This role will participate in the day-to-day process development and bioprocessing of postpartum tissue-based products, cell therapy or exosomes supporting the company’s product development and commercial needs.
Participate in the daily processing of the company’s postpartum tissue – based, cell therapy or exosome products, process feasibility, engineering and process transfer runs.
Contribute to research design and planning of new experiments and studies for process development activities.
Attention to detail and reporting any unexpected findings during bio-processing
Operate in ISO 7 and ISO 8 (Class 10,000 and Class 100,000) process development environments. Ability to gown appropriately for clean room/aseptic manufacturing is required.
Follow appropriate GMP-GLP guidelines
Work closely with Quality Control and Clinical Manufacturing teams in support of operational process transfer efficiency and flexibility and assurance of timely completion of all manufactured biological products.Maintain and deliver sufficient supply of appropriate grade material for regulatory submission – enabling GLP biocompatibility and other validation studies in accordance with project
Support development of technical reports, data summaries, presentations, SOPs, and batch records
Participate in the process development, training, and process transfers for existing and future products. Execute protocols to support product development operations.
Ensure the proper operation and performance of routine manufacturing equipment.
Completion of multiple equipment logbooks is required.
Participate in the process development equipment calibration to assure all equipment is maintained as per qualified methods.
Consistently perform various manual laboratory duties and techniques on time sensitive materials with accurate and precise manipulations and data recording.
Excellent verbal and written communication skills as well as strong focus and attention to details is required.
BS/MS in Bioengineeing, Biology, or related scientific discipline
1+ years’ relevant experience with tissue, cell, and biomaterial product development, decellularization processes, cell therapy, exosomes manufacturing in cGMP environments.
Researching developing and implementing new methods
Demonstrated hands on aseptic techniques, technical proficiency related to bioprocess development and process transfer to manufacturing.
Ability to develop SOPs and generate batch records supporting process development and transfer activities.
Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211).
Strong interest and passion for innovation and development of life saving products
Organizational and time management skills
Problem-solving for Biomanufacturing process development
Dynamic individual with the ability to communicate and engage others
Independent and self-starting. Ability to work with minimal supervision