Associate Director, Technical Operations - Small Molecule Drug Substance

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 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 .

So, if you are ready to:

Support delivery of new Drug Substance manufacturing capability

Drive operational and technical excellence in API production

Develop your leadership capability in a high-impact environment

…we encourage you to apply.

#ELKVACOE

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 {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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,