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

Employer
Pfizer
Location
Chapel Hill, North Carolina, United States
Posted
Oct 29, 2020
Ref
4778722
Required Education
Doctorate/PHD/MD
Position Type
Full time
ROLE SUMMARY

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.

ROLE RESPONSIBILITIES
  • 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 all quality 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.


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 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.


PREFERRED QUALIFICATIONS:
  • 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


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