Downstream Manufacturing Lead

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 Downstream Manufacturing Lead will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific Fremont location. As part of the Purification/Manufacturing group, you will have opportunities to work on a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into the GMP 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:

• Leads and oversees complex unit operations including but not limited to chromatography, TFF, depth filtration and virus filtration, buffer preparation in GMP manufacturing suites.

• Ensure manufacturing goals and project deadlines are met by the commitment date while maintaining compliance with the current manufacturing practices (cGMP).

• Maintains own training within compliance on protein purification in GMP environment upon completion of trainer qualification and ensure appropriate training is completed for all employees on the shift.

• 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.

• Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP downstream manufacturing activities.

• Author/review/approve technical documents such as tech transfer protocols and reports, 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 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 purification capabilities

• Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.

• 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 in Life Sciences, or related discipline with 4+ years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.

• In-depth knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing

• In-depth understanding of industry-standard purification processes (affinity, IEX, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables)

• Hands-on experience in running, developing, and validating processes.

• Experience with process monitoring software and equipment software (UNICORN, Pi Historian)

• 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 prioritize assignments and to manage multiple projects simultaneously.

Compensation Range: The base compensation range for this role is between $43-47 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.