Ironwood’s dynamic Drug Safety and Pharmacovigilance (DS PV) team is looking for an experienced Manager of PV Operations (Mgr PVOps). This new team member will play a key role in optimizing drug safety operations across various PV areas: clinical development, non-interventional studies and post-approval drug surveillance. Ironwood DS PV works with CROs and global business partners which makes for diverse and complex PV environment

The Mgr PV Ops ensures that drug safety operations in clinical development programs, and post marketing are aligned with DS PV policies and procedures, agreements and conventions. The Mgr. PVOps ensures that the Ironwood PV procedures meet best industry standards of efficiency and compliance. The Mgr. PVOps oversees exchange of safety data between functional groups within IRWD as well as between IRWD and its Partners. The Mgr. PVOps is responsible for providing training to all Ironwood representatives on their safety reporting responsibilities.

The PVOps reports to the head of Drug Safety Operations and Systems.

Responsiblites:

• Take part in the daily management of the DS&PV function
• Monitor compliance  with regulations, PV agreements and internal SOPs
• Ensure seamless and compliant Safety Data Exchange with all IRWD PV Partners and third parties
• Ensure adequate AE collection in all clinical development and post approval medical research
• Oversee or execute quality Adverse Event processes in house
• Represent DS& PV in selected IRWD clinical development or medical research project teams
• Develop and organize AE reporting training for all IRWD representatives.

Requirements:

• BS in a Life Science degree and/or clinical degree (Pharm. D., RN, RPh.) required
• Minimum 5 years of hands on experience in Pharmacovigilance operations
• Strong quality focus, with a good understanding of quality systems
• Be familiar with AE database systems (preferably Argus)
• Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines;
• Experience in SAE case management and development of case queries;
• Excellent communicator, both oral and written. Thrive in teams.
• Good medical writing skills
• Be proactive and use a risk based approach in complex processes

Position Title: Scientist I

Placement Type: Long Term Contract

Job Description

• Conduct in-vitro radiolabeled metabolism studies to understand the biotransformation routes and enzymatic pathways (mapping and phenotyping) for discovery and development candidates.
• Conduct in vitro studies to determine the metabolic stability and intrinsic clearance of discovery and development candidates.
• Conduct pre-clinical ADME studies to develop IVIVC with regards to metabolism and to understand the excretion routes and clearance pathways.
• Provide assistance for clinical ADME studies to understand the excretion routes and clearance pathways/mechanisms in humans.
• LC-β-RAM and LC/MS/MS method development for metabolite profiling, identification, and structure elucidation.
• Manage CROs for outsourced ADME related studies.
o Design study protocols
o Review data and assess need for additional experiments/analysis
o Finalize reports
• Write ADME reports in support of IND/NDA submission.
• Hot lab maintenance

Qualifications for Job (Knowledge, Skills, Abilities, Effectiveness, Collaboration and Leadership):
Strong knowledge of metabolic pathways and enzymology. Experience in ADME study design and conduct. Experience with developing LC/MS/MS methods for metabolite profiling, identification and structure elucidation. Experience with triple quadrupole/linear ion traps from ABSciex or similar mass spectrometers. Experience with writing supporting ADME reports for regulatory submission. Ability to work independently. Excellent written and oral communication skills. Fundamental knowledge of regulatory submissions guidelines a plus.

Requirements for Job (Years of experience, Education, Certifications):
Ph.D. in Analytical Chemistry, Pharmacology and/or Biotransformation with 1-2 years of hands-on experience with metabolite profiling and identification using LC/MS/MS techniques recommended. MS candidate with a minimum of 5 years of experience may be considered. A team player with excellent communication skills. Proven ability to work independently and effectively handle multiple projects.

JOB DESCRIPTION:

Within GL Operations the manager:
• Tracks compliance with Global Labeling processes, eg, implementation of CCDS information into product labeling, compiles metrics, prepares reports, and defines escalation needed
• Provides IT Systems Support for Global Labeling activities associated with Mosaic, PRISM, EAMS, EQMS and others, as requested.
• Manages Global Labeling Continuous Improvement and Monitoring activities such as QMS document authoring, review, and management, GL Training, preparation and support of reports for the Pharmacovigilance System Master File (PSMF), performs and provides auditing and support functions such as writing and tracking CAPAs
• Manages the Labeling Agreements archive, authors new agreements when needed in collaboration with the Global Labeling Lead, tracks and monitors compliance to Labeling Agreements, reviews Pharmacovigilance Agreements as requested.
• Provides operational support to Global Labeling activities

ACCOUNTABILITIES:
• Plan, evaluate, and improve the efficiency of business processes and procedures to enhance speed, quality and output.
• Ensure adequate and accurate QMS and supporting process documents to support GL activities; design and conduct necessary training.
• Review performance data and manage the preparation and maintenance of reports necessary to carry out the functions of the group, including measuring productivity. Prepare periodic reports for management to track strategic goal accomplishment.
• Oversee the documentation of LOC implementation of local labeling changes based on CCDS updates and support in the assessment of LOC implementation.
• Management of the GL Mailbox and GL Sharepoint Sites to ensure accurate recordkeeping in alignment with the Takeda records retention policy and to ensure availability of GL intelligence to stakeholders both within and outside of GL.
• Business owner for GL IT systems, as needed. GL representative on IT project teams to ensure IT support for GL processes.
• Perform other duties and responsibilities, as assigned.


EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• BS/BA degree preferred in a scientific or technical field, including Computer and IT.
• Experience with implementing IT programs and systems desired
• Demonstrated problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions.
• Excellent oral and written communication skills.
• Demonstrated project management, negotiation, and interpersonal skills.
• Ability to work in a team environment but can function equally well independently.

TRAVEL REQUIREMENTS:
• Willingness to travel to various meetings, including overnight trips. Some international travel may be required.
• Requires up to 10 % travel.

BASIC SUMMARY:  An entry-technical level with the expectations of supervised functionality, demonstrating a comfortable level of technical skills in the Veterinary Services Department.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Handle and restrain multiple species of animals, perform and record daily clinical observations, perform anesthetic management, pre and post-operative nursing care, perform dose administration and sample collection.
• Generate and manage data in compliance with GLP guidelines, document deviations and incidents with supervision, submit data in a timely manner.
• Perform data collection and quality control on assigned studies.
• Must have effective oral and written communication skills and work effectively as a team member.
• Perform other related duties as required.

QUALIFICATIONS:

Education: High school or GED required.  Associates (AS) or Bachelor’s degree (BS) in science preferred.

Experience: Experience in a regulatory, pre-clinical environment with involvement in the conduct of GLP studies is preferred.

 Certification/Licensure: Driver’s license; ALAT preferred.

PHYSICAL DEMANDS:  

• Must be able to perform laboratory procedures, which require talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with  hands and arms, working in narrow spaces, and wearing safety equipment (Personal Protective Equipment) according to OSHA regulations and company standards.
• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
• Ability to consistently lift and move at least 50 pounds.

WORK ENVIRONMENT:

• Animal facility and laboratories with moderate noise possible.
• Exposure to potential zoonotic agents, hazardous/noxious devices (e.g., needles, scalpel blades, etc.), chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc.) and/or radiation.
• Office working environment with quiet noise conditions.

COMMENTS:
• This position may require occasional domestic travel or performing duties on weekends and/or holidays. 

BASIC SUMMARY:  A mid-technical level with the expectations of semi-independent functionality, demonstrating a comfortable level of technical skills in the Veterinary Services Department. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Handle and restrain multiple species of animals, perform and record daily clinical observations, perform anesthetic management, pre and post-operative nursing care, perform dose administration and sample collection.
  • Generate quality data in compliance with GLP guidelines, document deviations and incidents with supervision, submit data in a timely manner.
  • Perform data collection and quality control on assigned studies in addition to maintaining study books, ensuring proper documentation, coordination of sample collection and processing, and test article control.
  • Train and assist junior technicians performing the above tasks.
  • Must have effective oral and written communication skills and work effectively as a team member.
  • Perform other related duties as required.

QUALIFICATIONS:

Education: High school or GED required.  Bachelor’s degree (BS) in science preferred.

Experience: Minimum of one year experience in a regulatory pre-clinical environment with involvement in the conduct of GLP studies.

• Exceptional experience in related preclinical and/or advanced education could substitute

 Certification/Licensure: Driver’s license; ALAT and/or LAT preferred.

PHYSICAL DEMANDS:  

• Must be able to perform laboratory procedures, which require talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with  hands and arms, working in narrow spaces, and wearing safety equipment (Personal Protective Equipment) according to OSHA regulations and company standards.
• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
• Ability to consistently lift and move at least 50 pounds.

WORK ENVIRONMENT:

• Animal facility and laboratories with moderate noise possible.
• Exposure to potential zoonotic agents, hazardous/noxious devices (e.g., needles, scalpel blades, etc.), chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc.) and/or radiation.
• Office working environment with quiet noise conditions.

COMMENTS:
• This position may require occasional domestic travel or performing duties on weekends and/or holidays.

BASIC SUMMARY:  A senior technical level with the expectations of independent functionality, mentor/trainer/leadership capabilities demonstrating superior technical skills in the Veterinary Services Department.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Handle and restrain multiple species of animals, perform and record daily clinical observations, perform anesthetic management, pre and post-operative nursing care, perform dose administration and sample collection.
• Routinely assist Surgeon and/or Interventionalist during technical procedures.
  • Generate quality data in compliance with GLP guidelines, document deviations and incidents with supervision, submit data in a timely manner.
  • Perform data collection and quality control on assigned studies in addition to maintaining study books, ensuring proper documentation, coordination of sample collection and processing, and test article control.
  • Mentor peers and provide training to junior technicians performing the above tasks.
  • Must have effective oral and written communication skills and work effectively as a team member.
  • Assist supervisor, as needed, with study scheduling and/or equipment maintenance.
  • Perform other related duties as required.

QUALIFICATIONS:

Education: High school or GED required.  Bachelor’s degree (BS) in science preferred.

Experience: Minimum three years experience in a regulatory pre-clinical environment with involvement in the conduct of GLP studies.

• Exceptional experience in related preclinical and/or advanced education could substitute.

 Certification/Licensure: Driver’s license; LAT/LATG preferred.

PHYSICAL DEMANDS:  

• Must be able to perform laboratory procedures, which require talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with  hands and arms, working in narrow spaces, and wearing safety equipment (Personal Protective Equipment) according to OSHA regulations and company standards.
• Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.
• Ability to consistently lift and move at least 50 pounds.

WORK ENVIRONMENT:

• Animal facility and laboratories with moderate noise possible.
• Exposure to potential zoonotic agents, hazardous/noxious devices (e.g., needles, scalpel blades, etc.), chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc.) and/or radiation.
• Office working environment with quiet noise conditions.

COMMENTS:
• This position may require occasional domestic travel or performing duties on weekends and/or holidays. 

Are you waiting to find just the right opportunity to fit your advanced logistics and manufacturing supply skills?  Our client, a clinical-stage biopharmaceutical company revolutionizing cancer treatment, is looking for an organized, detail-oriented, and multitasking individual to have an impact in their Manufacturing Supply side of the business from discovery through cGMP.  You must also be able to identify suitable vendors, establish procedures and specifications, prepare and negotiate agreements and work cross functionally across the company to streamline purchasing of materials and equipment. 

Qualifications/background

• BS or advanced degree in chemistry, biology, engineering, or related field.
• 10+ years of experience in biotech/pharma industry
• Proven track record of working in outsourcing or supply chain management.
• Knowledge of pharmaceutical processing and excipients
• Strong project management skills, high degree of attention to detail, and the ability to perform well in a team-based environment

If this sounds like an opportunity for you, apply today!

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™

Our Client, a pharmaceutical company located North of Boston, is looking for a Facilities Coordinator

The Facilities Coordinator is responsible for inventory, receipt and delivery of all item into warehouse storage.  Responsible for overall cleanliness, maintenance and organization of the warehouse. Also, maintain, calibrate and validate all environmental chambers and rooms.  Receives, pulls, ships and delivers Pharmaceutical (stability / storage) Samples and Biological Materials.  Performs inventory of material.  Maintains the data entry of the sample management system as well as monitoring storage conditions on a daily basis.

• Bachelor of Science in Chemistry or Biology / other science related degree or relevant industry experience
• 3+ years of pharmaceutical warehouse experience
• Warehouse experience desirable
• Validation of Equipment
• GMP experience

• 10+ years experience in bioinformatics or computational biology
  
• 3+ years of experience in a commercial product setting
• Development experience with C++ (preferred), Java or C#
  
• 7+ years of Python experience 

Our Client, a well recognized diagnostics company, is seeking a Sample Prep Associate.

The Sample Prep Associate will Accession and process clinical specimens sent to laboratory for Clinical testing. Log all applicable information into accessory Lab systems and databases.Identifies and properly handles discrepancies and/or missing information. Work with Client Services to resolve patient and client issues.

Education, Skills, and Experience

• High School diploma or equivalent required. Bachelors’ degree in Life Sciences is preferred.
• 1+ years experience in Accessioning or Data entry in a clinical setting

Our Client, Global Biotech, is seeking a Director/VP of Bioinformatics

You will be responsible for overseeing the planning, design, and delivery of NGS bioinformatics analysis and pipelines and building the Bioinformatics group.

• Provide leadership (technical decisions, defining strategy,  and mentoring team members)
• Designs, develops and implements NGS bioinformatics analysis pipelines
• Collaborate with internal stakeholders and outside collaborators

Required Experience:

• PhD in Computer Science, Mathematics or Physical Sciences, preferably related to bioinformatics or computational biology
• 10 + years experience in Bioinformatics
• 5+ years leading teams
• Commercial Product experience
• NGS bioinformatics algorithms and tool chains, especially those related to next generation sequence analysis
• Excellent communication skills and a demonstrated ability to work collaboratively

Our Client, a global Biotech company, is seeking a Bioinformatics Sr. Scientist.

You will be responsible for planning, design, and delivery of bioinformatics analysis and pipelines.  Develop various bioinformatics algorithms and tool chains, especially those related to next generation sequence analysis

Required Experience:

• MS/Phd in Biology, Bioinformatics, Mathmatics or Computer Software
• 7+ years work experience in bioinformatics or computational biology
• NGS data experience
• Development experience with C++
• Experience developing analytical tools with a scripting language, preferably Python

This role will support the generation of a broad scope of documents required for drug development in the areas of Chemistry, Manufacturing, and Control (formulation, process, analytical, cGMP, facilities).  This will include creating and editing regulatory documents for multi-agency submission, in CTD format, and assisting with generation and editing of internal and external study reports and the generation of summaries to support development goals and regulatory submissions.  The candidate will provide guidance and support to the technical functions on regulatory expectations and regulatory messaging.  Working with CTO and technical functions to ensure technical reports adequately support the regulatory submissions. Compilation and escalation of submission gaps/risks/mitigations. Driving functional alignment on key strategy and messaging. Coordination of functional reviews of the regulatory document content. Providing documents approved by the CMC organization and the technical functions to the Regulatory group.

Additional responsibilities include:

• Coordination of CMC writing activities with key personnel from Bioprocess, Quality, and Manufacturing groups
• Preparation of regulatory submissions: CMC sections of INDs and BLAs, regulatory briefing documents
• Editing and formatting of technical reports for bioprocess development: process, analytical, formulation, stability, validation.
• Work closely with scientists to support the development of Investigator’s Drug Brochures and INDs for new products as needed.
• Preparation of summaries of CMC studies as well as published literature to be included in submissions to Regulatory Authorities
• Preparation of other documents in support of CMC programs including publications, abstracts, statistical and safety analyses and reviews of literature.

 Education and Experience:

• Ph.D. with previous CMC Regulatory writing experience (MS with 5+ years of experience also considered)
• A minimum of 1-2 years of biopharmaceutical writing experience
• Biologics CMC experience in the biotech/pharma industry highly desirable
• Proven writing skills (non-confidential examples appreciated) 
• Ability to multitask and meet timelines
• Working knowledge of drug development process
• Excellent organizational skills
• Detail oriented with strong communication skills
• Ability to work both independently and as a team member
• Proficiency in the use of MS Word, SharePoint, eCTD, and other document software systems including Excel
• Working knowledge of template use for document creation; ability to work with different template styles and types as required
• Ability to understand and interpret clinical and scientific data
• Ability to present results in a straightforward and understandable manner

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™

For more information, go to: http://www.cwsciences.com/Current-Openings/Sr-Research-Associate--Cancer-Immunology

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Associate-Scientist--Cell-Based-Assays-

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Laboratory-Assistant

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

For more information, go to: http://www.cwsciences.com/Current-Openings/Sr-Scientist

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

We are looking for an experienced and knowledgeable cutting-edge molecular biologist to work closely with our experts in immunology, bioinformatics, and cell biology to explore the immunogenicity and T cell responses to neoantigens, a new and extremely varied class of immune targets created by the vast landscape of mutations found in cancer cells. Specific areas include producing a large number of neoantigen epitope-encoding constructs in parallel to assess immune responses, preparing vectors and sequencing libraries for massively parallel reporter assays, prepare single cell sequencing libraries, and automating cloning and sequencing platforms.   

Specific responsibilities include:

• Designing and applying high-throughput cloning strategies (e.g. – Gibson assembly, Lentiviral libraries, CRISPR/CAS9, etc)
• Ability to perform bulk and single-cell cloning/sequencing tools to address de-convolution of multi-component problems
• Ability to work collaboratively with immunologists and cell biologists
• Vendor management and validation
• Serving as molecular biology resource for the organization for all projects
• Contributing to patents, publications and technical reports used in regulatory filings

Requirements:

• BA or MS in molecular biology, immunology, biology, biochemistry or biophysical chemistry
• Specific recent laboratory expertise in molecular biology with application experience in cell biology, including high throughput cloning strategies, transfections, cell expression systems, cell-based assays and/or assay development
• Experience working cross-functionally in a fast-paced, matrixed environment (academic, biotechnology or pharmaceutical)
• Ability to work both independently and on a team
• Proven ability to deliver on timelines

Primary Role
The Gene Therapy Scientist is responsible to support Discovery Research internal and external gene therapy programs. The incumbent will represent Discovery Therapeutics Gene Therapy team independently to participate in matrix project teams within Discovery Therapeutics (eg. Protein Engineering, Protein Expression, Analytics and Cell Line Developments) and with other major functions in Research and Non-Clinical Development to advance preclinical drug candidates in a highly collaborative manner. Based on the specific needs of each project, additional responsibilities include design and optimize viral vector constructs; produce, purify and characterize vectors; design and conduct experiments to study vector properties, which contribute to the advancement of drug candidate through research and early development.

Responsibilities
70%
* Design and conduct experiments required to advance projects
* Perform hands-on molecular biology engineering, production and characterization of research scale viral vectors. Establish existing or develop new vector characterization assays.
* Develop a broad network and works occasionally and effectively with CROs to deliver materials and reagents needed for gene therapy drug development. Ensures compliance of Gene Therapy activities.

20%
* Represent Discovery Therapeutics Gene Therapy and participate in cross-functional project teams.
* Evaluate experimental design and results performed by project teams. Communicate with the supervisor regarding project team progress, rationale of experimental designs and interpretation of results effectively and regularly. The output can be in the format of verbal discussion, written report or presentation.
* Communicate with members of Discovery Therapeutics, Discovery Biology and Non-Clinical Development and Pharmaceutical Development.

10%
* Follow compliance of documentation in electronic laboratory notebooks.
* Author scientific reports that can be used for regulatory submission.

Education & Experience Requirements
* PhD in virology, genetics, pharmacology or related biological science and strong track record of scientific publications is required.
* Experience in viral vector knowledge is required. Experience working with adeno-associated viral vector is a plus.
* Hands on experience and proficiency with molecular biology including in silico vector design, DNA cloning, capability in designing gene expression vector constructs, performing transient and stable transfection in mammalian cells.
* Hands on experience with research scale vector production and purification. Experienced in using column-based purification method and trouble-shooting is required.
* Hands on experience and proficiency with the use of various analytical techniques including but not limited to PCR, qPCR, RT-PCR, ELISA, MSD, Western, Silver-stain, reporter-gene assays, enzymatic assays, cell-based assays, nucleotide hybridization techniques and flow cytometry.
* Ability to design and perform experiments for assay development and troubleshoot assay development with minimum supervision. Experiment in in vitro and in vivo experimental design and execution in individual and team settings.
* Data-driven, critical thinking, analytical and ability to interpret results and present the implications to manager and teams.
* Good organizational skills, and attention to detail, are essential.
* Excellent interpersonal, written and oral communication and presentation skills.
* Must be open to the ideas of others and utilize different perspectives to drive towards creative solutions in a timely manner while maintaining the highest of scientific and ethical standards.
* Ability to establish and develop relationships with internal cross-discipline scientists.
* Exhibit knowledge and sound judgment of interpreting experimental results.
* Highly independent and motivated to adapt to new environment; has ability to adapt to a fast paced environment and deliver results with a team-working spirit.
* Expected to work independently with modest supervision, demonstrate motivation in pursuing scientific answers.
* Independently develop solutions to diverse problems, including identifying methods for experimental design which may require sophisticated planning and cross-functional collaboration.
* Expected to be accountable for effectiveness and timelines of completion of milestones and project goals.

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.

Please apply at: Application URL:http://www.aplitrak.com/?adid=amVucy4yOTY1NS4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ

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 Andover Quality group is seeking a highly motivated individual for a project management position in the Quality Control Analytical group. The Project Specialist is accountable and responsible for management of all project timelines from initiation to completion in support of operational and department needs. The Project Specialist will participate in meetings and update management and project teams on all project related activities. The Project Specialist may also support other non-lab work projects as needed.

Responsibilities
The qualified candidate must have the experience and ability to participate in multiple projects within the Quality Control Analytical group.

Responsibilities include:
* establish project timeline and coordinate with appropriate personnel/group in achieving all key project deliverables and milestones
* collaborate with cross functional groups, both on site and off site, in developing appropriate milestones and resource planning for each project
* participate in project team meetings to evaluate the area of risk management, including the assessment, communication, and mitigation of risks associated with the fulfillment of project commitments and plan-of-record expectations
* responsible for identifying, analyzing project risk
* ensure the projects achieves all targeted objectives including schedule and resources
* provide periodic reports on status, schedule progress and performance of the project to appropriate management
* ensure project completion and closeouts are captured and documented in an appropriate electronic document system (e.g. project manager) such that they are easily transferable for presentation
* accountable for the preparation and maintenance of project lists and management boards
* support other non-lab projects such as stability report writing
* establish and maintain positive and collaborative working relationships with all QCA personnel as well as other quality groups

Qualifications
* BS degree or equivalent in chemistry or related discipline. Required 5 or more years of project management experience. Biopharmaceuticals industry experience is preferable. Demonstrated capability to work as a team member in a matrix management team.
* Strong oral and written communication skills and the ability to effectively manage project timelines with members of QCA as well as external group.
* Successful candidate must manage and influence team members both within their respective organizations as well as external team members.
* Candidate must be self-motivating and be able to adapt to rapidly changing project priorities.
* Knowledge of cGMP and industry standards and continuous improvement tools desired.
* Formal training in project management and prior project management experience is also desired.

Physical Requirements:
Normal sitting, standing and walking requirements to facilitate support of QCA staff in the office and on the floor (laboratory, suites, etc.). Position is first shift Monday through Friday.

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.

Please apply at: Application URL:http://www.aplitrak.com/?adid=SmltLlRhdm9saWVyaS4yMzI5MC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20