Quality Control Specialist, Plasmid DNA,
Bionova Scientific LLC

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. As part of our business expansion plan, we are building a state-of-the-art facility that specializes in the development and manufacturing of Plasmid DNA. This facility will be equipped with cutting-edge technology and staffed by a team of highly skilled professionals who are dedicated to advancing the field of Plasmid DNA process development and manufacturing. 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 challenges.

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:

• Support establishment of Plasmid DNA QC laboratories, including selecting equipment, setting up layouts and workflows, and ensuring alignment with industry standards and safety protocols.
• Assist in implementing GMP procedures, processes, and systems within the Quality Control (QC) team.
• Provide training to QC personnel on instrumentation, techniques, and analytical chemistry methods as needed.
• Participate/lead in the development, transfer, and validation of instrument and analytical test methods across various platforms including analytical test methods HPLC/UPLC, CE-SDS, SDS-PAGE, PCR, ELISA, Sequencing, wet chemistry and others as required.
• Support/lead stability studies program by generating protocols and reports and other tasks as required.
• Contribute/ author technical documents such as method qualification/validation/transfer protocols and reports, and regulatory filing documents as required by project specifications.
• Lead or oversee method transfer and qualification of analytical test methods (HPLC/UPLC, CE-SDS, SDS-PAGE, PCR, ELISA, Sequencing and others) as required.
• Lead/coordinate/support of internal and external projects related to analytical/Micro/EM.
• Support/evaluate new technologies and innovations to improve operational efficiency or expand QC capabilities.
• Participate/support internal and external audits.
• Initiate and investigate deviations, implement Change Control procedures, and manage CAPA activities.
• Revise/initiate general QC Standard Operating Procedures (SOPs), test methods, and test method forms as required.
• Conduct analytical testing for method qualification/validation/transfer, raw materials, in-process stages, lot release, and stability samples
• Analyze and interpret analytical data to support various initiatives, making recommendations for process improvements.
• Maintain laboratory equipment according to established procedures.
• Assist in investigating issues and non-conformities related to products and projects, including troubleshooting equipment and testing procedures to identify root causes of issues and participate in laboratory investigations.
• Support multi-compendial harmonization efforts (USP, EP, JP) for raw material, in-process, product release, and stability testing.
• Contribute to maintaining the QC lab in a clean, organized, and compliant manner at all times.
• Perform any other QC-related tasks as required.
• Interpret/review analytical data to support a variety of initiatives and make recommendations for best courses of action as they pertain to manufacturing.

Working Conditions:

• This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
• Initially, remote working conditions transitioning to long term permanent, onsite position; occasional travel.

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.
• In-depth understanding of analytical and microbial test methods and industry-standard analytical tools (HPLC/UPLC, sequencing, PCR, ELISA, microbiological assays, compendial assays, etc.).
• Experience with new laboratory start-up and equipment commissioning.
• Hands-on experience in running, qualifying, and validating analytical methods.
• Creative thinker that can identify and efficiently improve methods to address issues and gaps.
• Demonstrate ability to work independently and on cross-functional teams.
• Proven client interactions and project management experience desired.
• Strong attention to detail.
• Effective verbal and written communication skills.

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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