A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Head of Biologics Manufacturing position, located in St. Louis, MO, USA, leads our cGMP Manufacturing of biologic Active Pharmaceutical Ingredients, including Antibody Drug Conjugates (ADCs). The manufacturing site in St. Louis specializes in the clinical manufacture of ADCs, including: conjugation, chromatography, UF/DF and technology transfer. With its most recent expansion in 2015, the St. Louis facility allows clients to manufacture products from preclinical to commercial launch. The facility meets EU and FDA compliance criteria, is fully validated, and Safebridge certified for handling of high potent compounds. Facility features include:
- Separate facility areas for clinical and commercial manufacturing
- Dedicated areas for high potent handling, manufacturing, and bulk filling of the Bulk drug substance
- Designed for future expansion
The Head of Biologics Manufacturing is responsible for direction and coordination of manufacturing operations. This individual holds responsibility for development and implementation of programs 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 minimized through effective utilization of resources, equipment, facilities and materials.
- Ensure the successful and profitable operation of the department, including the cGMP manufacture and release of products
- Promote a culture of safety, quality and compliance, and achieve continuous improvement.
- Manage a multi-product manufacturing department including the supervision of approximately 32 staff who operate on a dynamic shift pattern
- Interact on a daily basis with customers, project management, QA/QC, process & analytical development, packaging, engineering, maintenance, materials management and business development.
- Partner with Quality group to report, investigate and resolve deviations encountered during GMP production
- Identify and mitigate risks in manufacturing that could adversely impact project outcomes and timely delivery of product to customers
- Engage in activities partnering with process & analytical development related to technology transfer and scale-up to ensure processes can be transferred, commercially scaled-up and validated to meet regulatory requirements
- Participate in the design, justification and execution of capital projects for manufacturing facilities and equipment
- Ensure the structure and staffing of manufacturing department is adequate to meet department 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
- Provide strong avenue of communication for employees maintaining a foundation of respect and dignity
- Ability to work independently when developing and executing plans to meet objectives
- Assist in development of departmental budget and manage areas of responsibility within approved budget and contracted scope of work
- Create and track metrics demonstrating a successful manufacturing operation
- Participate as the primary manufacturing representative for customer and regulatory audits
- Provide responses to RFI and RFP inquiries from potential customers
- Host current and potential clients, presenting operational related information and assisting with site tours
Who You Are
- Minimum 7 years demonstrated experience in a leadership role for Biologics cGMP production operations.
- Bachelor’s degree in relevant technical discipline (Chemical Engineering, Chemistry, Biochemistry, or related scientific discipline). Master’s degree preferred.
- Experience with SAP a plus
- Black belt certification a plus
- Other requirements
- Travel Requirements: Minimal travel (2-4X per year)
- Pre-Employment testing requirements:
- Physical Requirements (PPE, lifting): None
- Work schedule: Shift work may be required during manufacturing campaigns
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.