Senior Engineer, Gene Therapy Upstream Process Development job in Burlington, USA

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

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Job type: Permanent

Discipline: Design, Project Management, Operations Management

Location: United States

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Proclinical is seeking a Senior Engineer, Gene Therapy Upstream Process Development for a leading biotech company located in Burlington, MA.

The Senior Engineer will actively contribute to the internal and external development of upstream processes for viral vector production to combat genetic disorders. This individual will be supporting portfolio projects by designing and executing process development studies to systematically optimize cell growth, transfection, and the production phase of the cell culture.

Must be eligible to work in the US.

Job Responsibilities:

With minimal supervision, designs and executes studies in shake flasks and benchtop scale bioreactors to systematically study upstream process parameters. Builds in-depth process understanding to develop upstream process for clinical and commercial phase projects.
Works with cross-functional stakeholders to transfer, integrate and align process details. Identifies knowledge gaps and rationally proposes study design and timeline.
Analyzes study results and integrates feedback to make data-driven conclusions and process decisions.
Authors and reviews key process documents, including process descriptions, process flow diagrams, technical reports, batch records, SOPs, patent applications as appropriate.
Leads the evaluation of innovative technologies, such as AMBR bioreactors; oversee the ordering, installation, maintenance, and calibration of lab equipment.
Contributes to cross-functional operational improvement, laboratory organization, staff recruitment and training.

Skills and Requirements:

B.S. or M.S. in life sciences or engineering with 5-8 years (B.S.) or 2-5 years (M.S.) of industry experience in upstream process development for biologics.
Hands-on experience with bioreactor operation and troubleshooting for suspension cell culture.
Familiar with the operation of common laboratory equipment (ie. cell counters, osmometers, blood-gas analyzers, metabolite analyzers) and the proper GXP data documentation processes.
Attention to details and a can-do attitude for problem-solving.
Excellent written/verbal communication and time management skills
Demonstrated ability to analyze data, design and execute studies independently or as part of a team, manage project resource/timeline and elevate relevant issues timely.
Good data organization and presentation skills. Familiar with JMP, EXCEL, PowerPoint, SIMCA or programming languages.
Strong team player who consistently exemplifies company values: patient-first, action, unconventional thinking, talent, and integrity.
Support weekend work and handle up to 15-20 kgs occasionally.
Prior experience in drug substance development and technology transfer is strongly preferred.
Hands-on experience with automated bioreactors, such as AMBR15 or AMBR250.
Familiar with transient transfection, cell banking or media preparation.
Good understanding of risk assessments, such as facility fit analysis, fish bone, FMEA, CAPA.

If you are having difficulty in applying or if you have any questions, please contact Jessika Rodriguez at +(1) 617-391-0929 or j.rodriguez@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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