Sigma
Job Title: Director of Manufacturing
Work Location: Madison, Wisconsin The Director of Manufacturing is responsible for direction and coordination of all manufacturing operations. The position holds the responsibility for leadership of the manufacturing teams implementing programs and processes to ensure that product is manufactured in accordance with all safety, quality, cGMP, and applicable regulatory requirements. In addition, this individual assures production schedules are met to fulfill forecasted market demand and assures that manufacturing costs are optimized through effective utilization of resources, equipment, facilities, and materials. Key Responsibilities:
Manage multiple manufacturing areas including the supervision of approximately 130 staff operating 24/7 at two facilities. Promote a culture of safety, quality, and compliance, and achieve continuous improvement through operational excellence (OE) initiatives. Partner with Safety (EHS) and Quality group to trend and improve safety and quality performance fostering a strong quality culture. Ensure teams work in accordance with current GMPs and demonstrates proper operations safety and housekeeping practices, especially for the handling of high potent compounds. Establish and Monitor Performance Metrics to Drive Effective Actions for Successful Manufacturing Operations. Identify and mitigate risks in manufacturing that could adversely impact project outcomes and timely delivery of product to customers. Partner with Process and Analytical Development, Innovation, and Manufacturing Science & Technology (MSAT) teams, to ensure activities related to technology transfer and scale-up are successful. Participate in the design, justification, and execution of capital projects for manufacturing facilities and equipment. Develop yearly financial expense plan and manage areas of responsibility within approved budget to ensure business profitability. Ensure the structure and staffing of manufacturing department is adequate to meet site objectives. Define, implement, and optimize manufacturing schedules and resource shift patterns. Establish and maintain training requirements for manufacturing staff. Attract, develop, and retain skilled talent through strategic people engagement and development plans. Provide strong avenue of communication for employees maintaining a foundation of respect, dignity, and trust. Ability to work independently when developing and executing plans to meet objectives. Interact daily with Customers, Project Management, Supply Chain, Engineering, Facilities and OT, QA/QC, EHS, Process and Analytical Development, Innovation, MSAT, and Business Development. Participate in customer and regulatory audits as needed. Host current and potential clients, presenting operational related information. Who You Are
Minimum Qualifications:
Bachelor's degree in Engineering OR Chemistry, Biology, or another life science discipline Minimum 8 years demonstrated experience in a leadership role for production operations Ability to travel 2 to 4 times per year Shift work may be necessary to support operations around the clock, 24/7. Preferred Qualifications:
Experience leading small molecule manufacturing operations preferred Solid understanding of cGMP requirements for APIs, Pharmaceuticals, and Biologics (21 CFR 210 & 211 and/or ICH Q7A) Bachelor's degree in relevant technical discipline (Chemical Engineering, Chemistry, Biochemistry, or related scientific discipline). Master's degree preferred Strong leadership skills with proven ability to manage 24/7 manufacturing operations Experience with SAP a plus Black belt certification a plus The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Work Location: Madison, Wisconsin The Director of Manufacturing is responsible for direction and coordination of all manufacturing operations. The position holds the responsibility for leadership of the manufacturing teams implementing programs and processes to ensure that product is manufactured in accordance with all safety, quality, cGMP, and applicable regulatory requirements. In addition, this individual assures production schedules are met to fulfill forecasted market demand and assures that manufacturing costs are optimized through effective utilization of resources, equipment, facilities, and materials. Key Responsibilities:
Manage multiple manufacturing areas including the supervision of approximately 130 staff operating 24/7 at two facilities. Promote a culture of safety, quality, and compliance, and achieve continuous improvement through operational excellence (OE) initiatives. Partner with Safety (EHS) and Quality group to trend and improve safety and quality performance fostering a strong quality culture. Ensure teams work in accordance with current GMPs and demonstrates proper operations safety and housekeeping practices, especially for the handling of high potent compounds. Establish and Monitor Performance Metrics to Drive Effective Actions for Successful Manufacturing Operations. Identify and mitigate risks in manufacturing that could adversely impact project outcomes and timely delivery of product to customers. Partner with Process and Analytical Development, Innovation, and Manufacturing Science & Technology (MSAT) teams, to ensure activities related to technology transfer and scale-up are successful. Participate in the design, justification, and execution of capital projects for manufacturing facilities and equipment. Develop yearly financial expense plan and manage areas of responsibility within approved budget to ensure business profitability. Ensure the structure and staffing of manufacturing department is adequate to meet site objectives. Define, implement, and optimize manufacturing schedules and resource shift patterns. Establish and maintain training requirements for manufacturing staff. Attract, develop, and retain skilled talent through strategic people engagement and development plans. Provide strong avenue of communication for employees maintaining a foundation of respect, dignity, and trust. Ability to work independently when developing and executing plans to meet objectives. Interact daily with Customers, Project Management, Supply Chain, Engineering, Facilities and OT, QA/QC, EHS, Process and Analytical Development, Innovation, MSAT, and Business Development. Participate in customer and regulatory audits as needed. Host current and potential clients, presenting operational related information. Who You Are
Minimum Qualifications:
Bachelor's degree in Engineering OR Chemistry, Biology, or another life science discipline Minimum 8 years demonstrated experience in a leadership role for production operations Ability to travel 2 to 4 times per year Shift work may be necessary to support operations around the clock, 24/7. Preferred Qualifications:
Experience leading small molecule manufacturing operations preferred Solid understanding of cGMP requirements for APIs, Pharmaceuticals, and Biologics (21 CFR 210 & 211 and/or ICH Q7A) Bachelor's degree in relevant technical discipline (Chemical Engineering, Chemistry, Biochemistry, or related scientific discipline). Master's degree preferred Strong leadership skills with proven ability to manage 24/7 manufacturing operations Experience with SAP a plus Black belt certification a plus The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.