Job Description
Overview
Iovance seeks a highly motivated Associate Director, Quality Control (QC) Sterility Assurance. The incumbent is responsible for assisting in the development and oversight of the implementation of all microbial contamination control processes/procedures and is accountable for assisting in establishment of a robust and comprehensive microbial contamination control programs for the company’s clinical and commercial programs at two manufacturing sites in Philadelphia.
This role will effectively collaborate with multiple stakeholders to ensure the harmonized execution of contamination control policies across the two manufacturing sites in Philadelphia. This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods.
The Associate Director, QC Sterility Assurance will have strong leadership and substantial experience leading QC sterility assurance program in a Pharmaceutical or Biotechnology environment. The incumbent will be the subject matter expert (SME) in rapid microbial methods for Cell and Gene therapy. The Associate Director will be defending Microbial Safety Methods, EM program, Trend Reports, deviations, Risk Assessments, Contamination Control Therapy, etc., during Regulatory Audits.
Essential Functions And Responsibilities - Partner with Regulatory Affairs on new product induction(s), providing clear guidance and strategy on the 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.
- Oversite 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.
Subject Matter Expert (SME) - Subject matter expert (SME) for rapid microbial safety methods (Sterility (BacT), Mycoplasma (qPCR/BioFire), Endotoxin.
- SME on the EM program, Trend deviations, Risk Assessments, Contamination Control Strategy (CCS), etc.
- Participates as microbiology SME in Regulatory inspections defending the safety assays (endotoxin, mycoplasma, and sterility), EM trend reports, and any contamination control issues.
- Act as compliance and innovation subject matter expert (SME) during the selection and qualification of laboratory equipment for microbiological testing including Rapid Microbial Methods (RMMs).
- Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls.
General - Authors new and revised procedures for Sterility Assurance department.
- Ability to work in a team environment and independently as required. Maybe required to work Holidays and weekends.
- Ability to evaluate technical data and write technical documents.
- Intermediate understanding of statistics, control charts, action, and alert limits.
- Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.
Team Leadership - Will have manage direct and indirect personnel in the Sterility Assurance group to ensure all departmental and Company goals are met.
- Work closely with site and multi-functional SMEs to drive cohesion on robust control strategies meeting regulatory and compliance expectations and are continuously improved.
- Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking.
Required Education, Skills, And Knowledge - 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.
Preferred Education, Skills, And Knowledge - Advanced degree preferred.
- Experience with safety assay testing for cell therapy products is a plus.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands And Activities Required - Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
- Must be able to work in a cleanroom lab setting with biohazards / various chemicals.
- Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
- Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing up to 45
Mental Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment 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.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They do not constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the position’s duties at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com
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Job Tags
Holiday work, Full time, Local area, Flexible hours, Weekend work,