In this newly created position the BS/MS Research Associate, Downstream Process Development (PD) – Gene Therapy actively contributes to the execution of downstream process development activities for gene therapy vector production. This includes, but may not be limited to, cell and virus culture product purification and downstream Design Of Experiment (DOE) execution.
This individual also supports scale-up process and tech transfer from lab/pilot scale through full clinical and commercial scale and interacts extensively with Upstream Process Development, Analytical Development and Manufacturing personnel to deliver high-quality and robust downstream 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 BS/MS Research Associate, Downstream Process Development – Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Actively contributes to downstream process development activities for both internal and external projects.
Assists with on-going downstream process development and execution activities at CDMOs as appropriate.
Performs small-scale purification activities to support scale-up of gene therapy-based processes, including centrifugation, depth filtration, UF/DF, and chromatography.
Applies experience with single-use bioprocessing equipment and its application to gene therapy downstream process development and GMP manufacturing.
Works closely with Clinical Manufacturing to transfer downstream processes from PD to manufacturing, as appropriate.
Supports scale-up of downstream processes and writes reports as required.
May collaborate with Analytical Development to support downstream process understanding and design space via design and execution of in-process testing and control assays.
Actively contributes to, and assures the effective execution of, science-driven, phase appropriate, and risk-based process development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
May provide support for activities associated with writing and/or QC reviewing of relevant sections of global regulatory filings. These include, but may not be limited to, INDs, BLAs and ex-US filings
Note: This position initially will be located at our Bridgewater, NJ site, moving to Hopewell NJ during the third quarter of 2020.
* Minimum level of education and years of relevant work experience.
A Master’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant scientific discipline and a minimum of 1 year of progressively responsible experience in biologics and/or gene therapy process development roles OR a Bachelor’s degree in these same disciplines and a minimum of 3 years of relevant experience.
* Special knowledge or skills needed and/or licenses or certificates required.
Hands-on experience with centrifugation, depth filtration, UF/DF, chromatography, or other technologies used to filter or purify viral vectors, vaccines, or biologics.
Demonstrated ability to apply GLP and GMP requirements as they pertain to downstream process development and clinical manufacturing for gene therapy products.
Demonstrated ability to perform and document process developmentvalidation protocols and validation activities in support of regulatory filings.
Knowledge of CMC and regulatory expectationsrequirements, including the development of process and product specifications and writing and reviewing process development reports.
Ability to support technology transfer-in and transfer-out of downstream gene therapy manufacturing processes in all phases of development.
Ability to support downstream process development activities conducted by Contract Development and Research Organizations (CROs)/Contract Manufacturing Organizations (CDMOs).
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.
Experience in GMP upstream, downstream clinical manufacturing and small-scale product filling.
Knowledge of mammalian and insect cell culture, virology, and associated upstream processes.
Knowledge of viral vector analytical techniques, such as qPCR, ELISA, SDS-PAGE, and cell-based assays
Small company and/or start-up experience.
* 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.