Sr. Director Manufacturing
- Solothurn, Switzerland
The Sr. Director, Manufacturing directly manages the large-scale manufacturing plant in Luterbach and oversees and manages all manufacturing activities. The Sr. Director participates on the Site Leadership Team and collaborates closely with the HR Business Partner and other cross-functional entities to advance operational/Corporate/community strategic goals.
Reporting to the Site Head and Operations Leader in Luterbach, the Sr. Director of Manufacturing is accountable for concurrent manufacturing operations, all departmental budgets, safe operations, regulatory compliance, talent management/succession planning and engagement and retention strategies for the manufacturing function.
The incumbent is responsible for leading manufacturing functional leaders and managing a manufacturing operations budget of up to $50 million.
The incumbent confers with cross-functional site leaders to assess critical decisions, evaluate complex manufacturing issues and identify resolution strategies and to optimize throughput and output to advance operational objectives.
The incumbent also identifies and implements policies, procedures and business strategies to facilitate optimal operations, drives internal processes including risk assessment, strategic planning, and management of internal/cross-functional/cross-site alignment, leverages best practices, and advances operational excellence to optimize operations.
This person will provide overall leadership of site manufacturing operations and ensures alignment with Global Manufacturing strategies, policies and practices.
The incumbent provides operational direction for up to five (5) direct reports including an organization of 100-200 people. This role will partner closely with the SLT including Site Quality, Engineering, Manufacturing Sciences, Environmental Health and Safety, Finance, Human Resources and Information Technology site function leads.
This person assists in the strategic direction for the site, in alignment with Corporate and Pharmaceutical Operations and Technology (PO&T) strategic goals and objectives. Establishment of major strategic objectives and cross-functional priorities is a key responsibility to ensure the site is driving towards stable and reliable operations post initial start-up and validation activities. This leader is expected to set a culture of collaboration and alignment between Manufacturing, EHS, quality, Facilities, Engineering, MS and other site service functions, to ensure that these major strategic objectives are met. This person must work collaboratively with other site leaders at Cambridge, RTP, and Baar and supply chain to ensure seamless end to end integration of clinical and commercial products. Furthermore, this individual must partner closely with the development team, from an early stage, to stay abreast of new technology development and offer input on a frequent and consistent basis, and successfully implement new technology solutions.
- Responsible for operation of a best-in class Biologic's multi-product, large scale manufacturing facility.
- Be a leader in an integrated site leadership team that can support PO&T global strategies.
- Ensure site readiness for implementation of multiple clinical and commercial programs – both innovator and partnered programs. Ensure materials, personnel, and governing procedures are ready for continued concurrent manufacturing.
- Lead manufacturing organization that ensures flawless execution of a complex production schedule.
- Attract and hire top talent in bio-pharma. Provide development and career opportunities to retain key talent.
- Drive continuous improvement to operations and optimizing DS COGM.
- Ensure alignment and consistency with other Manufacturing entities regionally. Represent the site in regulatory engagement activities.
B.S./Master’s/PhD degree in Biochemical or Chemical Engineering or a related scientific discipline preferred.
A minimum of 15 years of experience in a biopharmaceutical/pharmaceutical operations environment demonstrated success in managing, motivating and continually strengthening a large, complex and multi-disciplinary organization.
Highly entrepreneurial and able to lead a very complex operation.
Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel on the district and national scale.
Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact and diplomacy.
Exceptional oral and written communication skills to all employment levels and to PO&T Senior Leadership.
Excellent organizational, planning and implementation skills inclusive of business modeling. Connected professionally to academic and industrial forums to enhance external impact on industry.
Passionate and experienced in recruiting underrepresented talent.
Proficient at understanding and analyzing financial reports and overall business acumen.
Demonstrated ability to analyze, extrapolate data, synthesize and implement.
The Sr. Director, Manufacturing in Solothurn directly manages the large-scale Bio-manufacturing Cells in Luterbach and oversees and manages a team of direct reports responsible for manufacturing operations in a large scale, multi-product biologic's facility. The site functional groups partner to drive safety, quality and reliability in all operations while executing on technology transfer, process validation, process improvement, investigations, process analytics/trending, warehouse operations, etc.
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