Senior Commercial Project Manager, Assay Development Services

Posted 12 May 2022

St. Louis, Missouri - United States

Req Id 244200

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.


Your Role:

The Senior Commercial Project Manager, Assay Development Services is a highly dynamic customer facing position offering a world class experience for our Applied and Research customers! This project management position is part of the BRM/Dx business and is responsible for leading the evaluation and execution of custom solutions. There is a heavy emphasis on business development including new process identification and implementation to support novel opportunities. This role will be leading cross functional teams developing and commercializing sophisticated solutions from inception to delivery. This position is the primary point of contact between MilliporeSigma and customers during development and may continue to offer support during ongoing commercial business.

 

Location: St. Louis, MO - Hybrid

 

Essential job functions

  • Manage implementation of programs that drive new business development. Identify requirements, propose solutions, develop matrix teams of partners, optimize existing capabilities and/or innovate new capabilities.
  • Identify future operations capabilities, develop, and present detailed plans in collaboration with Process Development, Engineering, Site leadership and Supporting Teams including but not limited to ISCO, CEX and Finance.
  • Facilitate the development of sophisticated 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 that will include writing, review, and acceptance of operations and regulatory documents. For certain opportunities coordination of DHF (design master file) with technical resources for submission to regulatory bodies would be required.
  • Strong understanding of regulatory requirements for producing IVD grade material for regulatory body submission.
  • Plan for operational requirements of new product transfer to include early identification of resource needs for production, QC, packaging, raw materials, equipment, regulatory requirements, distribution, order management and the generation and analysis of COGS estimates.
  • Define standard methodologies and ensure a consistent approach to project planning and delivery to achieve project management excellence.
  • Lead process improvement initiatives with quantifiable results in sales, service, savings, safety, or quality.
  • Independently coordinate planning for custom products. This includes assessing opportunity for site fit, providing quote and lead time for new inquiries, creating project schedules, and providing alternatives for custom product inquiries/orders to meet customer, operational, regulatory, and financial needs.
  • Present Operations capabilities and lead complex technical discussions during customer site visits and conference calls. Identify new capabilities and strategic initiates.
  • Drive outstanding customer experiences that foster trust. Ensure customer confidence that we will be a valued partner and an extension of their business.
  • Build collaborative energy with customers giving them confidence in our ability to transform their ideas into commercial products.
  • Work with Commercial to demonstrate knowledge gained from current custom business to promote future opportunities.
  • Act as the customer contact with the customer during nonconformance investigations and material supply issues. Troubleshoot using FMEA and/or Root cause analysis procedures.
  • 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.
  • Provide regular forecasts on key projects to business leaders and participate in ongoing forecasting process.
  • 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. Drive project development between customer and internal partners.
  • Regularly presents and consults at an executive level within the organization includes review and approval of CAPEX and high-level financial review of projects.
  • Lead the setup of master data in SAP for new products

 

Who You Are:

Minimum Qualifications:

  • Required: BS in Biotech, Diagnostics, or chemical, or science related field
  • Requires minimum 5+ years of Operations, Project Management and/or customer facing experience
  • Solid understanding of SAP or other operational systems (QUMAS, etc.)

Preferred Qualifications:

  • Preferred: MBA or advanced degree in chemistry or biological science
  • Critical: Extensive technical knowledge as it relates to production, analytical methodologies, and packaging of Biologics products
  • Critical: Independence, assertiveness, and ability to make complex decisions quickly and confidently.
  • Critical: Highly developed interpersonal, written, and verbal skills, including the ability to give presentations and to speak to large groups and executive teams. Establish rapport with non-technical teams.
  • Sales, service, and quality driven, strong motivator of people to drive toward desired results within a set timeframe.
  • Professional knowledge of OSHA, EPA, FDA Regulations, with emphasis on GMP and ISO13485 guidelines and regulations
  • Able to complete product costing analysis for complex, multi-product projects.
  • Knowledge of Design Control procedures for new product development
  • Planning and scheduling, problem solving skills including root cause analysis, Project Management, Time Management
  • PC/Software use
  • Expertise in Project Management and Process Improvement methodology
  • General financial knowledge and an eye for business
  • Excellent organizational, decision making and negotiation skills.

 


 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

 

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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

 

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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