Principal Scientist - ADC, Bioconjugation

Position Summary

The Purification Development Principal Scientist, Process Development will report into the Development organization. The primary role of the Principal Scientist is to lead the design and execution of lab scale experiments in the development, optimization and scale-up of downstream purification process including bioconjugation to support the client projects and process transfer to manufacturing. The ideal candidate will drive the bioconjugation and purification throughout the product life cycle and will require technical expertise in conjugation chemistry and downstream unit operations including tangential flow filtration, dead-end filtration, and protein chromatography. The successful candidate will lead the design and execution of laboratory experiments in the development, optimization, and characterization of product including ADCs. In addition, this role is expected to manage two to three direct reports, work effectively in a highly collaborative team environment, and communicate proactively and efficiently with cross-functional departments.

Duties & Responsibilities

• Leverage direct experience designing and implementing experiments to evaluate purification and bioconjugation processes for proteins and ADCs in order to lead development, execution, and technology transfer of purification and bioconjugation processes
• Serve as the Subject Matter Expert with direct experience designing and implementing experiments and technical transfers to evaluate Biologics and bioconjugation process development including ADCs
• Lead efforts to identify and champion new chemistries and process technologies for bioconjugation
• Communicate project strategy, milestones, and conclusions to stakeholders
• Develop, optimize, plan, and lead characterization of purification processes for antibodies and novel bioconjugation methodologies to improve antibody drug conjugates including High Throughput Screening methods for purification development
• Work collaboratively with SMEs and research scientists from other functions such as formulation, process, and analytical to understand relevant conjugation chemistries and to transition bioconjugation processes from research to CMC development, as applicable, to champion manufacturing in support of CMC activities of ADCs
• Deliver strong development experience to bring biologics from Phase I through commercial, including experience in late-stage activities such as CMC risk assessments, process characterization, and process validation
• Lead documentation of experiments, data analysis, generate high-quality technical reports, lead risk management approaches and assessments, and to drive strong CMC submissions
• Establish project priorities and resource allocation for team through planning and scheduling laboratory activities and deliverables to meet established project timelines
• Collaborate and work with a diverse group of scientists/engineers across multiple therapeutic areas, chemistry, and process development to ensure timely progress in research projects and drive technological innovations
• Lead continuous process improvements and advance technology for implementation in laboratory and manufacturing operations
• Provide technical experience for on-floor support for production of GMP antibody and ADC batches
• Trains, supervises, and develops key talent with well-established succession plans
• Ensures laboratory maintenance to sustain a safe, effective and productive environment and ensures that appropriate GLP/GMP procedures are followed

Education & Experience

Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related industry experience in biologics downstream manufacturing or manufacturing technology:

• B.Sc/B.Eng with >12 years
• M.Sc./M.Eng degree with >10 years
• Ph.D degree with >8 years of relevant bioconjugation, downstream purification industry experience.

Knowledge, Skills, Abilities

• Experience with ADC chemistry, conjugation chemistry, reaction processes and purification process development is required
• Demonstrated hands-on experience in the generation of antibody and antibody drug conjugates with scale-up knowledge is required
• Experience with CMC regulatory activities in relevant areas such as analytical characterization, formulation, and the general CMC scope for biologics and/or ADC molecules is required
• Hands-on experience and knowledge of protein purification and characterization using centrifugation, chromatography (Unicorn, Mobius Chrome), dead-end and depth filtration, Tangential flow filtration are required. Analytical techniques like Size Exclusion Chromatography (SEC), Liquid chromatography–mass spectrometry (LC-MS), Ion-Exchange (IEX), Reversed Phase (RP)-HPLC, routine DNA/RNA techniques, protein expression and purification, sodium dodecyl sulfate polyacrylamide gel electrophoresis, ultraviolet-visible spectrophotometry, high-performance liquid chromatography, etc is preferred
• Demonstrated experience working with Contract Development Manufacturing Organizations (CDMOs) is preferred

Physical Demands

• Laboratory-based position which requires appropriate levels of personal protective equipment (PPE). This role may require contact with biohazardous materials such as highly potent compounds, payload-linkers, and other hazardous chemicals including methotrexate, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step stools, and reaching may be required. This role may also require unassisted lifting (not to exceed 50 lbs). Repetitive use of arms/hands/wrists and grasping may also be required

Work Environment

• Laboratory-based position which requires appropriate levels of personal protective equipment (PPE). This role may require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including high potent compounds, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step stools, and reaching may be required. This role may also require unassisted lifting (not to exceed 50 lbs). Repetitive use of arms/hands/wrists and grasping may also be required
• The position is based indoors and the individual will primarily be working with others, but also independently and alone at times in the laboratory
• The position is a team and project-based position that will require occasional shift work, weekends, evenings, and holidays
• Dynamic, fast-paced, interactive, and entrepreneurial environment

Supervisory Responsibilities

The position may manage and lead a team of scientists / associates with potential to add contingent workers and other positions to the team. The position is responsible for career development of this team and must also lead the safety culture of the group.

Travel

<5% travel required for this position.

Target Bonus

16%

Work Location:

East Syracuse, NY