(Sr.) Research Associate, Cell Process Development
Beacon Hill Staffing Group

Our Client is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. They are looking for a Research Associate / Sr. Research Associate in Cellular Process Development to support innovative efforts in building clinical manufacturing processes for the company's novel TCR-engineered T cell therapy products. This newly created role will reside within the Technical Development & Manufacturing Team and will work closely with other members in process and analytical development as well as key members of the pre-clinical and discovery teams. Key activities will include the development of cellular manufacturing processes, process scale-up and optimization, IND-enabling activities, and the tech transfer to clinical manufacturing, amongst others.

The ideal candidate will (i) have a background in cellular bioprocessing and exposure to the cGMPs and ICH guidelines related to the manufacture of human cell and gene therapies; (ii) be a steadfast problem solver who is energized by a fast-paced, lean and agile environment; and (iii) be a team player who can foster productive relationships with internal colleagues.

The candidate should have experience in a variety of cell processing instrumentation including target cell isolation platforms, automated cell washing, electroporation systems, controlled rate freezing systems, amongst others, and have experience with culture expansion and cryopreservation systems. Experience with DoE-based experimental design and execution, design of custom aseptic connections / closed fluidics paths, as well as common in-process cellular analytics such as live/dead assays, cell enumeration, and flow cytometry are highly desired. A team player with a sense of urgency will thrive in this role.

Responsibilities:

• Responsible for the execution, interpretation, and presentation of results related to experimental studies
• Support development and optimization of a robust cell manufacturing process to support IND enabling studies and GMP manufacturing
• Implement standardized cellular processes to support our discovery pipeline and serve as a liaison for improving process workflows.
• Author and review of technical documentation to support early stage activities (development reports and supporting documentation for regulatory filings) as well as draft manufacturing documentation to support tech transfer
• Collaborate closely with the manufacturing team to tech transfer the developed process into GMP manufacturing and act as SME during training / process shake-down runs

Requirements:

• BS with 3+ years of relevant industry experience. Degree emphasis in immunology, cell biology, biological sciences, biomedical/chemical engineering or related field is preferred
• Experience developing manufacturing strategies for human primary T cell products is preferred, with focus on cell isolation and culture expansion- related manufacturing challenges
• Scientific creativity, critical thinking, ability to innovate, and analytical problem solving
• Excellent communication skills (both written and oral)
• Experience drafting manufacturing documentation and supporting documentation for regulatory filings is strongly desired.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Find Us on Facebook!

Follow Us on Twitter!

Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.

We look forward to working with you!

Beacon Hill. Employing the Future™