Job Description
We have an exciting opportunity for an Associate Director to join the technical operations team supporting a start-up of Human Health at our facilities in Durham, North Carolina. This new facility will include end-to-end processing of both drug substance and drug product and quality control laboratories.
The Associate Director, Technical Operations will be responsible for providing technical leadership to the drug substance manufacturing area as part of the Technical Operations team.
Responsibilities
- Reporting to the Director, Technical Operations, the incumbent will assist in strategy development and will independently manage project assignments.
- Effectively manage a team of engineers and scientists supporting drug substance technical transfer by developing a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members.
- Provide end-to-end technical support to assigned areas of focus throughout the project lifecycle including but not limited to quality risk management, strategy development, development of standard operating procedures and master batch records, process development, and process performance qualification.
- Lead, facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones.
- Review and approve project documents as necessary including drug substance and process support and media technical documents, documents pertaining to utilities, manufacturing equipment and other processes, change controls, batch records, standard operating procedures, corrective and preventative actions among others.
- Act as a subject matter expert in support of quality risk assessments and regulatory inspections.
- Supports team safety, environmental, and compliance objectives.
- Escalates and consults on an as-needed basis with next level manager on more complex decisions impacting critical project milestones.
Qualifications
Required
- Bachelor's, Master’s, or Doctorate degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or related life science or engineering discipline.
- Minimum of four (4) years (Doctorate), six (6) years (Master's), or seven (7) years (Bachelor’s) experience in pharmaceutical operations, technical services, and/or quality operations including prior people management experience.
- Effective decision-making, problem-solving, and communication skills.
- Ability to manage multiple priorities and complex problems in a fast-paced environment.
- Aseptic manufacturing and GMP manufacturing experience, preferably with biological drug substance.
Preferred
- Capital project experience.
- Experience using Lean/Six Sigma tools.
Required Skills:
API Manufacturing, Aseptic Processing, Biologics, Change Control Systems, Chemical Process Development, Cross-Cultural Awareness, Cross-Functional Teamwork, Equipment Qualification, Manufacturing Process Validation, People Leadership, Process Optimization, Regulatory Inspections, Regulatory Requirements, Results-Oriented, Strategic Thinking, Technical Guidance, Technology Transfer
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
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 if you need an accommodation during the application or hiring process.
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 .
You can apply for this role through (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:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
09/10/2026
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
