Assoc. Dir., Engineering
RemoteIndia
Job Summary
Lead API Technology & Portfolio Management projects, overseeing technical transfer, sourcing, and full-scale production for small molecule products manufactured externally. Define requested services, generate technical packages, and conduct due diligence for supplier selection to ensure supply, quality, cost, and innovation. Manage end-to-end execution of technical transfer schedules, including regulatory and formulation site inputs, while collaborating with external suppliers to assess chemistry, processing equipment, and mitigate risks. Provide strong leadership for cross-functional teams, conduct troubleshooting exercises, and drive process improvements within a highly regulated cGMP environment. Travel up to 30% to visit facilities and resolve technical issues.
Required Qualifications
- Ph.D. Degree in Chemical Engineering or Chemistry or equivalent
- Minimum 7 years of relevant experience in human or animal health working within a c.GMP environment
- Extensive experience working with external suppliers
- Experience with process development and scale-up and or technical transfer and be familiar with chemical processes
- Experience of working with highly regulated markets and examples of value added contributions to regulatory dossier submission and review
- A strong business acumen, communication skills, and a proven track record of managing projects in the areas of sourcing/commercialization/tech transfer/chemistry process troubleshooting supply of API products
- Strong Leadership attributes including a global mindset
- Demonstrated ability to lead a cross-functional teams with an end to end supply chain view
- Ability to collaborate across functions and geographies
- Strong interpersonal skills
- Ability to maintain strong working relationships with technical, quality and operations leaders in the internal and external network
- Ability to use Microsoft Project 2010
- Ability to communicate with Chinese and Indian suppliers and manage across time and space is required
- The ability to travel up to 30%
Desired Qualifications
- he/she should understand the technical characterization of product physical properties and familiarity or expertise with chemistry and finishing crystallization
- Expertise in troubleshooting and process improvement for chemical manufacturing for API
- Six Sigma certification
- Additional language capability
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