Site Head 5/18/2017
JOB DESCRIPTIONAPPLY A career with us is an ongoing journey of discovery: our 50,000 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.
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.
Your role: The Site Head is responsible for the planning, directing and controlling of manufacturing operations. This individual holds responsibility for the Carlsbad, CA site, including development and implementation of programs to minimize manufacturing costs through effective utilization of resources, equipment, facilities and materials. In addition, this individual assures production/supply chain schedules are met to fulfill forecasted market demand and assures that product is manufactured in accordance with all quality, cGMP and applicable regulatory requirements.
* Ensure the successful and profitable operation of the facility, including the GMP manufacture and release of products
* Promote a culture of quality and compliance, and achieve continuous improvement.
* Managing a multi-product manufacturing department, the supervision of approximately 120 staff
* Interact on a daily with business development, customers, project management, QA/QC, process development scientists, engineering, and materials management
Who you are:
* Demonstrated experience serving as Plant Manager/Site Head for a complex biologics production operations
* 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 critical treatment to patients
* Engage in internal process development activities related to technology transfer and scale-up
* Participate in the design, construction and commissioning of expanding manufacturing facilities
* Ensure the structure and staffing of manufacturing department is adequate to meet site objectives
* Establish and maintain training requirements for manufacturing staff
* Attract (interview) and retain skilled talent
* Ensure equipment and facility are in a state of qualification to perform routine GMP manufacturing
* Develop the budget and manage areas of responsibility within approved budget and contracted scope of work
* Create and track metrics demonstrating a successful manufacturing operation
* Define, implement and optimize the manufacturing schedules while keeping within the site budget
* Participate in process characterization and validation teams to ensure processes can be transferred, commercially scaled-up and validated to meet regulatory requirements
* Participate as the primary manufacturing representative for customer and regulatory audits
* Assist in preparation of business development presentations, and occasionally assist with site visits and tours
* Provide responses to RFI and RFP inquiries from potential customers
* Host current and potential clients, occasionally presenting operational related information
* Bachelor's degree in relevant technical discipline (Chemical Engineering, Microbiology, Immunology, Biochemistry, or related scientific discipline)
* Master's or MBA preferred
* Black belt certification a plus.
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.
MilliporeSigma is a division of Merck KGaA, Darmstadt Germany.