Subhash Naik
Biologics CMC and formulation leader
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About
Innovative biologics CMC and formulation leader with 14+ years of experience driving 10+ drug formulation programs from pre-IND through late-stage development spanning biotech and CDMO environments. Built and led high-performing, cross-functional teams to deliver robust formulation and stability strategies advancing 5+ programs to IND, supporting regulatory submissions, and contributing to intellectual property generation (9+ patents) under aggressive timelines. Recognized expert in high-concentration biologics (>200 mg/ml), with deep proficiency in analytical characterization, QbD development and excipient innovation.
Demonstrated success in translating scientific innovation into regulatory and commercial outcomes through tech transfer, client engagement and business development initiatives.
Experience
Principal PD Scientist & Formulation Subgroup Lead at AGC Biologics (2023-08 – Present)
Drove and directed formulation and stability strategy for a 5+ early- and late-phase biologics programs in a fast-paced CDMO environment, managing 3+ parallel client programs.
- Led and mentored a multidisciplinary team of 10+ scientists, providing technical oversight, performance coaching, and workload prioritization across parallel client programs.
- Served as the primary formulation SME interfacing with QC, MSAT, Analytical Development, Manufacturing, and external client teams to align CMC strategy and execution.
- Defined and directed DP and DS stability strategies, including forced degradation, in-use, and long-term ICH stability studies for regulatory and lifecycle decision-making.
- Authored and reviewed key CMC documentation including stability protocols and reports, identified Critical Quality Attributes (CQA), impurity risk assessments, CoA's/CoT's, and regulatory-supporting technical summaries.
- Oversaw analytical method development, transfer, qualification, and troubleshooting, ensuring robust release and characterization testing across multiple products.
- Partnered with Business Development on technical due diligence, proposal authorship, formulation strategy recommendations, and risk assessments for new business acquisition.
Senior Research Scientist, High Concentration Formulations & Drug Development at Comera Life Sciences (2017-08 – 2023-08)
- Invented and validated novel excipients, contributing directly to 9+ patent filings and helping company move from Series B start-up to NYSE listed entity.
- Led formulation development for 5+ high-concentration subcutaneous biologics and mAbs focusing on addressing viscosity, stability, and syringe compatibility challenges.
- Built and mentored formulation teams, training associates and junior scientists in DP/DS development, stability execution, and data interpretation.
- Established and executed long-term and in-use stability strategies to support clinical development and formulation down-selection of 5+ molecules.
- Assessed container closure and prefilled syringe (PFS) compatibility studies to successfully address silicone oil and interface-driven instability formulation issues.
- Developed in silico excipient screening and formulation modeling approaches, accelerating formulation optimization and reducing experimental burden.
Postdoctoral Researcher at University of Delaware (2014-09 – 2017-08)
- Developed method to quantify therapeutic protein stability within biodegradable matrices for Allergan/Abbvie.
- Developed technologies to follow GCSF protein degradation kinetics for Medimmune/BMS
Post-Doctoral Fellow at University of Kansas Medical Center (2013-01 – 2014-09)
- Developed a patented HTS drug discovery platform for protein misfolding diseases, amyloidosis and against anthrax
- Collaborated with David Volkin & Russ Middaugh (KU MVSC) to design and develop rapid assays to identify pre-aggregates in mAb formulations.
Education
Ph.D. in Biochemistry & Molecular Biology – University of Kansas Medical Center (2012)
Master of Pharmaceutical Sciences – National Institute of Pharmacy Education and Research, India (2005)
Bachelor of Pharmacy – Institute of Chemical Technology, Mumbai University (2003)
