We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World.
A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.
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
Target Bonus
16%
Work Location:
East Syracuse, NY
New York Pay Range
$91,000 - $142,000 USD
We are an Equal Employment Opportunity ("EEO") Employer.
We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!? If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!
