Associate Director, Technical Operations - Small Molecule Drug Product

Overview

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 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**

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.