A robust analytical testing network is essential to enable our company’s strategic priorities to deliver life-changing products through pipeline acceleration and uninterrupted supply of commercial product. The Director, Antisera Programs is accountable for the uninterrupted supply of well-performing, qualified antisera reagents to support analytical testing of our Company’s inline and newly launching products. The Director will provide oversight of external antisera production partners and, as the owner of the operational and technical strategy to secure reliable antisera supply, recommend prioritized actions to optimize the entire antisera process from sourcing through qualification and demonstrated performance during use. This role will also coordinate and control prioritization of internal company activities to facilitate antisera reagent characterization, reagent batch screening, qualification testing, and associated quality documentation across the critical reagent team and supporting functions.
The Director will use experience in immunology and antisera production/characterization to identify enhancements to the reagent characterization process and supply processes, including active participation in assay procedure life cycle assessments and resolution of antisera performance challenges during development and routine testing.
The ideal candidate for this position will have deep technical knowledge of immunology and antisera production processes as well as the ability to effectively organize, prioritize, and communicate the execution of complex workstreams across multiple functions. This role requires equal balance of operational and strategic elements to provide comprehensive management of qualified antisera reagents.
The Director is accountable to create and maintain characterization, qualification, and supply strategies for animal-derived reagents at the enterprise, product, test, and reagent level. This role will partner with external vendors/Contract Research Organizations, testing laboratories (internal, contract, and government), and scientific and business functions in manufacturing and research to ensure work is accurately forecasted, resourced, and executed to plan to ensure consistent high reagent quality and uninterrupted reagent supply. The scope of responsibilities includes animal-derived reagents for product and clinical testing associated with inline and pipeline large molecule programs (vaccines and biologics), with near term focus on reagent supply for inline product testing and late-stage development programs.
- Create and maintain scientifically based reagent characterization and qualification strategies.
- Develop short- and long-term reagent-specific supply strategies based on forecasted reagent demand that minimize supply risk and align to business needs.
- Develop tactical work plans for each component of a successful and sustainable reagent supply chain from antigen sourcing, productive animal seroconversion and sera collection, and preparation of final reagents. Forecast and coordinate with external and internal partners to oversee and successfully execute reagent work plans.
- Manage inventory for each reagent as it moves through qualification process. Track and report status of sourcing/qualification activities and ensure timely initiation of work packages to minimize supply risk.
- Provide active oversight of external vendors and Contract Research Organizations (CROs)
- Ensure changes have robust scientific/technical assessment and appropriate knowledge capture / change control.
- Understand and incorporate evolving best practices for animal-derived reagents to maintain reagent quality and protect animal health.
- Rapidly identify emerging issues and lead analytical technical activities to resolve.
- Deploy optimized of the antisera screening and testing capacity models to ensure efficient utilization of analytical assets to control speed of testing, quality standards, and costs.
- Ensure needs of animal-derived reagents and associated projects are reflected in analytical life cycle risk assessments, project portfolio prioritization process, and departmental business processes.
- Primary point of contact for procurement and finance for budget forecasting (expense and capital needs), purchasing, and contract updates.
- Development of optimized business tools to support efficient oversight, planning, and work management.
- Lead efforts to identify, prioritize, and implement improvements based on strong technical understanding of product/test-specific reagent use including items such as: enhanced reagent characterization approaches, alternatives to animal-derived reagents (to greatest extent possible), and optimized reagent images (concentration, volume) for improved efficiency in reagent use and testing operations.
- Foster effective cross-divisional collaborations at both local site and global levels both with internal and external collaborations in site laboratory planners, planners for external laboratories, Analytical R&D, supply chain, product teams and working groups, and CMC-Regulatory.
- Lead joint strategic engagements with external analytical testing providers.
Minimum Education Requirement and Experience:
- Master of Science (MS) degree in a field relevant to the production and performance of animal-derived reagents, such as: Veterinary Sciences, animal immunology, antibody design/characterization, adjuvant systems with eight (8) years of strong technical expertise in general large molecule analytical laboratory operations, equipment, and techniques OR
- PhD in a field relevant to the production and performance of animal-derived reagents, such as: Veterinary Sciences, animal immunology, antibody design/characterization, adjuvant systems with four (4) years of strong technical expertise in general large molecule analytical laboratory operations, equipment, and techniques. Post doc experience will be considered as a part of experience.
Required Experience and Skills:
- Deep experience in at least one of the following cores operational or scientific areas related to production or characterization of animal-derived reagents.
- Experience with animal immunization and/or characterization of immune responses and sera characterization
- Experience selecting and characterizing animal-derived reagents for potency or neutralization assays.
- Prior experience in clinical companion animal veterinary general or specialty practice,
- Experience with companion animal vaccines and parasiticides in industry (preferred) or research
- Experience modernizing methods dependent on animal-derived reagents, including characterizing antibody interactions in complex sample matrices.
- Demonstrated ability to manage complex projects/teams (direct or matrix) and/or oversee detailed technical work, and effectively communicate with stakeholders across the organization.
- Demonstrated ability to quickly learn and acquire technical competency in scientific field.
- Experience with supply chain strategy and capacity planning
- Experience with external vendor/contract laboratory management
- Excellent presentation, oral and written communications skills: ability to convey technical information in a manner easily understood.
- Strong project management competencies: ability to define and implement calendar plans for achievement of aligned metrics including measurement of key performance indicators.