Greetings! & very warm welcome to BEST-FIT Recruitment Riders,
highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors.
professional career opportunity
Please see the following position summary:
Head - R&D (Complex Generics & 505b2 Formulations)
Market: USA
Dosage Forms: Complex Generics - Sterile Injectable, Ophthalmic, Nasal, Topical / Transdermal
CEO / President & Founder (USA)
Direct Reportees: 6 + 8 Subsequent members
Role & responsibilities
- The Head R&D (India) will lead the entire pharmaceutical product development function for highly regulated markets, especially the US. The role requires deep technical expertise in complex generics, strong leadership across multi-disciplinary R&D functions, and the ability to drive end-to-end development, scale-up, technology transfer, and regulatory readiness.
- Responsible for heading overall pharmaceutical product development for highly regulated markets like (USA), for different Complex Generics Formulations products that includes a wide variety of generic formulation and drug products which includes wide range therapeutic categories and drug delivery.
- Supervising & guiding the overall R&D product development which include Formulation Development, Analytical Development, Technology Transfer, and Site Project Management.
- Assisting and guiding the other support functions at cross functional team level which includes sourcing, package development, regulatory, clinical, intellectual property, HR , Finance etc.
- Finalizing strategies for Products development activities, responsible for review of literature, Patent search, conceptualization, strategizing, experimental designing and supervision of entire developmental activities for Regulated markets (USA).
- Supervising the new product development by complying GLP procedures and ICH Q8-Q9 QbD approach to product development.
- Responsible for providing technical guidance for products being developed at external CROs.
- Interaction with CROs and CMOs as needed.
- Planning for scale-up and optimization of manufacturing process; pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet established project goals and timelines.
- Responsible for leading the technology/site transfer of products.
- Address all FDA deficiencies by providing sound technical inputs in timely manner.
- Finalizing strategies for in vitro dissolution media, bio relevant media for prototypes development and BE studies, including reverse engineering of RLD.
- Review of technical documents including product development report, quality overall summary and other relevant documents for the regulatory submission.
Preferred candidate profile
- M. Pharma / Ph.D. in Pharmaceutics, Formulation Science, Industrial Pharmacy, or a related field.
- Minimum 18+ years of experience in Pharmaceutical R&D for regulated markets (USA), with strong exposure to complex generics.
- Experience in FRD, specifically in sterile injectable, ophthalmic, nasal, complex generics, and 505(b)(2) development.
- Strong formulation development experience encompassing moderate to high-barrier solids and non-solids dosage forms including Sterile/Ophthalmic, Topicals / Transdermal.
- Strong exposure to USFDA regulatory submissions and successful ANDA / 505(b)(2) product launches.
- Proven experience in majority of the dosage forms (tablets, capsules, sterile injectable, topical formulation).
- Expertise in sterile facility operations, aseptic processing, and microbial control considerations.
- Experience working in US-focused R&D / global pharma environment is strongly preferred.
- Expertise in handling and optimizing most complex highly variable molecules designed.
- Business acumen with ability to align R&D strategy to organizational growth.
- Interaction with CROs and CMOs as needed.
- Skills in ensuring product delivery on target timelines.
- Ability to maintain confidentiality requirements of the position.
- Must be able to design innovative strategies & achieve goals in defined timelines
- Tactful be able to handle sensitive/ unpleasant situations.
- Excellent stakeholder-management abilities.
- Exceptional leadership, cross-functional management, and project management capabilities
- Excellent leadership, communication, and cross-functional collaboration capabilities.
Recruiter's Contact Details:
Dharmesh Sikligar
BEST-FIT Recruitment Riders
G-7, Amrit Complex,
Opp: Mahavir Jain Vidhyalaya & Jain Derasar,
R.V. Desai Road, Near Goyagate Circle,
Vadodara-390001, Gujarat, India
Mobile: 09558802906
Website: www.bestfitrecruitment.co.in
