Sr. QC Director
3 days ago
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.
- 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 required
- Experience with direct interaction with global regulatory agencies is required
- Experience with analytical method validation and optimization for drug substance/drug product release and stability testing is required
- Experience with applying the principles and techniques of analytical chemistry is required
- Extensive 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.
-
Sr. Director Project Management
1 month ago
Fremont, United States Vital Chemicals USA LLC Full timeJob DescriptionJob DescriptionSalary: Sr. Director Project Management –Required to speak MandarinWe are looking for an experienced Sr. Director of Project Management to plan, budget, oversee, and document key projects and manage a team of experienced Sr. Project Management professionals. The right candidate will have experience managing project teams...
-
Senior Quality Control Director
3 days ago
Fremont, California, United States Bionova Scientific Inc Full timeJob Title: Senior Quality Control DirectorBionova Scientific Inc is seeking a highly experienced Senior Quality Control Director to lead our analytical laboratories across the entire CDMO organization.Job Summary:The Senior Quality Control Director will be responsible for ensuring the success of Bionova Scientific's analytical laboratories through strategic...
-
Director of Quality Operations
1 week ago
Fremont, California, United States Scribe Therapeutics Full timeJob Title: Director/Sr. Director, Quality OperationsScribe Therapeutics is a molecular engineering company focused on creating innovative in vivo therapies that address the root causes of diseases. Our team of experts, including CRISPR inventors and leading molecular engineers, is dedicated to developing custom engineered enzymes and delivery modalities as...
-
Senior Sales Director – Data Center
2 months ago
Fremont, United States Delta Electronics Americas Full timeDelta, founded in 1971, is a global leader in switching power supplies and thermal management products with a thriving portfolio of smart energy-saving systems and solutions in the fields of industrial automation, building automation, telecom power, data center infrastructure, EV charging, renewable energy, energy storage and display, to nurture the...
-
Senior Sales Director – Data Center
3 months ago
Fremont, United States Delta Electronics Americas Full timeDelta, founded in 1971, is a global leader in switching power supplies and thermal management products with a thriving portfolio of smart energy-saving systems and solutions in the fields of industrial automation, building automation, telecom power, data center infrastructure, EV charging, renewable energy, energy storage and display, to nurture the...
-
Sr Clinical Laboratory Scientist
2 months ago
Fremont, United States Kaiser Permanente Full timeDescription: Under the general direction of the Laboratory Director, or their designee, performs pre-analytical, analytical and post-analytical procedures and analyses to provide data for health maintenance, diagnoses, treatment and monitoring of medical conditions. Enhances quality of patient care and service through interdepartmental cooperation and...
-
Sr. General Ledger Accountant
3 months ago
Fremont, United States Enovix Full timeAbout the job Enovix (Nasdaq: ENVX) is an advanced silicon battery company based in Fremont, Calif. Enovix is on a mission to power the technologies of the future. Everything from IoT, mobile and computing devices, to the vehicle you drive, needs a better battery. Our disruptive architecture enables a battery with high energy density and capacity without...
-
Fremont, United States Eurofins Full timeJob Description The position’s primary responsibilities will be to lead the North America Products business development team. The leader in this role will be responsible for daily management, defining and implementing the commercial strategy for NA direct sales and working closely with European and APAC business leaders. This role will be responsible...
