Associate Director, Quality Control, Sterility Assurance
1 week ago
Iovance Biotherapeutics, Inc. is seeking a highly motivated Associate Director, Quality Control, Sterility Assurance to join our team. This role will be responsible for assisting in the development and oversight of the implementation of all microbial contamination control processes/procedures and is accountable for assisting in the establishment of a robust and comprehensive microbial contamination control program for the company's clinical and commercial programs at two manufacturing sites in Philadelphia.
Key Responsibilities:- Partner with Regulatory Affairs on new product inductions, providing clear guidance and strategy on safety assay requirements.
- Provides guidance on safety method qualification/validation/verification for all markets (US, Canada, EU, Japan, etc.).
- Drafting/providing risk assessments and/or scientific justification for the Safety Method Qualification/Validation/Verification for all new indications.
- Assist in drafting the method sections of the safety methods for the regulatory filings.
- Drafting safety method protocols and reports, including special studies related to microbiology per industry standards.
- Championing sterility assurance principles at the site in the areas of aseptic processing and contamination control. Assist with the design of the contamination control strategy (CSS) programs.
- Develop and maintain microbial contamination/Cross contamination risk assessment (HACCP).
- Develop and maintain the EMPQ strategy and provides oversight of the EM testing program for regulatory compliance and technical soundness.
- Oversight of EM and Utility trending reports within deadlines, for the 2 sites in PA.
- Assist with the annual product review reports for products with safety assays and EM assessments.
- Assist with relevant internal and external inspection responses/action items related to contamination control issues, safety method qualification/validation/verifications, and EM trend reports.
- Establishes and implements appropriate training programs in collaboration with training leads.
- Plays a critical role in facility design and modification, cleaning and sanitization program, operator qualification, gowning certification, manufacturing support, training, investigations, inspections, and audits.
- Provide justification or reports to address any finding for Microbiology (EM program, CCS, or Safety Methods) for any Regulatory Audits or Filings.
- Troubleshoots contamination-related issues occurring in internal and external manufacturing sites.
- Support site QC in microbiology deviations, LIR, OOS, Change Controls, and CAPA records, including change control tasks associated with qualification or program revisions.
- Participates in continuous improvement and implementing best practices (ensuring understanding/compliance with SA-related regulations and guidance).
- Performs regular GEMBA-style assessments of the aseptic process on site to assess compliance of operations, including identification of deficiencies and provide real-time coaching to aseptic staff. Perform routine audits of the manufacturing areas.
- Bachelor's degree in a relevant discipline (biological sciences or equivalent).
- Minimum Ten (15+) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
- Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP, and JP monographs for microbiology. Knowledge and familiarity with Annex 1.
- Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin, mycoplasma testing, and microbiological control strategy required.
- Broad knowledge of quality control for cell therapy products with experience in microbial contamination control and microbiological risk assessments.
- Successfully interface with multi-disciplined teams.
- Extremely detail-oriented with strong analytical, written, and verbal communication skills.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- High level of ownership and accountability.
- Demonstrate sense of urgency; ability to recognize time sensitivity.
- Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders.
- Flexible and adaptable style with an eagerness to take on challenges.
- Problem solver who not only identifies issues but leads efforts to resolve them.
- Excellent oral and written communication skills with strong technical writing experience required.
- Advanced degree preferred.
- Experience with safety assay testing for cell therapy products is a plus.
This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.
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Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full timeJob Title: Associate Director, Quality Control, Sterility AssuranceIovance Biotherapeutics, Inc. is seeking a highly motivated Associate Director, Quality Control, Sterility Assurance to join our team.Job Summary:The Associate Director, Quality Control, Sterility Assurance will be responsible for assisting in the development and oversight of the...
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Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob Title: Associate Director, Quality Control, Sterility AssuranceJob SummaryIovance Biotherapeutics Inc is seeking a highly motivated Associate Director, Quality Control, Sterility Assurance to join our team. The successful candidate will be responsible for assisting in the development and oversight of microbial contamination control processes and...
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