Manager/Senior Manager, Quality Control (Analytical)

The Manager/Senior Manager provides oversite of a variety of analytical activities that occur in the Quality Control (QC) department supporting in process and final product testing, while ensuring that activities occur in an efficient and cGMP compliant manner.  This role will be responsible for working with a cross-functional team (Analytical Development, Manufacturing, Quality Assurance, etc.) in support of analytical method qualification, technology transfer, analytical method validation, manufacturing support, and product testing.  This role is responsible for the supervision of the QC analytical team and the Manager will play a crucial role in developing and maintaining this team.  The Manager will be the local subject matter expert (SME) for analytical testing for all regulatory inspections.  The Manager/Senior Manager will be based in Grove City, OH, and reports to the QC Director/Senior Director.

Responsibilities:

• Provides operational management of the Quality Control (QC) analytical team responsible for performing assays relevant to viral vector/gene therapy products, including in-process testing, in-process control, and lot release testing.
• Accountable for ensuring adherence to strict regulatory requirements to ensure product quality.
• Works with the Analytical Development (AD) and Manufacturing teams to ensure effective communication between all groups.
• Provides management for and ensures the effective transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
• Contributes to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.
• Ensures adherence to timelines in support of IND, BLA, and all relevant ex-US regulatory filings.
• Manages and mentors staff to build a highly functional QC team that may be cross-trained in analytical development assay areas, as needed.
• Reviews and approves GMP documentation associated with in process and final product testing controls, including, but not limited to, Standard Operating Procedures (SOPs), Specifications, and Analytical Test Methods.
• Provides support for Deviations, Change Controls, and CAPAs related to in process and final product testing.
• Manages tracking and trending of in process and final product testing data, including, but not limited to; leading/participating in out of specification (OOS)/out of trend (OOT) Laboratory Investigations.
• Ensures all laboratory records adhere to cGMP/GDP expectations.
• Supports regulatory and client inspections, and supports internal audits of GMP systems.
• Other duties as assigned.

Requirements:

• PhD in molecular biology, virology, biochemistry, or related discipline and a minimum of 2 years of experience in biologics and/or gene therapy QC roles, OR
  Master’s degree in these same disciplines and a minimum of 3 years of relevant experience, OR
  Bachelor’s degree in these same disciplines and a minimum of 5 years of relevant experience.
• Minimum 1 year of Supervisory experience.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Excellent oral and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Ability to present to and interact with Senior Management.
• Travel requirements: 0 to 15%.
• In our commitment to safety of our employees and customers a COVID vaccination is required.

Special Knowledge or Skills Preferred:

• Experience with the analytical methods used for gene therapy in-process testing, release testing and characterization, with an emphasis on potency assays.
• Advanced knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, and molecular biology techniques.
• Functional knowledge of mammalian cell culture.
• Advanced knowledge of cGMP requirements as they pertain to Analytical Development and Quality Control testing.
• Advanced laboratory skills for analysis of pharmaceuticals, biopharmaceuticals.
• Experience with electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc.
• Experience in high-level interactions with domestic and international Regulatory agencies.
• Knowledge of CMC analytical and regulatory requirements.
• Small company and/or start-up experience.
• Experience in cell and gene therapy (e.g., AAV manufacturing) is highly desirable.