Scientist III
$82,700–$137,900 year
On-site · Andover, Massachusetts, United States
Job Summary
Develop and validate analytical test methods, author test method documents, support specification and list of test method development and ensure effective method transfer from the technical support group to the release laboratory by training analysts. Draft and execute analytical method validation protocols in support of new material qualification. Provide technical support for new analytical methods, method troubleshooting, investigations and method improvements. Collaborate with site functional areas such as Global Procurement, Quality Assurance, Site Technical Services and Manufacturing Operations to support the site plan of record. Support sustainability of Integrated Manufacturing Excellence (IMEx) elements within the group. Identify technical issues, method performance issues, instrument malfunctions and methodology problems and participate in necessary investigations aimed at mitigation. Maintain all related data and records in compliance with cGMPs and quality procedures. Write and review various technical documents in support of new material validations/verifications, investigations and technical memos. Meet all timelines and deliverables in support of Andover plan of record and instrument qualifications (IQ/OQ/PQ). Execute method validations for PAT test methods within manufacturing operations.
Required Qualifications
- Bachelor's degree with 6+ years of experience OR Master's degree with 4+ years of experience
- Experience with GC and HPLC
- Knowledge of cGMPs and regulatory guidance
- Proficiency with computer systems (LIMS, etc.)
- Excellent oral and written communication skills
- Ability to manage timelines and prioritize
- Proactive team player
- Ability to write and review technical documents (test memos, protocols, etc.)
Additional Requirements
- U.S. work visa sponsorship (TN, O-1, H-1B, etc.) is not available for this role now or in the future
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