Senior Manager, Analytical Science & Technology - Gene Therapy

PTC Therapeutics, Inc.•Warren Township, NJ

12d•$146,800 - $172,700

About The Position

The Senior Manager, Analytical Sciences & Technology (AS&T), Operations – Gene Therapy is responsible for method transfers; method improvement; method remediation and method validation/verification and/or troubleshooting for commercial products within the Quality Control laboratories. She/he manages oversight of analytical data and all business-related documentation to and from vendors for routine release and stability testing and for post-marketing commitments for clinical and commercial products. In cooperation with Analytical Development, the Senior Manager, AS&T– Gene Therapy is also responsible for assisting with investigating commercial product complaints/issues at all manufacturing sites, internal and external. She/he may have direct reports. She/he works cross-functionally in a matrix management environment that includes, but may not be limited to, Analytical Development (AD), Process Development (PD), Clinical and Commercial Manufacturing, Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, Supply Chain, and Discovery Research. The Senior Manager, AS&T, Operations – Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

Master’s degree in molecular biology, virology, biochemistry, or related field and a minimum of 5 years of relevant and progressively responsible experience in these same areas or Bachelor’s degree with a minimum of 7 years of relevant and progressively responsible experience in these same areas.
Knowledge with the analytical methods used for gene therapy or biologics in-process testing, release testing and characterization, with an emphasis on potency assays.
Strong knowledge of CMC analytical and regulatory requirements.
Demonstrated and applied experience in laboratory operations, including development and adherence to quality metric programs
Demonstrated ability to contribute to departmental budgeting, capex procurement, IQ/OQ, safety, and status reporting to Senior Management.
Applied knowledge of cGMP requirements as they pertain to analytical development and quality control testing.
Knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, and molecular biology techniques.
Experience overseeing clinical or commercial release testing within CROs/CMOs.
Team oriented and able to manage assigned project responsibilities across various development stages.
Hands-on experience writing/reviewing SOPs and/or analytical methods in support of quality systems.
Proficiency with Microsoft Office.
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.
Excellent planning, organization and time-management skills including the ability to support and prioritize multiple projects.

Nice To Haves

Small company and/or start-up experience.
Experience in interactions with domestic and international Regulatory agencies.
Ability to present and interact in cross-functional teams.
Experience in managing statement of work (SOW), purchase orders (PO) and material inventory with external partners.
Certification in CMC technical writing.

Responsibilities

Manages oversight of analytical data and all business-related documentation to and from vendors for routine release and stability testing and for post-marketing commitments for clinical and commercial products.
Supports members of the AS&T team to manage analytical method review and approval, method performance trending, method improvement/ remediation, method versioning and specifications change control in quality systems.
Supports AS&T in continuous current Good Manufacturing Practices (cGMP) analytical improvement projects. This includes, but may not be limited to, ensuring that method SOPs and validation reports are compliant with global regulatory requirements.
Assesses issues with resource management and failure investigation review.
Establishes and manages strategic partnerships for multiple gene therapy programs, organizing timely flow of statement of work (SOW), purchase orders (PO), analytical documents and analytical results/data packages.
Ensure timely scheduling of testing at CTLs (Contract Testing Labs) as well as data and documents from CTLs are organized in internal repositories for multiple gene therapy programs.
May manage, coach and mentor direct reports.
Performs other tasks and assignments as needed and specified by management.