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Pfizer Sr. Principal Scientist, Quality Control Stability and Validation in Durham, North Carolina

Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.

What You Will Achieve

At Pfizer, we are always seeking to deliver breakthroughs that change patients' lives. In this role, you'll be working to help us achieve that goal by advancing biotechnologicallyderived products to the market through innovation and delivery of cutting-edge analytical testing. You will be part of a team which is focused on developing methods and strategies to support product and process development for biotherapeutics and vaccines, including antibodies, antibody-drug conjugates and therapeutic proteins, at all stages of clinical development. You will work across analytical functions and projects and will also play a role in developing leaders and providing technical counsel to other organizations and senior leadership.

As a Senior Principal Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be recognized as an outstanding scientist in your group. With your advanced knowledge of the discipline, you will regularly contribute in multi-disciplinary teams representing the department and influencing cross-functional teams. Your innovation is seen in way you promote the use of novel experimental approaches, create processes, hypothesesand methodologies. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience. You will be entrusted with setting objectives and planning resource requirements for projects. You will undertake mentoring activities to guide team members.

The qualified candidate will be a group leader in the Quality Control, Stability and Validation group at the Durham GTx manufacturing site, a part of the analytical organization (Analytical R&D). The qualified candidate will lead a group of 3-6 scientists as part of an organization focusing on quality control release and stability testing through cutting edge methods and technologies for the development of gene therapy products and other biotherapeutic modalities. The qualified candidate will deliver results in a matrix-oriented environment to support biotherapeutics at all stages of clinical development. 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.

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Manage 3-6 direct reports directly as well as provide matrixed support to the quality control group 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.

  • Excellent written and communication skills, effective time-management, an innovative spirit, and the ability and desire to work both independently and collaboratively in a multidisciplinary, fast-paced, team-oriented environment are essential for the position.

Qualifications

Must-Have

  • PhD with 6+ years of experience or BS/MS with 12+ 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 ELISA, separations, 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.

Nice-to-Have

  • 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

  • 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.

PHYSICAL/MENTAL REQUIREMENTS

Position requires occasional light lifting and periods of standing, sitting, or walking.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Some occasional travel to other Pfizer sites is possible. Overtime, off shift coverage, or holiday coverage, though rare, may be required.

Other Job Details

Relocation support available

Eligible for Employee Referral Bonus

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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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