Formulation Development Lead

Key responsibilities

• Lead formulation development of ANDA and 505(b)(2) products for solid oral dosage forms (tablets, capsules, modified/extended release) and injectables (solutions, suspensions, lyophilized products).
• Design and run pre-formulation, formulation and process development studies using QbD principles (QTPP, CQAs, risk assessment, DoE).
• Develop strategies for 505(b)(2) products, including reformulations, new dosage forms, new strengths and differentiated delivery.
• Perform RLD characterization, reverse engineering and patent/IP evaluation together with the IP and regulatory teams.
• Oversee scale-up, exhibit/submission batches and technology transfer to internal or CMO manufacturing sites.
• Prepare and review development documentation, including Pharmaceutical Development Reports (QbD), Module 3 (CTD/eCTD) sections and responses to USFDA and EMA deficiency letters.
• Work closely with Analytical Development, Regulatory Affairs, Quality, Clinical/BE and Manufacturing teams.
• Lead, coach and develop a team of formulation scientists.
• Mentor and supervise Masters students under SanSphere’s university collaboration program, guiding their research projects, theses and lab training.
• Make sure all development work complies with cGMP, GLP, ICH guidelines and data integrity (ALCOA+) requirements.

Qualifications and experience

• M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences or a related field.
• 10–15 years of hands-on formulation development experience in the pharmaceutical industry.
• Proven track record of ANDA and 505(b)(2) filings and approvals for USFDA and European markets.
• Strong expertise in both solid oral and injectable dosage forms.
• Thorough knowledge of ICH guidelines (Q8, Q9, Q10), USFDA and EMA regulatory requirements, and CTD/eCTD submissions.
• Experience with scale-up, technology transfer and exhibit batch manufacturing.
• Experience in team leadership.

Preferred

• Experience mentoring or supervising Master’s or Ph.D. students, or working with academic and research institutions.
• Exposure to complex generics (long-acting injectables, liposomes, nanosuspensions).
• Publications or patents in pharmaceutical formulation.

Key skills
Formulation development, ANDA, 505(b)(2), solid oral dosage, injectables, QbD, DoE, tech transfer, USFDA, EMA, CTD, team leadership, mentoringRole & responsibilities