Gene Therapy Upstream/Downstream Quality Operations Sr. Associate

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Nov 20, 2020
Ref
4799409
Required Education
Bachelors Degree
Position Type
Full time
ROLE SUMMARY

This job posting comprises two (2) positions to support Gene Therapy Upstream and Downstream processes, respectively.

As Gene Therapy Stage 2 is currently in the design phase, the successful candidate will be responsible for developing processes and procedures to perform responsibilities listed below. This will require working collaboratively with cross-functional groups in Gene Therapy Stage 2, at the Sanford site and across the Pfizer network.

The positions will be responsible for:

Performing batch disposition, manufacturing floor support, investigation approval, complaints handling, Biological Product Deviation Reports (BPDR) issuance and Annual Product Record Reviews (APRR).

Aligning with Gene Therapy Stage 1 Quality Operations and Sanford Vaccines Quality Operations teams to ensure consistent approaches and sharing of best practices.

Leading Continuous Improvement initiatives to create compliant, efficient processes. This includes developing and maintaining standard work, visual management and problem solving using DMAIC methodology.

Knowing, understanding, role modeling, and ensuring others follow Pfizer's values and culture.

Supporting initiatives that contribute to building and strengthening the quality culture within the Gene Therapy Facility. Practicing and encouraging quality cultural behaviors within both Quality and business lines.

Acting as SME for department to support site audits/inspections.

Interfacing with other parts of the organization such as Global Quality Operations groups and Pfizer Research and development groups.

QUALIFICATIONS
  • 3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
  • 1-2 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
  • Previous experience with a startup facility and developing Quality Operations processes is beneficial.
  • Experience with Drug Substance and Drug Product commercial manufacturing preferred.


PHYSICAL/MENTAL REQUIREMENTS

Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be the norm.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This is a first shift position, occasional shift work may be required to support manufacturing operations .

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

It will be necessary to work in areas that require aseptic gowning.

  • Last Date to Apply for Job: 12/4/2020
  • Eligible for Employee Referral Bonus
  • Eligible for Relocation Package


Sunshine Act

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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