Sr Manager, Bioconjugation Development

Abzena Inc.•Bristol, PA

About The Position

The Senior Manager, Bioconjugation is a people leader, program leader, and scientific-technical leader responsible for the successful execution of assigned bioconjugation process development programs. Reporting to the Head of Bioconjugation Development, this role leads and develops a team of scientists, serves as the primary technical contact for assigned customers, and ensures delivery of robust, scalable, phase-appropriate processes. The role also strengthens operating discipline in the Process Development laboratory, including procedural adherence, complete and contemporaneous documentation, data integrity, rigorous analysis and reporting, laboratory safety, and 5S standards. The role leads assigned programs across conjugation chemistry, downstream purification, scale-up, process analytics, technology transfer, and manufacturing support. It coordinates cross-functional teams and communicates program status, data, conclusions, recommendations, risks, decisions, and mitigation plans to customers and internal stakeholders. It also provides scientific direction, supports scale-up and manufacturing activities, and ensures technical decisions are evidence-based and connected to customer, quality, regulatory, and manufacturing requirements. The Senior Manager develops team capability and performance, plans resources across programs, and promotes an inclusive, respectful, high-accountability team environment. The role supports commercial activities, recruiting, onboarding, and organizational capability-building, and maintains current knowledge of relevant technical and regulatory developments.

Requirements

PhD in chemistry, biochemistry, bioorganic chemistry, chemical biology, chemical engineering, biochemical engineering, or a related discipline, with typically 8 or more years of relevant industry experience; or an MS with typically 12 or more 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.

Nice To Haves

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.

Responsibilities

Lead, coach, and develop direct reports, including Principal Scientists and other scientific staff, through objectives, feedback, development planning, and accountability.
Set expectations for scientific quality, execution discipline, collaboration, customer focus, and ownership; address performance or behavioral gaps constructively and promptly.
Build team technical depth and succession capability through mentoring, knowledge sharing, cross-training, and delegation.
Plan and allocate resources across programs, balancing customer commitments, technical risk, laboratory capacity, and employee development.
Create an inclusive, respectful, high-accountability team environment where issues are surfaced and resolved appropriately.
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 contact for assigned customer programs and communicate status, data, conclusions, recommendations, risks, decisions, and mitigation plans.
Coordinate cross-functional teams spanning Analytical Services, MSAT, Manufacturing, Quality, Regulatory Affairs, Project Management, and other functions.
Establish development strategies, technical milestones, decision points, and priorities; use resources effectively and escalate risks or scope changes in a timely manner.
Drive issue resolution using structured data review, root-cause thinking, risk assessment, and documented action plans.
Support scale-up, technology transfer, and manufacturing readiness through assessments, process risk reviews, training, and review of master batch records and supporting technical documentation.
Provide scientific direction for robust, reproducible, scalable, and manufacturable bioconjugation and purification processes.
Guide experimental strategies, including DoE, process characterization, critical process parameter evaluation, scale-down models, and phase-appropriate control strategies.
Ensure technical conclusions and recommendations are evidence-based and aligned with 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.
Ensure team adherence to approved procedures, protocols, SOPs, and development workflows; verify work is performed as written and deviations are identified, escalated, and addressed.
Ensure laboratory notebooks, electronic records, protocols, reports, batch records, presentations, and other documents are complete, accurate, contemporaneous, traceable, and reviewed on time.
Improve data analysis and reporting by requiring appropriate calculations, statistical treatment, visualization, interpretation, conclusions, and links to objectives and acceptance criteria.
Conduct 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 laboratory 5S, including organization, labeling, material and equipment control, housekeeping, visual standards, and routine audits.
Promote laboratory safety by identifying and correcting unsafe conditions, reinforcing safe practices, ensuring risk assessments and training are completed, and stopping unsafe work.
Partner with Quality and EHS to ensure compliance with applicable GxP expectations, company policies, procedures, and laboratory safety requirements.
Support 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; maintain high ethical standards and perform other duties as assigned.