San Diego, CA
Industry: Pharmaceuticals & Biotech•
Posted 163 days ago
The CMO Operations Director is accountable for balancing all external Exparel product supply requirements with the appropriate CMO’s operational capacity and contractual requirements. This role is a key strategic leader overseeing the CMO operations team and requires expertise in contracting, commercial manufacturing, budgeting, supplier development, finished goods transportation, and general project management. This role will also support future growth and global expansion of the company’s portfolio and ensure CMO capabilities and capacity meet Pacira’s business needs. An ideal candidate will demonstrate significant personal and team based accomplishments that drove value to their previous employers/ customer by managing complex projects and effective communicating with internal and external stakeholders at all levels including Senior Management. The position will report to the Vice President, Global Supply Chain and will have direct reports who manage day-to-day CMO relationships. The individual will assume a leadership role in projects with aggressive timelines and high business impact, supporting the general management of all aspects of the CMO product value stream to include product transfer to new manufacturing locations as well developing new CMO business opportunities. This position will also work with other members of Manufacturing, Global Supply Chain, Operational Excellence, Product Development and Quality Assurance to develop a global end to end Product Supply Chain for all current and future CMO operational products.
Ensures the CMOs have the capabilities and materials required to support the production plan and deliver to meet requirements
Must be able to build and maintain strong partnerships with all internal and external stakeholders and lead discussion, problem solving efforts and process improvements to ensure that performance targets are met or exceeded
Lead contract negotiations for CMO related contracts as well as ensure existing contracts are current and support Pacira’s product / business needs.
Create the replenishment forecast for the CMO, reviewing and/or aggregating demand to ensure all demand streams are represented to ensure a full and accurate demand picture.
Lead planning meetings and discussions with CMOs to review forecasts and ensure CMOs have the capacity to meet requirements; address any gaps through CMO management teams and/or coordinate with downstream customers if demand cannot be met
Develop useful metrics to measure and monitor performance of CMO and relationships and lead QBR discussions / meetings in efforts to achieve performance goals.
Participate in internal planning processes and forums to ensure alignment on production requirements at assigned CMOs.
Control PO’s and Forecasts to CMOs within contractual lead times, to procure CMO production/materials based on firm demand.
Work with CMOs to confirm feasibility of requested PO delivery date, ensuring availability of capacity, materials and other resources.
Participate in CMO selection activities and contract negotiations to ensure CMOs have the capabilities required to meet requirements
Drive initiatives to minimize inventory variances and write-offs
Lead efforts within CMO management team to facilitate issue resolution and problem solving within CMOs, CMO site managers and with external support partners to ensure production plan requirements are met
Identify, propose and manage improvement projects to address process deficiencies or improvement opportunities
Manage and drive CMO operations initiatives as well as managing people within the group to accomplish team goals
Support the Vice President in development and execution various global initiatives.
Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners
This position will be required to travel throughout the US and EU to support current and future CMO operations (up to 25% travel)
Bachelor’s degree in Life Science, Biology, or Engineering discipline from an accredited college or university, or equivalent required.
15 years combined experience in design, manufacturing, and operations roles in biotech/pharmaceutical industry. Ideal candidate also has10 years’ experience directly managing commercial operations teams and/ or projects.
Experience working in matrix organizations; works effectively within cross-functional and multi-location/ multi-cultural teams requiring large-scale coordination
Strong technical background with knowledge of engineering and pharmaceutical manufacturing processes and industry standards, technical disciplines, and manufacturing practices required to manage detailed scheduling and planning data
Proven track record of delivering successful projects with excellent project management capabilities and demonstrated evidence of analytical, planning, and execution capabilities.
Exhibit creativity in adapting to situations, develops contingency plans, and makes decisions
Proven leadership skills in the development of staff and managing CMO Operations.
Ability to lead, motivate, and engage others to ensure successful delivery of product to the marketplace.
Strong knowledge of relevant topics within Regulatory Affairs, QA, QC, Manufacturing, and Supply as required to efficiently lead cross functional teams.
A quick learner and team player, exceptional critical thinking and problem solving skills, and excellent verbal and written communication skills.
Familiarity with ERP systems and purchasing/planning functions.
Proficiency in all aspects of Microsoft applications with particular focus on MSProject Management