Sr. Engineer for a clinical-stage mRNA innovation company focused on bacterial diseases.

Summary:

Sr. Engineer with experience in Process Characterization (PC) and Process Validation (PV) Stage 1&2 to join the Conjugation process team. The Engineer will manage PC strategy for the Conjugation portion of the manufacturing process that will enable a timely and successful PPQ campaign. The engineer will also be responsible for CMO oversight.

Essential Functions:

• Define the scope and strategy of late-stage process development activities such as process characterization and development of scale-down models.
• In conjunction with CMO, help to define the scope and strategy of PPQ activities.
• Take the lead in scale-up activities to support manufacture of Phase 3 and Commercial scale quantities of the org's Conjugate Drug Substances.
• In conjunction with CMO, identify and implement the appropriate equipment required to perform late-stage manufacturing.
• Contribute to CMO Manufacturing oversight via document review, person in plant responsibilities, and troubleshooting when necessary.
• Facilitate cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs.
• Present/communicate data to the Conjugation Development team as well as broader CMC team.
• Serve as a guide and mentor to junior team members.

Requirements:

• PhD in Chemical/Biochemical Engineering or similar, with 2+ years of industry experience; MS with 5+ years of industry experience; or BS with 10+ years of industry experience.
• Experience with and theoretical knowledge of engineering principles involved in scaling processes from development lab to pilot / manufacturing plant.
• Knowledge of the requirements of GMP manufacturing, preferably with hands on GMP experience through either a Manufacturing or MSAT role.
• Experience working with CMOs highly desired; ability to effectively transfer processes to CMO, and to oversee development and manufacturing activities performed at CMO; ability to travel to CMO (some international travel required) to perform person-in-plant oversight activities.
• Principals of DoE (Design of Experiments); practical experience with DoE software; proficient in the design and interpretation of statistically modelled experiments.
• :ate-stage process development activities such as risk assessments (e.g., FMEA) and identification of CPPs and CQAs is a plus.
• Experience writing IND sections is a plus.
• Bioconjugate or protein purification knowledge and experience, including expertise in tangential flow filtration (TFF), process scaling and optimization, and reactor scale up is a plus.
• Strong interpersonal skills, with excellent written and verbal communication skills.

Reports to: Associate Director, Clinical Manufacturing & Conjugation Development