Role : Team Lead - Formulation Development (Biologics)
Location : Bengaluru, IN
What you would be doing
- Lead and strategically direct formulation development of biologics and biosimilar products (liquid and lyophilized).
- Design, plan, and oversee experiments for pre-formulation, formulation optimization, and process development, ensuring scientific rigor and reproducibility.
- Review and interpret analytical, stability, and process data to guide formulation decisions and define control strategies.
- Provide technical guidance and mentorship to junior and mid-level scientists, ensuring adherence to laboratory quality, safety, and compliance standards.
- Conduct in-depth literature reviews to identify formulation strategies, excipient compatibility, and applicable regulatory guidelines.
- Collaborate with Analytical Development, Process Development, Manufacturing, and Regulatory Affairs teams to ensure seamless project execution and technology transfer.
- Oversee proof-of-concept (POC) studies, stability studies, and process robustness evaluations.
- Author, review, and approve high-level technical documents including study protocols, formulation development reports, and regulatory submission packages.
- Lead technology transfer activities to pilot and commercial manufacturing sites, ensuring proper documentation, alignment with GMP requirements, and knowledge transfer.
- Participate in troubleshooting, root-cause analysis, and continuous improvement initiatives, applying advanced problem-solving strategies.
- Apply statistical tools such as Design of Experiments (DoE), regression analysis, and multivariate analysis for formulation optimization and process robustness.
- Provide scientific and strategic input to cross-functional teams, influencing program decisions, timelines, and technical direction.
Educational Background & Experience:
- MPharm / MTech in Pharmaceutical Sciences, Biochemistry, Biotechnology, or related fields with 9–11 years of relevant industry experience in formulation development of biologicals or complex injectables or
- Ph.D. in Pharmaceutical Sciences, Biochemistry, Biotechnology, or related fields with 1–3 years of relevant industry experience.
Required Experience:
- Deep expertise in formulation principles, excipient compatibility, protein stability, and biologics development.
- Hands-on experience with analytical techniques such as HPLC, GC, pH measurement, osmolality, KF, and UV spectroscopy.
- Strong understanding of cGMP, QbD principles, and regulatory expectations for biologics.
- Proven ability to lead multiple projects simultaneously and collaborate across functional teams.
- Experience in technology transfer, scale-up, and process optimization.
- Ability to mentor and develop junior scientists, fostering a culture of scientific excellence and compliance.
- Proficiency in statistical analysis tools, DoE, and multivariate approaches for formulation development.
- Excellent communication, documentation, and leadership skills, with a track record of delivering high-quality results in complex programs.
We are an equal opportunity employer and are committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, age, marital status, disability, veteran status, or any other status protected by applicable laws.
