AbbVie Manager, Quality Control, Environmental Monitoring and Microbiology in South San Francisco, California
Manager, Quality Control, Environmental Monitoring and Microbiology
USA, California, South San Francisco
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica®, Venclexta™, and Empliciti™ — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at Stemcentrx, AbbVie's South San Francisco, CA location.
Manager, Quality Control - Environmental Monitoring and Microbiology
As part of a talented and multi-disciplinary team advancing an exciting novel approach to drug development, the successful candidate will lead the Environmental Monitoring and Microbiology function to support the aseptic GMP manufacturing facility and QC testing of the products. The successful candidate will be responsible for providing strategic leadership and technical expertise overseeing the EM/Microbiology function to insure adherence to regulatory requirements and completion of microbiology testing activities as the company progresses through early clinical trials.
This is a hands-on role that requires close collaboration with Quality Control, Manufacturing, Quality Assurance and Regulatory groups.
Primary Duties and Responsibilities:
Design and implement a new EM/Microbiology Laboratory including setting up new SOPs, processes and test methods, and purchasing and qualifying new equipment.
Justify resource needs and recruit and hire qualified staff to support the activities of the new lab and provide training as applicable.
Manage all activities of the EM/Microbiology QC Lab including staff, workload, budget, and timelines.
Manage vendors and contract testing labs for activities that are outsourced per defined timeline.
Collaborate with Manufacturing to bring the Environmental Monitoring program in-house for aseptic manufacturing, including media fills, appropriate gowning requirements, and gowning and personnel qualification.
Establish processes and requirements for a robust EM trending program, taking responsibility for completing EM trending and presenting trend reports to management per established review cycles.
Lead investigations for EM excursions and recommend/assist in implementing appropriate corrective actions
Responsible for the cleaning and disinfectant efficacy activities.
Responsible for Microbiological testing of in-process and final products.
Understand Regulations and business processes required to maintain Abbvie’s and cGMP requirements for Microbiological Laboratory standards and Data Integrity.
• Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements
Assist in the preparation of CMC regulatory submissions
Provide technical expertise necessary for troubleshooting, investigating unexpected results/deviations, and developing appropriate CAPAs.
Athorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines. Understanding of regulations that apply to pharmaceutical manufacturing environments.
Experience in cleaning validation. Excellent interpersonal skills, organizational skills and communication skills including the proven ability to manage direct reports and influence collaborators in other departments.
Experience in managing budgets and timelines.
Experience in supporting audits and regulatory inspections.
Experience with LIMs systems, electronic document management systems and quality management systems a plus.
Excellent verbal and written communication skills.
Ability to operate in a fast-paced, multi-disciplinary industrial environment.
Educational and Experience Requirements:
- BS in Microbiology with a minimum of 8 years of experience or an MS/Ph.D with a minimum of 6 years of experience in the biotechnology or pharma industry with experience in sterile fill/finish facilities
Equal Opportunity Employer Minorities/Women/Veterans/Disabled