Work Location: Burlington, Massachusetts Shift: No Department: LS-PS-PVUC Validation Services E&L Lab US Recruiter: Beverly Dellisola
This information is for internals only. Please do not share outside of the organization.
Your Role:
At MilliporeSigma in Burlington, MA, we are seeking a detailed and results-oriented Sr. Chemist for our Extractables and Leachables (E&L) team within the North American Validation Services group. The successful candidate will be a part of a diverse team of scientists, specialists, and assistants, ensuring the delivery of compliant testing services that align with business objectives. In this role you will autonomously perform lab feasibility, standard and non-standard Extractables and Leachables testing following Protocols and SOPs on HPLC, GCMS and LCMS equipment.
Responsibilities:
Thoroughly read protocols and plan proactively for testing including equipment and chemical needs
Generate valid test data (ensuring accuracy and completeness) for customers in a timely manner
Write test protocols, reports, and other test-related documentation
Use computer software including Excel, Word, Smartsheet, MassHunter etc.
Generate accurate data and complete documentation of results during testing according to Good Documentation Practices and ALCOA+ principles
Handling of solvents and customer product samples in accordance with all safety rules (PPE, MSDS and EHS recommendations to be considered before to handle the products)
Assist with self-inspections and audits
Work as "Junior SME" to support lab on technical guidelines
Lead local projects, participate in global Continuous Improvement projects
Maintain a Growth Mindset, seeking opportunities to improve test efficiency and processes, approaching change with a spirit of curiosity
Maintain Equipment ensuring it is safe and fit-for-purpose. This includes but is not limited to assuring it is validated, qualified, calibrated, maintained and reliable. Support Vendor performance of IQ/OQ/PQ and PM
Who You Are:
Minimum Qualifications:
Bachelor's Degree in Chemistry, Biochemistry or other Science discipline
3+ years of experience in analytical chemistry with a focus on E&L testing within the pharmaceutical or medical device industry
Preferred Qualifications:
Master's Degree in a scientific discipline (e.g, Chemistry, Biochemistry, etc.)
Experience with laboratory electronic systems, including but not limited to: Gagetrack, LIMS, ELN, BMS, ECM, Mass Hunter etc.
Strong working knowledge of Validation Services operational systems such as, but not limited to: Mango, Trackwise, SFDC, Sharepoint, LabVantage and Oracle
Excellent communication skills, both verbal and written
Excellent Extractables and Leachables Technical knowledge
Excellent knowledge of good laboratory practices, cGMP, regulatory guidance, and recommendations as well as demonstrable operational management abilities
Demonstrated troubleshooting competencies
Demonstrated ability to manage change and implement improvement solutions
Strong background in Chemistry, excellent organizational and interpersonal skills, and a commitment to safety and compliance
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.