Associate Director API Technology portfolio management

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Reporting to the Director of the API Technology Portfolio Management as part of Global Technical Operations for Animal Health, the Associate Director 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 R&D Projects and coordinating the R&D portfolio. 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.

At the Associate Director level, the individual will be eligible for advanced projects, deep trouble shooting and innovation projects. A focus will be placed on coordinating the contract manufacturing and generic activity and will include owning several Research and Development projects. The individual will be a technical lead during API sourcing, 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.

Responsibilities include but are not limited to:

• Leveraging external API suppliers to provide material primarily to our Company Animal Health internal formulation facilities across the world.

• Enhancing the function through Operational excellence projects.

• End to end leadership of a contract manufacturing technical transfer after supplier selection including managing all aspects of the interface with the supplier and with the internal our Company Animal Health departments.

• Maintaining 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.

• During global sourcing leading to supplier selection, the individual will be expected to partner with External Manufacturing & Global Procurement organization of our Manufacturing Division 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.

• 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.

• 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 our Company Animal Health.

• Leading cross functional meetings with the external suppliers and Internal our Company personnel to monitor the technical aspects of the relationship including tracking all changes, deviations, and improvement projects.

• Lead the process change team inside of our Company Animal Health working closely with our formulation facilities, regulatory, and quality to execute changes at the supplier

• Following up on deviations and ensure resolved quickly and appropriately

• Ensuring appropriate knowledge management of API technology

• Developing and pursue innovation projects with the supplier as appropriate

• Leveraging appropriate software systems including for supplier communication, change control, budget, regulatory and project management.

• Providing strong leadership and business acumen for project management and lead cross-functional team members effectively

• Displaying our Company leadership behaviors and demonstrate a high emotional intelligence

• Creating and ensuring the overall project 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.

• Presenting 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.

• 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.

Education Required:

• PhD in Chemistry or Chemical Engineering or comparable appropriate for API technical understanding.

Required Experience or Skills:

• Minimum 10 yrs. of relevant experience

• 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 Leadership attributes including a global mindset

• Demonstrated ability to lead 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

• Experience using Microsoft Project

• The ability to travel up to 30%

Preferred Experience and Skills:

• An understanding of 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

Your role at our Company 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 our Company, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com. Visa sponsorship is not available for this position.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Requisition ID:R162330