Process Development CMC Leader - Bioconjugation
On-site · Bristol, Pennsylvania, United States
Job Summary
The Process Development CMC Leader leads, manages and develops a cross-functional team of scientists, engineers and research associates focused on the development of chromatography and purification processes for complex bioconjugates. Leads optimization of processes to improve efficiency, facility fit, yield and product quality to meet client requirements; plans, executes and completes development activities with adherence to technical and timeline requirements; manages group activities, resource planning, client communication, technical documentation, and training; provides mentorship and fosters a collaborative, innovative environment; leads process characterization including risk assessments, scale-down models, and development of control strategies for commercialization; collaborates across cell line, chemistry, analytical, and manufacturing groups to achieve program objectives; proposes innovative solutions to accelerate client programs and drive business value; maintains high ethical and quality standards and complies with policies.
Required Qualifications
- MS degree in applicable scientific field; PhD preferred
- Minimum of 8 years of directly related experience with an MS degree; with a PhD degree, minimum of 5 years in process development and cGMP manufacturing with leadership experience
- Experience leading and mentoring a multidisciplinary team of scientists and engineers
- Proven track record in developing and optimizing chromatography and/or purification processes for bioconjugates
- Strong communication and cross-functional collaboration skills
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