National Guard Employment Network
Sr. Director, Manufacturing Operations - Bothell, WA
National Guard Employment Network, Bothell, Washington, United States, 98011
Sr. Director, Manufacturing Operations - Bothell, WA
Attention Military Affiliated Job Seekers - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Purpose And Scope Of Position:
This role leads the manufacturing operations team at the Drug Product manufacturing facility at the BMS Manufacturing Site in Bothell, WA 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 the manufacturing plant. 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 to commercial and new product launch. 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. Roles And Responsibilities:
Leading the BMS Cellular Therapeutics Manufacturing Operations Team at the Bothell site to include: Managing the teams responsible for all operations, pack out, receipt, and logistics of the facility. Ensuring products are produced and stored according to the appropriate documentation in order to obtain the required quality and compliance; Hiring, mentoring, and developing exceptional people. Championing a culture of exceptional teamwork and communication. Building effective cross-functional relationships. 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. Ensuring that the required initial and continuing training of the department personnel is carried out and adapted according to need. 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 of the facility. Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients. Championing inspection readiness efforts to ensure operation is prepared for GMP Inspections. Effectively managing operating budgets for group and driving strategic value initiatives. 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. Qualification Requirements:
Education: Bachelor's or Graduate degree in Engineering, Life Sciences, or related fields. Experience: 12 or more years of experience in pharmaceutical manufacturing operations, manufacturing science and technology, manufacturing systems, and/or quality assurance. 6+ years in senior management position. Strong knowledge of GMP compliance and GMP manufacturing operations. Background in Protein Biologics or Cell Therapy Manufacturing required. Cross functional experience a must. Demonstrated experience in managing a commercial operations department. Demonstrated experience of leading organizations through dramatic change Skills & Abilities: 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. Demonstrated ability of building and leading cross-functional organizations. Travel Requirements: Occasional travel may be required such as collaboration visits to other manufacturing sites. Working Conditions:
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. The starting compensation for this job is a range from $229,260 to $277,800, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Attention Military Affiliated Job Seekers - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Purpose And Scope Of Position:
This role leads the manufacturing operations team at the Drug Product manufacturing facility at the BMS Manufacturing Site in Bothell, WA 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 the manufacturing plant. 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 to commercial and new product launch. 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. Roles And Responsibilities:
Leading the BMS Cellular Therapeutics Manufacturing Operations Team at the Bothell site to include: Managing the teams responsible for all operations, pack out, receipt, and logistics of the facility. Ensuring products are produced and stored according to the appropriate documentation in order to obtain the required quality and compliance; Hiring, mentoring, and developing exceptional people. Championing a culture of exceptional teamwork and communication. Building effective cross-functional relationships. 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. Ensuring that the required initial and continuing training of the department personnel is carried out and adapted according to need. 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 of the facility. Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients. Championing inspection readiness efforts to ensure operation is prepared for GMP Inspections. Effectively managing operating budgets for group and driving strategic value initiatives. 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. Qualification Requirements:
Education: Bachelor's or Graduate degree in Engineering, Life Sciences, or related fields. Experience: 12 or more years of experience in pharmaceutical manufacturing operations, manufacturing science and technology, manufacturing systems, and/or quality assurance. 6+ years in senior management position. Strong knowledge of GMP compliance and GMP manufacturing operations. Background in Protein Biologics or Cell Therapy Manufacturing required. Cross functional experience a must. Demonstrated experience in managing a commercial operations department. Demonstrated experience of leading organizations through dramatic change Skills & Abilities: 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. Demonstrated ability of building and leading cross-functional organizations. Travel Requirements: Occasional travel may be required such as collaboration visits to other manufacturing sites. Working Conditions:
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. The starting compensation for this job is a range from $229,260 to $277,800, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.