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Process Development Scientist – Cell Therapy

A growing biotechnology organization is seeking a **Process Development Scientist** to support the advancement of a **late-stage cell therapy program** . This role is responsible for developing and optimizing scalable, reproducible, and robust manufacturing processes to support clinical and future commercial production of a novel cell-based therapeutic.

The position offers a dynamic and collaborative environment where you’ll work cross-functionally to translate lab-scale methods into GMP-compliant manufacturing processes for human therapeutic use.

Salary: $80,000/year

No relocation assistance offered for non-local candidates

Key Responsibilities

Qualifications

+ Design and execute experiments for process development and optimization, including **cell expansion** , **purification** , **formulation** , and **cryopreservation** .

+ Analyze data, interpret results, and contribute to technical documentation including protocols and study reports.

+ Identify and implement **process improvements** aimed at increasing efficiency, reducing cost, and ensuring product quality.

+ Collaborate with **internal manufacturing teams and external partners** to support **technology transfer** and GMP production.

+ Conduct **process risk assessments** (e.g., FMEA), and define or validate **critical process parameters (CPPs)** .

+ Utilize **QbD principles** , including **Design of Experiments (DoE)** and statistical tools, to drive robust process design.

+ Remain current on trends and innovations in **cell therapy** , **bioprocessing** , and relevant regulatory developments.

+ Support internal knowledge sharing and, where appropriate, contribute to scientific communications.

+ Degree in **Biological Sciences** , **Bioengineering** , **Biochemical Engineering** , or a related field.

+ **PhD** with 2+ years

+ **MS** with 8+ years

+ **BS** with 12+ years

+ Strong hands-on experience with **cell culture** , **cell selection** , and **cell purification** techniques.

+ Proven contributions to **process development** and successful **technology transfer** into GMP manufacturing.

+ Familiarity with analytical methods such as **flow cytometry** , **PCR** , **ELISA** , and **cell counting/viability assays** .

+ Strong problem-solving skills and experience troubleshooting cell-based manufacturing challenges.

+ Clear and concise communication skills, both written and verbal.

+ Ability to work independently and collaboratively in a **fast-paced** , **cross-functional** environment.

Preferred Qualifications

+ Experience supporting or preparing **regulatory filings** (e.g., IND, BLA).

+ Knowledge of **GMP regulations** and regulatory expectations in the cell therapy space.

+ Proficiency with data analysis tools such as **JMP** , **Minitab** , or equivalent.

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