Process Dev Engineering Senior Scientist, Media Development

Vertex Inc.•Boston, MA

2d•Onsite

About The Position

Cell, gene and biologic therapies are rapidly growing parts of Vertex Pharmaceuticals, where research, development, and clinical manufacturing are highly integrated together at our new R&D site in Boston Seaport. Vertex is seeking a talented individual to join our Process Development team to support media development and optimization efforts. The focus of this position is to support advancement of the innovative stem cell culture medium development and optimization for cell and gene therapy applications. This position will collaborate with cross functional teams to advance media optimizations to enable process scaling, cost of goods reduction, and process robustness improvement through fundamental process understanding. The ideal candidate has deep expertise in media development and optimization, fundamental cell culture process understanding, thrive in a fast-paced environment and proven ability to perform under pressure. The position will be based in Boston, MA.

Requirements

Degree in relevant engineering or scientific discipline (e.g., chemical or biochemical engineering, natural or life sciences).
PhD with 2-5 years of relevant industry work experience, or a MS with 6-9 years of relevant industry experience, or a BS with 8-11 years of industry experience.
Strong fundamental knowledge in cell culture metabolism and biological pathways, and extensive experience of medium development (stem cell culture experience is preferred)
In-depth understanding and extensive experience of cell culture process development, perfusion process development, and bioreactors across scales.
Extensive knowledge and experience on raw material control and sourcing considerations.
Solid knowledge and experience with statistical principles and design of experiments (DOE).
Must have a working knowledge of cGMP.
Excellent verbal and written communication skills.
Ability to handle multiple tasks while meeting timelines and adapting to changing priorities.
Strong people skills and ability to work with diverse team dynamics, and potential in the future to manage a team.
Excellent organizational skills and high attention to detail.
Strong people skills and ability to work with diverse teams.
Participate in weekend work rotation with the broader team.
Authorized to work in the US.

Nice To Haves

Experience with high throughput and automated cell culture platforms is highly preferred.

Responsibilities

Develop robust and cost effective cell culture media for commercial scale manufacturing.
Define and implement technical roadmaps for media development and optimization, ensuring alignment with business priorities and leadership strategy.
Troubleshoot complex raw material sourcing and control challenges, with a strong understanding of GMP, regulatory, and quality requirements.
Develop and optimize high-throughput, small-scale media screening toolboxes to enhance media development processes.
Stay up to date with emerging analytical tools, omics technologies and scientific advancements to drive hypothesis guided media optimization.
Generate and review technical reports, regulatory filings, source documents, patents and external publications.
Support media preparation protocol transfer to pilot team, and support GMP manufacturing tech transfer.
Foster strong partnerships with internal and external stakeholders, proactively managing relationships to ensure alignment and efficient execution.
Potential of managing or mentoring a small group of junior level employees.
Lead by example, work closely with the team in the lab and conduct hands-on experiments.
Foster a culture of innovation and continuous improvement.