Responsible for leading the purification process development and validation of all commercial and clinical products under cGLP and cGMP guidelines.
Develops and qualifies/validates purification process for all commercial, clinical and preclinical materials.
Writes and supervises/executes protocols and reports according to the current GMP guidelines.
Trends process development, validation and manufacturing data and improve processes.
Generates SOPs and batch records for new processes.
Trains and cross-trains process validation and manufacturing personnel during tech transfer.
Technology transfers of downstream processing to CMOs and partners.
Interacts with Manufacturing, Quality Assurance and Compliance, Quality Control and Regulatory Affairs and helps with CMC regulatory submissions.
Follows appropriate guidelines and is able to work under cGLP for development and cGMP for manufacturing/validation.
Supervise the purification and delivery of research materials.
Carries out direct supervisory responsibilities in accordance with the department-set goals.
Must be detail oriented with strong aseptic techniques and the ability to follow SOPs and have familiarity with cGMP regulations and conditions.
Master’s or Ph.D. degree in biology, chemistry, engineering or related field, with 7+ years of experience in product/downstream process development and validation; or Bachelor’s degree with at least 15+ years of related experience; or equivalent combination of education and experience.
Experience with downstream process development and/or downstream manufacturing of monoclonal antibodies.
Must have a strong background of chromatography and filtration processes commonly used in antibody manufacturing, including a deep understanding of the nuances and challenges of process scale and scale-down modeling.
Must have strong leadership skills; possess excellent communication (oral and written), organizational, and interpersonal skills, with the ability to perform in a team environment.