About Company:
Innovation is the stepping-stone towards a better tomorrow.
In today’s dynamic global pharmaceutical market, BDR Pharmaceuticals has carved a niche for itself, with an avant-garde formulation’s portfolio for specialty medication. Their rich expertise and unique multi-branding strategy empower early identification, prompt development and smooth introduction of critical and lifesaving medicines, making them available to the masses at an affordable price.
Our Strengths
Our strength is innovation, shaping a healthier future.
Designation:
Manager/SR. Manager F&D(Complex injectable)
Qualification:
M.Pharma/ Ph.D. in Pharmaceutics or a related discipline.
Experience:
Experience: Minimum 10 years of experience in formulation development for complex injectables, particularly depot and lipo formulations, targeting regulated markets such as the US and EU.
Technical Expertise
Proven track record of developing and filing complex injectable products.
Expertise in working with depot formulations, liposomal drug delivery systems, or similar technologies.
Strong understanding of regulatory requirements for injectable products in regulated markets.
Soft Skills:
Excellent leadership, communication, and project management skills. Analytical problem-solving ability and attention to detail.
Key Responsibilities:
Formulation Development: Lead and oversee the end-to-end development of complex injectable formulations, including depot and lipo formulations, for regulated markets such as the US, EU, and other regulated regions. Design and optimize formulation strategies for novel and generic injectable products, ensuring alignment with regulatory and quality standards.
Project Management: Plan, execute, and manage formulation development projects, ensuring timely delivery within budget and meeting regulatory requirements. Collaborate cross-functionally with teams such as analytical development, regulatory affairs, and manufacturing for seamless technology transfer and scale-up.
Regulatory Compliance: Prepare and review technical documentation, including development reports, master formula records, and regulatory filings (e.g., ANDAs, NDAs, MAAs). Stay updated with the latest regulatory guidelines and ensure compliance with USFDA, EMA, and other regulatory standards.
Innovation and Research: Explore and implement innovative approaches in formulation development for complex injectables, including drug delivery systems. Work on identifying and resolving technical challenges in developing depot/lipo formulations. Team Leadership: Lead, mentor, and guide a team of scientists and associates to achieve project goals. Build technical capabilities within the team and promote a culture of continuous learning and excellence.
Work location:
Baska, Halol