Manufacturing Associate I, Downstream Processing jobs in United States
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Enzene Biosciences Ltd · 1 month ago

Manufacturing Associate I, Downstream Processing

enzeneinc is seeking a Manufacturing Associate I for their downstream processing operations. The role involves day-to-day operations in a clean room environment, including buffer preparation, chromatography, and aseptic processing to ensure compliance with regulatory standards.

BiotechnologyDeliveryManufacturing

Responsibilities

Prepare and maintain buffers and media required for downstream processes. Ensure accurate formulation and timely availability of all solutions. Maintain detailed records of preparation and usage
Operate and maintain chromatography systems for protein purification. Monitor process parameters and ensure consistent product quality. Troubleshoot and resolve any issues that arise during chromatography runs
Perform TFF operations for concentration and diafiltration of biopharmaceutical products. Optimize TFF parameters to achieve desired product specifications. Document all TFF activities and results
Conduct viral filtration to ensure the safety and purity of biopharmaceutical products. Validate and monitor viral filtration processes. Maintain compliance with regulatory standards for viral safety
Perform aseptic processing in a clean room environment. Adhere to strict aseptic techniques to prevent contamination. Ensure compliance with Good Manufacturing Practices (GMP)
Maintain a clean and organized work environment. Follow all clean room protocols and procedures. Participate in regular clean room maintenance and cleaning activities
Maintain accurate and detailed records of all manufacturing activities. Ensure compliance with GMP and regulatory requirements. Participate in audits and inspections as needed

Qualification

BufferMedia PreparationChromatographyTangential Flow Filtration (TFF)Viral FiltrationAseptic ProcessingCGMP ComplianceAnalytical skillsProblem-solving skillsEffective communicationTeamwork abilities

Required

Bachelor's degree in biotechnology, Biochemistry, Chemical Engineering, or a related field with 0+ years of relevant experience
H.S diploma with 4+ years of experience will be considered
Ability to follow instructions and procedures
Excellent problem-solving and analytical skills
Effective communication and teamwork abilities
Strong knowledge and experience working in a biopharmaceutical cGMP-regulated environment
Ability to stand for extended periods, bend, and lift objects weighing up to 50 pounds
Candidates must be physically capable of performing these tasks safely and effectively

Preferred

Experience with buffer and media preparation
Experience with chromatography
Experience with TFF
Experience with viral filtration
Experience with aseptic processing

Benefits

Health Insurance Medical, Dental, Vision
Life and AD&D Insurance
Disability Insurance
401k Retirement Plan
Paid Time Off (Vacation, Sick Leave, Holidays)

Company

Enzene Biosciences Ltd

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Enzene an integrated global CDMO offers services spanning discovery, development and commercial supply.

Funding

Current Stage
Late Stage
Total Funding
$50.26M
2023-01-30Series Unknown· $50.26M

Leadership Team

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Lourdes Gonzalez-Novo, MBA
Chief Commercial Officer (CCO)
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Company data provided by crunchbase