Sr Principal Scientist, Conjugation Process Development

Abzena Inc.; Bristol (VA); On-site; USD 150,000 - 190,000; Full time

Job summary

Abzena Inc. seeks a highly experienced Principal Scientist to drive conjugation process development for bioconjugates, including ADCs and other linker-payload therapies.

You will lead robust, scalable processes from early development to commercial readiness and provide scientific leadership across chemistry, analytics, tech transfer, and regulatory documentation. You will collaborate with CMC, analytical, manufacturing, quality, and project teams to deliver high-quality products and support CGMP

Qualifications

• Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field with 10+ years of industry experience; or M.S. with 12+ years in industry.
• Extensive experience in bioconjugation process development, particularly ADCs or related targeted therapeutics.
• Strong understanding of conjugation chemistries, linker-payload technologies, purification methods, and protein/conjugate characterization.
• Experience supporting CGMP manufacturing and technology transfer activities.
• Working knowledge of CMC development principles, regulatory expectations, and phase-appropriate development strategies.

Responsibilities

• Lead development and optimization of conjugation chemistry processes for bioconjugates, including ADCs and other linker-payload platforms.
• Design scalable and manufacturable conjugation strategies with a focus on process robustness, product quality, yield, and reproducibility.
• Develop and execute DOE campaigns, and scale-up strategies for clinical manufacturing.
• Serve as SME for conjugation chemistry, analytical characterization of conjugation processes, and process controls.
• Collaborate with analytical development teams to establish CQAs, in-process controls, and release specifications.
• Author and review technical reports, development summaries, batch records, SOPs, regulatory sections, and tech transfer documentation.
• Provide technical oversight during CGMP manufacturing campaigns as needed.
• Troubleshoot process deviations, investigations, and manufacturing challenges related to conjugation operations.
• Drive implementation of platform technologies and continuous improvement initiatives to enhance process efficiency.
• Mentor junior scientists and contribute to scientific strategy and leadership.

Skills

Bioconjugation

ADC technology

DOE design of experiments

CGMP manufacturing

Technology transfer

Regulatory documentation

Analytical characterization

Leadership

Education

Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related (10+ years)

M.S. with 12+ years in industry

Tools

HIC

SEC

LC-MS

CE-SDS

DAR characterization

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.

We are seeking a highly motivated and experienced Principal Scientist to drive conjugation process development activities supporting bioconjugates, including antibody-drug conjugates (ADCs), oligonucleotide conjugates (AOCs, ARCs, etc.), and other conjugate therapeutics. This individual will serve as a technical leader responsible for developing robust, scalable, and phase-appropriate conjugation processes from early development through commercial readiness.

The successful candidate will provide scientific leadership across process chemistry, analytical characterization, technology transfer, manufacturing support, and regulatory documentation while collaborating closely with CMC, analytical, manufacturing, quality, and project management teams.

Responsibilities

• Lead development and optimization of conjugation chemistry processes for bioconjugates, including ADCs and other linker-payload platforms.
• Design scalable and manufacturable conjugation strategies with a focus on process robustness, product quality, yield, and reproducibility.
• Develop and execute DOE campaigns, and scale-up strategies for clinical manufacturing.
• Serve as subject matter expert (SME) for conjugation chemistry, analytical characterization of conjugation processes, and process controls.
• Collaborate with analytical development teams to establish critical quality attributes (CQAs), in-process controls, and release specifications.
• Author and review technical reports, development summaries, batch records, SOPs, regulatory sections (IND/BLA/IMPD), and technology transfer documentation.
• Provide technical oversight during CGMP manufacturing campaigns as needed.
• Troubleshoot process deviations, investigations, and manufacturing challenges related to conjugation operations.
• Drive implementation of platform technologies and continuous improvement initiatives to enhance process efficiency and scalability.
• Mentor junior scientists and contribute to scientific strategy, innovation initiatives, and cross-functional technical leadership.
• Present development updates and technical recommendations to senior leadership and client project teams.Qu

Required Qualifications

• Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline with 10+ years of relevant industry experience; or M.S. with 12+ years of industry experience.
• Extensive experience in bioconjugation process development, particularly ADCs or related targeted therapeutics.
• Strong understanding of conjugation chemistries, linker-payload technologies, purification methods, and protein/conjugate characterization.
• Demonstrated experience supporting CGMP manufacturing and technology transfer activities.
• Working knowledge of CMC development principles, regulatory expectations, and phase-appropriate development strategies.
• Experience with statistical experimental design (DOE) and process characterization methodologies.
• Proven ability to independently lead complex technical programs in a fast-paced environment.

Preferred Qualifications

• Experience with site‑specific conjugation technologies and next‑generation ADC platforms.
• Familiarity with high‑potency compound handling and containment operations.
• Experience presenting development findings externally to client sponsors.
• Knowledge of analytical methods including HIC, SEC, LC‑MS, CE‑SDS, and DAR characterization.
• Prior experience supporting late‑stage or commercial process validation activities.

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.