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.
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.
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.