Associate Director, Analytical Sciences & Technology - Gene Therapy (NJ or Northeast/Mid Atlantic remote based) at PTC Therapeutics, Inc. in Pennington, New Jersey

Job Description:

Job Description Summary:

Job Description:

In this newly created role, the Associate Director, Analytical Science & Technology (AS&T) – 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 (QC) laboratories.  S/he manages both internal and external gene therapy programs, including but not limited to, stability testing and commercial Drug Substance (DS)/Drug Product (DP) release.

In cooperation with Analytical Development, the Associate Director, AS&T – Gene Therapy is responsible for investigating commercial product complaints/issues at all manufacturing sites, internal and external.  

S/he will be highly interactive and function at a high level in a matrix management environment that includes, but may not be limited to, Analytical Development, Process Development, Clinical and Commercial Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, and Discovery Research.

The Associate Director, AS&T – Gene Therapy ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:

• Monitors and manages the life cycle of assigned analytical methods supporting clinical and commercial products. This includes, but not limited to, oversight of stability programs, reference standards and post-marketing commitments.

• Designs, conducts and oversees experiments evaluating analytical methods associated with clinical and commercial products for feasibility, method improvement, remediation, and/or troubleshooting.

• Actively collaborates with members of the AS&T, AD and QC teams to manage analytical method review and approval, method performance trending, method improvement/ remediation, method versioning and specifications change control in quality systems.

• Troubleshoots method and/or equipment issues to the root cause.  Assesses issues with resource management and failure investigation review.

• Leads continuous cGMP analytical improvement projects. This includes, but may not be limited to, constant state of validation, improvement of methods and sustaining compliance with global requirements.

• Resolves non-routine laboratory issues and problems expeditiously.

• Provides scientific review and approval of protocols, reports, study design and standard operating procedures.

• Working in close collaboration with CMC Project Management, acts as the AS&T project leader for assigned gene therapy programs

Note: This position can be based out of our Hopewell, NJ site or will consider candidates in the Northeast/Mid Atlantic US regions (home based) which would include business travel to NJ as required.

* Minimum level of education and years of relevant work experience.

• PhD in molecular biology, virology, biochemistry or related field and a minimum of 7 years of progressively responsible experience in biologics/gene therapy Quality Control, MS&T or AS&T roles OR a Master’s degree in these same disciplines and a minimum of 9 years of relevant and progressively responsible experience in these same areas.

* Special knowledge or skills needed and/or licenses or certificates required.

• Comprehensive experience with the analytical methods used for gene therapy or biologics in-process testing, release testing and characterization, with an emphasis on potency assays.

• Expert level knowledge of CMC analytical and regulatory requirements.

• Significant and applied experience in laboratory operations, including development and adherence to quality metric programs

• Experience in departmental budgeting, capex procurement, IQ/OQ, safety, and status reporting to Senior Management.

• Expert level knowledge of cGMP requirements as they pertain to analytical development, method validation, technology transfer and quality control testing.

• Expert level laboratory skills for analysis of pharmaceuticals, biopharmaceuticals.

• Functional knowledge of mammalian cell culture.

• Experience in performing cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, and molecular biology techniques.

• Prior experience the clinical and commercial release testing within CROs/CMOs.

• Team oriented and able to manage multiple projects across various development stages.

• 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.

*Special knowledge or skills and/or licenses or certificates preferred.

• Small company and/or start-up experience.

• Demonstrated experience in performing mass spectrometry or molecular characterization techniques.

• Experience in high-level interactions with domestic and international Regulatory agencies.

• Ability to make and defend high-level decisions as they relate to Quality Control.

• Ability to present to and interact with Senior Leadership.

*Travel

• Up to 15%

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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