Bionova Scientific Inc
Sr. QC Director
Bionova Scientific Inc, Fremont, California, us, 94537
Company Summary:
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business supports biopharma drug development for both Clinical and Commercial capabilities. Bionova will be expanding over the next two years into Plasmid DNA and Viral Vector process development & manufacturing
Position Summary:
The Senior QC Director role is part of our Quality and Compliance organization responsible to lead Bionova Scientific's analytical laboratories across the entire CDMO organization. They are directly accountable for leading all analytical development, process development analytical support, and QC testing. These activities include raw material testing, in-process monitoring, facility monitoring, product release, method development, method transfer, method qualification, and method validation.
Primary Responsibilities:Ensure the success of the of Bionova Scientific's analytical laboratories through strategic and tactical leadership.Demonstrate a comprehensive understanding of analytical test methods used in development and commercial product testing to enable prompt and effective transfers and troubleshooting of methods and investigations.Demonstrate a deep understanding of the phase appropriate global cGMP regulations and expectations surrounding release and stability testing.Work closely with internal teams and clients to assess program risks and develop analytical strategies.Support development of new and existing methods for development and commercial programs and transfer of methods from/to partners to ensure that the phase appropriate testing expectations are met.Work closely with Quality Assurance colleagues in establishing appropriate Quality Systems for in-house QC labs.Work closely with process Development colleagues in establishing appropriate analytical support for dynamic, accelerated process decisions.Define and execute on continuous improvement opportunities for QC laboratory to drive efficiencies in operations.Establish clear expectations, metrics and KPIs, to monitor business process performance and stability.Provide leadership, coaching and guidance to the team.Be an effective communicator of ideas, project goals and results to team members across the development and commercial organization.Required Skills:
Advanced degree in Pharmaceutics, Biochemistry, Physical Chemistry, Organic Chemistry, Biochemical Engineering, or related experience.10+ years of experience leading and managing large teams in a AS/QC environment is requiredExperience with direct interaction with global regulatory agencies is requiredExperience with analytical method validation and optimization for drug substance/drug product release and stability testing is requiredExperience with applying the principles and techniques of analytical chemistry is requiredExtensive experience and knowledge of GMPs is required
Company Summary:
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business supports biopharma drug development for both Clinical and Commercial capabilities. Bionova will be expanding over the next two years into Plasmid DNA and Viral Vector process development & manufacturing
Bionova offered Benefits and Program
Full time employees will also be eligible to participate in certain employee benefit programs and policies that the Company have in effect generally for similarly situated employees at your level. Employee benefits are subject to the terms and eligibility requirements, which may be amended as per company policy.
Healthcare, Dental, and Vision insurance:
Bionova offers health benefits at a subsidized rate (90% coverage for employees and 80% coverage for eligible dependents). Full-time employees can enroll as soon as the first day of employment; however, the health plans take effect from the 1st of the month following the hire date. A benefit guide will be available on the first day of employment.
Life Insurance and Disability Program:
Life insurance is offered at 2x of annual base pay up to $750,000. Life insurance benefits start from the first day of employment.
Disability programs are 100% covered by Bionova; a waiting period may apply as per company policy.
Retirement Plan (401K):
Full-time employees are eligible to participate in the 401K plan from the first payroll following 30 days of employment. Bionova offers a 3% safe harbor contribution towards an employee's retirement plan and matches up to 5% dollar-for-dollar of an employee's base pay.
Paid time off:
Full-time employees may receive paid time off up to 3 weeks of PTO in a given full year.
Holiday:
Bionova Observe Ten (10) holidays each year.
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business supports biopharma drug development for both Clinical and Commercial capabilities. Bionova will be expanding over the next two years into Plasmid DNA and Viral Vector process development & manufacturing
Position Summary:
The Senior QC Director role is part of our Quality and Compliance organization responsible to lead Bionova Scientific's analytical laboratories across the entire CDMO organization. They are directly accountable for leading all analytical development, process development analytical support, and QC testing. These activities include raw material testing, in-process monitoring, facility monitoring, product release, method development, method transfer, method qualification, and method validation.
Primary Responsibilities:Ensure the success of the of Bionova Scientific's analytical laboratories through strategic and tactical leadership.Demonstrate a comprehensive understanding of analytical test methods used in development and commercial product testing to enable prompt and effective transfers and troubleshooting of methods and investigations.Demonstrate a deep understanding of the phase appropriate global cGMP regulations and expectations surrounding release and stability testing.Work closely with internal teams and clients to assess program risks and develop analytical strategies.Support development of new and existing methods for development and commercial programs and transfer of methods from/to partners to ensure that the phase appropriate testing expectations are met.Work closely with Quality Assurance colleagues in establishing appropriate Quality Systems for in-house QC labs.Work closely with process Development colleagues in establishing appropriate analytical support for dynamic, accelerated process decisions.Define and execute on continuous improvement opportunities for QC laboratory to drive efficiencies in operations.Establish clear expectations, metrics and KPIs, to monitor business process performance and stability.Provide leadership, coaching and guidance to the team.Be an effective communicator of ideas, project goals and results to team members across the development and commercial organization.Required Skills:
Advanced degree in Pharmaceutics, Biochemistry, Physical Chemistry, Organic Chemistry, Biochemical Engineering, or related experience.10+ years of experience leading and managing large teams in a AS/QC environment is requiredExperience with direct interaction with global regulatory agencies is requiredExperience with analytical method validation and optimization for drug substance/drug product release and stability testing is requiredExperience with applying the principles and techniques of analytical chemistry is requiredExtensive experience and knowledge of GMPs is required
Company Summary:
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business supports biopharma drug development for both Clinical and Commercial capabilities. Bionova will be expanding over the next two years into Plasmid DNA and Viral Vector process development & manufacturing
Bionova offered Benefits and Program
Full time employees will also be eligible to participate in certain employee benefit programs and policies that the Company have in effect generally for similarly situated employees at your level. Employee benefits are subject to the terms and eligibility requirements, which may be amended as per company policy.
Healthcare, Dental, and Vision insurance:
Bionova offers health benefits at a subsidized rate (90% coverage for employees and 80% coverage for eligible dependents). Full-time employees can enroll as soon as the first day of employment; however, the health plans take effect from the 1st of the month following the hire date. A benefit guide will be available on the first day of employment.
Life Insurance and Disability Program:
Life insurance is offered at 2x of annual base pay up to $750,000. Life insurance benefits start from the first day of employment.
Disability programs are 100% covered by Bionova; a waiting period may apply as per company policy.
Retirement Plan (401K):
Full-time employees are eligible to participate in the 401K plan from the first payroll following 30 days of employment. Bionova offers a 3% safe harbor contribution towards an employee's retirement plan and matches up to 5% dollar-for-dollar of an employee's base pay.
Paid time off:
Full-time employees may receive paid time off up to 3 weeks of PTO in a given full year.
Holiday:
Bionova Observe Ten (10) holidays each year.