Work Location: Madison, Wisconsin Shift: No Department: LS-SC-POWPA2 Madison & Verona Analytical Dev Group 2 Recruiter: Tina Ceci
This information is for internals only. Please do not share outside of the organization.
Your Role:
The Scientist - Analytical Development plays a pivotal role in coordinating the analytical aspect of incoming and ongoing projects for Millipore Sigma-Madison. This role involves utilizing state-of-the-art instrumentation to develop methodologies and analyze active pharmaceutical ingredients and synthetic intermediates. The Scientist contributes to discussions and communications with customers to achieve a desired project endpoint. Additionally, they are responsible for documenting methodologies needed to support the project in cGMP manufacturing, troubleshooting instrumentation, and generating and compiling results to solve or diagnose a problem.
The Scientist is tasked with developing or overseeing the development of analytical methods to support Process and Analytical Development (PAD), ultimately for validation and/or use in cGMP manufacturing. The Scientist is responsible for reviewing and evaluating analytical data for identification of products, intermediates, and raw materials as well as troubleshooting and guiding development. The Scientist is the subject matter expert (SME) in analytical chemistry and the requirements for cGMP manufacturing. Demonstrates a documented ability to execute and troubleshoot experiments as well as provides sound judgement in scientific and technical situations.
Specific Responsibilities Include:
Independently lead project teams, provide guidance, and assist in the development of other group members
Develop test methods for Process Development (PD) products, intermediates, and raw materials
Initiate documentation and methodologies needed to support cGMP manufacturing
Work in the scope of the project independently and in a group setting
Testing will involve the use of HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR, and XRPD among other tests and instruments
Ability to troubleshoot HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR and XRPD, among other instrumentation, and wet chemical assays is essential
Properly document and review group members lab work
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)
Maintain and calibrate/verify analytical and related equipment
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
Regular use of phones, computers, computer monitors, and all office / laboratory equipment
The employee will also utilize computer keyboard and can read CRTS / computer monitors
Physical Attributes:
Regularly sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for long periods of time
Use all human senses (speak, hear, smell)
Lift or push up to 50 pounds unassisted
Job involves use of close vision, distance vision, color vision, peripheral vision, depth vision
Wear appropriate (PPE) while working around mechanical parts and hazardous material(hard hats, glasses / goggles, chemical resistant suites, gloves, safety shoes, respirator)
Who You Are
Minimum Qualifications:
Bachelor's Degree in Chemistry, Chemical Engineering, or other Life Science discipline
5+ years of experience in an cGMP or GLP analytical laboratory environment
OR
Master's Degree in Chemistry, Chemical Engineering, or other Life Science discipline
2+ years of experience in an cGMP or GLP analytical laboratory environment
OR
PhD in Chemistry, Chemical Engineering, or other Life Science discipline
Preferred Qualifications:
Excellent written and verbal communication skills
Excellent documentation practices and attention to detail
Ability to excel in a team environment
Experience working in an analytical testing lab with hazardous and toxic chemicals
Superior technical writing skills to generate development reports
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.
