Aculife Healthcare Private Limited, formerly known as Nirlife, is a leading pharmaceutical company with over 30 years of prescribing healthcare innovation, specializing in sterile, injectable, and parenteral formulations. With a strong presence in markets like the US, EU, Canada, Brazil, and ROW, we are seeking an experienced AGM/DGM/GM for our Research & Development department at our facility in Ahmedabad. Join us to lead cutting-edge formulation development and drive global impact!
Job Overview
- Position: AGM/DGM/GM (Research & Development)
- Qualification: M.Pharm/Ph.D
- Experience: 15-25 years in sterile/injectable/parenteral formulation development
- Location: Aculife Healthcare Private Limited, Near Railway Crossing (Sanand-Viramgam Highway), Village: Sachana, Taluka: Viramgam, District: Ahmedabad – 382150, Gujarat
Job Responsibilities and Requirements
We are looking for a seasoned professional to lead our R&D team in developing innovative sterile dosage forms. Key responsibilities and requirements include:
Responsibilities
- Lead formulation development for sterile dosage forms (injectables, ophthalmic, lyophilization, nano suspensions/emulsions, complex injectables) compliant with US, EU, Canada, Brazil, and ROW guidelines.
- Conduct literature searches, pre-formulation, and compatibility studies to support product development.
- Oversee scale-up, technology transfer, and documentation for Contract Manufacturing Organizations (CMOs).
- Perform patent searches and analyze public domain sites for US and EU regulatory guidance.
- Prepare responses to FDA queries and pre-ANDA meeting documents.
- Drive packaging development activities and ensure comprehensive documentation.
- Manage and mentor the formulation development team, providing technical guidance and regulatory updates.
- Review and prepare all required documents to ensure compliance with global standards.
Requirements
- M.Pharm or Ph.D with 15-25 years of experience in sterile/injectable/parenteral formulation development.
- Expertise in developing complex injectables, lyophilized products, nano suspensions, and emulsions.
- Strong knowledge of USFDA, EMA, and other international regulatory guidelines.
- Proven experience in patent searches, FDA query responses, and pre-ANDA documentation.
- Excellent leadership skills to manage and upgrade R&D teams.
- Proficiency in technology transfer and collaboration with CMOs.
How to Apply
Interested candidates should:
- Email their updated CV to manojmore@aculife.co.in or balkrishnap@aculife.co.in.
- Visit https://www.aculife.co.in/ for more information about our company and career opportunities.
- Bring an updated CV and relevant documents if attending future walk-in interviews (to be announced).
Additional Information
- Note: Candidates with extensive experience in sterile dosage forms and familiarity with global regulatory markets are highly preferred. Aculife Healthcare is committed to innovation and quality, backed by a legacy of over 30 years in healthcare.
- Contact: manojmore@aculife.co.in or balkrishnap@aculife.co.in for inquiries.
Contact Us
For further details, reach out via email at manojmore@aculife.co.in or balkrishnap@aculife.co.in.
Join Aculife Healthcare and lead the way in prescribing healthcare innovation for global markets!
