Associate Scientist/Engineer II Technology, Development and Operations - Chemistry

Prime Medicine•Cambridge, MA

8d•Onsite

About The Position

Prime Medicine is actively seeking a talented and highly motivated Associate Scientist/Engineer II to join our RNA chemistry team. The individual will work with scientists and engineers in Technology, Development and Operations (TDO), CMC teams, scientists across various functions at Prime Medicine, as well as external partners to support the development, optimization, and tech transfer of a manufacturing process for Prime Editing. This is a hands-on role where the successful candidate will be directly involved in a range of process development and manufacturing activities on the highest priority projects. This is an exciting opportunity to work at the intersection of chemistry, biology, cell/bioprocessing, bioengineering, and clinical manufacturing to advance genetic medicine. The ideal candidate will excel as a member of a cross-functional team that works closely with colleagues in Research, Technical Development, Supply Chain/External Manufacturing, and Quality to advance Prime’s pipeline.

Requirements

BS or MS in biotechnology, engineering, chemistry, biochemistry, or related life science discipline with ideally 3+ years (BS) or 1+ years (MS) of relevant industry experience in biotech/biopharma.
Experience in chemistry process development of complex biomolecules; experience in oligonucleotide synthesis or downstream purification is a plus
Fast learner with a proven ability to understand process development unit operations understanding from first principles and operationally, and to set up and run equipment and instrumentation.
Prior hands-on experience with equipment and unit operations typically used in process development and manufacture of RNA is preferred
Experience working in a GMP manufacturing environment, including equipment qualification, investigation and troubleshooting, and operations.
Prior experience developing and writing standard operating procedures and draft batch records is a plus
Working knowledge of statistical software (e.g., JMP) for process analysis, and data visualization
Strong written and verbal communication skills
Able to manage time effectively and escalate relevant issues to other team members and team lead and/or manager.
Highly self-motivated, and driven, with a can-do attitude and the ability to reliably meet and exceed expectations.
Capable of continuous learning, open-minded, curious, highly organized, and detail-oriented
Able to work both independently and collaboratively in a fast-paced, dynamic, entrepreneurial, and team-based setting; passionate about helping patients

Nice To Haves

Experience in chemistry process development of complex biomolecules; experience in oligonucleotide synthesis or downstream purification is a plus
Prior hands-on experience with equipment and unit operations typically used in process development and manufacture of RNA is preferred
Prior experience developing and writing standard operating procedures and draft batch records is a plus

Responsibilities

Perform routine and non-routine responsibilities for solid-phase chemical synthesis of long guide RNA and downstream purification including chromatography, TFF and lyophilization at different scales using various state-of-the-art laboratory equipment
Work together with team members to discuss technical and analytical findings and incorporate into the process design for manufacturing implementation
Conduct hands-on manufacturing of IND-enabling and GLP/GMP RNA guides to support various Prime Editing programs as part of the chemistry team.
Author technical reports, standard operating procedures, draft batch records, and sections for regulatory submissions
Organize and present experimental data in both written and oral format at the cross-functional team meetings
Maintain various lab instruments such as ÄKTA synthesizers, AKTA purifiers, preparative scale HPLC, TFF skids, etc, in good operational conditions
Be willing to take accountability for helping the team to ensure goals and deliverables are achieved, and functional needs are met by carrying out all experiments and completing all technical reports in a timely manner
Apply AI tools in CMC work to make processes better, faster, and cheaper.
Support new technology evaluations with emphasis on product quality, productivity and/or process robustness
Keep meticulous experimental records in an electronic lab notebook
Critically evaluate experimental data and communicate scientific findings in oral presentations and written reports, including protocols, and technical reports in team settings, and at company R&D meetings.