Job Description

We have an exciting opportunity for an Associate Director, Technical Operations – Small Molecule Drug Product at our Elkton Site in Virginia, USA.

The successful candidate will provide technical leadership and operational support for the startup, technology transfer, validation, and ongoing commercial manufacture of oral solid dosage forms.

This role is responsible for leading technical activities across assigned processes and projects, supporting the capital project and facility startup phase through to commercialization and lifecycle management. The Associate Director will ensure safe, compliant, and reliable process performance, while driving continuous improvement and technical excellence.

• Recognized subject matter expert in Drug Product process support, and commercial manufacturing

• Provide technical oversight and hands-on leadership for oral solid dose manufacturing processes, including:

  • Blending and granulation (where applicable)

  • Roller compaction (dry granulation)

  • Tablet compression

  • Film coating and finishing operations

• Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness

• Lead process scale-up, technology transfer, and validation (pre-PPQ, PPQ) activities for assigned processes

• Drive improvements in process performance, yield, robustness, and impurity control

• Analyse technical data and support decision-making for process performance and improvements

• Identify and escalate risks, proposing practical, science-based solutions

Technology Transfer

• Lead and execute technology transfer activities for assigned processes across internal sites and external partners

• Support development and execution of tech transfer plans aligned with project timelines

• Provide technical support for:

  • Process fit assessments

  • Scale-up strategy from development to commercial scale

  • Equipment capability and process comparability assessments

• Ensure accurate process documentation, knowledge transfer, and batch record readiness

• Support process validation and continued process verification

Operational Excellence

• Partner with Manufacturing to ensure safe, efficient, and reliable plant performance

• Provide direct technical support to:

  • Campaign preparation, execution, and follow-up

  • Process troubleshooting during manufacturing

• Lead and support deviation investigations, OOS, and CAPA, applying structured root cause analysis

• Monitor process performance and cycle times, identifying improvement opportunities

• Drive continuous improvement initiatives for yield, cycle time, and cost

• Support process optimisation and debottlenecking activities

Regulatory & Compliance

• Ensure assigned processes operate in compliance with cGMP and regulatory expectations

• Support inspection readiness and audit activities

• Contribute to regulatory submissions and responses, including data generation and technical input

• Ensure data integrity and adherence to quality and safety standards

• Maintain compliance from startup through commercial operations

Cross-functional Leadership

• Collaborate with Engineering, Capital Projects, R&D, Quality, Supply Chain, and Manufacturing

• Act as a technical representative for assigned processes within cross-functional teams

• Support technology transfer and process improvements across the network

• Participate in interactions with external partners and CMOs as required

• Contribute to technical reviews and governance forums

• Lead and develop a team of technical specialists and engineers

• Provide coaching, technical guidance, and performance feedback

• Support resource planning and execution of departmental priorities

• Contribute to budget tracking and departmental administration

• Support recruitment, onboarding, and capability development initiatives

• Degree (BSc/BEng/Masters) or higher in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline

• Significant experience (typically 10+ years) in:

  • Oral solid dose manufacturing, formulation, or process development

• Strong background in:

  • Process engineering and scale-up

  • Process, equipment, and cleaning validation

• Working knowledge of:

  • cGMP manufacturing operations

  • Regulatory expectations and inspection readiness

• Experience with:

  • Deviation management and investigations

  • Electronic batch records and process systems (e.g., DeltaV)

• Exposure to capital projects, CQV, and facility startup

• Strong analytical, problem-solving, and communication skills

• Ability to work effectively across cross-functional teams and multiple priorities

Required Skills:

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

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: