A well-regarded company focusing on patient therapies is seeking an Associate Director, Quality Control to join their team. This is a great opportunity to work for an industry leader!
- Manage the transfer and validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to OTL or other sites. Validation of methods will be phase appropriate.
- Establish specifications and testing process of raw materials and cell therapy products.
- Establish user requirements for purchase, qualification of QC analytical equipment. Work with internal and external resources to maintain equipment in an optimal state.
- Responsible for OOS, lab and protocol deviations, Implement corrective action plans when necessary. Provide updates at daily and weekly meetings.
- Work with CMO and OTL to complete lot disposition
- Assist in the preparation of dossiers and data packages for interactions between company and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
- Review of records, generation of CoAs for product release. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Develop, revise and review SOPs.
- Responsible for QC’s training. Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Responsible for Data trending, control charts and metrics.
- Responsible for stability related testing and program
- PhD molecular biologist or biochemist preferred with 5-7 years of Quality Control experience or MS with 10 – 12 years of Quality Control experience.
- Candidate should be well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance.
- The ideal candidate has a strong experience in various analytical techniques: Flow cytometry, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals.
- Familiarity with validation and technology transfer to internal and external analytical labs of both partners and CMOs/CROs. Knowledgeable regarding the requirements for analytical testing and phase appropriate qualifications and validations at each stage of clinical development and product approval.
- Strong Experience in applying GMP in QC lab in conformance to U.S., EU, and ROW standards
- Ability to effectively negotiate and build collaboration amongst individuals
- Demonstrated ability to develop, coach, and mentor key employees
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities