Requisition ID: CHE006166
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
- The individual will be part of the API Technology Portfolio Management Group and will be responsible for a portfolio of Active Pharmaceutical Ingredient (API) projects and or supply nodes with a focus on R&D projects.
- He/She will focus on leveraging external API suppliers to provide material primarily to MAH internal formulation facilities across the world. The potential project types include sourcing, technical transfer, R&D, process improvement, and trouble shooting.
- The role is global and the individual will be part of a global team. Critical Skills include Technical, project management, verbal communication, and electronic communication.
- Operational excellence projects will be expected to be pursued to enhance the function.
- At the director level, the individual will be eligible for advanced projects, deep trouble shooting and innovation projects. A focus will be placed on contact manufacturing over generic activity and will include owning a portfolio of Research and Development projects. The individual will be a technical lead during API sourcing for contract manufacturing, will be an end to end leader of the contract manufacturing project execution after supplier selection, and will be a leader of supplier technical management for complex relationships. They will be expected to generate innovations with the supply base and lead global initiatives as required.
- End to end leadership of a contract manufacturing technical transfer after supplier selection requires managing all aspects of the interface with the supplier and with the internal MAH departments. Individuals will be responsible to maintain the project schedules, call regular global meetings with the needed departments to manage the relative work streams, and hold sponsor meetings to communicate the project status and request support at stage gates. Technical strength will be needed in areas such as process chemistry, process engineering, analytical chemistry, physical property engineering, environmental, Industrial Hygiene, and regulatory. Strong business acumen and partnership with procurement will be expected to ensure financial targets are met and contracts are managed well.
- During global sourcing leading to supplier selection, the individual will be expected to partner with External Manufacturing & Global Procurement organization of MMD Animal Health and the different Animal Health departments. During the sourcing phase of a project, the individual will be a technical lead on the sourcing team and be responsible to define the requested services and physical properties including generating technical packages, leading technical due diligence for supplier selection, planning formulation and regulatory timelines, and verifying that the evaluation of the supplier is balanced. A close partnership with procurement and formulation site leads during the sourcing process is important and knowledge of the importance of physical properties on formulation success is needed.
- For inline supply, Supplier Technical Management (STM) will be conducted to ensure the on time and full delivery of API to MAH. The individual will be expected to:
- Lead cross functional meetings with the external suppliers and Internal MSD personnel to monitor the technical aspects of the relationship including tracking all changes, deviations, and improvement projects.
- Lead the process change team inside of MAH working closely with our formulation facilities, regulatory, and quality in order to execute changes at the supplier
- Follow up on deviations and ensure resolved quickly and appropriately
- Ensure appropriate knowledge management of API technology
- Develop and pursue innovation projects with the supplier as appropriate
- Leverage appropriate software systems including for supplier communication and change control
- Importantly, in this role, the individuals must:
- Provide strong leadership and business acumen for project management and lead cross-functional team members effectively
- Display Merck leadership behaviors and demonstrate a high emotional intelligence
- Create and ensure the overall project schedules including regulatory and formulation site inputs are appropriate for the project delivering end to end outcomes
- Work closely with external suppliers to assess the chemistry and processing equipment and limit risk on transfer
- Evaluate material physical property and chemical comparability and mitigate risk
- Present status updates in the API Governance forum
- As required, the individual will assist communications with the suppliers during trouble shooting or visit facilities to conduct due diligence.
- PhD in Chemistry or Chemical Engineering or comparable appropriate for API technical understanding.
Required Experience or Skills:
- Minimum 10 yrs. of relevant experience
- He/she must have experience with chemical processes or a demonstrated high level of technical capability
- A strong business acumen, communication skills, and a proven track record of managing projects in the areas of sourcing / commercialization / tech transfer / chemistry process trouble shooting supply of API products
- Strong Merck 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 and support global activities
- 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
Preferred Experience and Skills:
- Understand the technical characterization or product physical properties and familiarity or expertise with chemistry and finishing crystallization is preferred.
- Expertise in trouble shooting chemical manufacturing for API
- Familiarity with Regulatory strategy and execution
- Six Sigma certification preferred
Travel: 15 to 30%
Reporting Structure: This position reports to the Head of the API Technology Portfolio Management as part of Global Technical Operations for Animal Health.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Job: Chemical Engineering
Other Locations: Rahway, NJ, US; Upper Gwynedd, PA, US
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable):
Company Trade Name: Merck
Nearest Major Market: New Jersey