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Associate Director, Chemical Technical Operations, North America External Manufacturing

MERCK SAINT LIÉVIN
il y a 1 jour

Location: Ames, IA | California, CA | Sacramento, CA | San Francisco, CA

Job Description

Our Small Molecule API Chemical Technical Operations Unit is seeking a highly motivated individual to fill an open Technical Lead position to support drug substance tech transfer and commercial manufacture within our North America External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in API manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the small molecule line of business at our company.

Key Responsibilities

  • Operate independently on priorities established with assigned External Partners.
  • Foster proactive partnerships with External Partners to meet business goals, identify and mitigate risks, and continuously enhance performance.
  • Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.
  • Serve as the primary technical contact for assigned External Partners while coordinating with impacted company sites and External Partners.
  • Collaborate with internal teams to ensure seamless product supply with an end‑to‑end mindset.
  • Initiate and drive change controls to completion.
  • Provide rapid support to External Partners to resolve manufacturing challenges and minimize supply disruptions.
  • Collaborate with Research Laboratories groups during New Product Introductions/Tech Transfers and new technology development.
  • Provide on‑site support at External Partners as required, proactively identifying risks and supporting all phases of execution.
  • Conduct technical due diligence assessments and provide expert consultation on chemical manufacturing matters.
  • Review process change requests and deviation reports while ensuring regulatory compliance.
  • Perform proactive process monitoring to enable robust manufacturing operations and early detection of process issues.

Education and Minimum Requirements

  • Bachelor’s in a technical field (Chemical Engineering, Biochemical Engineering, Chemistry, or Pharmaceutical Sciences) with a minimum of 7 years of relevant pharmaceutical industry experience; or Master’s with a minimum of 5 years of relevant experience; or PhD with a minimum of 3 years of relevant experience.
  • Experience in manufacturing, specifically in Small Molecule API process production, development, optimization, and tech transfer.
  • Ability to travel up to 50%.

Qualifications

  • Exceptional organizational skills and the ability to work independently.
  • Proven leadership attributes including a global mindset, an end‑to‑end supply chain perspective, and strong collaborative abilities across functions and geographies.
  • Demonstrated capacity to solve complex technical challenges, lead project teams, and influence stakeholders effectively.
  • A solid understanding of small molecule pharmaceutical manufacturing processes.
  • Strong technical communication skills with proven ability to tailor communications for various levels of the organization, inclusive of leaders and peers.

Required Skills

Chemical Manufacturing, CMO Management, Communication Management, Drug Product Manufacturing, External Manufacturing, External Partners, Global Mindset, Manufacturing Operations, Manufacturing Processes, Manufacturing Scale‑Up, Process Monitoring, Technical Transfer

Inclusion Statement

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights and EEOC GINA Supplement.

We are proud to be a company that embraces the value of bringing together talented, committed people with diverse experiences, perspectives, skills, and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado, and other U.S. State Acts.

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