Associate Director, Chemical Technical Operations, North America External Manufacturing

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.

This position reports to the Director, Chemical Technical Operations, North America API External Manufacturing.  The Technical Lead will be responsible for the management of the technical interface between our Company and External Partners (EP).  The technical lead will provide process support to External Partners for existing supply products to resolve production issues, evaluate and manage process change requests, proactively assess, and manage process/technical risks, and provide guidance on process improvement and capacity optimization. The technical lead will also provide oversight of External Partners during New Product Introductions and Technical Transfers, proactively identifying process/technical risks as part of pre-execution activities, providing on-site support during execution, and supporting post-execution activities.

 

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 & early detection of process issues.

Education and Minimum Requirements:

• Bachelors in a technical field (Chemical Engineering, Biochemical Engineering, Chemistry, or Pharmaceutical Sciences) with minimum 7 years of relevant pharmaceutical industry experience; or Master’s with minimum 5 years of relevant experience; or PhD with minimum 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:

Adaptability, Adaptability, Automation Systems, Capital Project Management, Change Management, Chemical Manufacturing, Clinical Manufacturing, Communication Management, Data Analysis, Decision Making, Drug Product Manufacturing, Environmental Health And Safety, Global Mindset, Interpersonal Relationships, Lean Manufacturing, Manufacturing Operations, Manufacturing Processes, Manufacturing Scale-Up, Mitigated Risks, Process Improvements, Process Monitoring, Process Redesign, Regulatory Compliance, Root Cause Analysis (RCA), Stakeholder Engagement {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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.

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:

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We are proud to be a company that embraces the value of bringing together, talented, and 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 US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/14/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.