In this newly created role, the Scientist , Formulation, Fill & Finish Process Development (PD) – Gene Therapy actively contributes to the development of formulation and drug product processes for gene therapy vector production. This includes establishing robust fill and finish processes for Gene Therapies using sound DOE design and execution.
This individual contributes to the design, and actively executes, experimental studies from lab scale through full clinical and commercial scale. S/he may also function as PTC’s Person in the Plant (PIP). In this capacity, s/he may provide Subject Matter Expertise (SME) for external, Contract Development Manufacturing Organizations (CDMOs)-executed processes to ensure their proper execution. S/he interacts with Downstream Process Development, Analytical Development and Manufacturing personnel to deliver high-quality and robust fill/finish processes in a regulated environment.
The incumbent works cross-functionally with internal departments and external resources as appropriate on downstream process development-related issues.
The Scientist , Formulation, Fill & Finish Process Development – Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Actively contributes to formulation and drug product process development activities for both internal and external projects, including formulation screening, development, characterization, and stability, as well as drug product fill/finish automation, visual inspection, labeling, and freezing.
May function as the PIP at CDMOs to monitor, and assist with, on-going formulation and drug product process development and execution activities.
Contributes to the design and execution of small-scale DOE studies to support the development and optimization of robust fill/finish processes with optimal product quality and stability.
Applies experience with various formulations for viral vector or vaccine products and drug product bioprocessing equipment to gene therapy drug product manufacturing.
Works closely with Clinical Manufacturing to transfer and scale-up drug product processes from PD to manufacturing. May write reports and train manufacturing personnel as required.
Works with Analytical Development to build the scientific knowledge, capabilities, and strategies in gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization.
Actively contributes to writing and/or QC review of relevant sections of global regulatory filings. These include, but may not be limited to, INDs, BLAs and ex-US filings.
Note: This position will initially be based at our Bridgewater, NJ facility, and will mve to Hopewell, NJ the third quarter of 2020.
* Minimum level of education and years of relevant work experience.
A PhD in Chemical or Biochemical Engineering, Pharmaceutical Technology, Biochemistry or other relevant discipline and a minimum of 2 years of progressively responsible experience in biologics and/or gene therapy process development roles OR a Master’s degree in these same disciplines and a minimum of 5 years of relevant experience OR a Bachelor’s degree in these same disciplines and a minimum of 7 years of relevant experience.
* Special knowledge or skills needed and/or licenses or certificates required.
Expert level knowledge of GMP requirements as they pertain to liquid or lyophilized drug product process development and clinical manufacturing for vaccines, biologics, or gene therapy products
Demonstrated, applied knowledge of CMC and regulatory requirements, including the development of process and product specifications and writing and reviewing development reports.
Demonstrated, hands-on experience overseeing and conducting technology transfer-in and transfer-out of drug product manufacturing processes in all phases of development.
Significant experience in laboratory operations, including budgeting, capex procurement and I/O/Q, safety, and status reporting to Senior Management is preferred.
Understanding of analytical instrumentation used in formulation development, such as UV spectrophotometry, fluorescence, light scattering, DSC, SEC, capillary electrophoresis, microflow imaging, etc.
Demonstrated ability to lead drug product process development activities conducted by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs).
Proficiency with Microsoft Office.
Excellent verbal 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.
Demonstrated experience developing, executing and documenting process validation protocols and validation activities in support of regulatory filings.
Experience with downstream purification of biological molecules such as preparative chromatography and tangential flow filtration is a plus.
Small company and/or start-up experience.
Experience in high-level interactions with domestic and international Regulatory agencies
Ability to make and defend high-level decisions as they relate to drug product processes
Ability to present to and interact with Senior Leadership
* Travel requirements
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.