Our client is a prestigious research university focusing on finding new treatments using innovative technologies in a start-up environment.
• 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 EH&S, fire and city regulations for laboratory safety.
•- Other duties may also be assigned
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related scientific field and four years of related experience, or Master’s degree and two years of related experience or an equivalent combination of education and relevant work experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
• Excellent understanding of scientific principles
• Working experience with aseptic cell culture
• cGMP clean room experience
• Excellent computer skills and ability to learn quickly and master computer programs, databases and scientific applications
• Ability to work independently, maintain relationships and provide ongoing reporting to functional management
• Excellent organizational skills and demonstrated ability to complete detailed work.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178