Sr. Manager, QC Immunoassay

Senior Manager, Quality Control Immunoassay

Summary:

Vaxcyte is looking for an energetic and talented Sr. Manager, QC Immunoassay to join our Quality Control team. The position will be an integral part of the team responsible for method validation/transfer and cGMP-compliance in routine operations for immunoassays performed for all phases of clinical development for Vaxcyte’s PCV product. The primary responsibility will be the QC lead for method validation/transfer of immunoassays and include supporting of the quality control activities including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory operations. The ideal candidate will apply technical expertise, strong cGMP experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches. 

Essential Functions:

• Author/Review validation and transfer protocols, data and reports for immunoassay and bioanalytical assays. Collaborate with internal stakeholders to set appropriate validation/transfer acceptance criteria.
• Collaborate with and interface with key internal stake holders to understand immunoassay and bioanalytical methods being performed onsite and at CMOs.
• Apply technical and compliance expertise to the review of immunoassay and bioanalytical test methods and in-process/release protocols, data and CoAs from CMOs.
• Provide technical and compliance feedback to internal and external stakeholders who have developed the immunoassay and bioanalytical methods.
• Manage outsourced cGMP and characterization testing supporting lot release.
• Manage sample submission forms, shipping and sample handling activities required between the CMOs to support on time validation immunoassay and bioanalytical assays.
• Serves as the QC liaison for outsourced immunoassay development, technology transfer and data management in a CRO or CMO/CDMO environment.
• Accountable for execution of quality control testing and supportive processes including sample /inventory management, scheduling, documentation, compliance review, results reporting (CoA), and scientific interpretation of data / method performance to ensure high quality data and control of immunoassay and bioanalytical methods.
• Responsible for quality event management (deviations, investigations, change control) related to immunoassay and bioanalytical assays.
• Author SOPs, technical reports and multiple regulatory submission when needed, and address health authority questions during various clinical phase filings.
• Work with others to identify opportunities for continuous improvement and implement/maintain solutions.
• Provide strong teamwork in establishing a quality culture and shared accountability. 

Requirements: 

Ph.D. in Biochemistry or immunology with 4+ of industry experience; MS or BS with 8 + years of industry experience in Pharma / Biotech industry required. GMP experience is required. Other combinations of education and/or experience may be considered.

• A proven track record of solving complex immunoassay and bioanalytical problems.
• Thorough understanding and hands-on experience of the MSD platform and troubleshooting is required.
• Previous experience in validation and transfer of immunoassay and bioanalytical assay and method development experience is highly desired.
• Ability to integrate and interpret interdisciplinary project information, with at least a high-level understanding of the drug/vaccine development process.
• Ability to work globally with CMOs in different countries and continents.
• Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
• Fundamental understanding of statistics and data analysis software, proficient with analytical software such as Softmax Pro.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to immunoassay method qualification/validation for biologics and vaccines and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy.
• Experience in IND, NDA and BLA submission is preferred.
• Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.

Reports to: Senior Director, Analytical Science & Technology for Quality Control

Location: San Carlos, CA

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $161,000 – $188,000