17 days old

Gene Therapy Drug Product Lead

Sanford, NC 27330
**Why Patients Need You** Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

**What You Will Achieve** The position will support the Pfizer Sanford, NC Gene Therapy Quality Operations department, focusing on drug product, by performing Quality Assurance activities associated with clinical and commercial product. Key responsibilities are providing quality support for sterile drug product manufacturing, including isolator filling equipment, visual inspections, AQL, and process simulation/media fills.

This position will perform Quality final authorization/approval/release of cGXP documentation/equipment/processes; plan and execute complex projects; suggests improvements and conducting continuous improvement activities; and provide guidance/coaching to less experienced colleagues.

**How You Will Achieve It** In this role, the Quality Drug Product Lead should:

+ Have extensive depth of knowledge of GXPs. Experience and knowledge with clinical and commercial drug product requirements is required.

+ Assess internal and external compliance with applicable regulations. Contributes to the interpretation of cGXPs for the commercial and clinical environment.

+ Act as Aseptic Filling & Inspection quality SME bringing insights to current industry best practice from a compliance and technical perspective

+ Represent Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.

+ Act as Quality lead on large projects.

+ Approve complex investigations.

+ Make decisions that involve complex quality and technical issues with minimal assistance from management.

+ Make decisions that may impact project progression and timelines.

+ Collaborate/independently engages with a wide range of co-workers, customers and management within the OpU to gather the input and background knowledge needed to complete assignments.

+ Recognize when such a multi-disciplinary discussion/issue is beyond their sphere of influence and escalates accordingly.

+ Anticipate issues and elevates them to appropriate management attention immediately.

+ Act as the Quality member of the project team empowered to speak for the Quality organization to other areas. Provides strategic input to accomplish team objectives. Established interpersonal skills (negotiation, managing conflict) to influence the team.

+ Provide training/guidance/coaching to less experienced colleagues.

+ Manage workload to meet established timelines.

**Qualifications** I


+ 7+ years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field

+ 4+ years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field

+ Quality experience with Drug Substance and Drug Product clinical and commercial manufacturing required

+ Quality experience with sterile drug product manufacturing, including isolator filling equipment, visual inspections, AQL, process simulation/media fill required

+ Individual must have knowledge of US, EU, and ROW cGXP, including focus on drug product requirements.


+ Individual should be proficient in Microsoft Office applications specifically Word and PowerPoint; Lean Six Sigma concepts; and Quality Risk Management.

+ Preferred experience with Global Quality Tracking System (TrackWiseTM application) and Document Management System (PDOCs)

+ Preferred experience with process validation document review and speaking in BOH audits.


Ability to stand for 3-4 hours at a time, sit for 2 to 3 hours at a time. It will be necessary to work in areas that require aseptic gowning. Mental requirements include working in fast paced/ high stress environment.


Primary 1st shift, occasional shift work may be required to support manufacturing operations such as media fill observations.

Limited travel for the position; no more than 5-10% traveling.

**Additional Job Details**

+ **Last Date to Apply for Job: 4/16/2021**

+ **Eligible for Referral Bonus**

+ **Eligible for Relocation Package**

**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.

Quality Assurance and Control



Posted: 2021-03-31 Expires: 2021-05-05

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Gene Therapy Drug Product Lead

Sanford, NC 27330

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