Manufacturing Associate I - Upstream

Essential Duties & Responsibilities

• Demonstrate a sound knowledge and understanding of cGMP requirements.
• Adhere to real-time documentation during production run and maintain accurate records/logs.
• Set up, operate, and break down upstream equipment including bioreactors, depth filtration, and disposables.
• Perform upstream processes at multiple scales in a cGMP environment.
• Perform calculations for processing, weighing materials, chemical and reagent additions.
• Use programs to collect and evaluate operating data to conduct online adjustments to products, instruments, or equipment.
• Work with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
• Follow all GMP instructions in the manufacturing area and take responsibility/ownership of environmental health and safety policies.
• Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
• Comply with all company policies and standards.
• Ensure all operations comply with cGMP, safety, and data integrity standards.
• Revise solution preparation batch records, SOPs, protocols and logbooks.
• Provide support during quality audits and regulatory inspections.
• Order, maintain, track, and stage raw materials and consumables for upstream, downstream, and media/buffer preparation processes.
• Perform label verification, receipt checks, and electronic inventory updates.
• Coordinate with warehouse and planning teams for material readiness.
• Manage material inventory inside cleanroom areas.

Minimum Qualifications

• High school diploma or equivalent required.
• Bachelor's degree preferred.
• Experience in a manufacturing environment or 1-2 years of relevant experience preferred.
• Familiarity with safety protocols/procedures.
• Ability to understand and adhere to written and verbal instructions.
• Excellent written and verbal communication skills.
• Ability to communicate technical details at all levels, including senior leadership.
• Ability to work well with a wide range of people from other groups in a team-oriented environment with cross-functional groups.
• Ability to learn to properly use various hand and electrical tools.
• Ability to work in a fast-paced environment and handle changing manufacturing demands.
• Proficient in MS Word, Excel, and PowerPoint.
• Ability to troubleshoot technical issues and propose short- and long-term solutions.
• Strong time-management skills and the ability to work under demanding timelines.
• Work in a team environment and be able to work independently with minimum supervision.

Preferred Qualifications

• General working knowledge of disposable bioreactors, filtration, depth filtration, and single-use consumable technologies such as bags, tube sets, and manifolds.
• Hands-on experience with mammalian cell culture and/or media preparation tasks in a biopharma or biotech manufacturing setting.
• Proficiency in aseptic operations and in-process sampling.
• Experience in supporting cGMP operations and commercial exposure is a plus.

Schedule

Manufacturing Operations is 12hr shifts for 24/7 coverage (2-2-3 work schedule), including holidays and weekends. Shift A (day shift): 7:00 AM to 7:00 PM EST. Initial training may be performed on the day shift. Required overtime (time-and-a-half pay), holidays, and weekends.