Upstream Manufacturing Lead

Asahi Kasei America Inc; Fremont (CA); On-site; Full time

Job summary

A leading company in biologics CDMO is seeking a Manufacturing Lead for their Cell Culture team in Fremont, California. The role involves overseeing complex GMP operations, mentoring staff, and ensuring compliance with industry standards. Ideal candidates will have a background in Engineering or Life Sciences, with significant experience in biopharma manufacturing and a commitment to quality and teamwork.

Benefits

Health benefits at a subsidized rate

Life Insurance and Disability Program 100% covered

Retirement Plan (401K) with up to 8% employer match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave

Qualifications

• 4+ years of relevant experience in biopharma manufacturing.
• Experience with bioreactor operations and mammalian cell culture.
• Working knowledge of cGMP compliance.

Responsibilities

• Leads GMP upstream operations including media prep and cell culture.
• Trains and mentors technical staff.
• Documents work according to cGMP and cGDP.

Skills

Analytical skills

Attention to detail

Effective communication

Creative thinking

Adaptability

Education

BS, MS in Engineering or Life Sciences

Tools

Process monitoring software

UNICORN

Wonderware

Job description

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 Manufacturing Lead, Cell Culture will actively contribute to the manufacturing projects at the Bionova Scientific West Warren site. As part of the Cell Culture / 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 position performs coordination and reporting of various project work according to Bionova Scientific guidelines and project management strategies. The role will provide hands-on execution of complex experiments in a team setting. The position will train, supervise, and mentor technical staff with opportunities for growth into management.

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.), Quality records management (Deviations, CAPA, Events and Change Control) equipment validation execution support and single-use assembly design.

Essential Duties and Responsibilities :

• Executes, leads and oversees complex GMP upstream operations including but not limited to media prep; cell culture thaw, expansion, and cell banking; operation of single-use bioreactors, process monitoring and harvest operations.
• Performs internal support activities such as maintenance of analytical 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 equipment troubleshooting, validation executions, pilot scale material generation, and non-GMP tox material generation.
• Be present at the shift transition with the outgoing shift lead and ensure shift transition / communication to the next incoming shift
• Provide strong people leadership with a focus on creating / maintaining a positive work environment through effective communication, performance management, accountability, etc.
• Author / review / approve technical documents such as tech transfer documents, production batch records, 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 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, events and change control.
• Collaborate with other departments for raw materials, utilities, testing requirements, documentation, validation, maintenance, and scheduling
• Present during inspections from regulatory agencies and client audits
• Other duties as assigned to ensure appropriate compounding practices

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.

Qualifications

• BS, MS in Engineering, Life Sciences, or related discipline with 4+ years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
• Must have bioreactor operations experience.
• In-depth understanding of mammalian cell culture performance is required.
• Hands-on experience in running, developing, and validating processes
• Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing
• Experience with process monitoring software and equipment software (UNICORN, Wonderware)
• 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.
• Effective verbal and written communication skills
• Flexible mindset for a dynamic environment.
• Ability to independently evaluate technical situations and propose potential solutions.
• Must be able to work independently as well as work with a diverse team.
• 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 $37 and $45 an hour. However, 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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Manufacturing Lead • Fremont, California, USA