Senior MS&T Specialist

Job Title: MS&T Specialist

We are seeking an experienced MS&T Specialist to join our team. The ideal candidate will possess expertise in Extractable and Leachable (E&L) risk assessment, including the ability to determine risk levels and update risk assessments.

• The successful candidate will be responsible for building a comprehensive material library with corresponding E&L test data.
• They will also manage coordination for Extractables studies or product-specific leachable studies, prepare E&L Risk assessment, testing Protocol, and Report.
• Additionally, they will compile E&L data and provide information to Toxicologists for assessment.
• Proficient in risk evaluation, decision matrix, Gap Analysis, and outcome understanding manufacturing materials.
• Comprehensive knowledge of chemical and physical properties (leaching tendency) of MOC materials.
• Skilled in defining original risk levels, Mitigation factors, and Final risk levels as part of the Risk Assessment process.
• Expertise in Extractable studies, methodologies, analytical strategies, and design.
• Setting AET (Analytical Evaluation Threshold) and SCT (Safety concern threshold) for extractables and leachables detected during testing.
• Detailed understanding of E&L guidelines (SOPs, Pharmacopoeia, and ICH standards).
• Identifying and assessing Worst-case material representative approach.
• Collecting material lists and data information from development centers and manufacturing sites.

• Preparation of process and cleaning validation documentation (Protocols, reports) as well as change evaluations for new product launches and Life cycle management activities.
• Ensuring project tracking documentation/tools are updated according to plan.
• Collaborating closely with the development organization (or sending site) for technical transfers and new product launches.
• Ensuring data integrity checks are conducted to verify complete, consistent, and error-free data before proceeding with further analysis or reporting.
• Coordinating documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable.
• Preparing, approving, and life cycle managing Gxp documents.

• Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS.
• Min 5 years of experience in MS&T or in the manufacturing of pharmaceutical Drug substance and Product for Small and Large molecules.
• Familiarity with regulatory guidance on ICH Q3, Validation, Product filing, and Post approval changes.
• Proven project management experience in a cross-functional environment (e.g., multi-site, technical development, other functions).
• Expertise in reviewing and writing technical reports.
• Good communication, Presentation, and Interpersonal skills.
• Proficiency in English (oral and written) is required.

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

• Own the Training Curriculum for Own Job Profile.

• Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS.
• Min 5 years of experience in MS&T or in the manufacturing of pharmaceutical Drug substance and Product for Small and Large molecules.
• Familiarity with regulatory guidance on ICH Q3, Validation, Product filing, and Post approval changes.
• Proven project management experience in a cross-functional environment (e.g., multi-site, technical development, other functions).
• Expertise in reviewing and writing technical reports.
• Good communication, Presentation, and Interpersonal skills.
• Proficiency in English (oral and written) is required.