Associate Director, Technical Operations - Small Molecule Drug Substance

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

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Biopharma Careers is seeking an Associate Director, Technical Operations – Drug Substance for our Elkton, VA site in the United States. You will provide technical leadership across API manufacturing, tech transfer, validation, and lifecycle management to ensure safe, compliant production of active pharmaceutical ingredients.

The role drives continuous improvement, collaborates with cross-functional teams, and guides capital projects through startup to commercialization.

Qualifications

• Degree in Chemistry, Chemical Engineering, or related discipline.
• 10+ years API process development or manufacturing experience.
• Strong knowledge of cGMP and regulatory expectations.

Responsibilities

• Provide technical oversight for API manufacturing processes and tech transfer.
• Lead process scale-up, validation, and ongoing manufacturing support.
• Drive process improvements, yield, and impurity control.
• Ensure compliance with regulatory inspections and data integrity.

Skills

API process development

Process scale-up

cGMP manufacturing

Regulatory compliance

Cross-functional leadership

Problem solving

Data analysis

Education

Chemistry or Chemical Engineering degree

Tools

DeltaV

Electronic batch records

Job description

Job Description

We have an exciting opportunity for an Associate Director, Technical Operations – Drug Substance 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 active pharmaceutical ingredients (APIs).

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 Substance process support, and commercial manufacturing

• Provide technical oversight and hands‑on leadership for API manufacturing processes, including:
  • Chemical synthesis
  • Purification
  • Crystallization and drying 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
• Provide technical guidance on:
  • Process chemistry
  • Reaction performance
  • Critical process parameters and control strategies
• Analyze technical data and support decision‑making for process performance and improvements
• Identify and escape 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:
  • Raw material evaluation
  • Process fit and manufacturability
  • Scale‑up readiness [
• 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 optimi zation 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 Chemistry, Chemical Engineering, or related discipline
• Significant experience (typically 10+ years) in:
• API process development and/or manufacturing
• Strong background in:
• Process chemistry 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.

Required Skills

• Adaptability
• Adaptability
• Automation Systems
• Batch Processing
• Biopharmaceutical Industry
• Business Management
• Capital Project Management
• Change Management
• Chemical Engineering
• Clinical Manufacturing
• Commercialization
• Data Analysis
• Data Integrity
• Decision Making
• Drug Product Manufacturing
• Interpersonal Relationships
• Knowledge Transfer
• Lean Manufacturing
• Manufacturing Scale-Up
• Operational Excellence
• Process Documentation
• Process Optimization
• Regulatory Compliance
• Root Cause Analysis (RCA)
• Strategic Thinking

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.

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.