Associate Research Fellow, Cell Therapy Manufacturing Process

Job Title
Associate Research Fellow, Cell Therapy Manufacturing Process

Job Description

Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description
Help establish and lead a team to develop and characterize clinical-scale manufacturing processes for Chimeric Antigen Receptor T-cell (CAR T) therapies, establish strategies for analytical characterization, release and stability, develop and qualify appropriate analytical methods and tech transfer and support successful GMP manufacturing and release, initially at a CMO. Develop novel technologies/ approaches to meet future CART analytical needs. This position will work in close collaboration with key stakeholders the CART Research including group and Biotherapeutics Pharmaceutical Sciences Analytical R&D.

Responsibilities
Responsible for successful development, qualification and execution of state-of-the-art analytical methods in support of lentiviral-based, engineered T-cell therapy process development – accomplished technical leader who applies extensive scientific and technical experience and business acumen to establish analytical testing strategies, drive safe and high-quality lab technical work and deliver suitable and robust analytical methods. Provides creative and pragmatic technical and operational problem-solving options.

Responsible for analytical support of clinical-scale non-GMP, IND-enabling, Toxicology studies that are representative of intended GMP clinical manufacturing, and Tech Transfer of in-process and release methods to CMO for validation and execution in support of manufacturing and release of GMP material. Experienced cGMP (QC) leader familiar with FDA/ EMA Regulatory expectations, who drives high quality, compliant analytical testing paradigms and outcomes.

Provides visible, passionate and optimistic organizational/ technical/ personal leadership and actively fosters colleague engagement; models and engenders desired values and behaviors, including quality, integrity, respect, collaboration and personal accountability.

Has the ability and mastery (technical and interpersonal skills, awareness of functional area deliverables and business/ Regulatory context) to train/ mentor more junior colleagues in specific lab techniques or methods.

Establishes and drives relevant and impactful innovation programs, to enhance CART characterization technologies and work-processes; ensures that innovation strategy is aligned with broader business drivers and current and emerging Regulatory paradigms.

Contributes to Project, Technical and Strategic Teams as appropriate; reaches across organizational, functional and geographic boundaries to provide appropriate context and communication (in both directions) so as to ensure effective technical and strategic integration at all internal and external interfaces (Research, Bioprocess development, Analytical, Safety, CMOs, Commercial manufacturing, etc.), as appropriate.

Ensures effective, high-quality, timely and appropriate documentation in electronic laboratory notebooks and internal Technical Reports; contributes to Regulatory Filings and responses to Regulatory questions; presents data/ strategy to scientists and management in appropriate internal and external venues (technical meetings, Project Team meetings, conferences) and publishes in peer-reviewed journals, as appropriate.

Contributes to safe, efficient, effective and harmonious lab environment through personal responsibility/ accountability – ensures appropriate cleanliness and status/ operability of shared or assigned lab space or equipment; strong lab citizen and collaborative team player; approaches the job with energy and commitment; demonstrates initiative – identifies what needs to be done and makes it happen.

Qualifications
EDUCATION AND EXPERIENCE

PhD degree in Immunology/ Molecular Biology or related field - with 10+ years of postgraduate experience in biotech/ biopharma industry (preferably in the development of analytical methods for characterization and GMP release of cell-based or gene-therapies).

TECHNICAL SKILLS REQUIREMENTS

Relevant and substantial experience in some or all of the following areas:
- Molecular immunology
- T cell biology/ primary T cell culture/ expansion and characterization
- Development of analytical methods for characterization and GMP release of cell-based or gene-therapies, especially cell-based and FACS-based assays for characterization and release/ stability testing
- Familiarity with cGMPs and appropriate Regulatory Guidance documents

PHYSICAL POSITION REQUIREMENTS

Travel to other Pfizer sites (St Louis MO, Andover MA and others) and to support process Tech Transfer to contract manufacturing organizations in USA/ EU as appropriate

Equal Employment Opportunity
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.

Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.


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Desired Skills and Expertise
Doctorate Degree

Industry
Science

Experience
5+ years

Job Type
Full Time

Salary / package
Not Specified

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