Cerilliant Corporation Head of Biologics Manufacturing in St. Louis, Missouri
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
Job Requisition ID: 176897
Location: St. Louis
Career Level: D - Professional (4-9 years)
Working time model: full-time