Who we are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany – a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
Your Role: The Scientist, Quality position is responsible for the analysis of samples in the Quality Control department and all related paperwork. Analysis involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. The position demonstrates the ability to work on, and solve, problems independently with some guidance. This position is responsible for performing method qualification and validations, as well as for developing analytical methods to support validations, and for maintaining project timing/costs by interacting with internal/external clients to assure project goals are met. This position is responsible for writing protocols and standard operating procedures, and training other staff on laboratory techniques. Other responsibilities include participation in process improvement initiatives, maintaining a clean and safe working environment, and supporting the department in maintaining the laboratory in an audit ready state. The Scientist, Quality position, like all positions at SAFC, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.
- Work on complex problems in which analysis of data requires an in-depth evaluation of various factors.
- Exercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining results.
- May determine methods and procedures on new assignments and provide guidance for new or less experienced personnel.
- Able to solve problems and make decisions with minimal assistance.
- Able to interpret analytical data (including FT-IR, 1H NMR, MS).
- Write stability protocols, maintain stability chambers/programs, review/manage stability reports, interact with customers to support stability program.
- Develop testing methods to support cleaning verification program; validate or verify methods as necessary.
- Perform cleaning verification by executing existing methods.
- Perform review of analytical data for accuracy and quality.
- Train new or less experienced personnel in SOP content, analytical techniques, and instrument use.
- Meet with internal project groups to keep projects on track.
- Maintain projects and timelines with minimal oversight.
- Execute method transfers into QC and write summary reports.
- Perform method validations and write technical reports.
- Perform instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair.
- Analytically test in-process, final products, intermediates, and raw materials. Testing will involve the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
- Participate in OOS investigations via testing and good documentation.
- Apply critical thinking and good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with minimal assistance from supervisor
- Perform requalification of reference standards, and maintain reference standard inventory/documentation.
- Write and revise SOPs including raw material, intermediate, and final product specifications.
- Document testing properly and in a timely fashion, including keeping laboratory notebooks accurate and up to date.
- Demonstrate proper laboratory techniques.
- Work cooperatively within the QC department and with other departments to achieve project goals. Communicate with project management and provide technical updates
- Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable
- 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.
Education: B.S. in Chemistry or related biological sciences.
Experience: Minimum 5 years’ experience in a GLP or cGMP analytical laboratory environment, or equivalent industry experience.
Essential and Critical Skills: Excellent written and verbal communication skills, as well as excellent documentation practices. Ability to work in a team environment. Ability to work in analytical testing labs with hazardous and toxic chemicals. Knowledge and understanding of organic analytical chemistry. Adequate technical writing skills to generate project reports.
What we offer: Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.
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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.