The Sr. Director, Site Manufacturing Operations leads the manufacturing operations team of 200+ at the Drug Product manufacturing facility at Juno's Manufacturing Site in Bothell, WA (JuMP) and will directly report into the Site Head. This role is accountable for overseeing multiproduct clinical and commercial GMP manufacturing operations, departmental budgets, talent management/succession planning and engagement and retention strategies for the Bothell manufacturing operation. Responsible for identifying and implementing policies, procedures and manufacturing strategies to facilitate optimal production and performance.
This person is a key leader at the site and has overall responsibility for manufacturing operations. Responsibility includes delivering on critical project milestones and managing a functional area that will have a direct impact on the growth and success of JuMP.
As a member of the site leadership team, the candidate will be responsible for helping set strategic direction for the site, in alignment with corporate goals and objectives, including transitioning the site from a clinical manufacturing site to a commercial ready site (including successful launch of our first product). Responsible for establishing and driving a culture of collaboration, continuous improvement and alignment between various functions and departments on site, to ensure that major site strategic manufacturing objectives are met.
- Provide leadership to the JuMP Cell Therapy Operations Team by presenting a clear vision for the future, providing clarity and connection and recognition. This will also include involvement in the hiring, mentorship and development of exceptional talent.
- Championing a culture of exceptional teamwork and communication
- Ensuring manufacturing employees have the appropriate level of training for assigned area
- Build effective cross-functional relationships across the organization
- Ensuring a culture that embraces the safety of the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
- Establishing continuous improvement and "right first time" mindset
- Participating in the transition of a clinical to commercial site
- Designing and operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
- Ensuring the schedules of the people, facility, equipment, materials, and documents are established and maintained to support the capacity/throughput pf the facility
- Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effect therapies to patients
- Champion inspection readiness efforts to ensure operation is prepared for Pre-Approval Inspections
- Effectively managing annual operating budgets for group
- Identify and implement operational efficiencies
- Review and sign/approve controlled and executed documents, to include:
- Reviewing and approving controlled master documents including standard operating procedures, batch records, material specifications, and validation protocols
- Reviewing and signing executed documents including batch records, facility operations and equipment forms and logbooks, and validation reports
- Ensuring deviations from approved procedures are (1) accurately recorded in the original documentation and (2) properly justified/investigated with respect to impact to the process and/or product
- Actively encourages a culture of inclusion and seeks out diverse experiences and perspectives to help drive innovation and transformative business results
- Guide and empower team leaders on communication, talent development, and promoting a positive organizational culture by promoting organizational values
- Masters or higher degree in a biology, chemistry, engineering or other related field.
- Strong knowledge of GMP compliance and GMP manufacturing operations
- Background in Protein Biologics or Cell Therapy Manufacturing required
- 12 or more years of experience in pharmaceutical manufacturing operations, manufacturing science and technology, manufacturing systems, and/or quality assurance with at least 6+ years in senior management position.
- Demonstrated ability of building and leading cross-functional organizations
- Demonstrated experience in managing a commercial operations department
- Demonstrated startup experience or leading organizations through dramatic growth.
- Demonstrated excellence in written and verbal communication.
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
- Demonstrated ability to work effectively with US FDA, EMA and other regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP, ISO and other applicable standards.
- Demonstrated record with driving continuous improvement and fostering an operational excellence culture
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a site leadership team member and to engage and influence team members in a matrixed environment.