Job Description

ROLE SUMMARY

* A Senior Principal Scientist/ Group Leader position is available within the Culture Process Development (CPD) group in Bioprocess R&D (BRD).
* The successful applicant will lead a group of scientists and engineers responsible for the development of scalable culture processes for the clinical/ commercial manufacture of proteins and other biologicals,.
* 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 CPD deliverables.

ROLE RESPONSIBILITIES

* Responsible for successful development, characterization and execution of state-of-the-art manufacturing processes for mammalian and microbial 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 manufacturing processes.
* Provides creative and pragmatic technical and operational problem-solving options.
* Familiar with cGMP manufacturing operations and FDA/ EMA regulatory expectations.
* 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 manufacturing/ 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

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

BASIC 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/ microbial fermentation processes for therapeutic proteins and monoclonal antibodies.

PREFERRED QUALIFICATIONS

* Expert knowledge in developing cost effective, scalable cell culture processes.
* Expertise on 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.
* Some experience with intellectual property / patents would be a plus.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

* Travel to other Pfizer sites (Andover MA and others) and to support process Tech Transfer to contract manufacturing organizations in USA/ Rest of World as appropriate.

ORGANIZATIONAL RELATIONSHIPS

* The individual will lead project teams, working closely with specialists in cell line development, upstream and purification process development, analytical development, clinical and commercial manufacturing, regulatory affairs, and other functional areas.

PHYSICAL/MENTAL REQUIREMENTS

* Ability to perform mathematical calculations and ability to perform complex data analysis.
* Capable of carrying out cell culture experiments in the lab.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

* Travel to other Pfizer sites (Andover MA and others) and to support process Tech Transfer to contract manufacturing organizations in USA/ Rest of World as appropriate

Other Job Details:

* Last Date to Apply for Job:
* Eligible for Relocation Package: YES
* Eligible for Employee Referral Bonus: YES

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 providers 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.

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.

Research and Development

LI-PFE