Process Development Senior Scientist - Drug Product Technologies

Key Responsibilities

• Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership.
• Plan and execute formulation and fill/finish process studies for early-stage programs.
• Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab-scale sterile filling.
• Build process understanding across unit operations to support scalable drug product development.
• Evaluate in-use compatibility and drug product stability under clinical conditions.
• Investigate ADC- and biologics-relevant CQAs (e.g., aggregation, fragmentation, drug-to-antibody ratio, free payload, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions.
• Leverage high-throughput tools for formulation screening and processability assessments.
• Identify and address technology gaps impacting ADC stability, linker-payload integrity, protein-excipient interactions, and process-related stress responses.
• Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making.
• Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing.
• Author technical documents, control-strategy inputs, risk assessments, IND/CTA regulatory sections, and tech transfer packages.
• Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit assessments, person-in-plant support, and troubleshooting during manufacturing campaigns.
• Present findings to internal/external stakeholders and participate in cross-functional teams.

Basic Qualifications

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
• OR Masters degree and 3 years of Scientific experience
• OR Bachelors degree and 5 years of Scientific experience

Preferred Qualifications

• PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 24 years of postdoc or industry experience.
• Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation experience is strongly preferred.
• Demonstrated understanding of ADC drug product development considerations, including linker-payload stability, drug-to-antibody ratio, free drug or payload degradation, quality attributes, and product/process comparability.
• Experience integrating formulation, stability, and analytical data to advance ADC candidates from discovery or preclinical development into clinical manufacturing is highly desirable.
• Strong foundation in analytical and biophysical techniques relevant to ADCs and biologics (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, etc.).
• Familiarity with clinical-stage development, manufacturability, and risk-based decision-making.
• Experience applying AI/ML (e.g., LLMs, in silico tools) to streamline R&D and optimize performance.
• Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs).