Fort Worth Metro Area, Texas
Plan and perform scientific experiments (or pilot plant processes) for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader. Focus is sterile ophthalmic preparations. Contribute to maintenance of lab instruments/infrastructure.
Meet quality, quantity and timelines in all assigned projects.
Plan, organize, perform and document scientific experiments/plant activities in collaboration with experienced team members if necessary. Seeks proactively for support and coaching from Project Leader, Scientific Expert or other team members during the whole process if necessary.
Plan and perform scientific experiment/plant activities and plan, perform and contribute to project related scientific/technical activities under minimal guidance from more experienced team members under guidance. (e.g. contribute to interpretation and report results)
Provide efficient and robust processes for the manufacture and/or specialized facilities e.g. containment/sterile labs as an expert w/ adequate guidance.
Provide raw data documentation, evaluation and results interpretation. Propose and provide input for the design of next experiments.
Optimize existing methods (lab or plant) and develop more efficient ones.
Generate lab procedures, reports and/or instructions.
Actively transfer procedures/instructions to pilot plant or production, including troubleshooting, process steering controls etc.
Communicate and address problems, perform safety and literature searches under moderate guidance from more experienced team member.
Keep record of and manage chemicals, intermediates, excipients and solvents within own area of responsibility.
Collaborate with other team members to facilitate deliveries of DS and/or DP.
Utilize special tools/equipments and/or specialized facilities e.g., containment/sterile labs.
Contribute to maintenance of infrastructure/equipment.
Actively participate in project teams/meetings/networks.
Actively contributes to team goals.
Ensure all own activities are aligned with overall drug development process.
Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & the client's Guidelines.
Minimum of 3 successful years of formulation development experience.
Awareness/proven experience for safe handling of chemicals, potentially dangerous materials and equipment.
Good scientific or technical knowledge in Formulations development
Adequate knowledge in scientific/technical areas of collaboration.
Proficient with laboratory and/or technical tools.
Adequate knowledge of software and computer tools.
Basic presentation skills and scientific/technical writing skills.
Good Communication skills
Minimum: BS or equivalent.
Desirable: MS or equivalent.