Associate Director, Technical Operations - Small Molecule Drug Product

Biopharma Careers; Elkton (KY); On-site; USD 142,000 - 224,000; Full time

Job summary

Biopharma Careers seeks an Associate Director of Technical Operations for Small Molecule Drug Product at Elkton Site, VA. You will provide technical leadership for startup, tech transfer, validation, and ongoing commercial manufacture of oral solid dosage forms.

Leading cross-functional teams, you will ensure safe, compliant, and reliable process performance while driving continuous improvement and lifecycle management. Strong background in OPD operations and cGMP is essential.

Qualifications

• Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related field.
• Experience with oral solid dose manufacturing and process development.
• Strong knowledge of process engineering, scale-up, validation and GMP.

Responsibilities

• Lead process scale-up, technology transfer and validation activities for oral solid dose processes.
• Drive improvements in process performance, yield, robustness, and impurity control.
• Support design, commissioning, qualification and startup readiness for capital projects.
• Ensure compliance with cGMP and regulatory expectations across processes.
• Collaborate with cross-functional teams including Engineering, Quality and Supply Chain.

Skills

Oral solid dose

Process engineering

Scale-up

cGMP

DeltaV

Process validation

Education

Chemical Engineering / Pharmaceutics / Pharmaceutical Sciences (BSc/BEng/Masters)

Related discipline

Tools

DeltaV

Job description

Job Description

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

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast‑following into production with a focus on quality, safety, and operational excellence.

At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

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.

Key Responsibilities

Technical Leadership

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 escalation 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

People, Capability & Business Leadership

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

Qualifications

• 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

Our Culture

We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world’s most challenging healthcare needs. We believe breakthrough innovation happens when experienced leaders empower talented teams in an inclusive environment.

So, if you are ready to:
Support delivery of new Drug Product manufacturing capability
Drive operational and technical excellence in Oral Solid Dose production
Develop your leadership capability in a high‑impact environment

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

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: 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

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 .

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 09/8/2026

Requisition ID: R407466