Senior Scientist, Process Development

Posted 23 Oct 2019

Madison, Wisconsin - United States

Req Id 198390

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 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 current position is a laboratory scientist position in a business based process development and manufacturing environment. The department’s primary focus is the development of synthetic and analytical platforms for the manufacture of Active Pharmaceutical Ingredients (APIs). Scientists are expected to support the innovative development and execution of technical projects within the MilliporeSigma team-based environment. General job requirements will include: Planning and implementing innovative chemical and analytical solutions appropriate for the commercial manufacture of APIs; Achieving positive laboratory results through a combination of personal hands-on lab experience and overseeing the efforts of Associate and Assistant Scientists through a matrix relationship within the MilliporeSigma organization; Executing Kilo Lab and Pilot Plant manufacture of APIs and intermediates if called upon to do so; Simultaneous management of 2-3 chemistry-based projects at various states of maturity; Responsibility. The senior scientist is further expected to ensure that assigned projects are conducted in accordance expected timelines and budgets; To work well in a team environment and serve as Project Team Leader; To author, utilize, and train employees on a wide variety of written procedures, including batch records and operating procedures; To provide input to Management regarding the development and implementation of newly innovative technologies; To work in accordance with FDA, OSHA, EPA, DNR, DOT and other regulatory agency guidelines; To act as a primary or secondary operator if requested; To maintain accurate and concise cGMP records; To accurately perform routine and non-routine in process testing of raw materials, intermediates, and finished products; To adhere to MilliporeSigma’s ethical and behavioral standards as outlined in the employee handbook; and To become a role model for other process development and manufacturing employees through superb work habits and excellent occupational behavior.

In addition, specific program requirements will include evaluation of existing chemical processes; suggesting and implementing process improvements; evaluation and support of scale-up and risk-mitigation strategies; supporting regulatory justifications as a member of the technical regulatory response team; authoring and reviewing technical documents to support regulatory filings; development and execution of procedures to support continuous process monitoring in production.

 

Who you are: 

 

Basic Qualifications:

  • A Ph.D. in organic chemistry with 5+ years’ experience in industry, including process chemistry and regulatory experience.

Preferred Qualifications:

  • A Ph.D. in organic chemistry with 8+ years’ experience in industry, including process chemistry and regulatory experience.
  • Experience supporting a commercial program.
  • Broad hands-on knowledge of organic synthesis and associated analytical techniques, including areas of medicinal chemistry and chemical process development and scale-up of APIs.
  • Knowledge of experimental design techniques and thermal hazard evaluation techniques in the process development field.
  • Scientific problem solving skills, including the ability to identify critical issues in experimental work and to suggest possible solutions.
  • Knowledge and understanding of the overall goals, implementation and application of cGMP and other relevant quality systems.
  • Superior organizational skills and the ability to multi-task proficiently
  • Strong verbal skills, including the ability to give presentations and to speak to large groups.  Must be able to establish rapport with non-technical parts of the company as well.
  • Proficient in use of standard office computers as well as software for laboratory work (data capture, data analysis, etc.) and statistical analysis. Specifically, MS Office 365, MS Project, ChemOffice, etc.

RSRMS

 

 

 

 


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 https://jobs.vibrantm.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 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.

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