MSD Wellcome Trust Hilleman Laboratories (Hilleman Labs), is a joint venture between Merck & Co., Inc. (which operates in India as MSD Pharmaceuticals Pvt. Ltd.) and Wellcome Trust (which is a UK based research charity).
A first-of-its-kind initiative, Hilleman Labs is an equal joint-venture partnership formed between Merck & Co., a research-driven pharmaceutical company and Wellcome Trust, a global charitable foundation dedicated to human and animal health. Headquartered in India, Hilleman Laboratories is an international organization strengthened by presence of global leadership and scientific team, which is working incessantly to develop safe, effective, affordable and sustainable vaccines for developing countries.
Post: Senior Manager – Product Development (Delivery Devices)
Job Description
Hilleman Labs is looking to fill the position of Senior Manager – Product Development (Delivery Devices), who will be responsible for co-ordinating with the internal R & D team, device engineering companies and external Contract Manufacturing Organizations (CMO’s) towards the development of appropriate oral delivery devices for vaccine candidates. The position will be based out of New Delhi. The position incumbent, will provide scientific and regulatory guidance and participate in the design of innovative and affordable packaging solutions for the vaccine formulations under development. S/he should have a comprehensive understanding of ICH/WHO requirements, principles, concepts, industry practices and standards.
The key indicative functions for this position will be against the following dimensions
Propose clinical development plans supporting the strategic objectives of the development program and ensure excellence in their operational implementation.
- Serve as the interface between the internal R&D team and external delivery device development companies, CMO’s and regulatory bodies
- Contribute towards the development of innovative, multifunctional, and affordable packaging solutions and delivery devices for oral vaccine candidates as per requirements for emerging markets.
- Ensure excellence in the operational implementation of new vaccine delivery devices in line with the strategic objectives of the Company’s development program
- Provide technical expertise to internal R&D and external CMOs to advance the product from prototype to commercial manufacturing
- Provide guidance to internal clinical R&D and CROs to advance clinical development programs using novel delivery devices as per regulatory requirements
Candidate Profile
Ideal Qualifications/ Experience
Master’s degree in Pharma, Biotech, Life Sciences or Engineering with 8 – 10 years of experience in device development and packaging solutions in the vaccine workspace
Should have thorough knowledge of national and international regulatory requirements for oral vaccine packaging and delivery systems
Expertise in extractables and leachables testing, and container closure assessment necessary
Experience in co-ordinating with national and international oral delivery device manufacturers, CMOs and regulatory agencies required
Prior experience of taking a concept from design to commercial production desirable
Other Personal Characteristics
Ability to work in a start-up organization
Excellent written and oral communication skills
Team player with an ability to influence in a matrix structure
Ability to develop strong relationships with all stake holders
Additional Information:
Experience: 8-10 Years
Qualification: M.Pharm
Location: New Delhi
Functional Area: R&D
Industry Type: Pharma/Biotech/Clinical Research
End Date: 13th March, 2014
Email: astha.sehgal@hillemanlabs.org
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