Assoc. Dir., Engineering

MSD Malaysia; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

MSD Malaysia seeks a seasoned Project Manager for Pharma API technology transfer and external manufacturing partnerships in a highly regulated environment. You will oversee API development, sourcing, and technical transfer with global suppliers, ensuring compliant, timely delivery across the supply chain.

The role emphasizes leadership, cross-functional coordination, and risk management, with extensive collaboration with R&D, QA, and manufacturing teams to optimize processes and regulatory

Qualifications

• Ph.D. in Chemical Engineering or Chemistry, or equivalent.
• Minimum 7 years of relevant experience in pharmaceutical API/manufacturing.
• Experience with regulatory dossiers and external supplier management.

Responsibilities

• Lead technology transfer and API development projects with external manufacturers.
• Define service requirements, perform due diligence, and assess supply risk.
• Coordinate with external manufacturing, global procurement, and R&D teams.
• Monitor project timelines, quality, and regulatory readiness.
• Drive process improvements and troubleshooting across supply chains.

Skills

API Manufacturing

Business Acumen

Change Control Systems

Chemical Engineering

Chemical Manufacturing

Education

Ph.D. in Chemical Engineering or Chemistry

Job description

Job Description Purpose of the role

We are looking for candidates whom can demonstrate strong Project Management skills with experience in Pharma API, technology transfer, and a highly regulated manufacturing and chemical environment. The candidate will be able to demonstrate achievements in process improvement and development as well as strong examples of prolonged partnership with external manufacturers and suppliers.

Welcome in our team

The API Technology & Portfolio Management group is the steward and owner of the science and technology and the associated processes for small molecule products in our company being manufactured by our external partners. The group is also responsible for the scale up and commercialization of new products. We practice excellence in the technical activities to support the sites including validation, qualification, engineering and maintenance. The group helps ensure a compliant, safe, environmentally conscious and reliable supply for research and in-line products by leveraging appropriate technology, innovating and improving our processes. We manage the portfolio of project execution, troubleshooting and technical knowledge.

Main responsibilities

• Leveraging external suppliers for API development and full-scale production and the potential project types include sourcing, technical transfer, R&D, process improvement, and troubleshooting.
• Operational excellence projects will be assigned as able.
• Interfacing with the External Manufacturing & Global Procurement organization of our Animal Health Manufacturing Division and the different Animal health R&D departments to develop and manage the supply base and complete sourcing projects.
• Define the requested services including generating technical packages, lead technical due diligence for supplier selection, and verify that the aspects of supplier selection are considered appropriately, including assurance of supply, quality, service, cost, and innovation.
• Follow-up the quality and the timeliness of the delivered services
• On Technical Transfer projects the individual will typically be the overall project lead and ensure the execution of the project is on time and in full.
• Providing strong leadership and business acumen for project management and lead cross-functional team members effectively
• Displaying leadership behaviors and demonstrate a high emotional intelligence
• Creating and ensuring the overall technical transfer schedules including regulatory and formulation site inputs are appropriate for the project delivering end to end outcomes.
• Working closely with external suppliers to assess the chemistry and processing equipment and limit risk on transfer
• Evaluating material physical property and chemical comparability and mitigate risk
• Conducting troubleshooting exercises and process improvements with the existing API suppliers.

Your profile

As required, the individual will assist in communications with the suppliers and visit facilities to conduct due diligence and or resolve technical issues. Technical and project management skills are critical. 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%

Preferred Experience and Skills

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

Required Skills

• API Manufacturing
• API Manufacturing
• Business Acumen
• Change Control Systems
• Chemical Engineering
• Chemical Manufacturing"