Gene Therapy Quality Tech Transfer Lead

ROLE SUMMARY

As a member of the Gene Therapy Quality Operations Team the Quality Tech Transfer Lead will serve as a Technical lead for process transfers into Sanford's Gene Therapy facilities.

The successful applicant will provide strong quality and organizational leadership, effectively support multi-project late phase clinical and commercial portfolio and make strong quality contributions to multi-disciplinary/ cross-functional project teams so as to ensure efficient and timely execution of process transfers, manufacture of late phase clinical batches, process validations and commercial launches.

Role may transition to people leader as necessary, however, initial role is an individual contributor.

ROLE RESPONSIBILITIES

• Serve as a Quality lead for process transfers
• Interface with R&D, Operations, Engineering, Manufacturing Technical Services and Regulatory Affairs group
• Provide quality leadership to process transfer team
• Reviewing and approving technical documentation to support process transfers
• Attending risk assessments for process changes and developing mitigation plans
• Approving necessary process changes and implementation of potential process improvements in conjunction with manufacturing operations.
• Assist in facility/process fit assessment
• Support for regulatory submissions and PAI readiness
• Provide guidance/coaching to less experienced colleagues

QUALIFICATIONS

Required

• 8 -10 years of quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
• 5 -7 years of quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
• Transfer and Scale up Experience in GMP environment
• Process Validation experience
• Strong leadership, organizational and project management skills is required to work with multi-disciplinary teams.
• Must be self-motivated and work with minimum direction
• Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments

Preferred

• In depth knowledge of aseptic Drug Product process
• In depth knowledge of regulatory requirements of late phase clinical, process validation and commercial processing.
• Knowledge of statistical tools, quality systems and quality risk management tools
• PAI readiness experience

No unique physical requirements

Mental:

-Remains organized &; positive in ambiguous and fast-paced, rapidly changing environment

-Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations

-Ability to process complex information and make recommendations with incomplete data set

Limited travel for the position; no more than 15% traveling.

May be necessary to work in areas that require aseptic gowning.

• Last Date to Apply for Job: 11/2/2020
• Eligible for Relocation Package
• Eligible for Employee Referral Bonus

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