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Senior Manager, Bioanalytical Development
Halozyme Therapeutics, Inc. • San Diego, CA
Posted 11 days ago
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We are 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, applies a unique approach to targeting solid tumors, potentially providing increased tumor access for co-administered cancer therapies. By breaking down potential barriers to cancer, PEGPH20 may help make existing treatments more effective by allowing therapies to reach the tumor.
We are built on a foundation of value-driving partnerships with leading pharmaceutical companies including, Roche, Pfizer, Janssen, Baxalta, AbbVie and Lilly, for our ENHANZE™ drug delivery technology platform, which enables biologics and small molecule compounds currently administered intravenously to be delivered subcutaneously. This technology may also allow for more rapid delivery of therapies that are already delivered subcutaneously.
We are a diverse team, who are committed to bringing therapies and results to patients. It's not enough to be qualified and experienced at what you do, we are looking for people who believe in our mission and match our values. We are building a company where people can pursue their career goals in a supportive and collaborative team environment.
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. This position also acts as a point of contact for Legal contracts with CROs and vendors (CDAs, MSAs).
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
- 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 review method validation plans, method validation reports and bioanalytical study reports (nonclinical and clinical, from external and internal studies), regulatory filings and responses to requests for information
- 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 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, 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 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.
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.
- Travel may be required up to 10% of your time
As the Company is dedicated to its ambitious goals, it is imperative that he or she be first and foremost a team player. The successful individual will also possess many critical personal characteristics, including:
Excellent Communication Skills, Both Written and Oral: The successful individual's communication style should be diplomatic and direct, but not confrontational. He or she must be able to articulate clear, tangible objectives for the organization and can deliver an honest assessment of the level of achievement of those goals. He or she must work well in a collaborative team environment.
Accountability: The successful candidate must be able to quickly energize the team and to focus it throughout its future growth stages. He or she should be a self-motivated, results oriented team player who leads by example, holds him or herself accountable for performance, takes absolute ownership, and champions the Company’s programs.
Indomitable Work and Teamwork Ethic: The successful candidate will reject setbacks and will enthusiastically persevere until ambitious goals are achieved, both personally and from a team perspective. He or she will be resourceful and innovative at tackling multiple challenges.
Entrepreneurship, Sense of Urgency: The successful candidate will react to situations quickly and decisively, possessing self-confidence to be assertive when taking a position, not being afraid to make decisions.
Integrity and Presence: The successful candidate will understand the importance of maintaining a high level of integrity. As such, he or she must project the appropriate professional image of the Company.