Associate Director, Technical Operations - Molecule Drug Substance

Position: Associate Director, Technical Operations - Small Molecule Drug Substance
Location: Elkton

** 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 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:

+ 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…