General Manager Research And Development

18.0 - 25.0 years

40 - 60 Lacs

Bengaluru

Posted:1 week ago| Platform: Naukri logo

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Skills Required

Formulation Research Development Injectable formulation research USFDA Innovation Parenteral Sterile Intellectual Property Injectables Formulation Development Ophthalmology

Work Mode

Work from Office

Job Type

Full Time

Job Description

Off Targets is a leader in pharmaceutical innovation, committed to developing advanced therapeutic solutions that address unmet medical needs. We are looking for an experienced and dynamic professional to lead our Formulation Development department, driving the development of cutting-edge injectable drug products. Job Description We are seeking an accomplished R&D leader to head our Injectable Formulation Development function. The ideal candidate will bring deep technical expertise in complex injectable products and a strategic mindset aligned with 505(b)(2) development, regulatory planning, and IP differentiation. Key Responsibilities: Lead end-to-end formulation development of complex injectable drug products (liposomes, emulsions, depot injections, suspensions, etc.). Design and drive a robust R&D pipeline focused on 505(b)(2) opportunities . Provide strategic input into USFDA regulatory planning (CMC sections, QbD, stability). Contribute to patent strategy and product differentiation from early development. Collaborate with analytical, regulatory, IP, and business development functions. Mentor a high-performing R&D team and build scientific leadership. Solve scale-up and technology transfer challenges. Maintain strong compliance with global quality and documentation standards. Key Skills: Injectable Formulation, 505(b)(2), Liposomes, Emulsions, Depot Injections, Formulation R&D, CMC, USFDA, Drug Delivery, Intellectual Property, Team Leadership, Innovation Strategy Desired Candidate Profile: Qualification: Ph.D. / M.Pharm in Pharmaceutics or related field Experience: 15+ years in pharmaceutical R&D with at least 5 years in a strategic leadership role Proven expertise in injectable formulations and 505(b)(2) development Strong knowledge of USFDA CMC expectations, IP evaluation , and regulatory submission processes Excellent leadership, innovation, and cross-functional collaboration skills Perks and benefits Opportunity to lead a key department in a forward-thinking pharmaceutical company. A collaborative and supportive work environment that encourages professional growth and innovation. Competitive salary and benefits package, with opportunities for advancement. Access to state-of-the-art facilities and cutting-edge technology. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com

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Off Targets Research
Off Targets Research

Biotechnology

San Francisco

50-100 Employees

4 Jobs

    Key People

  • Dr. Jane Doe

    CEO
  • John Smith

    CTO

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