Senior Scientist, Process Development

Obsidian Therapeutics • Cambridge, MA

20h

About The Position

The Senior Scientist, Process Development is a key role within our Technical Operations group and will be responsible for leading critical workstreams within Process Development and CMC teams. We’re looking for a leader to contribute to process characterization and late phase process development of the first autologous cell therapy product in our pipeline targeting cancer. Working collaboratively within the Process Development team and in partnership with Analytical Development you’ll lead aspects of optimizing and understanding the TIL manufacturing process. You’ll be a vital part of a highly collaborative and mission driven team working to deliver OBX-115 to patients and achieve Obsidian’s vision of translating innovative science into medical breakthroughs. This is a unique opportunity to contribute to advancing a novel cell therapy that has the potential to become a meaningful option for patients with advanced or metastatic melanoma and other solid tumors. Supported by blue chip investors, field-leading advisors, best-in-class partners, and an experienced team, you'll be part of a dynamic, innovative, passionate, and collaborative team.

Requirements

• PhD in a relevant discipline (chemical or biomedical engineering, immunology, cell biology, or related field) with a minimum of 3+ years of relevant industry experience including prior direct experience in cell therapy development with a progressive track record of leadership and impact (or MS and 10+ years of relevant industry experience).
• Expertise in cell therapy process development.
• Experience supporting late-stage development and process characterization, preferably in cell therapy.
• Deep subject matter expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scale-up/down, cell biology/physiology
• Strong working knowledge of cGMP and quality systems requirements.
• Excellent oral and written communication skills

Nice To Haves

• Experience transferring processing to and/or working with CDMOs is a plus

Responsibilities

• Design, plan, and execute process development and characterization experiments, working both independently and as part of a highly collaborative PD team.
• Provide leadership within PD, helping to train and mentor junior scientists on experiment design and data analysis with appropriate scientific rigor and proper documentation.
• Interpret results, troubleshoot technical hurdles, and propose solutions to the team.
• Maintain excellent records of experiments, including Electronic Notebook entries.
• Author and review technical and scientific documents including but not limited to study protocols and reports.
• Collaborate effectively across the Obsidian organization, present internally to project teams, management, scientific teams, and external partners.
• Establish strong relationships with internal and external stakeholders, including Analytical Development, MSAT, Research, CMC team, partners, and CDMOs.
• Represent the Process Development function as a subject matter expert as needed for regulatory interaction and author relevant CMC sections in regulatory documents.

Benefits

• Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level.
• We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees