The Sr. Manager, Bioanalytical Development will be a subject matter expert in large molecule bioanalysis and responsible for technology development, transfer, validation and operations supporting PK/PD, immunogenicity and biomarker analyses at Contract Research Organizations (CROs) in accordance with current regulatory expectations/guidance and industry standards. As a senior member of the bioanalytical team, this individual will interface with Halozyme Program Teams, its Corporate Partners and the internal bioanalytical and clinical pharmacology teams to enable preclinical, clinical and post-market commitment bioanalyses. Additionally, the individual will be accountable for aspects of regulatory filings related to PK/PD/ immunogenicity along with presentation of results and key messages to internal teams, executive management and corporate partners. May supervise bioanalytical scientific staff.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
Lead and manage bioanalytical CRO relationships, processes, including method development/transfer, optimization, validation, critical reagent supply and assay lifecycle management; enable stage-appropriate bioanalytical support for internal and external partners and programs
Interface with Halozyme corporate partners in support of alliance programs; recommend/implement appropriate bioanalytical strategies in support of clinical development programs at all stages, especially related to immunogenicity, PK and PD of Halozyme product(s). Interface with the Clinical Pharmacology team as appropriate in development of strategies
Develop operational work plans including requests for proposals/quotes, preparing purchase orders, tracking of project milestones, timelines, develop risk mitigation strategies and technical troubleshooting
Design, author and/or review method validation plans, method validation reports and bioanalytical study reports (nonclinical and clinical, from external and internal studies), regulatory filings, including relevant modules of BLA/MAA filings and responses to requests for information from Health Authorities
Initial qualification and/or ongoing oversight of CRO activities to ensure scientific integrity and compliance, including technical site visits as appropriate. Implement and maintain method monitoring processes and data review to ensure robust bioanalytical method performance over time
Review data and analysis of PK/PD/immunogenicity results; present and report results to internal/external teams, in technical reports and in regulatory filings
Support bioanalytical critical reagent supply program, contributing to strategies for production, characterization and monitoring of materials over time
Support in the management of and planning/forecasting of departmental budgets, goals and objectives
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Qualify, assess and/or audit current and prospective vendors, requiring some travel
Present and advance Halozyme science at relevant scientific conferences, and/or publish findings in peer-reviewed journals
Other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
Bachelor’s degree in life science with a minimum of 8 years of relevant industry experience in Biology, Biochemistry, Pharmacology or related discipline is required [an equivalent combination of education (eg PhD, MD, MSc or M. Pharm) and experience may be considered]
High degree of proficiency in large molecule ligand-binding based bioanalytical sciences and strong ability to discern/communicate how bioanalysis is utilized in drug discovery and development
Experienced with all aspects related to the bioanalysis, reporting and interpretation of data from nonclinical and clinical studies, as well as the bioanalytical flow from discovery to production including technology transfer and oversight of the Sponsor-CRO relationship
Expert understanding of regulatory requirements, especially related to immunogenicity analyses, including experience with GxP audits and regulatory submission processes (FDA, EMEA)
Excellent written and verbal communication skills with strong ability to present scientific/technical information to diverse audiences
Advanced knowledge and experience in the appropriate assay systems and current technology platforms used to perform bioanalytical testing for large molecules including standard ELISA (chromogenic, fluorogenic) and Electrochemiluminescent (e.g. MesoScale Discovery) platforms. Knowledge/experience with LC-MS/MS and/or Singulex or Gyros platforms a bonus
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other laboratory equipment as necessary.
Software Knowledge: Windows, MS Office (Outlook, Word, Excel, Powerpoint). Knowledge of other software required: Mesoscale Discovery Workbench, SoftMax Pro, JMP (preferred but not required)
INTERNAL AND EXTERNAL RELATIONSHIPS:
Successful contributor in a matrix team environment
Transparent and openly communicate information to colleagues within Halozyme and with extramural collaborators in a timely manner
Interface with internal bioanalytical scientists, Non-clinical Development, Clinical Pharmacology, Product Development, Business Development and Clinical Teams, Halozyme Project and Program Teams
External collaborators / corporate partners, as well as Contract Research Organizations and Vendors
Employer will assist with relocation costs.
Halozyme is a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapies that target the tumor microenvironment. Our lead proprietary program, investigational drug PEGPH20 (pegvorhyaluronidase alfa), applies a unique approach to targeting solid tumors, potentially providing increased immune response and tumor access for co-administered anti-cancer therapies.
In addition to our proprietary product pipeline, Halozyme has value-driving partnerships with leading pharmaceutical companies, including Roche, Pfizer, Janssen, Baxalta, AbbVie, Eli Lilly, Bristol-Myers Squibb and Alexion for our ENHANZE® drug delivery technology, which enables biologics and small molecules currently administered intravenously to be delivered subcutaneously and may provide additional benefits. We are headquartered in San Diego.