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QC Manager
1 month ago
QC Manager
Title: QC Manager for Biologics, Cell and Gene Therapy Operations (BCGT)
Location: 760 Pennsylvania Drive, Exton, PA 19341
Reports to: Senior Director of BCGT
Full-time /Part-time
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The QC manager supports the GMP testing operations in BCGT business unit at Frontage Laboratories, Inc. This position involves managing and supervising the routine GMP testing team daily to meet compliance and business requirements. The focus of the role is to closely collaborate with scientists from multi-disciplinary teams and to ensure Frontage consistently provides high quality of work for the clients in drug safety services, pharmaceutical drug development, and services including stability study and IND/BLA submission.
Roles & Responsibilities:
Lead continuous improvements of QC (Quality Control) procedures and systems, improve organization effectiveness and compliance.
- Generate and analyze metrics related to performance of the GMP laboratories.
- Review technical reports, Deviation, and Investigation reports.
- Responsible for initiation of document reviews, periodic reviews and documentation revisions as needed.
- Train and develop staff scientists on GMP and GDP practices.
- Manage budgets and balance resource allocation to project priorities.
- Perform gap assessments for analytical potency assays.
- Oversee new technology introduction for GMP assays.
- Lead team to identify and mitigate risks to meeting GMP testing milestones and goals.
- Track revenue and support budget and resource analysis.
- Leverage the resources from multi-disciplinary teams to ensure business development.
- Closely interact with clients through various means of communication and ensure high client satisfaction.
Education, Experience & Skills Required:
PhD or MS in Biological Sciences, Molecular Biology, Biochemical Engineering, or related disciplines.
Experience:
MS/BS in Biological Science, Biochemical Engineering, or related discipline with 5 - 8 years’ relevant industrial GMP testing and/or analytical development experience for biologics or cell and gene therapy products.
- Knowledge of general GMP laboratory operations, method transfer, qualification, and validation.
- Direct knowledge of CMC and BCGT Quality Control methodologies.
- Excellent communication skills for liaising and communicating with vendors, customers, and internal departments.
- Able to quickly assess compliance risk of events and make decisions that are scientifically sound, compliant to the regulations and defensible.
- Strong written and oral communication skills as well as organizational skills.
- Knowledge of industry standards and guidelines, experience supporting compliance audits.
- Demonstrated ability to work effectively under established guidelines and instructions.
- Proficiency with Microsoft Office Programs, Building Smart Sheets, and Excel Charts.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Knowledge of relevant and current FDA, EU, USP, ICH guidelines and regulations.
- A desire to make an impact as part of a high-growth department and provide strategic vision for the team.
- Experience with ZENQMS and stability software, such as NuGenesis or LIMS, is preferred.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
