Associate, Manufacturing

Role Summary

The Associate, Manufacturing is responsible for supporting biological manufacturing. All functions and roles of the manufacturing process are required to be performed with adherence to cGMP and GDP to ensure successful, quality operations.

Responsibilities

• Performs manufacturing activities according to cGMP guidelines, including batch record execution and review, product and equipment changeover, manufacturing equipment troubleshooting, issue resolution.
• Execute process operations in accordance with dynamic production timeline.
• Ensures safety and cGMP compliance in manufacturing area at all times
• Communicate transparently with management on all manufacturing related activities
• Utilize Cell culture expansions and aseptic techniques
• Develop and author necessary supporting cGMP documentation that supports all Cell Culture manufacturing processes.
• Maintain aseptic gowning qualification status and participate in semi-annual media fills.
• Engage cross-functionally with other departments in order to stream-line all operations supporting cGMP manufacturing.
• Cross-train on and assist with multiple cell lines operations as required.
• Contribute to and develop process improvement initiatives with all Cell Culture manufacturing equipment and operations.
• Assist and/or execute ordering of material and ensure that equipment and materials are available for production runs.
• Adhere to Standard Operating Procedures (SOPs) and cGMP guidelines.
• Maintain and sustain all organizational training profile requirements.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Qualifications

• Bachelor‚Äôs degree in chemical engineering, genetics, molecular biology, biotechnology, microbiology, biochemistry, or a related field is required
• Relevant industry or research experience is preferred
• Bio-Manufacturing experience is preferred

Knowledge, Skills, & Abilities

• Attention to detail, cleanliness, physical and mental flexibility
• Good perception to implement what has been learned, following guidelines precisely
• Understanding and application of safety and quality requirements
• Solid adherence to cGMP
• Ability to successfully work in a team environment with effective communication skills
• Hands on approach to learned skills
• Team player with good communication skills
• Skill in Microsoft Word, Excel, and PowerPoint
• Ability to read, understand and apply Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs)

Education

Additional Requirements

• This position works onsite and depending on location may need to travel to other buildings
• This position works in a lab environment
• Must have ability to perform work while wearing the appropriate gowning material for cleanroom environments and work under aseptic conditions in a class 100 environment (BSC).
• Ability to work on unscheduled days occasionally to support the dynamic production schedule and relevant timelines.
• Ability to manage up to fifty (50) pounds at a time and stand for extended periods of time while wearing appropriate clean room gowning material and appropriate personal protective equipment is required