Biosample Operations Manager (BOM)
475 E Grand Ave., SSF42 South San Francisco, CA 94080
Bayside Solutions is seeking a Biosample Operations Manager (BOM) to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Biosample Operations Manager (BOM)
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- The Biosample Operations Manager (BOM) plans and coordinates all operational activities required for the collection, delivery and assay of Biomarker Samples (Dx and PD) within a clinical study.
- The BOM works closely with Scientists to execute exploratory and Companion Diagnostic biomarker strategy.
- The BOM serves as a single point of contact on Protocol Execution Teams, Biomarker Subteams and with CRO partners on all aspects of Biosample operations.
- Operations support for Biomarker Scientists
- Provide input on Protocol/ICF development and IRB/HA/EC questions in alignment with study protocols
- Facilitate Central Lab set up, including sample collection and processing instructions, kit contents, shipping conditions and logistics
- Oversee outsourcing to CROs and vendor management (specialty lab vendors for biomarker assays)
- Manage timelines for sample testing and data transfer with both internal testing labs and external vendors
- Single point of contact for status of clinical trial samples and biomarker data
- Manage sample transfer/discrepancy resolution with Central Lab, Sample Handling and testing group/vendor
- Provide sample and assay status updates (high level metrics provided to Biomarker subteams)
- Execution of Biomarker and CDx strategy
- Develop Biomarker Plan with the Biomarker Subteam Leader (outline execution of exploratory and CDx biomarker strategy and testing timelines)
- Lead Biomarker Execution Working Group (review study updates, timelines/milestones, align on Biomarker Plan and deliverables)
Summary of Qualifications:
- Life sciences degree and a minimum of 4 years working experience in the healthcare industry
- Proven clinical development experience working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator site
- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
- Proven critical reasoning skills including the identification and resolution of complex problems
- Detail oriented with the ability to work independently and manage multiple competing priorities
- Excellent verbal, written and presentation skills
- Proven ability to work successfully under pressure
- Ability to work in a multi-functional team environment, interact with a wide variety of internal and external customers and relate effectively to people at all levels of the organization