Manufacturing Associate II - Upstream
Amneal
Summary
The Manufacturing Upstream Scientist II is a hands-on position responsible for manufacturing operations executing mammalian cell culture processes and producing recombinant proteins for a wide range of mammalian-based biosimilars. Responsible for executing cell culture batches from 50L to 2000L volumes within a current Good Manufacturing Practice (cGMP) environment.
Job description
Essential Duties & Responsibilities
- Demonstrate a sound knowledge and understanding of cGMP requirements; adhere to real-time documentation during production runs 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 and maintain production equipment
- Follow all GMP instructions in the manufacturing area and take ownership of environmental health and safety policies
- Coordinate investigations and corrections for issues found during batch execution
- 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
Material & Inventory Management
- 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 in a team-oriented, cross-functional environment
- 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 ability to work under demanding timelines
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 supporting cGMP operations and commercial exposure
Manufacturing Operations is 12-hour 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.
Requirements
- 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 cross-functional groups in a team-oriented environment
- 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 ability to work under demanding timelines
- General working knowledge of disposable bioreactors, filtration, depth filtration, and single-use consumable technologies
- Hands-on experience with mammalian cell culture and/or media preparation in biopharma or biotech manufacturing
- Proficiency in aseptic operations and in-process sampling
- Experience supporting cGMP operations and commercial exposure
Benefits
- Health Insurance
- 401(k) Matching
- Short-Term Incentive
- Performance-Based Bonus
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.