MSAT Sr Engineer/Scientist - Bioconjugation

• Adhere to all GDP, GLP, and cGMP requirements as well as Abzena policies, procedures, and mission while fulfilling duties, responsibilities, and tasks.
• Demonstrate working knowledge of USP, 21 CFR, and ICH guidelines applicable to bioconjugation and cGMP manufacturing.
• Serve as the MSAT subject matter expert (SME) for bioconjugation processes including ADCs and AOCs across early development through commercial lifecycle stages.
• Provide technical leadership for technology transfer from internal or external process development teams into cGMP manufacturing, including facility fit assessments, scale up planning, and risk assessments.
• Lead technology transfer of bioconjugation processes into cGMP manufacturing from internal teams and external development partners.
• Author and revise cGMP batch records and master batch production documents for early phase, late phase, and commercial programs.
• Draft and maintain cGMP documentation, including BOMs, specifications, SOPs, technology transfer documents, PFDs, and P and IDs, as required to support execution and readiness.
• Lead or support process investigations, deviations, CAPAs, and root cause analysis related to conjugation, UF/DF, and chromatography operations.
• Provide in-person and real-time manufacturing production support required for project success.
• Drive continuous improvement initiatives related to process robustness, documentation, and manufacturing efficiency. Including compatibility and assembly strategy for single use components, including connector selection, weld and seal parameters, and failure modes. Drive assembly standardization across programs to reduce execution risk.
• High potency and containment alignment, translate OEB controls into practical manufacturing requirements for equipment, PPE, waste, and cleaning. Lead cross functional reviews with EHS, Facilities, and QA for campaign readiness
• Technical training and knowledge management. Develop training content for new processes, new equipment, and new batch record revisions. Maintain a living knowledge package per program, including lessons learned, known failure modes, and standard responses.
• Design and implement process characterization, scale-up, and control strategies in collaboration with PD, Manufacturing, and QA/QC teams.
• Maintain a strong working knowledge of cGMP raw materials, consumables, assemblies, in-process materials, designs, and part numbers to complete detailed cGMP records.
• Participate in or lead PPQ campaigns, including planning, execution support, and regulatory documentation contributions.
• Control strategy ownership, define and maintain the process control strategy, including CPP setpoints, acceptable ranges, sampling plans, and in-process controls.
• Support regulatory inspections, client audits, and due diligence activities as the MSAT technical lead for assigned programs.
• Contribute to cross-functional project teams to deliver clinical and commercial batches of bioconjugates on time and within scope.
• Demonstrates technical proficiency, scientific creativity, and collaboration with others.
• Operate to the highest ethical and moral standards.
• Ability to multi-task, supporting multiple projects simultaneously ensuring all deadlines are on budget and on time.
• Discuss and present manufacturing campaign data and analysis to internal project teams and respective clients
• Perform other duties as assigned.
• This is a senior level individual contributor position with future plans to expand into a manager level MSAT role with oversight of Bioconjugation technology transfers.

• PhD or MS in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline
• 5+ years of experience in biopharma MSAT or technical operations, with a focus on ADC and/or AOC processes.

Knowledge

• Proven track record in both development and commercial-stage support, including batch record authorship and process documentation.
• Working knowledge of GMP operations, including manufacturing floor support, deviation resolution, and change control.
• Knowledge and skill with aseptic technique required: BSC Operations, and aseptic processing, including welding/sealing and/or single use sterile connectors
• Hands-on experience with conjugation chemistries, tangential flow filtration (TFF), Protein A, ion exchange (IEX), and hydrophobic interaction chromatography (HIC).
• Strong understanding of Microsoft Office Suite including basic functions and graphing within Microsoft Excel
• Familiarity with semi/fully automated manufacturing equipment
• Proven ability to troubleshoot bioprocess operations and equipment.
• Understanding of relevant analytical, processing, and scale-up calculations.
• Proven ability to build, modify, and utilize digital data storage, visualization, and analysis systems/tools.
• Strong interpersonal and communication skills, with the ability to interface effectively with cross-functional teams and clients

Preferred Qualifications:

• Experience with Contact Development and Manufacturing Organizations (CDMOs)
• Experience with high-potency APIs and handling OEB 4–5 level materials.
• Familiarity with process validation (PPQ), commercial tech transfer, and lifecycle management.
• Understanding of ICH, FDA, and EMA regulatory expectations for complex biologics and bioconjugates.