Downstream Manufacturing Associate III Wed-Sat Shift

Manufacturing Associate III is focused on biologics manufacturing (downstream purification). Operators are expected to perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other regulations that apply.

• Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities)
• Strong knowledge and understanding of manufacturing process and equipment to perform various production steps
• Ability to train employees
• Subject matter expert operating production equipment, as needed
• Monitor and record batch parameters, including computer data entry
• Complete relevant paperwork following GDP/GMP guidelines as well as perform mathematical calculations related to production processes
• Initiate new documents for procedures; may make minor revisions to existing documents
• Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies
• Troubleshoot process problems and respond to alarms
• Provide information for unplanned events, including entering data into event management software
• Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution
• Order, receive and distribute supplies into production area as needed
• Pushing buffer containers ranging from 50L to 200L
• Sitting for periods of 2 to 3 hours
• Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment
• Convey information to external stakeholders (auditors, global colleagues, etc.) and oversee support for groups that support manufacturing (such as external cleaners, etc.)
• Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.)
• Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers
• Provide knowledge in areas of training process improvements
• Such additional responsibilities as the Company may also assign

• High school diploma (or associate degree in Life Sciences/Engineering field) with 6+ years of related experience (Biotech Certificate preferred)
• Bachelor’s degree with 3+ years of related experience
• Demonstrated knowledge of CGMP manufacturing
• Knowledge of laboratory and pharmaceutical production equipment
• Ability to read and follow detailed written instructions and have good verbal/written communication skills
• Ability to write legibly and grammatically correct entries on records; must author technical procedures and create forms
• Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
• Good computer skills, knowledge of Microsoft Word, Excel
• Good interpersonal skills and ability to work effectively and efficiently in a team environment
• Ability to meet required schedule; position may include shift, weekend, holiday work and overtime as dictated by the 365‑day production schedule
• Ability to work in a clean‑room environment and comply with hygiene standards and use of special garments
• Personal protective equipment must be worn due to safety requirements

• Experienced in GMP downstream manufacturing; especially with TFF, Chromatography systems and purification of Mabs
• Specific equipment/systems used:
  Akta Ready, Akta Process, XDUos buffer systems and disposable technology systems
• Experience with troubleshooting of equipment and process and excellence in clinical manufacturing
• Adaptable to changes, works well cross‑functionally and with key stakeholders
• Self‑motivated, takes initiative and drives for solutions with the team
• Can lead in the absence of the manager
• Can train newer operators once up to speed
• Other possible responsibilities may include writing deviations/investigations and revising batch records if needed

Normal office working conditions: computer, phone, files, fax, copier. Personal protective equipment must be worn as required. May require lifting amounts of 25 lbs. Manufacturing operations tasks require operator to regularly remain on feet for shift.