A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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 Site Operations – Madison/Verona position, located in Madison, WI, USA, leads the operations responsible for cGMP Manufacturing of Active Pharmaceutical Ingredients, including High potent compounds (HPAPIs). The two manufacturing sites in Madison and Verona, Wisconsin are responsible for contract manufacturing of both clinical and commercial APIs. The facilities meet EU and FDA compliance criteria, are validated, and include separate manufacturing areas for Highly potent and non-potent compounds on a variety of scales (kilo lab to plant scale). The operations functions cover Manufacturing, Quality, Technical Operations, EHS & Facilities/maintenance with business partners in HR, Finance, Project management, Planning and Process & Analytical Development.
The Head of Site Operations Madison/Verona is responsible for the planning, directing and controlling of manufacturing operations. This includes leadership responsibilities for staffing, organizational design and performance management of all operations personnel. This individual assures that product is manufactured and tested in accordance with all safety, quality, cGMP and applicable regulatory requirements. This individual will partner with commercial teams to understand customer demand to ensure sufficient capacity and resourcing is maintained to meet business strategy and client expectations. In addition, this individual is responsible to manage operations with continuous improvement in mind to ensure long term profitability of the business.
- Manage multi-product manufacturing facilities including the supervision of approximately 200 staff operating from 24/7 to 8/5 shift patterns.
- Promote a culture of safety, quality and compliance, and achieve continuous improvement through Operational Excellence initiatives.
- Develop & monitor financial plans (expenses, capital, absorption) with proactive management of variances to ensure business profitability.
- Drive the execution of business strategy including the justification and execution of capital projects for new/replacement equipment and facilities
- Create and track metrics demonstrating successful site operations
- Ensure oversight from Quality group to trend and improve quality KPIs
- Identify and mitigate risks in manufacturing that could adversely impact project outcomes and timely delivery of product to customers
- Lead Technical operations team, to ensure activities related to technology transfer and scale-up are successful.
- Ensure the structure and staffing levels are adequate to meet site objectives including optimizing work schedules and resource shift patterns
- Attract, develop, motivate 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
- Interact on a daily basis with customers, project management, process & analytical development, and business development.
- Participate in customer and regulatory audits as needed
- Host current and potential clients, presenting operational related information
- Minimum 5 years demonstrated experience in a leadership role for cGMP production operations within a contract manufacturing organization (CMO)
- Experience leading small molecule (organic synthesis) manufacturing operations preferred
- 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
- Travel Requirements:
- Travel between WI based sites approx. 15 minutes. 1-3X per week.
- Travel outside of local WI area: 5-8 X per year – customer visits, other site best practice sharing, training etc.
- Pre-Employment testing requirements:
- Physical Requirements (PPE, lifting): None
- Work schedule: The facilities maintain a multiple shift operating pattern. Primary job duties are M-F day shift, however night and weekend operations may require attention.
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 https://jobs.vibrantm.com
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