Associate Ii, Manufacturing

Job Description Duties: The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is responsible for performing day to day operations. KEY ROLE AND RESPONSIBILITIES: Execute the Day-to-Day Manufacturing Processing ● Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients. ● Adhere to the current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs). ● Escalate manufacturing operations issues to management and quality assurance in a timely manner. ● Maintain production facilities at a high standard of cleanliness and organization. ● Perform equipment maintenance and calibrations as required. ● Complete and review GMP documentation in a timely manner. ● Maintain appropriate level of training for assigned responsibilities. ● Assist with inventory management of supplies in the manufacturing facility. ● Assist with daily tasks and support manufacturing. Collaborate Effectively ● Be a team player, offer assistance, and respond well to requests for help from team members. ● Use strong communication and build relationships. ● Demonstrate technical acumen, operational understanding, and GMP compliance. ● Support operational excellence initiatives. ● Support a culture of safety and GMP compliance. ● Identify opportunities for continuous improvement.

Skills: ● A Minimum of 2 years’ experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation. ● Experience with quality management systems (e.g. Deviations, CAPAs, Change Management). ● Experience with electronic systems such as MES and ERP.  ROLE DESCRIPTION KNOWLEDGE, SKILLS AND ABILITIES: ● Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies. ● Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time. ● Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills. ● The desire and ability to work in a fast-paced, start-up environment. PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following: ● Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and drug product. A vision test will be required. Use of corrective lenses is acceptable. ● Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe nonsterile and sterile gowns.          ● Work inside the processing facility for extended hours, and gowning into and out of   Grade A and B environments.  SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE: Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.

Education: ● BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field) with a minimum of 2 years’ experience. 

Schedule Notes: This position will be Sunday - Wednesday, 4x 10 hour shifts, 0700-1730. Overtime is acceptable as operations tend to run over, or there is often shift coverage opportunities. We ask for flexibility.

Hours Per Day: 8.00 Hours Per Week: 40.00 Department: 510000 : Manufacturing Job Category: Technical Operations