Asahi Kasei
Bionova Lab Manager, Quality Control
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. The Lab Manager, Quality Control (QC) is responsible for HPLC and CE testing activities for biomolecules. 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 with a background in HPLC and CE testing under GMP conditions and operating Chromatography Data Systems, preferably Empower. The QC leader must also have demonstrated ability to develop and lead teams and influence across networks and with global organizations. Position Responsibilities: Being the lead subject matter expert for HPLC and CE testing Establish and operate an Empower based GMP compliant Chromatography Data System with the associated workflows Training, mentoring and leading a team of skilled analysts in their area of expertise 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. Reviewing and interpreting analytical data to identify trends, potential and initiate corrective actions. Leading investigations into any deviations or OOS, OOT, OOR and OOE, including root cause analysis and corrective actions. Authoring analytical procedures and their associated validation and qualification documents for new analytical testing methods or equipment or training and mentoring junior QC team members therein Authoring general lab procedures. Supporting other QC lab units by providing cross trained team members for urgent analytical activities. 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 Minimum of 5 years of experience in analytical or quality control environments. Minimum of 2 years of GMP Quality Control Laboratory experience including instrument qualification, microbiological testing, environmental monitoring, and method transfer 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, ICH, Eudralex etc.) Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events Strong technical writing skills and expertise with GMP software (e.g. LIMS, Empower, SoftmaxPro or equivalent systems) 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 $110,000 and $130,000. 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.
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. The Lab Manager, Quality Control (QC) is responsible for HPLC and CE testing activities for biomolecules. 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 with a background in HPLC and CE testing under GMP conditions and operating Chromatography Data Systems, preferably Empower. The QC leader must also have demonstrated ability to develop and lead teams and influence across networks and with global organizations. Position Responsibilities: Being the lead subject matter expert for HPLC and CE testing Establish and operate an Empower based GMP compliant Chromatography Data System with the associated workflows Training, mentoring and leading a team of skilled analysts in their area of expertise 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. Reviewing and interpreting analytical data to identify trends, potential and initiate corrective actions. Leading investigations into any deviations or OOS, OOT, OOR and OOE, including root cause analysis and corrective actions. Authoring analytical procedures and their associated validation and qualification documents for new analytical testing methods or equipment or training and mentoring junior QC team members therein Authoring general lab procedures. Supporting other QC lab units by providing cross trained team members for urgent analytical activities. 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 Minimum of 5 years of experience in analytical or quality control environments. Minimum of 2 years of GMP Quality Control Laboratory experience including instrument qualification, microbiological testing, environmental monitoring, and method transfer 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, ICH, Eudralex etc.) Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events Strong technical writing skills and expertise with GMP software (e.g. LIMS, Empower, SoftmaxPro or equivalent systems) 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 $110,000 and $130,000. 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.