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Senior Quality Engineer

Location: San Diego, CA, United States
Job # 11056631
Date Posted: 06-14-2018
Senior Quality Engineer
San Diego, CA 92121
6 Month Contract (Strong Potential to Convert or Extend)
Pay: Depends on Experience
Start Date: ASAP
Client Overview
Our client is a clinical late-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. We have the highest-quality protein production and bioanalytic technology platform approach that allows us to create biosimilars in a highly efficient manner from concept to commercialization.

Job Description
We are looking for a Senior Quality Engineer to work as an individual contributor on the engineering side. In this role, you will be responsible for execution of tasks supporting the product testing and stability programs, primarily data review of data generated by contract testing labs. The testing programs include Release and In-Process Testing and the Stability Program for multiple drug products, drug substances, intermediates, cell banks, and reference standards; recombinant biologic and vaccine products at clinic stage. This position supports all aspects of the testing program including management and oversight of contract test labs, review and approval of all contract test lab data packages, Certificate of Analysis (CoA) generation and approval, management and oversight of laboratory investigations stemming from contract test labs, review and approval of method validation protocols and reports, review and approval of test methods implemented at contract test labs, review of method transfer reports, and management of the stability software system. You will support the Product/Batch Disposition group within Quality Assurance department to ensure timely and compliant review of data packages and CoA issuance. You will also serve as a liaison to the Quality Systems group to ensure change controls, investigations, corrective actions, and complaints stemming from or relating to the testing program are tracked to conclusion.

  • Support of Contract Testing Labs:
    • Review method validation protocols and reports.
    • Review and Approve test methods, method transfer protocols and reports.
    • Support laboratory investigations notified by contract test lab and coordination for investigations that escalate to full scale manufacturing investigations involving the product quality and quality systems team members.
    • Support compliance group with development of metrics and data inputs for metrics related to contract testing labs and testing/stability programs.
    • Support compliance group with preparation for testing lab routine qualification audits, where applicable.
  • Execute Data Package Review and Certificate of Analysis Generation
    • Review of of data packages from contract test labs for release, in-process, and stability testing of drug products, drug substances, intermediates, cell banks, and reference standards.
    • Data entry oversight into iStability LIMS for stability programs.
    • Issuance of Certificate of Analysis for products.
    • Provide assurance of data integrity during data review.
  • Support of Product Stability Programs:
    • Protocol review and approval; Report review and approval. In some cases may author protocols and reports to be reviewed and approved by another member of the quality group.
    • Oversight of sample shipping between manufacturer, the stability chamber contract site, and contract testing labs.
    • Data entry into iStability LIMS, Oversight of the iStability LIMS System.
    • Ensuring the receipt of test reports from each stability time point.
    • Trending of stability studies and trending report issuance.
    • Preparing tables for reports/ submissions; responsible for delivering the stability section for regulatory submissions.
    • Manage product expiry and retest based on up-to-date stability.
  • Support review and approve change controls for product specifications/test methods.
  • Adherence to internal quality system procedures related to testing and stability programs.
  • Review and Approve Reference Standard Qualification Protocols and Reports, issue Reference Std. CoAs.
  • Review and Approve Cell Bank Testing Qualification Protocols and Reports, issue Cell Bank CoAs.
  • Support product quality, product development, analytical, and manufacturing functions to determine appropriate testing and sampling plans for release, in-process, stability, reference standard qualification, cell bank qualification, and analytical similarity studies.
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; and participating in professional associations/groups/memberships.
  • Makes recommendations to improve processes and procedures on an ongoing basis (continuous improvement); executes or drives changes as required.
  • Proactively takes initiative to identify, research and solve complex technical problems and issues; communicates status in a timely manner.
  • Remains current on global regulations, industry trends, current practices, new developments, and applicable laws regarding quality assurance.
  • Knowledge of all relevant FDA/ICH/EMA guidance and directive documents.
  • Bachelor's degree in life sciences/physical sciences or other relevant biologic discipline required; Master's degree helpful.
  • 3+ years of relevant, progressive and broad-based biopharmaceutical experience required.
  • 3+ years of experience in a publicly-traded and/or highly-regulated drug/pharma development organization required.
  • Significant experience and understanding of CGMP, GLP, and ICH regulations required.
  • Analyzes reports, metrics and results as required; provides SME and strategic guidance based on findings.
  • Appreciates and respects the necessity for confidentiality.
  • Demonstrated ability to build relationships and work collaboratively with a variety of individuals within the department, company and external vendors alike.
  • Demonstrated ability to lead, manage and motivate others to support objectives and mission and to achieve goals set out (even if not direct reports).
  • Demonstrated ability to work in fast-paced, team-oriented and self-directed environment.
  • Demonstrated strategic planning with proven ability to communicate a vision and drive results.
  • Demonstrated, proven and effective project- and time-management abilities and follow-through skills.
  • Detail oriented and highly organized with a strong business/technical acumen.
  • Excellent verbal and written communication skills, an innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic.
  • Possesses and demonstrates exceptional research and resource utilization skills as well as practical problem solving capabilities.
  • Proven ability to work in a lean organization and creatively tackle problems using colleague networks and publicly available solutions; work independently and successfully in a matrix environment; and prioritize and manage multiple tasks simultaneously.
  • Significant experience using computers and software programs required (e.g., LIMS, MS Office Suite; EDMS software)
  • Other skills and abilities as required
Supplemental Experience as a Strong Plus
  • Experience working in a biosimilars drug-development organization highly preferred.
  • Experience with the full product lifecycle of a biopharmaceutical product (i.e. Phases 1 4) highly preferred.
Please submit your resume in PDF or Word format to be in consideration. #DI
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