The Senior Manager, Analytical Sciences & 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 laboratories. S/he manages both internal and external programs in the gene therapy space, including but not limited to, stability testing and commercial Drug Substance (DS)/Drug Product (DP) release.
In cooperation with Analytical Development, the Senior Manager, AS&T – Gene Therapy is responsible for investigating commercial product complaints/issues at all manufacturing sites, internal and external.
S/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 – Gene Therapy supports 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 commercial products. This includes, but not limited to, oversight of stability programs, reference standards and post-marketing commitments.
Supports members of the AS&T, AD and QC teams to design experiments evaluating analytical methods associated with commercial products for feasibility, method improvement, remediation, and/or troubleshooting.
Supports the AS&T in 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.
Assists with troubleshooting method and/or equipment issues to the root cause. Assesses issues with resource management and failure investigation review
Supports the AS&T team in resolving non-routine laboratory issues and problems expeditiously.
Provides scientific review and approval of protocols, reports, study design and standard operating procedures.
Actively supports project lead for more than one gene therapy program.
Note: This position can be based at our Hopewell, NJ location, or be home based (EST time zone)
* Minimum level of education and years of relevant work experience.
PhD in molecular biology, virology, biochemistry or related field and a minimum of 6years of progressively responsible experience in biologics/gene therapy Quality Control, MS&T or Analytical team lead on CMC project team, roles OR a Master’s degree in these same disciplines and a minimum of 8years of relevant and progressively responsible experience in these same areas.
* Special knowledge or skills needed and/or licenses or certificates required.
Experience with the analytical methods used for gene therapy 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
Some experience in 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.
Strong laboratory skills for analysis of pharmaceuticals, biopharmaceuticals.
Functional knowledge of mammalian cell culture.
Demonstrated knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, and molecular biology techniques.
Some experience with commercial release testing within CROs/CMOs.
Team oriented and able to manage assigned project responsibilities 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.
Experience in interactions with domestic and international Regulatory agencies.
Ability to make and defend decisions as they relate to QC.
Ability to present and interact in cross-functional forums.
**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.
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.
