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 Custom & New Product Support (CNPS) Project Manager 2 is a highly dynamic customer facing position offering a world class experience for our Applied and Research customers. This project management position is embedded in Biologics manufacturing sites and is responsible for leading the evaluation and execution of custom solutions to create a differentiated experience for our customers. This position works closely with Commercial sales and in partnership with Operations and Quality to quote and deliver complex custom solutions. As a commercial project manager, the CNPS Project Manager 2 is responsible for delivery performance of operations including prioritization, escalation and identification of bottlenecks, as well as providing a solution to deliver on time/in full. This position is the primary point of contact between MilliporeSigma and the customer during an active project, and may continue to offer support during ongoing commercial business.
ESSENTIAL JOB FUNCTIONS
Independently 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 complex 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.
Present Operations capabilties and lead complex technical discussions 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 complex manufacturing, packaging, QC and scale up processes with R&D or the external customer. Strong 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 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 and Operations.
Act as the primary point of contact with the customer during nonconformance investigations and material supply issues. Troubleshoot using FMEA and/or Root cause analysis procedures.
Lead process improvement initiatives with quantifiable results in sales, service, savings, safety or quality.
Who You Are:
- BS in Biotech related field.
- Requires minimum 3 years of combined Operations and Project Management experience.
- M.S. or Ph.D. in Biotech related field with special course in area of expertise
- Strong knowledge of SAP and other operational systems (QUMAS, etc.)
- Extensive technical knowledge as it relates to production, analytical methodologies and packaging of Biologics products
- Independence, assertiveness and ability to make complex decisions quickly and confidently.
- Highly developed interpersonal, written and verbal skills, including the ability to give presentations and to speak to large groups. They must be able to establish rapport with non-technical parts of the company.
- Sales and quality driven, strong motivator of people to drive toward desired results within a set timeframe.
- Working knowledge of OSHA, EPA, FDA Regulations, with emphasis on GMP and ISO13485 guidelines and regulations
- Knowledge of Design Control procedures for new product development
- Planning and scheduling, Problem Solving Skills including root cause analysis, Project Management, Time Management
- Knowledge of Process Improvement methodology
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill 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.