Scientific / Project Manager, In Vivo (GEMM) & Study Externalization

Who We Are
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

POSITION SUMMARY:

We are seeking a motivated Research Specialist Project Manager to join the BioMarin Animal Resources (Vivarium) Group to assist in managing outsourced study administrative functions and genetic rodent model creation and use in the animal program. 

The successful candidate will have a dynamic role in managing external breeding colonies at contract research organizations (CRO’s).  This will include coordinating genotyping assay development for in house use, tissue sampling, and data and ensuring the multiple Therapeutic Area groups attain the appropriate rodent model cohorts on the timeline needed for studies.  The successful candidate will also assist in the creation development, optimization, and implementation of genetic rodent models of multiple rare diseases. In addition, the successful candidate will manage project placement and externalization of animal studies at external CRO’s.  This will include assisting with evaluation of these external CRO capabilities and working with contracting and project monitoring. 

The ideal candidate will have extensive in-vivo experience and familiarity with genetically engineered mutant (GEMM) rodent models, including mouse of disease models.  Experience in breeding colony management and familiarity with mouse model creation processes and techniques (e.g. CRISPR, Cre-lox and Tet-on systems, mouse IVF concepts) and familiarity with mutant model types (transgenic, knockout and knock-in models, conditional and traditional mutant lines) is highly desired.    Additionally, proficiency in in-vivo methods such as administration of test articles, perfusion and tissue collection, blood collection, as well as rodent surgical models is preferred. Familiarity with Animal Care and Use Laws and Regulations is highly desired as this position will be required to manage animal use inventories/census against Animal Care and Use Protocols (ACUPs). Organization, attention to detail, and ability to manage timelines is a critical requirement for this position.  Graduate level degree preferred in Biological Sciences, Genetics, or a related field is required for this position.  Candidate level at hire will depend on education and experience.

RESPONSIBILITIES:

• Heavy involvement in creation and design of genetically engineered mouse models in collaboration with outside vendors
• Organize and maintain genetically engineered rodent colonies including recommendation of breeding schema and application of 3R
• Evaluate, track, and complete CRO animal program audits for ongoing and potential In Vivo study sites.
• Assist with internal and external study protocol writing and review as well as other regulatory needs as assigned
• Engage with project teams and Therapeutic Area (TA) scientists in a collaborative manner to ensure efficiency in cohort planning and study project externalization and study monitoring management of externalized studies, including protocol development and follow through of external In Vivo studies and coordination of sample management
• Track inventories and manage contract process with outsourcing and invoices
• Recognize, understand, and adhere to IACUC approved protocols, policies, and procedures
• Manage genotyping assay development and sample processing with external vendors
• Perform In Vivo lab procedures including but not limited to rodent dosing (ip, iv, sc, im, etc.) studies, breeding setups and husbandry, genotyping sample collection, blood/tissue collections
• Manage GEMM creation vendor, genotyping vendor, and coordinate CRO audits as needed and plan site visits
• Prepare summary reports for colonies and studies being managed
• Share responsibility for lab maintenance duties
• Other Animal Program duties as assigned

EXPERIENCE:

• Bachelor's degree in science related field with 4-8 years of work experience in drug development (pharma/biotech or contract research organization), with a minimum of 3-5 years GEMM management or rodent breeding experience required. Master’s or PhD preferred.
• Experience with animal In Vivo study project management, Experience in pharmaceutical industry or biotechnology preferred. AALAS certification preferred (LATG or CMAR level).
• Ability to easily work on several projects simultaneously
• Excellent verbal and written communication skills in the English language.
• Highly collaborative and agile in nature
• Ability to work toward established goals without daily supervision
• Excel at organizing and tracking
• Highly adept at using computerized databases and other animal facility and regulatory management tracking software

WORKPLACE REQUIREMENTS:

• This position is full-time on-site, and will be based in Petaluma, CA.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.