Director, Drug Product Development & Manufacturing

Compensation

: $107,710.00 - $156,290.00 /year *

Employment Type

: Full-Time

Industry

: Executive Management



The newly created role of Director, Drug Product Development & Manufacturing will provide leadership for clinical and commercial fill finish operations within the CMO organization and will partner with internal development and supply operations teams for technical support. This person will be the technical and leadership resource for commercial manufacturing, provide engineering and scientific expertise on equipment and process optimization, technical document authoring, continuous improvement, equipment, and process quality system ownership, process validation, and continuous process verification. The position is also responsible for ownership of the drug product process control strategy and providing specialized expertise in support of manufacturing-related critical investigations and change control activities. This person will report directly to the Vice President of Technical Operations and will be based in Redwood City.

Responsibilities:

  • Provide strategic leadership, technical expertise and specialized knowledge in antibody drug product fill finish operations
  • Direct technology transfer to/from contract manufacturing organizations and provide technical oversight of drug product manufacture
  • Ensure routine technical support of the CMOs for deviation management, batch record reviews, and lot disposition
  • Ensure that CMC life cycle strategies for products are implemented at CMOs and support regulatory submissions and approvals
  • Lead the commercial CMO selection process by evaluating CMO/supplier technical capabilities against applicable manufacturing, quality and compliance requirements
  • Develop risk-based strategies for the CMO technical oversight, taking into account the product life cycle, technical complexity and CMO capabilities
  • Develop process and product monitoring plans, master data and documentation management, compliance to Allakos quality systems, and other operational readiness support activities
  • Provide assistance to manufacturing sites globally to resolve significant quality events and manage complex change controls
  • Lead development and management of drug product manufacturing budget and long-range plans
  • Serve as SME for areas of responsibility during regulatory inspections.
  • Work collaboratively and cross-functionally with other key leaders to ensure the proper execution of organizational goals
  • Able to travel internationally (~10%)


Qualifications & Expertise:

  • At least 15 years of experience (12+ with MS, 10+ for PhD) successfully working in an operations environment, with at least 8 years managing cross functional projects
  • Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages
  • Extensive experience working with Contract Manufacturers is required with overall knowledge of monoclonal antibody drug product production in a cGMP-regulated environment including US/EU regulatory and quality requirements, practices and standards
  • Experience with start up and validation of manufacturing equipment
  • Strong track record of developing strategies and transforming them into actionable plans, driving results and achieving expected outcomes
  • Strong leadership skills and ability to influence at all levels
  • Excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners and health authorities
  • Experience in technical supervision, coaching and mentoring or leading small matrixed teams of people or scientific projects
  • Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CMOs, and multi-functional/multi-cultural teams


Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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