Senior Scientist

• 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.

Key Requirements and Technology Experience: 

• Must have skills: MSAT or Manufacturing background
• Python and SQL
• Programming And Coding Experience
• Manufacturing environment (pharma, biotech, medical device, or related)
• Role can be HYBRID or REMOTE, but must be in EST time zone, prefers the candidate lives in NJ or PA
• Masters degree is required
• Required experience with Python and SQL - REQUIRED
• Must have MSAT or Manufacturing background
• Will work on a major project, will help setup connections, and explore data analysis
• Will research specific materials
• Must be a critical thinker
• Must be eager to learn
• MUST HAVE PROGRAMMING AND CODING EXPERIENCE
• Will help with coming up with unique ways to solve problems or obstacles
• Must have hands on coding experience (versus using AI solutions)
• MUST SUBMIT CODING EXAMPLES WITH RESUMES or they will be rejected out
• 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.