QUALITY CONTROL MANAGER

Apply for this Position

Application Form     (* indicates required field)

Please attach the following files

Please upload either a word or PDF version of your cover letter for this position.
Please upload either a word or PDF version of your current resume.
Such as letters of recommendation, work examples, etc.

I certify that the answers given herein are true and complete to the best of my knowledge. I understand that any misrepresentations, omissions of facts or incomplete answers in any application document may disqualify me from further consideration for employment. I further understand that, if employed, any misrepresentations or omissions of facts in any application document may be cause for my dismissal at any time without prior notice. I consent to and authorize Vir Biotechnology to contact my former employers, references, and any other persons and organizations for information bearing upon my qualifications for employment. I further authorize the listed employers, schools and personal references to give Vir Biotechnology (without further notice to me) any and all information about my previous employment and education, along with any other pertinent information they may have and hereby waive any actions which I may have against either party(ies) for providing a good faith reference.

I expressly agree and understand that, if employed, my employment is not for a specific term, is based on mutual consent and may be terminated by me or my employer with or without notice or cause at any time. I further understand that no oral promise, employer policy, custom, business practice or other procedure (including the basic employment policies, personnel handbook or any personal manuals) constitute an employment contract or modification of the at-will employment relationship between me and the employer(s). I also understand that this aspect of my employment may not change absent an individual written agreement signed by both me and the president of the company.

I understand that applicants for certain positions may be required to qualify for employment based on additional employment criteria. For example, I may be required to take job-related tests/assessments; submit to a background investigation; and/or take a pre-employment drug screen. If I am offered employment or start work before any required test is completed, my employment is contingent on a satisfactory result on all required tests. I further authorize the release of any background check results or any drug/alcohol test to any state or federal authority requesting such information and in response to a valid subpoena or other legal document.

You must agree to the disclosure statement provided in order for us to accept your application.

To finalize your application, please confirm you are not a bot

You will receive confirmation after we have received your application.

Vir integrates diverse innovations in science, technology, and medicine to transform the care of people with serious infectious diseases.  Vir is taking a multi-program, multi-platform approach to applying these breakthroughs, including the development of treatments that induce protective and therapeutic immune responses.  Vir’s scale and scope together with leading scientific and management expertise, allow it to perform significant internal R&D, in license or acquire innovative technology platforms and assets, and fund targeted academic research.

 

JOB SUMMARY:

Vir Bio is seeking an experienced analytical/QC scientist to oversee and coordinate work performed internally and at contract testing organizations. The QC Manager will coordinate outsourced laboratory activities and integrate with internal functions of Vir and its partners. He or she will represent the CMC Analytical department on project teams and coordinate team objectives with the rest of the organization. This position will also support method lifecycle management, including internal and external assay tech transfer, assay qualification and validation, and selection/evaluation of instrumentation and critical reagents; it requires working closely with Analytical Development to ensure methods are GMP-ready, designing and leading method lifecycle programs, and authoring reports and applicable CMC sections of regulatory submissions.

RESPONSIBILITIES:

  • Manage lot release testing, stability, and validation studies performed at external vendors and coordinate with internal groups at Vir and its partners.
  • Manage resolution of contract lab deviations, OOS and lab investigations, and change control in accordance with Vir internal policies.
  • Perform QC data review and CoA generation to support lot disposition.
  • Manage assay transfer, implementation, optimization, and validation of analytical test methods, both in house and at contract labs.
  • Design and oversee execution of in-use studies to support clinical product handling procedures.
  • Work cross-functionally with the Analytical Development and Process Analytics groups to create assay trending programs, define assay system suitability criteria, and create and refine drug product specifications.
  • Author QC SOPs, analytical test methods, protocols and reports, and applicable sections of regulatory filings.
  • Provide scientific evaluation of contract laboratory test methods, study protocols, and data
  • Represent QC on project teams and in other cross-functional forums.

QUALIFICATIONS AND EXPERIENCE:

  • Strong scientific background in analytical methods in a Quality Control and/or assay development setting.
  • Industry experience with analytical test method optimization, validation, and transfer as well as working with contract organizations.
  • Strong technical knowledge and hands-on experience in one or more of the following areas: potency assays, protein analytical chemistry methods, virology assays, PCR, sequencing, flow cytometry.
  • Strong knowledge of cGMP/ICH/FDA/EMA regulations.
  • Demonstrated ability to work in a productive and collaborative cross-functional manner.
  • Highly collaborative team player who fosters open communication and ensures involvement of key stakeholders in decision-making.
  • Prior industry experience in biologics such as antibodies, viral vaccines, or cell therapies.
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Strong written and verbal communication skills, and experience with representation/leadership on inter-disciplinary and cross-functional teams.

EDUCATION:

BS/MS in relevant scientific discipline and 10+ years’ experience in analytical methods, contract manufacturing and testing, QC, or equivalent combination of education and experience.

Location: QA/QC in San Francisco, CA
Apply for this Position
Apply at: https://vircareers.zhire-zuman.com/job/59218/quality-control-manager