Scientist, Manufacturing Sciences

• Drive the development of new formulation and manufacturing processes.
• Drive drug product processes development activities (Hold time study, material contact study, free / thae study, mixing, filtration, filling pump / shear stress, etc).
• Process and SUS Design : Develop processes and design single-use systems for clinical, scale-up, and registration batches, including the tech transfer of projects.
• Formulation Development : Responsible for formulation and process development of sterile injectables, including high concentration mAb and protein molecules.

Troubleshoot and problem-solve unresolved or new formula issues.

• Draft production batch records, protocols, reports, and memos and review protocols, results, and reports for projects.
• Batch support during manufacturing : Provide support during manufacturing batches to ensure successful production runs.
• Problem Solving : Actively participate in or lead problem-solving initiatives for formulations, equipment, and processes for assigned projects.
• Project Leadership : Lead projects with minimal supervision, ensuring all technical aspects are reviewed and planned to meet appropriate timelines and milestones.
• Project Management : Handle projects autonomously, ensuring timely completion by meticulously planning and being responsible for all technical aspects.
• Client Interactions : Lead clinical interactions during client calls, providing scientific justification for development decisions.
• Cross-Functional Collaboration : Work with project managers, Analytical, Quality Control, Quality Assurance, and other departments on projects.
• Client Engagement : Contribute to the development of project timelines and lead relevant client meetings.
• Make scientific presentations to internal and external teams.
• Maintain the development lab and ensure compliance with safety and operational standards.
• Write SOPs for lab equipment, perform periodic reviews of SOPs, and maintain lab equipment.
• Equipment Maintenance : Work with vendors to perform preventive maintenance on lab equipment.
• Lab Training : Provide general lab training for new hires.
• Single-Use Systems : Demonstrate some understanding of disposable single-use systems.
• Time Management : Exhibit good time management skills, ensuring efficient and effective use of time.
• Organization : Maintain a well-organized workspace and approach to project management.

Target Competencies :

• Customer Focus : Prioritize customer requirements and dedicate efforts to consistently meeting and exceeding customer expectations.
• Improving Processes : Continuously enhance internal procedures to benefit the customer and contribute to the team's achievements.
• Innovation : Challenge the status quo by introducing and proactively seeking out new ideas and solutions to strengthen team and site performance.
• Thorough knowledge of the pharmaceutical industry, particularly formulation and process development.
• Knowledge of cGMP and regulatory requirements of biopharmaceutical manufacturing, FMEA, and technology transfer.
• Knowledge of drug product formulation and fill finish.
• Strong communication skills.

Target Behavior :

• Cultivate a collaborative environment by working closely with colleagues and clients to achieve shared goals and objectives.
• Show flexibility in scheduling to support operational needs and adapt to changing priorities.
• Self-Motivation : Demonstrate a strong determination to acquire new knowledge and maintain a proactive approach, consistently pursuing avenues for professional development.
• Reliability : Be reliable and committed to seeing tasks through to completion, consistently delivering high-quality work.

Education :

Bachelor's degree in a technical field such as Biochemistry, Chemistry, Biology, or Medical Engineering or related field with a minimum of 5+ years of experience in a CDMO or product development in pharma / biopharma or PhD in relevant program.