DOWNSTREAM SUPERVISOR - cGMP MANUFACTURING
Full Time Regular: Manufacturing
We are on the cutting edge and we are committed to providing a work environment that fosters creativity and success while giving our employees the ability to achieve their full potential. We believe that as our industry grows, so will our employees.
WHAT WE HAVE TO OFFER:
A Meaningful Career- Forward-thinking individuals working together to explore and create state of the art medicines that change the lives of people around the world.
An Energetic Community – Headquartered in Oklahoma, offering everything you look for in a modern metropolitan community. An abundance of arts, quality health care, excellence in education and more. It is a distinctly livable city where you can chase your dreams and still enjoy a rich quality of life. Visit abetterlifeokc.com
A Competitive Benefit Package – Our Company offers a competitive 401k match, Medical benefits, Professional Development and Tuition Reimbursement, Paid Holidays, and a generous amount of paid time away from your job.
HOW WILL YOU MAKE AN IMPACT?
We are looking for highly motivated and driven leaders. This person will be accountable for leading the execution of procedures for purification manufacturing and support area of manufacturing using SOP's and batch records. Operating production equipment for purification that may include process monitoring, purification and formulation.
WHAT YOU WILL BE TASKED WITH:
• Supervision of manufacturing processes and personnel
• Coordinate with other production supervisors, managers, and project managers to execute production campaigns on-time.
• Provide daily production updates to production managers, client representatives, and program managers.
• Assemble, prepare, and maintain process equipment; chromatography skids, columns, TFF systems, and ancillary equipment.
• Collaborate with MST and development groups to assist with tech-transfer, scale-up, and translation activities.
• Interface with Quality Assurance group to ensure completeness of GMP documentation.
• Represent the department to clients and on cross-functional project teams.
• Initiate non-conforming events and participate in investigations, corrective actions / preventative actions.
• Provide support to cross-functional teams to meet production or timeline demands.
• Conduct performance reviews of manufacturing associates.
• Provide input for hiring new manufacturing associates and conduct interviews.
• Provide guidance for continuous improvement initiatives within downstream team.
• Demonstrate understanding and train new staff in scientific concepts, technical operations, safety, and Good Manufacturing Practice.
WHAT YOU BRING TO THE TABLE:
• Bachelor's Degree - Life Sciences or Chemical Engineering and 5 to 7 years in GMP environment with experience in GMP production and purification including aseptic processing, chromatography, TFF, Final Formulation and Filling and buffer preparation.
• Must be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environment.
• Must be proficient in Word and Excel.
• Ability to interpret process trends and data and react appropriately to unexpected outcomes.
• Innovative spirit, strong initiative and work ethic, and positive attitude.
• Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.
• Detail oriented
• Able to follow written instructions and document work performed
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand and sit. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; toxic or caustic chemicals; and risk of electrical shock. The noise level in the work environment is usually moderate. A large amount of the work is completed in a cleanroom environment. While working in the area the gowning requirements are safety glasses, shoe covers, hood, gown, mask boots and gloves. Working conditions can include standing for long periods of time