Kelly is working with an establish Research Organization who is currently growing the team and looking for talented Process Development & Manufacturing Scientists.
Title: Process Development and Manufacturing
Job Type: Permanent
Process development and manufacturing activities related to clinical materials manufacturing and clinical trial investigational products under cGMP.
- Lead development activities for new processes and procedures for first-in human clinical materials development including design of process scale-up and scale-out, closed systems and engineering runs to meet clinical materials requirements.
- Lead clinical materials manufacturing campaigns; responsible for oversight and coordination of junior staff in conducting all activities related to manufacturing; lead decision-making when collaborating with functional teams: operations, regulatory affairs, quality systems, business administration; maintain regular reporting to functional manager.
- Develop methods for, perform and supervise manufacturing of clinical materials according to cGMP standards in Biosafety Level 2 BSL2 , cGMP-level work conditions and adherence to corresponding requirements.
- Develop standard operating procedures SOPs, Batch Records and product specifications.
- Critically assess experimental data, provide interpretation of results, and ensure data quality and integrity.
- Present data to functional manager and collaborative groups to support product and process specification.
- Author or co-author of manuscripts for publication in peer-reviewed journals.
- Remain current on literature and standard industry practices by attending scientific meetings/conferences.
- Provide support for regulatory filings including drafting Chemistry, Manufacturing and Controls CMC section of Investigational New Drug IND Regulatory Filing.
- May manage two or more staff in day-to-day operations for functional area s of responsibility.
- Responsible for hiring and retaining staff, career coaching, personal development for direct reports and accountable for the performance of employees.
- Ensure work completion within schedules and constraints.
- May serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
- May serve as safety officer; responsible for ensuring implementation of EHS, fire and city regulations for laboratory safety.
- Other duties may also be assigned
- cGMP experience.
- Gene editing experience e.g. CRISPR/Cas9
- Process development experience
- Bachelor's degree in related scientific field and four years of related experience.
- Master's degree and two years of related experience or an equivalent combination of education and relevant work experience.
- Excellent understanding of scientific principles.
- Working experience with aseptic cell culture cGMP clean room experience
Apply today for immediate consideration!
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