MERCK
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Associate Director, Engineering (API Drug Substance)
role at
Merck 1 day ago Be among the first 25 applicants Join to apply for the
Associate Director, Engineering (API Drug Substance)
role at
Merck Job Description
Submit your CV and any additional required information after you have read this description by clicking on the application button.
As a Technical Lead, you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in managing the technical interface between our company and our External Partners (EP) for Active Pharmaceutical Ingredients (API) and intermediates. You will be responsible for providing process support, resolving production issues, evaluating process change requests, and proactively managing process and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative efforts. Job Description
As a Technical Lead, you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in managing the technical interface between our company and our External Partners (EP) for Active Pharmaceutical Ingredients (API) and intermediates. You will be responsible for providing process support, resolving production issues, evaluating process change requests, and proactively managing process and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative efforts.
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/Technical Transfers and new technology. Offer 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.
Education And Minimum Requirements
Bachelor’s degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work experience in manufacturing or development, in the areas of process start up, technology introduction, manufacturing and/or technical transfer A minimum of 7 years of experience in manufacturing, specifically in API process production, development, optimization, and technical transfer.
Skills Requirements
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. Fluency in English is essential. Willing to travel up to 50% of the time
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.
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
EEOC GINA Supplement
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
$139,600.00 - $219,700.00
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:
Domestic
VISA Sponsorship
No
Travel Requirements
50%
Flexible Work Arrangements
Hybrid
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
n/a
Required Skills
Active Pharmaceutical Ingredients (API), Chemical Manufacturing, Clinical Manufacturing, Compliance Reviews, Data Analysis, Environment Health and Safety, Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause Analysis (RCA), Stakeholder Engagement, Stakeholder Relationship Management, Standards Compliance, Strategic Thinking, Technical Transfer
Preferred Skills
API Manufacturing
Job Posting End Date
08/8/2025
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.
Requisition ID: R358817Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionEngineering and Information Technology IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Merck by 2x Get notified about new Associate Director Engineering jobs in
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Associate Director, Engineering (API Drug Substance)
role at
Merck 1 day ago Be among the first 25 applicants Join to apply for the
Associate Director, Engineering (API Drug Substance)
role at
Merck Job Description
Submit your CV and any additional required information after you have read this description by clicking on the application button.
As a Technical Lead, you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in managing the technical interface between our company and our External Partners (EP) for Active Pharmaceutical Ingredients (API) and intermediates. You will be responsible for providing process support, resolving production issues, evaluating process change requests, and proactively managing process and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative efforts. Job Description
As a Technical Lead, you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in managing the technical interface between our company and our External Partners (EP) for Active Pharmaceutical Ingredients (API) and intermediates. You will be responsible for providing process support, resolving production issues, evaluating process change requests, and proactively managing process and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative efforts.
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/Technical Transfers and new technology. Offer 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.
Education And Minimum Requirements
Bachelor’s degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work experience in manufacturing or development, in the areas of process start up, technology introduction, manufacturing and/or technical transfer A minimum of 7 years of experience in manufacturing, specifically in API process production, development, optimization, and technical transfer.
Skills Requirements
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. Fluency in English is essential. Willing to travel up to 50% of the time
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.
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
EEOC GINA Supplement
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
$139,600.00 - $219,700.00
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:
Domestic
VISA Sponsorship
No
Travel Requirements
50%
Flexible Work Arrangements
Hybrid
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
n/a
Required Skills
Active Pharmaceutical Ingredients (API), Chemical Manufacturing, Clinical Manufacturing, Compliance Reviews, Data Analysis, Environment Health and Safety, Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause Analysis (RCA), Stakeholder Engagement, Stakeholder Relationship Management, Standards Compliance, Strategic Thinking, Technical Transfer
Preferred Skills
API Manufacturing
Job Posting End Date
08/8/2025
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.
Requisition ID: R358817Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionEngineering and Information Technology IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Merck by 2x Get notified about new Associate Director Engineering jobs in
Rahway, NJ . Rahway, NJ $139,600.00-$219,700.00 2 weeks ago Associate Director: Software Engineering New York, NY $172,925.00-$222,300.00 1 month ago Associate Director: Software Engineering Manhattan, NY $172,925.00-$222,300.00 4 days ago New York, NY $145,000.00-$175,000.00 3 weeks ago Whippany, NJ $209,639.00-$225,161.00 1 month ago Summit, NJ $166,600.00-$235,200.00 3 days ago Whippany, NJ $223,000.00-$230,000.00 3 weeks ago Summit, NJ $152,150.00-$214,800.00 1 week ago Senior Software Engineering Lead - Private Equity & Real Estate Technology New York, NY $175,000.00-$235,000.00 1 month ago New York, NY $175,000.00-$225,000.00 2 days ago Lyndhurst, NJ $140,000.00-$160,000.00 1 day ago New York, NY $120,150.00-$180,226.00 6 days ago Associate Practice Area Director - Aviation/Transportation and Commercial New York, NY $126,158.01-$180,226.00 1 week ago Senior Software Engineer - Buy-Side Violation Manager New York, NY $160,000.00-$240,000.00 1 week ago Sr. Principal Scientist, (Sr. Director) Health Economics Rahway, NJ $206,200.00-$324,600.00 1 week ago Jersey City, NJ $134,000.00-$182,000.00 2 weeks ago Principal Scientist (Director) - Outcomes Research Ophthalmology Rahway, NJ $187,000.00-$294,400.00 2 days ago Senior Manager, Strategic Projects - Partnerships New York, NY $135,000.00-$165,000.00 22 hours ago Vice President, Senior Software Engineer - Capital Markets New York, NY $166,000.00-$205,000.00 2 weeks ago Senior Enterprise Delivery Manager, Migrations New York, NY $140,700.00-$208,400.00 3 days ago Senior Project Coordinator – Public Realm Manhattan, NY $80,091.00-$116,999.00 1 year ago Front-End Designer & Animator, Senior AssociateReact.JS Software Engineer (Senior Full Stack React.JS Developer)Associate Director/Director of Facilities New York, NY $100,000.00-$140,000.00 1 month ago New York, NY $175,000.00-$195,000.00 2 weeks ago Senior Project Manager (Location: NY, Connecticut, Massachusetts, New Jersey, Pennsylvania, or Vermont)Building Envelope Consultant- Senior Project Manager New York, NY $100,000.00-$160,000.00 2 weeks ago Senior Engineer Identity & Access Management Parsippany, NJ $115,000.00-$155,000.00 2 hours ago New York City Metropolitan Area 1 week ago Senior Project Manager, Moderate Rehabilitation and Stabilization Loan Programs for the Division of Preservation Finance New York, NY $87,500.00-$87,500.00 6 days ago Managing Consultant - Life Sciences Advisory - Commercial We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr