Sr Manager, Bioconjugation Development

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 180,000 - 230,000; Full time

Job summary

Abzena Inc. is a leading bioconjugation CDMO delivering from concept to patient.

We seek a Senior Bioconjugation Process Development Leader to drive end-to-end programs across conjugation chemistry, purification, scale-up, analytics, tech transfer, and manufacturing support. The role requires cross-functional leadership with Analytical Services, MSAT, Manufacturing, Quality, Regulatory Affairs, and Project Management to deliver robust, scalable processes and strong technical leadership for

Qualifications

• PhD in chemistry, biochemistry, or related field with 8+ years of industry experience.
• Experience leading scientists and technical teams with direct people management.
• Customer-facing technical or program lead experience in a CDMO/biotech/pharma environment.
• Hands-on conjugation process development, scale-up, and technology transfer.
• Working knowledge of cGMP/GxP, data integrity, and development documentation.
• Experience applying DoE, statistics, data visualization, and technical reporting.
• Strong communication, conflict resolution, prioritization, and cross-functional leadership.

Responsibilities

• Lead, coach, and develop direct reports through clear objectives and feedback.
• Establish expectations for scientific quality, execution, collaboration, and ownership; address gaps promptly.
• Build technical depth and succession through mentoring and knowledge sharing.
• Plan and allocate resources across programs balancing commitments and capacity.
• Lead end-to-end bioconjugation PD programs across conjugation chemistry, purification, scale-up, analytics, tech transfer, and manufacturing support.
• Serve as primary scientific contact for customer programs and communicate status with clarity.
• Coordinate cross-functional teams to deliver integrated program outcomes.
• Establish development strategies, milestones, and priorities; escalate risks or scope changes.
• Drive issue resolution using data review, root-cause thinking, and action plans.
• Ensure successful scale-up, tech transfer, and manufacturing readiness, including master batch reviews.

Skills

People leadership

Program leadership

Cross-functional collaboration

DoE analysis

Data integrity

Communication skills

Problem solving

Strategic thinking

Education

PhD in chemistry/biochemistry/related field

MS in related field

Job description

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

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.

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.