Production Analyst

The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionique Testing Laboratories LLC (Bionique) has been a leading global provider of mycoplasma testing services for the biopharmaceutical industry for over 30 years. Bionique offers the full breadth of services from lot and Final Drug Product release testing per regulatory guidelines to a GMP compliant Real-Time PCR assay to support clients’ needs from concept to clinical trials and commercialization for biopharmaceutical and cell therapy products. Bionique’s experience and expertise extends to development and validation of rapid microbiological methods to support abbreviated release timelines. Additional services such as regulatory and compliance consultancy add to Bionique’s unique position in this niche analytical testing space. Located in Saranac Lake, NY, Bionique is an FDA registered and GMP compliant contract testing facility. Bionique aims to offer unsurpassed quality mycoplasma testing services to meet the specific scientific and regulatory needs of each client and partner.

Company:

Bionique Testing Laboratories LLC

Job Description:

Summary:

The Production Analyst I is responsible for supporting routine testing, product development, and research and development (R&D) efforts by preparing high-quality reagents, and broth and agar media supplies. The role involves executing standardized production and quality control processes to ensure the integrity, sterility, and performance of media used in mycoplasma and sterility testing.  This position is also responsible for assisting laboratory personnel and supporting the quality control, sterility control, and safety agenda of the organization with various functions withing the facility. This entry-level position requires attention to detail, adherence to current Good Manufacturing Practices (cGMP), and effective communication within the Production and Quality teams.

Key Accountabilities and Responsibilities:

• Produce all broth and agar media bases and supplements necessary for media completion.

• Prepare reagent preparations such as buffers, alcohol solutions, and bleach.

• Perform quality control testing on prepared reagents and media, including growth promotion testing for mycoplasma and sterility testing.

• Operate and maintain laboratory equipment such as autoclaves, plate pourers, laminar flow hoods, incubators, microscopes, refrigerators, freezers, and water systems.

• Sterilize glassware, containers, and production materials to support sterile operations.

• Monitor and manage media inventory to meet internal demand projections, ensuring accurate documentation, labeling, and delivery.

• Follow all standard operating procedures (SOPs) and maintain full training compliance.

• Maintain the laboratory in an audit-ready and cGMP-compliant state.

• Assist with monitoring and maintaining general laboratory inventory, receiving, and stock assigned areas with laboratory supplies and reagents.

• Assist in the archiving and/or disposal of samples.

• Review quality control data to confirm compliance with specifications and support deviation investigations when necessary.

• Participate in non-routine projects to support departmental innovation and improvement.

• Contribute to the creation and revision of SOPs and related documentation.

• Assist laboratory personnel with routine tasks and facility support functions as part of the organization’s quality and safety initiatives.

• Communicate clearly with supervisors and colleagues regarding material needs, equipment calibrations, scheduling, and deviations.

• Ensure safe work practices and adherence to environmental and safety guidelines.

• Perform data review and basic trending analysis as required.

• Complete tasks as assigned and escalate issues promptly to meet deadlines.

• Additional duties as assigned

Requirements:

• Bachelor’s degree in microbiology, cell biology, biochemistry, or a related scientific discipline preferred. Equivalent combinations of education, training, and experience may be considered in lieu of degree.

• Experience in a regulated laboratory environment (e.g., cGMP, ISO) preferred.

• Strong organizational skills and attention to detail.

• Effective verbal and written com