Research Development & Sciences - Scientific Technician

Job Description: The individual will provide document support for raw material and critical reagent enrollment in support of vaccine process and product development programs. Incumbent will author and manage change controls, material enrollment forms, evaluations, risk assessments, SOPs and other required documents. Additional responsibilities include support execution of laboratory assays in support of sa-mRNA development, effective interactions/communication with cross-department management, and support of the analytical team. The Scientific Associate II should be able to work effectively within the group and across the site to collaborate as needed.

• Authors and manages change controls, material enrollment forms, product evaluations, risk assessments, SOPs, and other documents to support enrollment of raw materials and critical reagents for clinical trials under limited supervision/guidance.
• Provides support to supply chain and process to ensure all documentation required for materials and critical reagents to be used in the manufacturing and testing of CTM.
• Serves as interface between vendors, TD, Supply Chain, and Process Development, and represents TD department in cross-functional forums to support manufacturing and QC
• Works closely with a cross-functional team to deliver necessary documentation.
• Evaluate material to determine if additional testing is required upon receipt of material and coordinate with appropriate analytical teams.
• Able to work under tight deadlines.
• Ensures all documentation are compliant with highest quality and regulatory standards.
• Partners with diverse team members from various functions, countries and members at various levels in the organization.
• Functions effectively as a core team member
• Support analytical testing as necessary to support the sa-mRNA program (gel electrophoresis, capillary electrophoresis, plate-based assays, and other DNA/RNA/LNP methods)
• Utilizes knowledge and experience with analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing
• Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work
• Generates a supportive business case, and supports cross-functional teams to deliver those opportunities
• Completes individual training and maintains a state of compliance
• Adheres to all safety requirements
• Supports communication/updates as required

Requirements

• B.S. with 2+ years of industry experience
• Experience in biotech or pharmaceutical development in one or more of various disciplines including (but not limited to) Analytical Chemistry, Biochemistry, Biomolecular Sciences, etc. Hands on laboratory experience in bioanalytical methods (gel electrophoresis, plate-based assays) required.

Additional Skills:

• Has in-depth conceptual and practical expertise in Biochemistry Methods listed
• Hands on experience with mRNA analysis is highly desired
• Demonstrated Lominger competencies in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, perseverance and problem solving
• Data collection and reporting with knowledge of GLP/GMP environments preferred
• Good verbal & written & presentation communication skills in a cross functional environment
• Attention to detail is a must
• Proactively owns and drives assigned tasks to completion