Job Description:

Position Summary:

We are seeking a Senior Upstream Manufacturing Associate/Upstream Manufacturing Associate to join our dynamic Manufacturing Operations team. In this role, you will contribute to the operations of a GMP multi-product manufacturing facility, taking ownership of a range of projects including troubleshooting, investigations, system and workflow implementation, facility buildouts, and process tech transfers. You will execute complex experiments hands-on in a team setting, with responsibilities ranging from document writing (SOPs, deviation initiation, investigations), equipment validation, and single-use assembly design.

Essential Duties and Responsibilities:

• Execute complex unit operations such as media preparation, cell culture thaw, expansion, production banking, bioreactor operations, process monitoring, and harvest operations with oversight of qualified staff.
• Support internal activities like maintaining analytical equipment, stocking consumables, discarding expired reagents, coordinating materials, and assisting with weigh and dispense tasks.
• Ensure compliance with training requirements and assist in training GMP associates after qualification.
• Troubleshoot equipment issues and support cell inoculum and downstream operations.
• Author, review, and approve technical documents, including tech transfer protocols, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filings.
• Document all work according to cGMP and cGDP guidelines.
• Adhere to site regulations and established cGMP practices.
• Maintain cleanroom standards and ensure housekeeping practices align with SOPs.
• Identify minor issues with equipment and documentation, take corrective actions within scope, and notify leads/managers of discrepancies.
• Contribute to quality activities, including investigations, walk-throughs, and supporting the creation of deviations, CAPA, and change control documents.
• Perform other duties as assigned to support compounding practices.

Working Conditions:

• The position is based in a GMP Production Plant and requires proper gowning.
• Physical demands include walking, standing, stooping, kneeling, and crouching. The employee may need to lift and move up to 20 pounds independently.

Qualifications:

Minimum:

• BS in Engineering, Life Sciences, or a related field with 0+ years of relevant experience or a combination of experience and a relevant degree, preferably in a biopharma manufacturing role.
• Bioreactor operations experience and understanding of mammalian cell culture performance is required for a Senior Manufacturing Associate.
• Working knowledge of cGMP compliance as it applies to procedures, processes, and manufacturing.
• Familiarity with process monitoring software and equipment software (UNICORN, Pi Historian) is a plus.
• Creative thinker capable of identifying efficient methods to address operational issues.
• Ability to work independently and as part of cross-functional teams.
• Strong attention to detail and the ability to handle multiple tasks in a fast-paced environment.
• Excellent analytical skills and a flexible mindset for a dynamic work environment.
• Willingness to work flexible hours, including weekends and holidays, to meet business needs.

Compensation:

• Base compensation range: $25 to $30 per hour, dependent on experience and qualifications.

Health Benefits:

• Healthcare, Dental, and Vision insurance.
• Life Insurance and Disability Program (100% covered).
• Retirement Plan (401K) with up to 8% employer match.
• Paid time off (up to two weeks).
• 10 days of Holidays and 5 days of Sick Leave.

Equal Opportunity Employer:

We are an equal opportunity employer and believe in a diverse workforce. We are committed to supporting the continuous changes in the economy, society, and environment by promoting an inclusive work environment.

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