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'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:
The Animal Resources Group at BioMarin is a dynamic, collegial, interactive group where teamwork, ingenuity, and scientific excellence are highly valued.
We are seeking an experienced Senior Scientific IACUC Manager with a strong background and experience with vivarium and animal program (IACUC) administration, and experience with in vivo bio methods. The successful candidate will serve as the centralized single point of contact and resident expert in project management of animal program functions (IACUC support, training, document tracking, CRO animal program audit evaluation, animal protocol use tracking, SOP and policy writing and implementation). It is preferred that this candidate have a strong understanding of genetics and genetic modification methods for creation of animal models (Transgenics, vector mediated knockout/knock in/knockdown, CRISPR), characterizing animal models, and gene therapy modalities (Oligonucleotide therapy, Vector gene therapy, Gene Editing therapy, and Gene therapy delivery mechanisms).
RESPONSIBILITIES:
- Coordinate with internal Research teams to provide end to end protocol support of early-stage research supporting both internal studies and external studies conducted at partner CRO's. This includes receiving and providing initial reviews of Animal Use Protocols for completeness, recommending the initial level of review (DMR or FCR), compliance with policies, Institutional requirements, and State/Federal regulations prior to submission to the IACUC
- Evaluate, track, and complete CRO animal program audits for ongoing and potential in vivo study sites.
- Provide timely IACUC correspondence and written reports as required. These would include correspondence related to non-compliant items identified and related corrective actions, Post-approval Monitoring write ups.
- Coordinate/participate in IACUC facility and post-approval monitoring inspections, including follow-up inspections.
- Coordinate/participate in investigations of non-compliance and provide guidance and oversight to correct issues found.
- Prepare/distribute meeting agendas and compliance-related materials for committee review. Oversee the recording and production of official minutes of all IACUC meetings and reviews to ensure proper documentation.
- Partner with internal stakeholders for compliance within biosafety, EHS and occupational health & safety
- Collaborate with Vivarium staff in the creation of SOP's and policies, processes, and assist with various services in the new vivarium, as needed.
- Create internal IACUC SOP's, policies, and processes
- Administer the animal program training for the IACUC program (Educational guidance regarding IACUC roles in research, protocol generation, amendment, and review processes, BioMethods)
- Serve as a liaison between BioMarin and federal and accreditation inspectors and officials.
- Oversee all animal ordering and receipt and ensuring animals are tracked against the correct protocols.
- Administrator for the IACUC programs animal compliance software (familiarity with computer databases for protocol management, Cayuse preferred).
- Other compliance and animal program support as required.
EXPERIENCE:
- Bachelor's degree in a science related field required and three to five years related IACUC/research administration experience required. Master's or PhD preferred.
- Experience with vivarium and animal use program management, Experience in pharmaceutical industry or biotechnology preferred with Certified Professional IACUC Administrator (CPIA) certification required. 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
- Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated
Workplace Requirements and Benefits:
- This is a full-time on-site management role based in Petaluma, CA
- Relocation possible based on company policy and guidelines
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.