Manufacturing Associate

7 days ago

Fremont, United States Asahi Kasei America Inc Full time
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.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:
Bionova Scientific LLC

Job Description:

Company Summary:

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.

Position Summary:

The Senior Manufacturing Associate / Manufacturing Associate will actively contribute to the manufacturing projects at the Bionova Scientific West Warren site. As part of the Aseptic Operations Manufacturing group, you will have opportunities to work on and take ownership of a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, facility buildout, and tech transfers of processes into a GMP multi-product manufacturing facility. The role will provide hands-on execution of complex experiments in a team setting. The role will support GMP readiness and manufacturing activities. The scope of responsibilities may include but are not limited to Document writing (SOPs, Equipment URSs, etc.), equipment validation execution support and single-use assembly design.

Essential Duties and Responsibilities:
  • Executes complex unit operations including but not limited to cell culture thaw, expansion, generation and maintenance of Master and Working Cell Banks, End of production banking, and drug product filling.
  • Performs internal support activities such as maintenance of analytical and product filling equipment, stocking of consumables, discarding expired reagents, material coordination and weigh and dispense.
  • Maintains own training within compliance and trains other GMP associates upon completion of trainer qualification.
  • Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP Upstream, GMP Downstream, and Bulk Fill activities.
  • Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
  • Documents work according to cGMP and cGDP.
  • Adheres to established regulations and follows cGMP established by site.
  • Maintain cleanroom standards, practices, and housekeeping according to SOPs.
  • Recognize any minor issues from the equipment and any affiliated documentation and take appropriate corrective action within scope. Notify leads/managers of issues and discrepancies immediately.
  • Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
  • Evaluate new technologies and innovations to improve operational efficiency or expand cell culture capabilities.
  • Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.
  • MSAT support, Material receipt, and inventory organization.
  • Other duties as assigned to ensure appropriate compounding practices

Working Conditions:
  • This position requires work in GMP Production Plant with gowning requirements. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
  • Requires work inside Biological Safety Cabinet with additional gowning requirements.

Qualifications
  • BS in Engineering, Life Sciences, or related discipline with 2+ years of relevant experience; AA degree with combination of industry experience and relevant degree; or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
  • Must have aseptic technique experience is a must for a Senior MFG Associate.
  • Basic Upstream and/or Downstream experience is a plus.
  • Cell Banking experience is a plus.
  • Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing
  • Creative thinker that can identify better and more efficient methods to address issues and gaps.
  • Demonstrate ability to work independently and on cross-functional teams.
  • Ability to handle more than one task at a time, while maintaining attention to detail and working in a fast-paced environment.
  • Strong analytical skills and attention to detail.
  • Flexible mindset for a dynamic environment.
  • Flexibility with work hours to meet business needs, including weekends and holidays, as needed.

Compensation Range: The base compensation range for this role is between $32 to $37 an hour, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program: Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

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