Merck Gruppe
Work Location: Madison, Wisconsin
Shift:
Department: LS-SC-POWPA1 Madison & Verona Analytical Dev Group 1
Hiring Manager: Dennis Milanowski
This information is for internals only. Please do not share outside of the organization.
Your Role: A Data Review Scientist in the Analytical Development group is responsible for leading and executing scientific/technical review of analytical data and reports in support of incoming and existing projects for MilliporeSigma-Madison. This position is responsible for review of data, documentation and reports supporting method development and verification, technology transfer to the Quality Control department, and Process Development and Manufacturing support activities. The data review scientist is also responsible for contributing to discussions and communications with customers to achieve a desired endpoint, initiating and reviewing documentation and methodologies needed to support the project in cGMP manufacturing, and generating and compiling results to solve or diagnose a problem. This will also include interpretation of data generated by state-of-the-art instrumentation as necessary to perform report review. Understanding and interpreting HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR and XRPD, among other instrumentation, and wet chemical assays is part of the role. The Data Review Scientist will review and evaluate analytical data and technical reports for identification of products, intermediates and raw materials. You will also complete data review and approval of protocols and standard operating procedures as well as technical reports and specifications. The Data Review Scientist will maintain project timing and interacting with clients to assure project goals are met in an efficient and well documented manor. Working with colleagues in PAD, the Data Review Scientist is part of a team of professionals advancing pharmaceutical candidates to cGMP manufacturing. The Data Review Scientist is considered an expert in analytical chemistry and the requirements for cGMP manufacturing (though the data that will be reviewed will be non-GMP). The Scientist is recognized as a significant individual contributor in the scientific and technical areas within PAD. Perform and lead analytical data and report reviews to ensure accuracy, quality, and compliance with ALCOA+ principles and cGMP standards. Identify and resolve issues in scientific documentation, demonstrating strong scientific literacy and attention to detail. Guide and support team members in documentation practices and data review processes, fostering continuous improvement and training efforts. Interpret and review a wide range of analytical data (e.g., HPLC, GC, LCMS, NMR, FTIR, XRPD) across various tests and instruments. Write, revise, and review SOPs and specifications for raw materials, intermediates, and final products. Collaborate with global teams, internal departments, and external clients to ensure alignment and progress on project goals. Manage multiple projects and timelines independently, ensuring quality, regulatory, manufacturing, and safety considerations are met. Communicate effectively across teams, demonstrating strong organizational and technical writing skills while maintaining a safe and clean work environment. Physical attributes: Sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch or crawl for long periods of time. Talk, hear, taste and smell. Occasionally lift and/or move up to 50 pounds unassisted and push and pull heavy materials to complete assignments. May lift more poundage with assistance. Close vision, distance vision, color vision, peripheral vision, depth vision, and adjust focus. Use of phones, computers, computer monitors, and all office / laboratory equipment. Type at a computer keyboard and have read CRTS / computer monitors. Work near moving mechanical parts and wear appropriate protective gear, (hard hats, glasses / goggles, chemical resistant suites, gloves, safety shoes) and other personal protection equipment “PPE” to protect themselves from toxic or corrosive chemicals in the forms of liquids, solids, vapors or airborne particles. Work in an environment where highly potent / hazardous materials are handled and manufactured. Who You Are: Minimum Qualifications: Bachelor’s in Chemistry, Biology, or other Life Science discipline 5+ years of analytical laboratory environment operating under GLP or cCMP conditions OR Master’s in Chemistry, Biology, or other Life Sciences discipline 2+ years of analytical laboratory environment operating under GLP or cCMP conditions OR PhD in Chemistry, Biology, or other Life Sciences discipline. 1+ year in an analytical laboratory environment operating under GLP or cGMP conditions. Preferred Qualifications: Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detail. Ability to work in a team environment. Ability to work in an Analytical testing lab with hazardous and toxic chemicals.
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.
#J-18808-Ljbffr
This information is for internals only. Please do not share outside of the organization.
Your Role: A Data Review Scientist in the Analytical Development group is responsible for leading and executing scientific/technical review of analytical data and reports in support of incoming and existing projects for MilliporeSigma-Madison. This position is responsible for review of data, documentation and reports supporting method development and verification, technology transfer to the Quality Control department, and Process Development and Manufacturing support activities. The data review scientist is also responsible for contributing to discussions and communications with customers to achieve a desired endpoint, initiating and reviewing documentation and methodologies needed to support the project in cGMP manufacturing, and generating and compiling results to solve or diagnose a problem. This will also include interpretation of data generated by state-of-the-art instrumentation as necessary to perform report review. Understanding and interpreting HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR and XRPD, among other instrumentation, and wet chemical assays is part of the role. The Data Review Scientist will review and evaluate analytical data and technical reports for identification of products, intermediates and raw materials. You will also complete data review and approval of protocols and standard operating procedures as well as technical reports and specifications. The Data Review Scientist will maintain project timing and interacting with clients to assure project goals are met in an efficient and well documented manor. Working with colleagues in PAD, the Data Review Scientist is part of a team of professionals advancing pharmaceutical candidates to cGMP manufacturing. The Data Review Scientist is considered an expert in analytical chemistry and the requirements for cGMP manufacturing (though the data that will be reviewed will be non-GMP). The Scientist is recognized as a significant individual contributor in the scientific and technical areas within PAD. Perform and lead analytical data and report reviews to ensure accuracy, quality, and compliance with ALCOA+ principles and cGMP standards. Identify and resolve issues in scientific documentation, demonstrating strong scientific literacy and attention to detail. Guide and support team members in documentation practices and data review processes, fostering continuous improvement and training efforts. Interpret and review a wide range of analytical data (e.g., HPLC, GC, LCMS, NMR, FTIR, XRPD) across various tests and instruments. Write, revise, and review SOPs and specifications for raw materials, intermediates, and final products. Collaborate with global teams, internal departments, and external clients to ensure alignment and progress on project goals. Manage multiple projects and timelines independently, ensuring quality, regulatory, manufacturing, and safety considerations are met. Communicate effectively across teams, demonstrating strong organizational and technical writing skills while maintaining a safe and clean work environment. Physical attributes: Sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch or crawl for long periods of time. Talk, hear, taste and smell. Occasionally lift and/or move up to 50 pounds unassisted and push and pull heavy materials to complete assignments. May lift more poundage with assistance. Close vision, distance vision, color vision, peripheral vision, depth vision, and adjust focus. Use of phones, computers, computer monitors, and all office / laboratory equipment. Type at a computer keyboard and have read CRTS / computer monitors. Work near moving mechanical parts and wear appropriate protective gear, (hard hats, glasses / goggles, chemical resistant suites, gloves, safety shoes) and other personal protection equipment “PPE” to protect themselves from toxic or corrosive chemicals in the forms of liquids, solids, vapors or airborne particles. Work in an environment where highly potent / hazardous materials are handled and manufactured. Who You Are: Minimum Qualifications: Bachelor’s in Chemistry, Biology, or other Life Science discipline 5+ years of analytical laboratory environment operating under GLP or cCMP conditions OR Master’s in Chemistry, Biology, or other Life Sciences discipline 2+ years of analytical laboratory environment operating under GLP or cCMP conditions OR PhD in Chemistry, Biology, or other Life Sciences discipline. 1+ year in an analytical laboratory environment operating under GLP or cGMP conditions. Preferred Qualifications: Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detail. Ability to work in a team environment. Ability to work in an Analytical testing lab with hazardous and toxic chemicals.
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.
#J-18808-Ljbffr