Team Leader R&D Injectable Products

Off Targets Research; Bengaluru; On-site; INR 4,500,000 - 7,500,000; Full time

Job summary

Off Targets Research seeks a technically strong Leader/Head Formulation Development (Injectables) to head the formulation development section within Injectable R&D. The role involves hands-on formulation and process development for differentiated injectable products—from early feasibility through scale-up and technology transfer.

This is a section-head role for a hands-on formulator who can lead a small team of scientists, manage day-to-day development, and ensure timely deliverables meeting

Qualifications

• Ph.D./M.Pharm./M.S. in Pharmaceutics, Pharmaceutical Sciences, Industrial Pharmacy or related field.
• Strong hands-on experience in sterile/injectable dosage form development is essential.

Responsibilities

• Lead formulation development activities for injectable programs from preformulation to scale‑up and exhibit batch support.
• Develop complex injectable formulations including suspensions, emulsions, lyophilized products, and depot systems.
• Coordinate compatibility studies, excipient screening, container closure evaluation, and process optimization.
• Apply QbD principles and risk-based approaches to design and troubleshooting.

Skills

Team Leadership

Formulation Development

Sterile Injectables

Tech Transfer

Program Management

Education

PhD./M.Pharm./M.S.

Job description

Role & responsibilities

Position Summary

Off Targets Research is seeking a technically strong Team Leader / Head Formulation Development (Injectables) to lead the formulation development section within our Injectable R&D function. This role owns hands‑on formulation and process development for differentiated injectable products — solutions, suspensions, emulsions, lyophilized products, depot/long‑acting injectables, and other sterile dosage forms — from early feasibility through scale‑up and technology transfer.

This is a section‑head level role for a hands‑on formulator with strong technical depth, who can lead a small team of scientists, manage day‑to‑day development execution, and ensure formulation deliverables are met on time and to the quality standard required for regulatory submission and technology transfer.

Key Responsibilities

• Lead formulation development activities for assigned injectable programs, from preformulation and prototype development through optimization, scale‑up, and exhibit batch support.
• Independently drive development of complex injectable formulations, including suspensions, emulsions, RTU products, lyophilized products, and other differentiated sterile systems.
• Plan and execute compatibility studies, excipient screening, container closure evaluation, and process parameter optimization.
• Apply QbD principles and risk‑based approaches to formulation design and troubleshooting.
• Coordinate closely with Analytical R&D for method alignment, characterization, and stability study execution.
• Troubleshoot formulation and process issues such as stability failures, precipitation, particle size drift, syringeability/injectability concerns, reconstitution behavior, and process robustness gaps.
• Prepare and review development reports, protocols, specifications, and technology transfer documentation.
• Support technology transfer to pilot/manufacturing sites and provide technical input during scale‑up and exhibit batch manufacturing.
• Supervise, mentor, and develop a team of formulation scientists; review their work, build technical capability, and ensure development discipline within the section.
• Liaise with QA, Regulatory Affairs, and external CDMO/CRO partners on formulation‑related queries and deliverables.
• Provide technical inputs during due diligence or partner discussions when required, under the guidance of the Head of R&D.

Preferred candidate profile

Education

• Ph.D. / M.Pharm / M.S. / Masters in Pharmaceutics, Pharmaceutical Sciences, Industrial Pharmacy, or a related discipline.
• Strong academic and technical foundation in sterile/injectable dosage form development is essential.

Experience

• 10–16 years of relevant pharmaceutical R&D experience, with substantial hands‑on experience in injectable/sterile product development.
• Prior experience leading or co‑leading a formulation development team or section is preferred.
• Strong preference for candidates from:
• Injectable R&D of pharmaceutical companies
• Injectable R&D CRO/CDMO environments
• Specialty or complex generic product development organizations

Technical Expectations

Strong preference for candidates with demonstrated hands‑on experience in:

• Sterile dosage forms and injectable product development
• Complex injectables — suspensions, emulsions, depot systems, lyophilized products, RTU injectables
• Preformulation and formulation design
• Process development and scale‑up
• Technology transfer to manufacturing sites
• Analytical collaboration for method development/characterization/stability
• Development under regulated market (US FDA 505(b)(2)/ANDA) expectations
• CMC documentation
• Problem‑solving in complex formulation and manufacturing settings

Leadership Expectations

• Ability to lead and mentor a small formulation development team
• Strong hands‑on technical ownership combined with the ability to review and guide the work of others
• Good scientific communication and cross‑functional coordination skills
• Ability to manage multiple development programs and priorities with speed and rigor

Why join Off Targets Research

Off Targets is an innovative specialty pharmaceutical company focused on creating value through reformulation and differentiation of established pharmaceutical products, with a strong focus on injectable products for regulated markets.

Our development model emphasizes:

• Differentiated injectable products
• Complex formulation problem‑solving
• 505(b)(2) and specialty generic opportunities
• Scientific rigor with commercial relevance
• Fast‑moving, high‑accountability development culture

This is an opportunity to take hands‑on technical ownership of formulation development for a pipeline of differentiated injectable assets, while building and leading a growing formulation team.