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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:

QC lab in Bionova is seeking for a self- motivated and innovative, a strong technical and communication skills, a team player QC Scientist with 8+ years of work experience and expertise in analytical testing of biologics to contribute to our expanding business. As part of the rapidly growing QC team, you will be able to influence decisions and develop your own talent with the team to meet project goals that ultimately will improve patient outcomes.

Essential Duties and Responsibilities:

  • Perform analytical testing to support method qualification/validation/transfer, raw materials, in-process, lot release, stability, and other types of samples to meet Clients’ needs.
  • Assist in QC team implementation of GMP procedures, processes, and systems.
  • Train QC staff on instrumentation, techniques, analytical chemistry methods.
  • Lead/Participate in development, transfer, and validation of instrument and analytical test methods (HPLC/UPLC, CE-SDS, icIEF, ELISA, SoloVPE, qPCR, Bioassay, Binding ELISA, wet chemistry, and others).
  • Lead stability studies program including protocol and reports generation.
  • Author/review/approve technical documents such as method qualification/validation/transfer protocols and reports, and regulatory filing documents per project needs.
  • Initiate/Investigate deviations, Change control and CAPA.
  • Interpret analytical data to support a variety of initiatives and make recommendations for 
  • Maintain lab equipment as appropriate per procedures.
  • Contribute to investigation of issues and non-conformities to products and projects and perform troubleshoot of equipment and testing procedures to identify root causes of issues and participate in lab investigations.
  • Support multi-compendial harmonization (USP, EP, JP) for raw material, in-process, product release and stability testing.
  • Help in maintaining the QC lab in a clean, organized and compliance at all times.
  • Perform other QC tasks as required. 

Working Conditions:

  • This position is required to work in a lab setting.
  • Must be able to lift, push, and carry up to 25 lbs.

Qualifications:

Bachelor's Degree or above from an accredited institution in Chemistry, or Biology (or closely related degree).

  • Requires 8+ years of quality pharmaceutical, bio-pharmaceutical, or combi-medical device experience, and analytical testing experience on Biologics.
  • An energetic scientist and a creative thinker who can explore and identify better and more efficient methods to address issues and gaps.
  • Demonstrate ability to work independently and on cross-functional teams.
  • Strong attention to detail and following procedures and requirements.
  • Effective verbal and written communication skills.
  • Great interpersonal and teamwork skills.
  • At least 2 years of Technical Writing skills.

Compensation Range: The base compensation range for this role is between $90,000 and $100,000. However, the actual compensation may vary depending on your experience and qualifications.

Bionova offered Benefits and Program

Healthcare, Dental, and Vision insurance: Bionova offers health benefits at a subsidized rate.

Life Insurance and Disability Program: Life insurance is offered at 2x of annual base pay up to $750,000. Life insurance benefits start from the first day of employment. Disability programs are 100% covered by Bionova; a waiting period may apply as per company policy. 

Retirement Plan (401K) Up to 8% of Employer Match: 3% safe harbor contribution towards an employee's retirement plan and matches up to 5% dollar-for-dollar of an employee's base pay.

Paid time off: up to 120 hours (3 weeks) of PTO in a given full year.

Holiday: Ten (10) holidays each year.

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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Confirmed 12 hours ago. Posted 30+ days ago.

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