Work Location: Madison, Wisconsin Shift: Department: LS-SC-POWPDE Madison & Verona Process Dev Group 3 Recruiter: Genie Hooper
This information is for internals only. Please do not share outside of the organization.
Your role:
At MilliporeSigma, as the Senior Scientist, Process Development you will support 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.
Design and lead the development of robust processes for the manufacture of pharmaceutical intermediates and APIs
Develop successful processes through a combination of personal hands-on lab work as well as overseeing the efforts of junior scientists
Participate in all project team activities as the technical team leader
Demonstrate a thorough understanding of modern analytical techniques to interpret spectra and data
Act as a consultant for process/analytical development issues
Simultaneously manage 2-3 projects at various stages of maturity with minimal level of guidance
Oversee process transfer to the production labs and provide technical support for trouble shooting activities
Provide technical support for process validation and post-validation activities
Prepare comprehensive process development reports for clients and for internal use
Provide innovative and effective solutions to address technical and analytical challenges that arise during process development and cGMP manufacturing
Display strong customer-facing communication skills that instill client confidence
Demonstrate strong written communication skills with effective documentation of process development activities
Perform job functions in accordance with current operating procedures
Adequately document experimental data in electronic documentation formats
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
Mentor junior scientists and other colleagues and lead initiatives in the PAD organization
Proactively consider the impact of quality, regulatory, manufacturing, and safety requirements when planning project development activities
Author, utilize, and train employees on written procedures, including batch records and operating procedures
Work in accordance with FDA, OSHA, EPA, DNR, DOT and other regulatory agency guidelines
Who you are:
Basic Qualifications:
PhD in a scientific discipline (e.g., Organic Chemistry, Biochemistry, Chemistry, etc. ) with 1+ years' of experience in process chemistry
Master's Degree in a scientific discipline (e.g., Organic Chemistry, Biochemistry, Chemistry, etc. ) with 3+ years' of experience in process chemistry
Bachelor's Degree in a scientific discipline (e.g., Organic Chemistry, Biochemistry, Chemistry, etc. ) with 5+ years' of experience in process
Preferred Qualifications:
PhD in Organic Chemistry with 8+ years of industry experience, including process chemistry and regulatory experience
Experience supporting a commercial program
Experience in handling High-Potency APIs
Knowledge of experimental design techniques and thermal hazard evaluation techniques in the process development field
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.
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.