La Jolla, CA, United States
Manager, Operations, Executive, Manufacturing, Engineering
Senior Director of Manufacturing Operations
The Senior Director of Manufacturing Operations (OIW) reports to the Vice President of Manufacturing Operations and is responsible for strategy, planning and execution for the company’s manufacturing operations for Dermagraft and TransCyte product lines. Develops production and resource plans that meet production goals in terms of safety, quality, output and cost. Develops best practices for managing, allocating and retaining resources in anticipation of strategic growth. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Manage employees and hands-on operations of the company’s manufacturing function including upstream subassemblies, whether in-house or sub-contracted.
Ensure that, as the company grows, manufacturing capabilities meet or exceed all industry and customer requirements for cost, quality and responsiveness.
Work closely with the VP of Manufacturing Operations on manufacturing plans, goals, and efficiency improvement initiatives
Play an active role in negotiations and oversight of subassembly manufacturing partners and critical raw material suppliers
Develop and manage budgeting and budget execution with a focus on product costs and margins.
Direct all production control and production process development partnering with key stakeholders in quality, purchasing and distribution
Cross-functionally identify, correct, investigate and resolve all quality issues in a timely and efficient manner
A minimum of 10 years of experience in manufacturing management and/or operations at a life sciences GMP / FDA regulated company.
Prior experience in technical transfers, qualification, validation, trouble shooting, FDA inspections, process scale-up, and commercial operations support.
Success deploying commercial components into high-volume production with fast time-to-market and cost-sensitivity requirements.
Self-starter and a team player that will thrive in a dynamic environment.
Experience leading high-throughput teams leveraging best practices.
Experience in meeting company strategy, performance objectives and customer expectations.
Minimizing company risks and maintaining conformity for safe and healthy work environment
Skills and Specifications -
Must have thorough knowledge of manufacturing operations in a clean room environment – ISO Class 7 or better
Excellent organizational and communication skills
Excellent planning and administration skills
A flexible style which fosters the rigidity of management of a GMP facility compliantly while remaining flexible to the competing demands of our programs
Must understand the needs of key collaborators and customers, and interact effectively intra- and interdepartmentally to achieve alignment and consensus
Outstanding interpersonal, verbal, written and presentation skills
Strong understanding of budgeting/expense management with a basic understanding of financial and accounting practices
Track record of attracting, developing, inspiring and retaining key talent
Education and Qualification
Bachelor’s degree in a relevant scientific/engineering discipline required. Life Science based degree preferred
Demonstrated leadership skills with proven ability to create and grow high performance manufacturing teams
Highly skilled in cross-functional Technical Transfer methodologies and Design for Manufacture considerations
Demonstrated use of Lean or Kaizen principles and evidence of establishing a continuous improvement culture
Organogenesis Inc. West Coast Operations / Dermagraft Manufacturing - La Jolla, CA 92037 US (Primary)
10 - 20%
Website : http://www.organogenesis.com