Sr Manager, Bioconjugation Development

Responsibilities

People Leadership, Coaching, and Performance  

• Lead, coach, and develop direct reports, including Principal Scientists and other scientific staff, through clear objectives, regular feedback, development planning, and differentiated accountability.  

• Establish clear expectations for scientific quality, execution discipline, collaboration, customer focus, and ownership; address performance or behavioral gaps promptly and constructively.  

• Build technical depth and succession capability through mentoring, knowledge sharing, cross-training, and purposeful delegation.  

• Plan and allocate resources across assigned programs, balancing customer commitments, technical risk, laboratory capacity, and employee development.  

• Create an inclusive, respectful, and high-accountability team environment in which issues are surfaced early and resolved at the appropriate level.  

Program and Customer Leadership  

• Lead end-to-end execution of assigned bioconjugation Process Development programs across conjugation chemistry, downstream purification, scale-up, process analytics, technology transfer, and manufacturing support.  

• Serve as the primary scientific and technical point of contact for assigned customer programs; communicate program status, data, conclusions, recommendations, risks, decisions, and mitigation plans with clarity and credibility.  

• Coordinate cross-functional teams spanning Analytical Services, MSAT, Manufacturing, Quality, Regulatory Affairs, Project Management, and other functions to deliver integrated program outcomes.  

• Establish development strategies, technical milestones, decision points, and program priorities; ensure effective use of resources and timely escalation of risks or scope changes.  

• Drive proactive issue resolution using structured data review, root-cause thinking, risk assessment, and documented action plans.  

• Ensure successful scale-up, technology transfer, and manufacturing support, including readiness assessments, process risk reviews, training, and review of master batch records and supporting technical documentation.  

Scientific and Technical Leadership  

• Apply strong understanding of bioconjugation chemistry and bioprocess engineering and provide scientific direction for the development of robust, reproducible, scalable, and manufacturable bioconjugation and purification processes.  

• Guide experimental strategy, including use of design of experiments (DoE), process characterization, critical process parameter evaluation, scale-down models, and phase-appropriate control strategies.  

• Ensure technical conclusions and recommendations are evidence-based, appropriately qualified, and connected to customer, quality, regulatory, and manufacturing requirements.  

• Champion platform technologies, standard work, process improvements, and innovative approaches that improve robustness, speed, reproducibility, and knowledge transfer.  

• Provide on-the-floor or in-lab scientific support for complex development, scale-up, technology transfer, and manufacturing activities as needed.  

Documentation, Data, Safety, and Laboratory Standards  

• Own team adherence to approved procedures, protocols, SOPs, and established development workflows; verify that work is performed as written and that deviations are identified, escalated, and addressed.  

• Ensure laboratory notebooks, electronic records, protocols, development reports, batch records, technical presentations, and other documents are complete, accurate, contemporaneous, traceable, and reviewed on time.  

• Raise the standard of data analysis and reporting by requiring appropriate calculations, statistical treatment, data visualization, interpretation, conclusions, and linkage to predefined objectives and acceptance criteria.  

• Implement routine technical and documentation reviews to improve right-first-time quality and prevent incomplete records, unsupported conclusions, transcription errors, and late reports.  

• Lead and sustain 5S in the Process Development laboratory, including ownership for organization, labeling, material and equipment control, housekeeping, visual standards, and routine audits.  

• Promote a strong safety culture by identifying and correcting unsafe conditions, reinforcing safe work practices, ensuring completion of required risk assessments and training, and stopping work when conditions are not safe.  

• Partner with Quality and EHS to ensure compliance with applicable GxP expectations, company policies, procedures, and laboratory safety requirements.  

Organizational Contribution  

• Support scientific and commercial activities, including technical scoping, proposal development, customer discussions, and bid defenses, as assigned.  

• Participate in recruiting, interviewing, onboarding, and capability-building for the Bioconjugation Process Development organization.  

• Maintain current knowledge of advances in bioconjugation, bioprocessing, analytical technologies, and relevant regulatory expectations.  

• Communicate effectively with customers, colleagues, leaders, and staff; operate to high ethical standards and perform other duties as assigned.  

Qualifications

• PhD in chemistry, biochemistry, bioorganic chemistry, chemical biology, chemical engineering, biochemical engineering, or a related discipline, with typically 8+ years of relevant industry experience; or an MS with typically 12+ years of relevant industry experience. Equivalent combinations of education and experience may be considered.  

• Demonstrated expertise in bioconjugation or biotherapeutic conjugate process development, such as ADCs, AOCs/ARCs, PDCs, DACs, or related modalities.  

• Prior experience leading scientists and technical teams, including direct people-management responsibility or substantial team-lead experience with readiness to assume direct people leadership.  

• Demonstrated success as a customer-facing technical or program lead in a CDMO, biotechnology, or pharmaceutical environment.  

• Hands-on experience with conjugation process development, preparative chromatography, normal-flow filtration, TFF/UF-DF, scale-up, and technology transfer.  

• Working knowledge of cGMP operations, GxP principles, development documentation, data integrity, and phase-appropriate CMC expectations.  

• Experience applying DoE, statistical analysis, data visualization, and structured technical report writing to process-development decisions.  

• Strong communication, conflict-resolution, prioritization, and decision-making skills, with the ability to lead across functions without relying solely on formal authority.  

Preferred:
 

• Experience developing and transferring bioconjugation processes from bench through pilot, toxicology, clinical, or GMP manufacturing scale.  

• Experience with large-scale and single-use bioprocess equipment, including process vessels, pumps, biowelders, biosealers, rocker systems, chromatography skids, and single-use assemblies.  

• Experience leading laboratory 5S, continuous-improvement, documentation-quality, or safety-culture initiatives.  

• Experience supporting regulatory filings, process validation strategy, deviation investigations, CAPA, or manufacturing troubleshooting.