Goodwin Biotechnology, Inc.
Scope of Function:
The manufacturing associate II position is expected to possess a clear understanding of the fill finish operations. This position involves aseptic fill operations including preparation and execution of manual filling operations, and validation runs according to the GMP regulations. The candidate will also be interacting with cross-functional departments to troubleshoot, request materials, and to overcome challenges to meet the production schedule.
Senior Manager of Downstream Manufacturing
· Execute daily tasks such as washing and sterilizing vials and filling components for use in production operations. Perform area clearance on equipment and rooms that involve cleaning, and integrity testing pre/postproduction.
· Perform aseptic filling operations, including but not limited to preparation, filling, stoppering, crimping.
· Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP).
· Record activities in production batch records, and equipment logbooks as well as updating and/or authoring SOPs.
· Maintain an inventory of manufacturing supplies and order additional materials as necessary.
· Assist in activities related to other onsite departments such as the execution of validation protocols.
· Perform tasks under minimal supervision, and within tight timelines to meet production schedule.
· Support Goodwin Biotechnology QA during audits and regulatory inspections.
· Support other manufacturing processes teams and other GBI groups as necessary to achieve manufacturing goals.
Education and Experience:
· BS degree in Science or Engineering, or other related field and 2 year of experience with biologic production processes under GMP compliance.
· Minimum of High School Diploma or equivalent and 3 years of experience with biologic production processes under GMP compliance.
· Excellent documentation skills including comprehension and review & establishing batch production records.
· Quality Assurance
· Quality Control
· Facilities & Engineering
· Supply Chain
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.