Manager/Senior Manager, CMC Quality Control

3 weeks ago

Brisbane, United States The Steely Group Full time
Job DescriptionJob Description

 

This is a hybrid role requiring 2 days onsite in Brisbane, CA and 3 days remote work.

 

Our client is seeking a highly motivated and experienced professional as Manager/Senior Manager for our external stability programs in the CMC Quality Control department, West coast US, with the passion and creativity to support development of great medicines for rare and ultra-rare diseases.  The Manager/Senior Manager will be responsible for all aspects of the CMC QC program(s) support for commercial and clinical programs, including all modalities and all molecules.  The Manager/Senior Manager will provide support to internal QC representors who work with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality standards are met to support of the quality control activities as assigned. 

The successful candidate will have a good understanding of cGMPs, ICH stability, and regulatory drug requirements, be a self-starter with the ability to work under limited supervision and have the desire to be part of an innovative team. 

This is a unique opportunity to join a biotech company focused on developing life transforming therapeutics for patients with rare diseases.  This position will be instrumental in supporting the company’s therapeutic products from early-discovery development stage to commercial launch and be a critical part of innovation team for the development of the company’s next generation products.  The individual in this role is expected to carry out all quality control activities in a strict regulated environment (ICH/Compendial/FDA and EMA).

Responsibilities:

Main focus: The Manager/Senior Manager of CMC QC will work across all our clients products/programs as assigned (Clinical & Commercial products at West coast US) for quality control operational support

  • External Contract Organization management: Support the external contract organization activities to fulfill the GMP QC testing needs.
  • Quality Control Operational support: Provide internal support to QC operations to support the development, manufacture, and release of Biologics, small molecule, and oligonucleotide products.
  • Regulatory Compliance: Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies.
  • Method Development and Validation: Support the development and validation of analytical methods used for QC testing of small molecule and oligonucleotide products.
  • Quality Systems: Implement and maintain quality systems to ensure the integrity and reliability of QC data.
  • QC data review: Manage, review, and organize Release/stability data from active stability programs and generate interim stability trending assessments and reports
  • Stability Program management: Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines
  • Other responsibilities may include:
  • Work within QC and with QA and other departments to address review comments on QC/analytical documents
  • Manage/assist the document creations and reviews via Veeva Document System
  • Create and update batch analysis tables for stability data
  • Keep track of contract lab stability time point pulls for different programs
  • Create Excel/JMP tables and graphs for stability data trending
  • Initiate and manage change controls, deviations and CAPA in Veeva Document System
  • Assist in OOE/OOS/OOT investigations and deviations
  • Ensure compliance with current GMP’s in a manufacturing environment such that the products are assessed to agreed upon specifications in a timely manner in order to support release and stability testing

Requirements / Qualifications:

  • Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
  • Quality Manager: 3 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
  • Senior Quality Manager: 5 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
  • Working experience and knowledge in a wide variety of quality control stability methodologies is highly desirable
  • Experience in conducting stability studies per ICH Guidelines is highly desirable.
  • Good oral and written communication skills and a fast learner
  • Proficient in project and personnel management, excellent organizational skills and the ability to work on multiple projects with tight deadlines
  • Proficiency in MS Office, Word and Excel
  • Proficient in statistical analysis software desired (Excel/JMP)
Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.

  • Manager, Quality Assurance

    2 weeks ago

    Brisbane, California, United States Cutera Full time

    Job Description Position Summary: The individual is responsible for activities that lead to, and maintain compliance to/with Cutera’s Quality Management System and maintains regulatory approval to market devices. Additionally, the individual is responsible for the assessment of device changes for quality and regulatory implications and developing...

  • Clinical Trial Manager

    4 weeks ago

    Brisbane, United States Vera Therapeutics Full time

    **Title: Clinical Trial Manager** **Location**:Brisbane, CA** **About Us**: Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological...

  • General Manager

    3 days ago

    Brisbane, United States Transdev Full time

    Overview The General Manager will have overall responsibility for Transdev’s San Francisco paratransit operations location, including the call center, bus operations depot, and maintenance facility, along with oversight of 150 employees, most under a collective bargaining agreement (CBA) and the delivery of safe and reliable service, management of...

  • Senior Director, Clinical Pharmacology

    3 weeks ago

    Brisbane, United States Ultragenyx Pharmaceuticals Inc. Full time

    Position Summary: ultraimpact - Make a difference for those who need it most The Senior Director of Clinical Pharmacology will develop clinical pharmacology plans and deliver data packages to help advance the clinical development of a diverse pipeline of therapeutic modalities (e.g., small molecules, biologics, nucleic acid therapeutics, and gene...

  • Marketing Project Manager

    2 weeks ago

    Brisbane, United States The Judge Group Full time

    The Judge Group is an international leader in staffing & recruiting. With over 30 locations across the U.S., Canada & India, Judge is proud to partner with the best and brightest companies in business today. Our client is currently seeking a Marketing Procurement Project Manager This is a 9-month + contract opportunity with a hybrid work schedule with an...

  • Marketing Project Manager

    4 weeks ago

    Brisbane, United States The Judge Group Full time

    The Judge Group is an international leader in staffing & recruiting. With over 30 locations across the U.S., Canada & India, Judge is proud to partner with the best and brightest companies in business today.Our client is currently seeking a Marketing Procurement Project ManagerThis is a 9-month + contract opportunity with a hybrid work schedule with an...

  • General Manager Genesis

    2 days ago

    BRISBANE, United States Compass Group, PLC Full time

    This individual will be responsible for developing and executing strategy to meet operating and financial goals. They will lead the account by ensuring areas of responsibility meet objectives and client expectations, demonstrating a balance of culina General Manager, Manager, Restaurant, Retail

  • Food Safety

    3 days ago

    Brisbane, United States dnata Full time

    Overview: We recruit the best talent and invest in their ongoing development, through training and mentoring. We provide opportunities to work across our national network. dnata catering U.S. is looking for a **Food Safety & Quality Assurance **Coordinator **to join our **Brisbane, CA** team. Key Responsibilities: As a **Food Safety & Quality Assurance...

  • Senior Mine Engineer

    5 days ago

    Brisbane, United States Rock People Pty Ltd Full time

    Renewable Energy Storage Brisbane or Sunshine Coast Monday to Friday role Well into the design, planning and permitting phase this project is further enforcing Queensland commitment to a renewable energy and sustainable supply future. To further enhance the capability of their existing highly skilled technical team, they are now looking for a Senior...

  • Senior Director, Market Access

    4 weeks ago

    Brisbane, United States Vera Therapeutics Full time

    Job DescriptionJob DescriptionTitle: Senior Director, Market Access & ReimbursementLocation: Brisbane, California or RemoteAbout Us:Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic...

  • Senior Biomedical Engineer

    4 days ago

    Brisbane, United States Cutera Full time

    Job Description Position Summary: The individual is responsible for contributing to the development of new medical applications and product concepts through modeling, benchtop biomedical experiments, and clinical studies. Programs involve a broad range of technologies including complex laser and optical delivery systems, radiofrequency, and ultrasound...

  • Engineering/Maintenance - HVAC Engineer

    4 weeks ago

    Brisbane, United States C&L Group Full time

    HVAC Engineer Pay Rate: $41.00 Per Hour Duration: 6 Month Contract to Hire Location: 1600 Sierra Point Parkway Brisbane, CA 94005 Shift Times: Day shift-Monday-Friday: 9-5:30pm Job Specific Responsibilities: Building management CMMS-Ticket system for work orders, look at system and navigate for repairs/problem solve Ability to be medically cleared...

  • Operations Safety Supervisor

    6 days ago

    Brisbane, United States Transdev Inc. Full time

    AboutTransdev:  Based near Chicago, Transdev is North America'slargest private-sector operator of multiple transit modes,including bus, rail, streetcar, paratransit, and shuttle services.Transdev is committed to being the trusted partner of cities andtransit authorities through quality execution and innovations inmobility. Its parent company, Transdev...

  • Operations Safety Supervisor

    2 days ago

    Brisbane, United States Transdevna Full time

    About Transdev: Based near Chicago, Transdev is North America's largest private-sector operator of multiple transit modes, including bus, rail, streetcar, paratransit, and shuttle services. Transdev is committed to being the trusted partner of cities and transit authorities through quality execution and innovations in mobility. Its parent company, Transdev...

  • Operations Safety Supervisor

    1 week ago

    Brisbane, United States Transdev Inc. Full time

    About Transdev:  Based near Chicago, Transdev is North America's largest private-sector operator of multiple transit modes, including bus, rail, streetcar, paratransit, and shuttle services. Transdev is committed to being the trusted partner of cities and transit authorities through quality execution and innovations in mobility. Its parent company,...

  • Operations Safety Supervisor

    3 days ago

    Brisbane, United States Transdev Inc. Full time

    About Transdev:  Based near Chicago, Transdev is North America's largest private-sector operator of multiple transit modes, including bus, rail, streetcar, paratransit, and shuttle services. Transdev is committed to being the trusted partner of cities and transit authorities through quality execution and innovations in mobility. Its parent company,...

  • Operations Safety Supervisor

    3 days ago

    Brisbane, California, United States Transdev Inc. Full time

    About Transdev: Based near Chicago, Transdev is North America's largest private-sector operator of multiple transit modes, including bus, rail, streetcar, paratransit, and shuttle services. Transdev is committed to being the trusted partner of cities and transit authorities through quality execution and innovations in mobility. Its parent company, Transdev...

  • Corporate Counsel

    1 month ago

    Brisbane, United States Tempest Therapeutics Full time

    Summary and Scope: We are seeking a highly motivated and experienced Corporate Counsel to join our dynamic team at Tempest Therapeutics. This job will play an important role in providing a wide range of legal services, including negotiating and executing agreements, contracts, licenses, and transactional documents, ensuring compliance with all applicable...

  • Corporate Counsel

    4 weeks ago

    Brisbane, United States Tempest Therapeutics Full time

    Summary and Scope: We are seeking a highly motivated and experienced Corporate Counsel to join our dynamic team at Tempest Therapeutics. This job will play an important role in providing a wide range of legal services, including negotiating and executing agreements, contracts, licenses, and transactional documents, ensuring compliance with all applicable...

  • Customer Service Representative

    1 day ago

    Brisbane, United States BiRite Foodservice Distributors Full time

    **CUSTOMER SERVICE REPRESENTATIVE** BiRite Foodservice Distributors is a third generation, family-owned company that offers you a Complete Foodservice Solution. We offer unsurpassed service to all areas of foodservice throughout the greater Bay Area and Sacramento. Since 1966 we have focused on being the best foodservice partner in the Bay Area. We remain...