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QC Manager/Senior Manager

Fremont, CA ยท Full time


Job Description

Bionova is seeking a motivated and innovative QC manager looking to serve as a leader in the Quality Control group. As part of the QC leadership group, you will have opportunities to work on and take ownership of a wide-ranging set of projects from system and workflow implementation, to facility and lab buildout and troubleshooting and investigations. Bionova is currently in the process of expanding its capabilities from a CDO to a CDMO through construction of a state-of-the-art GMP manufacturing facility and QC testing laboratory. As part of the rapidly growing QC team, you will be able to make decisions and influence changes from the ground floor as we grow the organization and expand capabilities to meet project goals that ultimately will improve patient outcomes.

Duties & Responsibilities (including some or all of the following):

Lead establishment of QC function through implementation of GMP procedures, processes, and systems

Manage a team of QC analysts or mentor and train junior staff members based upon prior experience level

Oversee day-to-day operations of the department and direct reports

Project management and coordination of various high impact internal and external projects where analytical input is valued

Oversee method transfer and validation of analytical test methods (HPLC/UPLC, CE, ELISA, binding affinity, mass spectrometry and others)

Author/review/approve technical documents such as method validation and qualification protocols/reports, and regulatory filing documents per project needs

Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones

Lead meetings with clients to move projects forward and/or triage issues

Evaluate new technologies and innovations to improve operational efficiency or expand QC capabilities

Manage QC testing to support GMP production, raw material testing, facility controls (environmental monitoring), stability studies, and standalone QC testing projects

Interpret analytical data to support a variety of initiatives and make recommendations for best courses of action as they pertain to manufacturing

Troubleshoot equipment and testing to identify root causes of issues

Ensure equipment is maintained as appropriate per procedures

Ensure staff training is kept up to date per role and function

Represent the QC function during inspections from regulatory agencies and client audits

Represent the QC function during inspections from regulatory agencies and client audits

Requirements

BS, MS, or PhD in Biological Sciences or related disciplines with 8-10+ years of relevant industry experience in a regulated cGMP environment.

In-depth understanding of protein chemistry and industry-standard analytical tools (CE, HPLC/UPLC, Mass Spec, ELISA, microbiological assays, compendial assays, etc)

Experience in being, or desire to be, a leading figure

Hands-on experience in running and validating analytical methods

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

Strong attention to detail

Effective verbal and written communication skills

Eligibility Requirements

Must be legally authorized to work in the United States without restriction.

Must be willing to take a drug test and post-offer physical (if required).

Must be 18 years of age or older.

Ready to Apply?

Send your cover letter and resume to the email address below.

Email us

careers@bionovascientific.com

Bionova Scientific is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.