Senior Principal Scientist / Group Leader-Gene Therapy-Process Development
Location:
Chapel Hill, North Carolina
Posted:
September 20, 2016
Position Type:
Full Time
Category:
Research
Reference:
1039232


About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company 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. the company, 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 Gene Therapy area of the Bioprocess R&D department is responsible for the development of GMP manufacturing processes for our gene therapy products. As a member of the Bioprocess R&D development department, the Senior Principal Scientist / Group Leader position will lead a group of scientists and engineers responsible for the development of scalable culture processes for the clinical/ commercial manufacture of viral vectors. She/He will be expected to provide strong technical, strategic and organizational leadership, effectively manage a multi-project development portfolio and make strong technical and strategic contributions to multi-disciplinary/ cross-functional development project teams so as to ensure efficient and timely execution of process development deliverables.

Responsibilities
Responsible for successful development, characterization and execution of state-of-the-art manufacturing processes for mammalian cultures- accomplished technical leader who applies extensive scientific and technical experience and business acumen to establish strategies, drive safe and high-quality lab technical work and deliver well-controlled and characterized culture processes. Provides creative and pragmatic technical and operational problem-solving options. Experienced (cGMP) manufacturing operations leader familiar with FDA/ EMA Regulatory expectations, who drives high quality, compliant manufacturing procedures 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 processes.

Establishes and drives relevant and impactful innovation programs, to enhance upstream process 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 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
PhD degree in Chemical/Biochemical Engineering, Biotechnology, Cell Biology, Microbiology or related field, - with 8+ years of postgraduate experience in biotech/ biopharma industry in the development and characterization of mammalian cell culture processes.
• Experience with gene therapy process development and manufacturing is a significant plus
• Expert knowledge in developing cost effective, scalable culture processes
• Scale-up/ Scale-down of bioreactor processes
• Demonstrated supervision / leadership of high caliber scientists and ability to mentor junior staff and peers
• Demonstrated experience with managing multiple projects in parallel, including key participation on multi-disciplinary project teams.
• Experience in authoring INDs, BLA/MAAs and other regulatory documents
• Demonstrated experience in process development utilizing quality risk management and quality by design concepts.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel to other the company sites and to support process Tech Transfer to contract manufacturing organizations in USA/ EU as appropriate

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
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