Upstream Manufacturing Associate III

About the role

This position is focused on biologics manufacturing, which includes processing in upstream (cell culture) and downstream (purification). Operators are expected to perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply.

Schedule

This role will follow a day shift 4/3 Pitman schedule, Wed–Sat, 6:00 am–6:30 pm.

Responsibilities

• Operate manufacturing process equipment to perform various manufacturing production steps
• Knowledge on initiating new revisions for procedures
• Proficient operating inside of a BSC, sampling, and performing with aseptic techniques
• Monitor and record batch parameters, including computer data entry; complete relevant paperwork following GDP/GMP guidelines
• Troubleshoot process problems and respond to alarms; provide information for unplanned events, including entering data into event management software
• Order, receive and distribute supplies into production area as needed
• Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers
• Participate in (and may lead, as requested) team meetings and facilitate multi-department discussions
• Convey information to external stakeholders (auditors, global colleagues, etc.)
• Provide support for groups that support manufacturing
• Participate on Continuous Improvement Teams
• May perform other duties as assigned (during production processing these activities may increase)

Physical requirements

• Manufacturing operations tasks require operator to regularly remain on feet for shift
• Pushing buffer containers ranging from 50 L to 200 L
• Sitting for periods of 2 to 3 hours
• 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

Qualifications

• With high school diploma: normally requires 7+ years of related experience or an associate degree in Life Sciences/Engineering field; biotech certificate preferred
• With bachelor’s degree: normally requires 4+ years of related experience
• Good with Microsoft Office – Outlook, Word, Excel

Working conditions

• Normal office working conditions: computer, phone, files, fax, copier
• Personal protective equipment must be worn as required
• May require lifting amounts of 25 lbs

Pay

Base pay range: $36/hr – $46/hr