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 Operations Integration Scientist is a point of contact for the Applied and Research sales forces for Biologics custom opportunities and leads the transfer of new products into Operations. This project management position works cross functionally with Sales, Operations, Marketing, and outside customers to efficiently bring new products to market while maintaining quality. New products may consist of Custom or Contract Manufacturing products from external customers, OEM products with MilliporeSigma labeling, or developed products from R&D.
ESSENTIAL JOB FUNCTIONS
- Coordinate planning for custom products. This includes assessing opportunity for site fit, providing quote and leadtime for new inquiries, creating project schedules, and providing alternatives for custom product inquiries/orders to meet customer, operational, regulatory, and financial needs.
- Manage opportunities from initial inquiry through final shipment of product. Collect cycle time, first pass success, fulfillment, and on time delivery data to measure and monitor system performance. Work with Business Development to leverage knowledge gained from current custom business to promote future opportunities.
- Discuss Operations capabilties and provide technical input during customer site visits and conference calls.
- Plan for operational requirements of new product transfer to include early identification of resource needs for production, packaging, and QC, raw materials, equipment, regulatory requirements, and the generation and analysis of COGS estimates.
- Facilitate the development of manufacturing, packaging, QC and scale up processes with R&D or the external customer. Technical knowledge of operational capabilities and limitations is used to guide R&D or customer development towards manufacturability.
- Address documentation and systems needs for new product transfer to include writing, review, and approval of operations documents and set up of new products in SAP.
- Lead the manufacturing, packaging and QC testing of engineering and/or validation lots and first build at a designated manufacturing site with Operations and R&D or the customer.
- Communicate process needs, project schedules and project status in a timely manner through leadership of team meetings, documentation of key decisions and issues, maintenance of metrics, and elevation of issues. Act as a liaison between the customer or MilliporeSigma R&D and Operations.
- Act as a point of contact with the customer during nonconformance investigations and material supply issues.
- Lead process improvement initiatives with quantifiable results in sales, service, savings, safety or quality.
Who You Are
- BS in Biotech related field with special course in area of expertise
- M.S. in Biotech related field with special course in area of expertise desired
- Requires 3 + yrs
- Technical production, R&D, Analytical or New Product Transfer experience;
- Independent decision making capacity, knowledge of SAP and other operational systems (QUMAS, etc.)
- Knowledge and Skills:
- Critical: Technical knowledge in Life Science as it relates to production, analytical methodologies and packaging.
- Critical: Design control and transfer of products into operations from R&D or an external customer Critical: People interaction and cross-functional teamwork across departments and locations worldwide and with external customers.
- Familiarity with laboratory instrumentation and production equipment
- Working knowledge of OSHA, EPA, FDA Regulations, GMP and ISO 13485 guidelines and regulations
- Troubleshooting issues using FMEA and/or Root cause analysis procedures
- Able to complete product costing analysis
- Planning and scheduling, Problem Solving Skills, Project Management, Time Management, Priority & Decision Making
- Good Communication Skills both oral and written
- PC/Software use
- Knowledge of Process Improvement methodology
ADDITIONAL LOCAL NEEDS
- Require occasional lifting of no more than 35 lbs. and pushing heavy objects.
- Must be able to use standard office computers daily. Must be able to use a telephone for communication.
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.