Scientist IV, Biologics Drug Product

SUMMARY/

JOB PURPOSE:

The incumbent will be responsible for the day-to-day execution activities directed to support development and manufacturing of biological (antibody drug conjugates, mAbs, bispecifics) drug products (DP). The activities include formulation development, DP manufacturing process development & technical transfer, activities to support preparation and administration of DP and selection of primary container closure. The work would include but not limited to outlining, designing, executing and managing various activities in house including maintaining up to date documentation and records.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Design and execute in-house laboratory experiments to support biologics development.
• Perform biophysical characterization and analytical assays, including but not limited to DLS, HIAC, MFI, DSC, SEC, freeze dry microscope, karl fisher, CE, and cIEF.
• Design and conduct formulation studies, stability studies, compatibility studies, and container closure selection studies, as well as other drug product development and manufacturing-related activities.
• Perform lyophilization of biologics and related process development studies.
• Prepare documentation, review data, and present findings to functional teams and leadership.
• Maintain laboratory instruments by scheduling preventive maintenance, managing inventory, and troubleshooting issues to ensure optimal functionality.
• Collaborate closely with internal CMC teams (conjugation, analytical, drug substance), QA, RA, and cross-functional colleagues, as well as external contract laboratories, ensuring clear and effective communication.
• Maintain strong relationships with internal and external partners through proactive and professional engagement.
• Stay current with scientific literature and evolving regulatory requirements related to formulation and drug product development.
• Contribute to the development and drafting of work instructions and SOPs for relevant methods.

SUPERVISORY RESPONSIBILITIES:

• This is an independent role

EDUCATION/EXPERIENCE/KNOWLEDGE &

SKILLS:

Education/

Experience:

• BS/BA in Pharmacy, Chemical Engineering, Biochemistry, Biotechnology, Physical Chemistry, or related discipline and a minimum of five years of related experience; or,
• MS/MA in Pharmacy, Chemical Engineering, Biochemistry, Biotechnology, Physical Chemistry, or related discipline and a minimum of three years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Experience in formulation development and biophysical characterization of biologics (mAbs, ADC etc.) and novel biological modalities such as gene and cell therapies in industry or in academia is preferred.
• Experience with lyophilization development, DP process development, container closures and devices, preparation and administration of biological modalities is preferred.
• Experience conducting stability studies is preferred.
• Hands on experience with analytical instrumentation is preferred.
• Experience planning, generating, analyzing, and linking experimental capabilities and results to critical CMC objectives is preferred.

Knowledge/

Skills:

• Formulation and Drug product development and/or manufacturing
• Knowledge of CMC biologics processes
• Ability to collaborate and work effectively cross-functionally and in a team setting, both internally and with external CDMOs and partners
• Ability to multi-task in a fast-paced dynamic environment while delivering high quality work
• Excellent interpersonal, presentation, and written communication skills
• Creative thinker and complex problem solver

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