Process Development Scientist

Job Summary: The Process Development Scientist is responsible for designing, developing, and optimizing manufacturing processes to support the scale-up, transfer, and commercialization of biopharmaceutical products. This role involves collaborating cross-functionally with Research, Manufacturing, Quality, and Regulatory teams to ensure robust, reproducible, and compliant processes from early development through commercial production. The ideal candidate will combine deep technical expertise with strong problem-solving and project management skills to deliver innovative solutions that meet project timelines and quality standards.

Key Responsibilities: Design, execute, and analyze experiments to develop, optimize, and scale manufacturing processes for biologics, small molecules, or cell/gene therapies (depending on company focus).Develop assays for biomaterial and cell/biomaterial combination characterization and process validation. Implement and evaluate process improvements to increase yield, reduce costs, and improve product quality. Author and review technical reports, batch records, Standard Operating Procedures (SOPs), and regulatory documentation. Support technology transfer activities to internal manufacturing sites or external contract manufacturing organizations (CMOs/CDMOs).Apply statistical tools and Quality by Design (QbD) principles to process characterization and validation. Collaborate closely with cross-functional teams to align development activities with project goals, timelines, and regulatory requirements. Troubleshoot process-related issues during development, scale-up, and manufacturing campaigns. Maintain detailed and accurate laboratory records in compliance with Good Documentation Practices (GDP).Stay current with industry trends, regulatory guidance, and emerging technologies in process development.

Qualifications: PhD in BioEngineering, Chemical Engineering, Cell Biology, Molecular Biology, or related field; or MS/BS with significant (4+ years) industry experience.1–4+ years of experience in process development within the biopharmaceutical industry (early- to late-stage development).Hands-on experience with upstream (cell culture/) and/or downstream (purification) processes. Familiarity with cGMP regulations and technology transfer best practices. Strong data analysis skills and proficiency with statistical software (e.g., JMP, Minitab).Excellent written and verbal communication skills. Ability to work both independently and collaboratively in a fast-paced environment.

Preferred Skills: Experience with single-use technologies and process automation. Prior exposure to regulatory submissions (IND, BLA, NDA, etc.).Knowledge of PAT (Process Analytical Technology) and cell-based products. Experience with automated cell processing platforms (e.g., CliniMACS Prodigy, Cocoon, Quantum).Prior involvement in process validation and regulatory submissions for cell & gene therapy products. Experience in cell engineering, including cell cloning. RBL LLC is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other protected characteristic as defined by applicable laws. If you require reasonable accommodation during the application or hiring process, please contact hr@rbl-llc.com.