Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules — both New Chemical Entities (NCE’s) and New Biological Entities (NBEs’), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market. The USA subsidiary also markets APIs to regulated and semi-regulated countries.
Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.
Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company.
Position summary
The Director of Device Engineering will provide device development expertise to the respiratory product development group to develop and deliver OINDPs across all markets. This role will require a thorough understanding of the device development process as applied to combination (respiratory) products. Working with several outside technology providers, as well as global multifunctional project teams in a highly complex environment will require exceptional Product Development, organizational and self-motivational skills.
Overall Job Responsibilities
- Device development – Project support (70% of time)
Assure the device development aspects of Glenmark’s respiratory projects follow product development timelines and comply with various regulatory requirements. Contribute technical expertise to planned experiments and review resulting data. Coordinate with other departments and external vendors to execute the assigned projects. Use knowledge and understanding of regulatory requirements for achieving successful product approvals. Write or review technical reports for submissions. Contribute to writing technical sections for submission documents. - Support the establishment of the Device Development function globally (15%)
Support the implementation of device development (R&D) as well as Marketed Product support groups at R&D centers and Manufacturing sites. Assure harmonization of techniques and procedures. - Innovation Management (10%).
Maintain understanding and communicate to the respiratory business new developments in respiratory device technology. Recommend devices/technologies/ companies for possible business development activities. - FDA Interactions (5%)
Contribute to the CMC portion of FDA questions and interactions.
Education (degree / diploma)
Degree in Engineering
Experience
10 years of experience in respiratory device development
Knowledge and Skills (Functional / Technical)
• Medical device, inhalation device development.
• CAD/Solidworks design of devices, dose counters/indicators, precision molding of plastic componentry.
• Development of automated assembly equipment for devices.
• Development of automated test equipment for devices.
• Understanding of computational fluid dynamics (prefer expertise).
Leadership / Managerial Attributes
• Major contributor to Respiratory R&D project teams for the device engineering function.
• Experience with management/interactions with international (preferably Indian) pharmaceutical R&D.
• Ability to remotely influence and lead a project.
Other requirements (licenses, certifications, specialized training)
High skill level on supportive software such as Autocad/Solidworks. Microsoft Project, Powerpoint, Sharepoint, etc.
Must be legally authorized to work in the U.S.
Send applications to hrus@glenmarkpharma.com
