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Job description
Associate Director, Technical Operations - Small Molecule Drug Product
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 elevate 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
…we encourage you to apply.
Salary and Benefits
Salary range: $142,400 - $224,100. Benefits include medical, dental, vision, healthcare, 401(k), paid holidays, vacation, and sick days. More information about benefits is available at
Employee Status
Regular
Relocation
Domestic
VISA Sponsorship
No
Travel Requirements
10%
Flexible Work Arrangements
Not Applicable
Shift
Not Indicated
Valid Driving License
No
Hazardous Materials
n/a
Job Posting End Date
08/15/2026
Requisition ID
R
Equal Employment Opportunity
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, Learn more about your rights, including under California, Colorado and other US State Acts
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Worksite address
elkton, VA, 22827, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.