Associate Director, Technical Operations - Molecule Drug Product

Job Overview

Associate Director, Technical Operations – Small Molecule Drug Product at our Elkton Site in Virginia, USA. The role is focused on the startup, technology transfer, validation, and ongoing commercial manufacture of oral solid dosage forms. The Associate Director will provide technical leadership and operational support from capital project through commercialization and lifecycle management, ensuring safe, compliant, and reliable process performance while driving continuous improvement.

• 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, granulation, roller compaction, tablet compression, film coating, and finishing operations.
• Capital Project Support: Contribute to design, commissioning, qualification, and startup readiness for capital projects.
• Technology Transfer: Lead and execute technology transfer activities across internal sites and external partners, including process fit assessments and scale‑up strategy from development to commercial scale.
• Process Validation: Support process validation, continued process verification, and batch record readiness.
• Operational Excellence: Partner with Manufacturing to ensure safe, efficient, and reliable plant performance; support deviation investigations, OOS, CAPA, root‑cause analysis, and continuous improvement initiatives.
• Regulatory & Compliance: Ensure processes operate in compliance with cGMP and regulatory expectations; support inspection readiness, audit activities, and regulatory submissions.
• Cross‑Functional Leadership: Collaborate with Engineering, Capital Projects, R&D, Quality, Supply Chain, and Manufacturing; represent processes in governance forums.
• People & Business Leadership: Lead and develop a team of technical specialists and engineers; coach, provide feedback, plan resources, manage budget tracking, and support recruitment and onboarding.

• Degree (BSc/BEng/Masters) or higher in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline.
• 10+ years of experience 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 and regulatory expectations.
• Experience with deviation management, 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.

Salary range: $ – $. Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement 401(k), paid holidays, vacation, and compassionate and sick days.

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 any other legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.