Associate Director, Technical Operations - Small Molecule Drug Substance

About the role

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).

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
• 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 optimization 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

• Education:

• Degree (BSc/BEng/Masters) or higher in Chemistry, Chemical Engineering, or related discipline

• Experience:

• 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

Preferred Skills

• Adaptability
• Automation Systems
• 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