Job Detail

Description

Summary:

The Senior Manager, External Manufacturing Operations is accountable for meeting Seattle Genetics’ supply demands, both clinical and commercial, at the Contract Manufacturing Organizations (“CMOs”) she or he manages, with an emphasis on drug-linker and/or small molecule/API manufacturing. The Sr Mgr, External Mfg Ops, is the primary point of contact and escalation between Seattle Genetics and the assigned CMOs and focuses on achieving uninterrupted supply while pursuing excellence in quality and compliance. Results are obtained by direct communication with CMO site management on production planning, execution, and issue resolution, as well as working closely with internal groups (Quality, Planning, Logistics, Manufacturing Sciences & Technology, and Technical Development) and leading the corresponding virtual plant teams. The position may have direct reports assisting in the operational management and oversight of CMOs.

Principal Responsibilities:

• Serve as “Virtual Plant Manager” for key CMOs, achieve and maintain in-depth understanding of the CMO’s systems, capabilities, and capacity utilization, and be actively engaged in the CMO’s operations to ensure on-time, in-full delivery of clinical and commercial products


• Primary owner of Seattle Genetics relationship with the CMOs and the key point of contact for all interactions between the parties


• Leader of the cross-functional Virtual Plant teams consisting of representatives of External Manufacturing, Supply Planning, Packaging Operations, Quality, Manufacturing Sciences & Technology, Development etc.


• Align scheduling of CMO production with internal supply planning


• Drive resolution of operational issues e.g. issues, deviations, corrective and preventive actions, production delays etc.


• Participate in or lead matrix teams to drive life cycle management projects, both internally and externally. Such projects include technology transfers, process improvements, validation activities, packaging changes, regulatory submission reviews etc. and associated change management and/or project management


• Manage change planning and ensure timely implementation of changes in line with regulatory strategy and inventory management constraints


• For clinical products, align Development and CMO processes and expectations and participate in Tech Transfer teams


• Proactively drive risk assessment across the whole value chain and work closely together with Ext Mfg Ops Management, the Virtual Plant teams, and CMOs to manage and mitigate risks aiming at uninterrupted supply and full compliance with quality and compliance standards


• Assist in efforts for the identification and selection of new contract manufacturers and negotiate Supply Agreements, aligned with Quality Agreements. Manage contract modifications and termination, as required


• Establish overview of contract manufacturer’s capacity (e.g. stated capacity, actual capacity, future capacity plans, time horizon / lead times required etc.), and provide recommendations for capacity expansion at contract manufacturers, as required


• Ensure alignment of the Supply and Quality agreements


• Run CMO working team(s) for CMO(s) under her/his responsibility, facilitate and participate in periodic Business and Relationship Review Meetings, monitor site performance according to standard KPIs, negotiate metrics targets with CMOs based on governance team’s input


• Work with the Ext Mfg Ops Leadership to develop and execute the External Manufacturing Network Strategy

 Qualifications:

• Minimum of seven years industrial experience in manufacturing operations, process development, MSAT, quality or similar functions in biopharmaceutical or chemical industry required


• Strong knowledge and hands-on experiences in small molecule/API process development or manufacturing


• Experience with highly potent (HiPo) manufacturing is a plus


• Must have thorough knowledge of cGMP’s and regulatory expectations for pharmaceutical manufacturing and facility compliance


• Must have demonstrated competence and proficiently in key quality systems, including investigations, corrective actions, and change management


• Direct experience with Health Agency inspections (e.g., FDA or EMA cGMP surveillance and/or pre-approval inspections) is a plus  


• Must possess excellent interpersonal, communication, project management, collaboration, negotiation and analytical skills


• Has demonstrated strong leadership in a team environment


• Ability to work independently with minimum supervision


• Ability to handle complex projects in fast-changing, challenging environment. Must be decisive in ambiguous situations


• Heightened level of cultural awareness and sensitivity


• Ability to travel within Europe and US occasionally with periods of frequent travel


• Fluency in English, some proficiency in French, German, Italian, Portuguese or Spanish is a plus

 Education:

• PhD with 7-8 years of experience, Masters with 8-10 years of experience, or Bachelors with 10+ years of experience is desired