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Head of Site Operations, Madison\/Verona

Posted 13 Jun 2018

Madison, Wisconsin - United States

Req Id 177381

Details

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.


Who We Are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany – a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
 

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.

Your role:

The Head of Site Operations Madison/Verona is responsible for the planning, directing and controlling of manufacturing operations. This individual assures that product is manufactured and tested in accordance with all quality, cGMP and applicable regulatory requirements. This individual will partner with commercial teams to understand customer demand to ensure sufficient capacity 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.

Responsibilities

  • Manage multi-product manufacturing facilities including the supervision of approximately 175 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

Required Qualifications

  • Minimum 5 years demonstrated experience in a leadership role for cGMP production operations. 
  • 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

Other requirements

  • 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: Your possibilities to develop in our growing company are just as important as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.

MilliporeSigma 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.


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.

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