Associate Director, Technical Operations - Small Molecule Drug Product

About the role

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.

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
• Maintain compliance from startup through commercial operations

• 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

• Cross-functional Leadership

• Collaborate with Engineering, Capital Projects, R&D, Quality, Supply Chain, and Manufacturing
• 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 Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline

• Experience:

• 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
• Able to work effectively across cross-functional teams and multiple priorities

Preferred Skills

• Adaptability
• Automation Systems
• Biopharmaceutical Industry
• Business Management
• Capability Development
• Capital Project Management
• Change Management
• Chemical Engineering
• Clinical Manufacturing
• Data Analysis
• Decision Making
• Drug Product Manufacturing
• Interpersonal Relationships
• Leadership
• Lean Manufacturing
• Manufacturing Scale-Up
• Operational Excellence
• Organizational Performance Management
• Pharmaceutical Sciences
• Process Scale Up
• Regulatory Compliance
• Root Cause Analysis (RCA)
• Strategic Thinking

Benefits

• Annual bonus and long-term incentive, if applicable

• Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

• Valid Driving License

• Hazardous Material(s) n/a

Pay

$142,400.00 - $224,100.00

Schedule

Not Indicated

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

10%