Assoc. Director/Director, Drug Product Manufacturing
Associate Director/Director Drug Product Manufacturing is responsible for supporting MEI Pharma’s clinical and Commercial programs with expertise in drug product manufacturing, process validation, and data review. The incumbent will help set and define program goals from inception through to completion by implementing the procedures required to achieve success; this includes active management and oversight of outside contractors throughout MEI’s product development process.
Management Scope: None at this time
Responsibilities & Duties (include but not limited to):
- The ideal candidate will be an experienced pharma/biotech leader with a strong record of accomplishment in Late Stage Clinical and Commercial cGMP Manufacturing of small molecule oral dosage form and parenteral products using global CMO’s
- This position will oversee global CMO’s and provide operational leadership and technical support, perform risk assessments, and oversight for the successful planning and execution of programs aligning with MEI’s strategic direction across all supporting functions
- Selection and qualification of contractors in accordance with MEI SOPs.
- Manage the contract manufacturing of finished drug products for clinical trial and commercial supplies.
- Ensures manufacturing instructions are technically and operationally well written to ensure compliant and successful execution of all production steps
- Manage drug product CMOs for commercial manufacturing operations, technology transfers, investigations, and batch documentation reviews and responsible for continuous improvement and operational excellence at CMOs
- Work collaboratively with MEI CMC Development functions including Analytical and Pharmaceutical Development
- In collaboration with the CMC Development functions, define and manage the phase-appropriate development of finished drug product, manufacturing processes, analytical methods and specifications.
- Support the CMC Development functions and CMC Regulatory, as needed, with CMC documents for regulatory purposes, including INDs, IMPDs, FDA meeting briefs, PIPs, NDAs, MAAs and NDSs, and performs as a subject matter expert in response to Regulatory Agency inquiries.
- Help develop and manage budgets for Tech Ops projects.
- Provide any necessary guidance and support to line management as required.
- Assists in the development and implementation of departmental processes, procedures and policies.
- Establish Manufacturing Excellence at CMOs for both small molecule oral dosage form and parenteral products
- Working with project-based CMC teams, directly contribute to and represent Operations in areas of process and product development strategy
- In collaboration with Quality and Pharmaceutical Sciences, conduct risk assessments on commercial manufacturing processes and develop risk mitigation plans
- Provide guidance and direction for manufacturing production goals, budgets, and other operational activities to ensure Right First Time (RFT) manufacture and timely delivery of drug substance and drug product materials to meet program and company goals
- Provides expert review and evaluation of CMC documents during due diligence
- Available to travel if/when needed to support manufacturing or CMO oversight activities
Minimum Education & Experience Requirements
- Bachelor's degree from college or university in Chemistry, Chemical Engineering, Pharmacy or closely related field, and a minimum of 10+ years of experience in the Pharmaceutical Industry. Graduate degree is preferred.
- Must have 8+ years of experience in pharmaceutical drug product manufacturing environment
- In depth knowledge of commercial manufacturing of small molecule oral dosage form and parenteral drug products
- Possess scientific knowledge relevant to the development and manufacturing continuum of drug product supporting clinical trial materials & commercial products
- Demonstrated experience in successfully bringing development compounds through late-stage clinical phase to post commercial launch
- Extensive understanding in the areas of manufacturing, validation, tech transfer, quality, supply planning and Tech Ops business systems
- Working understanding of cGMP, GLP, GCP and GvP compliance requirements associated with U.S., EU, ICH and other pertinent regulatory agencies
- Knowledgeable in LEAN principles and Manufacturing Excellence
- Experience with contract manufacturing of parenteral and oral dosage forms is required
- Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates and issues to the key stakeholders
- Familiarity with document management platforms, e.g. Veeva, Master Control
- Proficiency with Microsoft Office suite (e.g. Word, Excel, PowerPoint, Outlook) and project timeline management tools, e.g. SmartSheet, MS Project
- Experience with shipping logistics is a plus
- Good culture fit to MEI’s workplace values of Dedication, Shared Commitment, Personal Accountability, Mutual Trust, and Fiscal Discipline.
- Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
- Regular communication (hearing/speaking)
- Lifting up to 25 lbs
- Routine office duties including computer keyboard use
- Vision requirements include: close vision and ability to focus
- Noise conditions range from quiet to moderate