Associate Scientist, Upstream Process Development

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Job description

Job Description Summary:

Job Description:

The Associate Scientist , Upstream Process Development (PD) - Gene Therapy actively contributes to the execution of upstream process development activities for gene therapy vector production. This includes, but may not be limited to, cell and virus culture development and Design Of Experiment (DOE) execution.

This individual executes scale-up studies from pilot through full clinical and commercial scale and interacts extensively with downstream Process Development, Analytical Development and Manufacturing personnel to deliver high-quality and robust upstream processes in a regulated environment.

The incumbent works cross-functionally with internal departments and external resources as appropriate on upstream process development-related issues.

The Associate Scientist , Upstream Process Development - Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:

* Actively contributes to upstream process development activities for both internal and external projects.
* Assists with on-going upstream process development and execution activities at CDMOs as appropriate.
* Applies experience with single-use bioprocessing equipment and its application to gene therapy upstream process development and GMP manufacturing.
* Works closely with Clinical Manufacturing to transfer upstream processes from PD to manufacturing, as appropriate.
* Supports scale-up of upstream processes and writes reports as required.
* May collaborate with Analytical Development to support upstream 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
* 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.
* Demonstrated ability to apply GLP and GMP requirements as they pertain to upstream process development and clinical manufacturing for gene therapy products.
* Demonstrated ability to perform and document process validation protocols and validation activities in support of regulatory filings.
* Knowledge of CMC and regulatory requirements, 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 upstream gene therapy manufacturing processes in all phases of development.
* Ability to support upstream 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.
* Experience in GMP upstream, downstream clinical manufacturing and small-scale product filling.
* Knowledge of mammalian and insect cell culture, virology, and associated upstream processes.
* Small company and/or start-up experience.

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.

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