Process Development Scientist

Key Responsibilities

• Design and execute complex process development efforts using genomic and epigenomic engineering tools and platforms.
• Analyze, interpret, organize, and present data to internal and external groups in clear and concise manner.
• Author and review experimental proposals, SOPs, and technical reports for scientific publications and regulatory filings.
• Ensure data integrity, maintain laboratory records, and prepare protocols and reports in a GMP-compliant manner.
• Work closely with internal and external partners to support technology transfers and implementation of new process technologies.
• Collaborate with and participate in teams to facilitate IND-enabling studies.
• Participate in GMP manufacturing campaigns for in-house products.

Required Qualifications

• For Associate Specialists - A Master’s degree (or equivalent degree) in Immunology, Biological Sciences, Biomedical Engineering, or related field or five to ten years of relevant experience is required.
• For Full Specialist – A PhD (or equivalent degree) in Immunology, Biological Sciences, Biomedical Engineering, or related field or ten or more years of relevant experience is required.
• Working knowledge of basic scientific principles and methods in order to independently design and perform experiments of moderate scope and complexity.
• Hands-on experience with aseptic tissue culture techniques and flow cytometry.
• Experience with genome editing techniques (e.g. CRISPR/Cas9 editing, base editing, prime editing, etc.).
• Experience working with GMP-compatible or automated cell processing platforms and equipment (e.g., electroporation systems, closed-system cell processing devices, automated cell culture or cell washing platforms).
• Organizational abilities and decision-making to prioritize work assignments.
• Effective written and verbal communication skills with internal and external collaborators.
• Ability to work in a collaborative manner, to assist in identifying any challenges or barriers.

Preferred Qualifications

• Familiarity with Design of Experiments (DoE) approaches for process optimization.
• Experience working in regulated environments supporting IND-enabling studies, process qualification, or clinical manufacturing.
• Experience with analytical methods such as flow cytometry, ddPCR/qPCR, or next-generation sequencing for characterization of edited cells.

Document Requirements

• Curriculum Vitae - CV must clearly list current and/or pending qualifications (e.g. board eligibility/certification, medical licensure, etc.).
• Cover Letter
• Reference Requirements 3 required (contact information only)