefits package!

We seek an extraordinary Associate Director of GLP Quality to join a remarkably strong Quality Compliance Management organization in the Boston area. In this high profile position, the qualified candidate will lead a team of Quality Assurance organization chartered with the oversight of non-clinical and clinical GLP initiatives in accordance with FDA regulations and standards. This GLP leader is charged with developing and managing the strategic alignment of team objectives, programs and activities while actively seeking to improve improving existing projects.  In addition, the AD of GLP Quality oversees and develops the professional and technical development of internal team members, driving excellence in terms of GLP QLP quality programs in accordance to management expectations and time lines.

Top Line Responsibilities:

• Plan, modify, manage, report and improve all facets of GLP related goals and programs to meet and/or exceed corporate objectives.
• Effectively lead groups both within the GLP team and those that are cross functional with the goal of fostering team harmony whilst ensuring GLP related matters are consistently followed at all levels inside the corporation and with external partners.
• Communicate and listen to a wide variety of interested parties – seeking consensus that drives positive GLP outcomes.
• An exceptional leader with demonstrated skills and experience in managing teams and programs that are complex and of high value while proactively reporting on project statuses and meeting established deadlines.
• Actively keeping up to speed with GLP related industry trends, methods and standards with personal initiatives to ensure other team members also made aware of pertinent changes/matters.
• Partner with internal thought leaders to establish, drive and manage team goals and individual team member goals/responsibilities.
• Highly effective ability and experience hiring, mentoring and setting goals for team – motivating each towards excellence as it relates to GLP efforts.
• Clear, thoughtful and conscience verbal presentation abilities specifically related to GLP quality programs and initiatives within a group setting (Executive and team meetings).

Education & Experience & Personal Attributes

• BS or MS in a corresponding scientific degree related to GLP Quality Compliance efforts.
• 5 – 8 years of industry experience within a GLP focused position, including 3 years managing people.
• Create, organize, and supervise/manage GLP quality programs supporting programs initiated, designed or managed by our client.  Specifically focused on qualifying and holding accountable GLP Service Providers and conducting the various jobs demanded of an internal Quality Assurance Unit. 
• Partner and work cross functionally with various internal groups/departments supporting corporate strategy relating to GLP standard quality principles and FDA regulations.
• Based upon your expert opinion, actively offer GLP Quality insight and knowledge to internal departments.
• Develop, report and improve existing compliance metrics corresponding with GLP initiatives/programs.
• Interest and ability to travel up to 10% travel.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.