Position summary – Senior Scientist
MSAT Material Science is seeking a scientist to drive raw material quality and traceability initiatives that support regulatory compliance and dependable manufacturing outputs. This candidate will provide technical support to the MSAT Material Science team on a variety of deliverables critical to successful technical materials deliverables. This role will support a range of activities including investigations, specification development, material qualification, change control and technology transfer support, analytical method evaluation and data driven traceability efforts. The role will collaborate closely with Process, Planning, Manufacturing, Quality, Supply Chain/Procurement, Supplier Quality, and IT/data teams to improve raw material traceability, resolve material issues, and produce regulatory quality documentation.
Key responsibilities
Support the MSAT Material Science team on material related investigations and deviation analyses: gather and analyze manufacturing and analytical data, contribute to technical assessments, and help implement solutions as applicable.
Assist MSAT Material Science in developing and revising raw material specifications: draft language, define acceptance criteria, compile technical justification, compendial review and coordinate SME deliverables.
Support material qualification and requalification activities on behalf of the MSAT Material Science team: prepare qualification plans/protocols, coordinate testing with internal or external labs/vendors, analyze returned data, and draft qualification reports.
Provide technical input for change controls: prepare technical assessments, perform impact and risk evaluations, coordinate verification/validation activities, and compile evidence for closure.
Support technology transfer activities: prepare transfer documentation, align material requirements between development and manufacturing, and coordinate post transfer monitoring and follow up.
Contribute to material traceability and data mapping initiatives: work with Process, Planning, and IT/data teams to map raw material usage to manufacturing campaigns and produce actionable visualizations.
Interface with Supplier Quality and Procurement to support vendor qualification, incoming material review, sample evaluations, and supplier investigations.
Prepare and maintain regulatory grade documentation on behalf of MSAT Material Science: investigation summaries, specifications, test method rationales, SOPs, qualification packages, and technical reports.
Support audits and inspections by preparing evidence, supporting response to technical queries, and assisting in closure of material related findings under Quality oversight.
Communicate findings and recommendations to the MSAT Material Science team, cross functional partners, and leadership; present at technical meetings as required.
Mentor and guide junior staff, contractors, or interns on data review, documentation standards, and investigation best practices.
Qualifications
Advanced degree in Materials Science, Chemical Engineering, Chemistry, Polymer Science, or closely related discipline preferred; Master’s with 3-5 years experience. PhD with 0-3 years experience.
Experience coordinating testing with external/internal analytical labs and interpreting lab reports.
Knowledge of GMP principles, validation strategies, and risk assessment methodologies (e.g., FMEA).
Familiarity with supplier qualification practices and vendor communications.
Demonstrated experience supporting material investigations, specification setting, qualification oversight, change control, and tech transfer in a regulated manufacturing environment (pharma, biotech, medical device, or related) preferred.
Strong data analysis skills and ability to synthesize manufacturing and analytical datasets to support root cause and risk assessments.
Proven technical writing skills for regulatory grade reports, specifications, and protocols.
Experience collaborating with Process, Planning, Manufacturing, Quality, Supply Chain/Procurement, Supplier Quality, and IT/data teams.
Familiarity with electronic quality systems (eQMS, LIMS), manufacturing systems (MES), SAP and common data tools (Excel, Python/R, JMP, or similar).
Prior industry experience in MSAT or material science support roles within regulated manufacturing preferred.