Quality Control Stability & Microbiology Group Lead, Analytical R&D

Chapel Hill, North Carolina
November 22 2020
Position Type
Full Time
Organization Type

The qualified candidate will be a group leader in Quality Control Stability and Microbiology, a part of the analytical organization (Analytical R&D), seeking to lead the industry in technologies applied to advance biotechnologically-derived products to the market through innovation and delivery of cutting-edge analytical testing for Gene Therapy products. The qualified candidate will lead a group of 4-8 scientists as part of an organization that focuses on microbiology requirements in the manufacturing facility in addition to supporting quality control release and stability testing for biochemical and separation methods and technologies for the development of gene therapy products.

The qualified candidate will deliver results in a matrix-oriented to support advancing biotherapeutics and with a focus on gene therapy at all stages of clinical development. The leader will be accountable for overseeing microbiology at the Chapel Hill GTx manufacturing site as well as manufacturing in process, release, and stability testing. To accomplish this, the candidate will lead an organization to ensure the tactical operations, compliance, strategic decisions and technical advancement to enable the manufacturing of clinical supplies that meet regulatory and quality expectations. The candidate will work across different analytical functions, quality and projects and will also develop leaders and provide technical counsel to other organizations and senior leadership.

  • Manage 4-8 direct reports directly as well as provide matrixed support to the Chapel Hill QC group of ~20 colleagues and additional contract staff
  • Work with manufacturing leads to plan and resource work
  • Responsible to partner with Quality Operations to ensure allquality and regulatory requirements are being met
  • The qualified candidate will be expected to maintain laboratory audit readiness for regulatory and internal inspections, supervising training of direct reports, assuring laboratory records and operations comply with Quality and regulatory expectations.
  • They will support the in process, release and stability testing assuring compliance and timelines are achieved.
  • Work across the Pfizer network to ensure success of our portfolio and proactively deal with emerging technical opportunities and regulatory issues.


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.

  • PhD with 5+ years of experience or BS/MS with 10+ years of experience with interdisciplinary drug development teams and industrial experience in a cGMP testing environment.
  • Degree in biology, biochemistry, immunology, molecular biology, analytical chemistry, or related field.
  • Experience in biologic drug development and the analytical strategies and methods in support of product development and to assess the quality and characteristics of biotherapeutics.
  • Experience with technologies focused on analysis of biomolecules and conjugates such as HPLC, qPCR, and compendial assays. Proven record of leading analytical investigations with strong technical skills and scientific expertise in method development and troubleshooting with a strong quality culture mindset.
  • Proven record of delivering results in a fast-paced environment and effective communication to project teams and with internal and external audits (e.g. regulatory authorities).
  • Demonstrated technical writing and presentation skills. Track record of people management skills through direct line supervision or as leaders of project teams. Outstanding leader behaviors and the ability to collaborate with and mentor others is a must.

  • M.S. / Ph.D. in above, plus coursework in statistical analysis, physical biochemistry, quantitative analysis.

DESIRABLE (one or more areas):
  • Desire to train and develop colleagues, comfortable delegating.
  • Experience working in a regulated environment.
  • Experience in a manufacturing environment and background in microbiology.
  • Experience in the field of Gene Therapy development and analytical testing.
  • Direct experience working with Quality, FDA or other regulatory authorities, and familiarity with ICH and compendia requirements.

Other Job Details:
  • 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 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.

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.

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