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Scientist - Cleaning Method Development
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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
The Scientist – Cleaning Method Development in the Analytical Development group is responsible for developing test methods (primarily HPLC-UV-MS) to be able to detect and quantify low levels of API that may be left in manufacturing equipment after production. This work will also involve spiking coupons with product and determining recovery of the API from them both via rinsate and swab sampling. Once suitable methods are developed, the work will include transfer of the methods to the Quality Control group for use in plant changeover testing and method validation. State-of-the-art instrumentation will be used to develop methodologies and analyze active pharmaceutical ingredients as well as the synthetic intermediates, contributing to discussions and communications with customers to achieve a desired endpoint. The Scientist will initiate documentation and methodologies needed to support the project in cGMP manufacturing, troubleshoot instrumentation, and generate and compile results to solve or diagnose a problem. This position will be using and troubleshooting HPLC, GC, LCMS, GCMS, DSC, TGA, KF, FTIR, NMR and XRPD, among other instrumentation, and wet chemical assays. The Scientist is responsible for development, or directing the development, of analytical methods to support Process and Analytical Development (PAD) for eventual validation and or use in cGMP. The position is responsible for reviewing and evaluating analytical data for identification of products, intermediates and raw materials while maintaining project timing and interacting with clients to assure project goals are met in an efficient and well documented manor. While working with colleagues in PAD, the Scientist is part of a team of professionals advancing pharmaceutical candidates to cGMP manufacturing. The Scientist is considered an expert in analytical chemistry and the requirements for cGMP manufacturing while demonstrating a documented ability to execute and troubleshoot experiments as well as provides sound judgement in scientific and technical situations. The Scientist is recognized as a significant individual contributor in the scientific and technical areas within PAD. Additional responsibilities include:
- Independently develop methods to test for low level API carryover in manufacturing equipment and to find suitable means for recovery the API from the surfaces of the manufacturing equipment.
- Develop test methods for Process Development (PD) products, intermediates, and raw materials
- Initiate documentation and methodologies needed to support cGMP manufacturing
- Work on and be able to both independently and in a group, solve problems of significant scope
- Analytically test PD final products, intermediates, and raw materials. Testing will involve the use of HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR and XRPD among other tests and instruments
- Properly document and review group members lab work
- Ability to manage and prioritize daily and project activities
- Suggest specifications for final products, intermediates, and raw materials
- Transfer analytical test methods to Quality Control
- Train Analytical and Quality Control personnel in operation of analytical equipment and methods
- Write and evaluate reports, protocols, SOP’s and other documentation
- Work with clients (internal and external) to achieve project goals
- Interpretation of analytical data (including NMR, MS, FTIR)
- Proactively consider impact of quality, regulatory, manufacturing, and safety requirements when planning activities.
- Work in a safe manner and maintain the cleanliness of the work environment
- Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines
Who you are:
- B.S. in Chemistry or other biological science
- 5+ years in an GLP or cGMP analytical laboratory
- Master’s Degree
- Experience in the research field
- Ability to work in a team environment
- Ability to work in an Analytical testing lab with hazardous and toxic chemicals
- Adequate technical writing skills to generate development reports
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!
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 Colorado or New York City, 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.