Manufacturing Supervisor (Downstream) - 12 Hour Night Shift
Amneal
Summary
The Downstream Manufacturing Supervisor is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian-based biosimilars. The candidate will be responsible for the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents.
Job description
Essential Duties & Responsibilities
- Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis
- Provides technical direction in the execution and development of the purification process
- Uses programs to collect and evaluate operating data to conduct on-line adjustments to products, instruments or equipment
- Prepare / review all quality management related documents (Deviation / Change control / investigation reports etc.)
- Ensure that engineering and clinical batches are executed in a timely manner
- Establishes operating equipment specifications and improves manufacturing techniques
- Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment
- Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies
- Coordinate the conduction of investigations and corrections for issues found during the batch execution process
- Performs other functions as required or assigned
- Complies with all company policies and standards
Qualifications
Experience: Must have a minimum of 7 years of related experience in the biopharmaceutical industry. Previous experience working in GMP and aseptic manufacturing environment. Experience working with AKTA Process skids or similar and familiarity of single use manufacturing consumables such as bags, tube sets, columns and process manifolds. Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation.
Education: Requires a Bachelor's Degree in chemical, biological or biochemical sciences; Master's degree a plus.
Special Skills: Must be able to work a 12-hour night shift. Ability to work with other team members and independently - good interpersonal skills. Good communication / documentation skills: verbal and written, good computer and organization skills, detail oriented. Basic computer skills, including knowledge of Word, Excel and spread sheet. Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review. Knowledgeable in cleaning verification/validation.
Requirements
- Minimum of 7 years of related experience in the biopharmaceutical industry
- Previous experience working in GMP and aseptic manufacturing environment
- Experience working with AKTA Process skids or similar
- Familiarity with single use manufacturing consumables such as bags, tube sets, columns and process manifolds
- Knowledge to execute engineering and clinical batches
- Familiar with GMP documentation
- Bachelor's Degree in chemical, biological or biochemical sciences
- Must be able to work a 12-hour night shift
- Good interpersonal skills
- Good communication / documentation skills: verbal and written
- Good computer and organization skills
- Detail oriented
- Basic computer skills, including knowledge of Word, Excel and spread sheet
- Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review
- Knowledgeable in cleaning verification/validation
Benefits
- Health Insurance
- Insurance Benefits
- 401(k) Matching
- Short-Term Incentive
- Performance-Based Award
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.