Sr. Manager QC - EM and Microbial Testing at Bionova Scientific LLC in Fremont, California

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, agility and an interest in transformative action are also common attributes among our team.



Position Summary:



The Sr. Manager/Associate Director, Quality Control (QC) - Environmental Monitoring and Microbial Testing, is responsible for operations relating to Microbiological Testing and Environmental Monitoring. This role will partner with the Senior Director, Quality Control, to lead the overall quality control department with a focus on developing robust laboratory operations with a strong quality and safety culture. This leader will implement the Bionova Quality Management System in the laboratory and ensure that appropriate capabilities and business processes are developed and sustained. The leader will also partner with engineering to deliver a state-of-the-art laboratory utilizing the latest in automation to further the analytical capabilities of the organization. This position involves working cross functionally within the site and with Bionova clients. This includes assurance that laboratory results are timely, reliable, and in accordance with regulatory requirements.


The individual in this role must have expertise in Quality Control operations, specifically microbiological and environmental monitoring test methods, and quality systems. The QC leader must also have demonstrated ability to develop and lead teams and influence across networks and with global organizations.



Position Responsibilities:

• Supervising a team of microbiologists and Environmental Monitoring personnel responsible for collecting, analyzing, and interpreting environmental and microbiological samples.


• Establish a laboratory operation compliant with Bionova's quality standards and regulatory requirements through development of effective processes and through maintenance and monitoring of laboratory key performance indicators.


• Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation.


• Designing and maintaining comprehensive environmental monitoring plans, including sampling sites, frequencies, and testing methods, aligned with regulatory requirements.


• Reviewing and interpreting microbial data to identify trends, potential contamination issues, and initiate corrective actions.


• Owns the Bionova contamination control strategy and works cross-functionally with Manufacturing, QA, Validation and Engineering to ensure implementation and effectiveness of the contamination control strategy.


• Leading investigations into any deviations from established microbial limits, including root cause analysis and corrective actions.


• Participating in validation and qualification activities for new microbial testing methods or equipment.


• Participate in client audits, as well as Health Authority inspections as SME and/or audit/inspection execution roles.

Working Conditions:



This position requires 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 15 pounds independently.



Qualifications:

• Bachelor of Science degree or equivalent in a scientific field (preferably microbiology)


• Minimum of 5 years' GMP Quality Control Laboratory experience including instrument qualification, microbiological testing, environmental monitoring, and method transfer


• Minimum of 5 years' leadership experience (ideally in Quality Control). Extensive experience in pharmaceutical or biotechnology industry microbiology, with a strong focus on environmental monitoring.


• Expertise in data analysis, trend analysis, and statistical methods.


• Excellent written and verbal communication skills to effectively document findings and present technical information


• Working knowledge of GMP regulations and guidance (21 CFR, ANNEX 1, ICH, etc.)


• Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events


• Strong technical writing skills and expertise with EM software (e.g. LIMS, NovaEM, etc.)


• Effective interpersonal and communication skills. Communication at all management levels and all staff is required

Compensation Range: The base compensation range for this role is between $120,000 and $160,000. 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. Apply Now