Your Role: The St. Louis, MO, Cherokee CDMO site is a center of excellence for antibody drug conjugates (ADCs), bioconjugates, and small molecule production. We are currently completing a $76M investment to optimize existing production capacity and enhance process and analytical labs to support the rapidly expanding ADC market.
The Site Head of the St. Louis, MO, Cherokee site is responsible for the strategic planning, directing, and controlling of development, manufacturing and quality operations. You are responsible for development and implementation of programs to permanently improve safety and quality systems and processes and ensure GMP compliant and cost-efficient manufacturing through effective utilization of resources, equipment, facilities, and materials. In addition, this individual assures production/supply chain schedules are met to fulfill forecasted market demand.
The Cherokee Site Head is critical in the realization of our CDMO business, Advanced Solutions Life Science ambition and Integrated Supply Chain Operation (ISCO) strategic goals to become the market leading CDMO player in the industry with a best-in-class supply chain.
Key accountabilities in this role include:
- Ensure safe and compliant operation, making Safety and Quality the top priorities for your site.
- Ensure the successful and profitable operation of the facilities, including the General Manufacturing Practices manufacture and the in-spec and on-time release of products.
- Provide leadership to the site, supervising the site leadership team including process and analytical development, manufacturing, engineering, quality, and supply chain; total staff 400.
- Make final decisions on critical operations matters and ensure best in class services are delivered to customers.
- Partner and collaborate with customers, business development, project management, and various Group Functions such as Innovation, Supply Chain, EHS, Quality, HR, Finance.
- Ramp-up production capacity in the facility with the approved expansion project, ensuring Commercial Readiness across all functions.
- Support and drive development of robust manufacturing processes for drug product from clinical to commercial.
- Ensure appropriate staffing of people resources and capabilities and drive production schedule, optimizing utilization of resources and assets.
- Develop the budget and manage areas of responsibility within approved budget and contracted scope of work.
- Make recommendations concerning long-range capacity planning, as well as upgrading of capital investments into existing site which is in line with strategic planning.
- Develop relevant KPIs for CDMO Excellence in collaboration with other CDMO sites and drive performance accordingly.
- Ensure highly effective and efficient training.
- Drive digitalization, automation and advancement of manufacturing and quality technologies in collaboration with company-wide initiatives.
- Support commercial team with customers' request for proposals, business presentations, etc.
- Strengthen site in their customer engagement and focus on value creation for the customer needs.
- Ensures service targets and customer's on-time delivery in full expectations are met.
- Be the accountable host for regulatory and customer audits and site visits.
- Identify and mitigate risks in operations including manufacturing, engineering, facilities management and quality that could adversely impact project outcomes and timely delivery of critical treatment to patients.
- The St. Louis, Cherokee site is dedicated to CDMO business, with close partnership with the Bioconjugation & Small Molecules Modality leadership to ensure strategic business needs are included and voiced in both the manufacturing strategy and operational targets for the site.
Who you are:Minimum Qualifications: - Bachelor's degree in relevant technical discipline (Chemical Engineering, Immunology, Biochemistry, or related scientific discipline).
- A minimum of 10-15 years' experience in Manufacturing/Operations/Quality in the Biotech/Life Science CDMO Industry.
- A minimum of 5 years at a senior level leading an organization of significant size in a life science, GMP/FDA regulated industry such as pharmaceutical and biopharmaceutical.
- Experience with regulated products or services.
- Strong cross-functional communication abilities across both Operations and Business communities, as well as customers.
- Excellent management and communication skills at C-level as well as at operators' level.
- Excellent working knowledge of US and EU GMP regulations, and direct experience in communicating with regulatory authorities.
- Leadership skills in managing change, influencing others outside areas of direct responsibility, attracting/developing talent.
- Strong situational leadership - ability to couple high performance standards and can-do attitude with strong coaching and empowerment approach.
- Ability and proven track record to build and grow high performing teams.
- Interested and experienced in driving digitalization effort.
- Strong problem-solving skills based on analytical strengths, active listening, and a diversity mindset .
- Experience with troubleshooting and technology transfers.
- Strong business acumen and experience with financial management.
Preferred Qualifications: - Masters, PhD and/or MBA preferred.
- Experience with common continuous improvement tools (e.g. six sigma).
- Ideally participated in the design, construction and commissioning of expanding manufacturing facilities.
- Ability to travel domestically and internationally, up to 10%.
Pay Range for this position: $208,000 - $340,900
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
