Resilience (Resilience US, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.
For more information, visit www.resilience.com.
Position Summary & Role
The Sr. Specialist II, Quality Assurance - Batch Release will organize and execute aspects of GMP implementation at the East Norriton manufacturing facility. The successful candidate will possess an understanding of cGMP, specifically building and maintaining quality systems in support of sterile/gene therapy/cell therapy manufacturing. In addition, the ideal candidate must have a proven track record self-situational leadership by way of project leadership or direct supervision of staff.
- Work collaboratively with internal stakeholders and as necessary external partners/vendors to execute within a world-class GMP Quality Program.
- Build strong relationships and collaborate closely with CMC/Operations/Development teams and other relevant groups to ensure the manufacturing and testing operations will comply with all US and International regulatory expectations.
- Review documentation for manufacturing activities including but not limited to executed batch records and master batch records.
- Independently performs batch record review.
- Releases batches manufactured at East Norriton.
- Reviews and approves the certificate of analysis.
- Review deviations, change controls and/or CAPAs, as needed.
- Author and review technical documents including but not limited to SOPs, various quality reports.
- Compile and report performance metrics for batch review and release
- Understand risks and delays to batch release and communicate appropriately
- Mentor, coach and train Quality Associates in the QA Operations Team
Preferred Experience, Education & Qualifications
- B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
- 7-10 years relevant life sciences quality experience within quality and/or quality related functions.
- Demonstrated track record with the successful support of GMP manufacturing and testing environments.
- Demonstrated quality experience and the ability to collaborate with and effectively influence others.
- Demonstrated experience with quality batch review.
- Specific experience with aseptic, cell therapy and/or viral vector manufacturing strongly preferred.
- Comfortable in a fast-paced, collaborative environment, working with minimal direction and able to adjust workload based upon changing priorities.
- Familiarity with electronic quality systems/software applications.
- Familiarity with electronic laboratory and manufacturing execution systems.
- Working knowledge of GLP/GCP and GxP Regulatory requirements.
- Experience in preparation and participation in regulatory authority plant/site inspections.
- Experience supporting biologics manufacturing preferred.
Other Ideal Personal Characteristics:
- Comfortable in a fast-paced, collaborative company environment, working with minimal direction and able to adjust workload based upon changing priorities.
- Excellent oral and written communication skills.
- Performs with Integrity.
- Ability to collaborate and manage conflict in a fast-pace environment, working across functions.
- Experience in application of lean methodologies and operational excellence to continuously improve.