A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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.
At MilliporeSigma, the Senior Scientist, Process Development 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.
Responsibilities will include:
- Design and lead development of the synthetic routes and manufacturing processes toward pharmaceutical intermediates and APIs
- Achieve positive laboratory results through a combination of personal hands-on lab work as well as overseeing the efforts of Associate and Assistant Scientists through a matrix relationship within the MilliporeSigma organization
- Work within a team environment and serve as a Project Team Leader
- Provide input to Management regarding the development and implementation of newly innovative technologies
- Simultaneous management of 2-3 chemistry-based projects at various states of maturity
- Completing projects independently
- Participation in project team meetings with clients
- Plan and execute laboratory research including kilo lab work
- Use a thorough understanding of modern analytical techniques to interpret the corresponding spectra and data
- Provide innovative solutions to address current technical and analytical challenges during process development for the commercial manufacture of APIs
- Take a leading role for process development and plant support when needed
- Development and execution of procedures to support continuous process monitoring in production
- Lead technology and documentation transfer and implementation of the process and serve as the technical point of contact for the process development function
- Deliver comprehensive process development reports to clients and for internal use
- Author, utilize, and train employees on a wide variety of written procedures, including batch records and operating procedures
- Work in accordance with FDA, OSHA, EPA, DNR, DOT and other regulatory agency guidelines
- Maintain accurate and concise cGMP records
- Support regulatory filings and justifications as a member of the technical regulatory response team
Who you are:
- PhD in Organic Chemistry or other related Scientific discipline with 5+ years’ experience in process chemistry
- PhD 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
- Experience in handling High-Potency APIs is a plus
- 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
- Excellent communication skills, including the ability to give presentations and to speak to large groups. The ability 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.
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.