BioAnalytical Manager III
660 East Grand Avenue South San Francisco, CA 94080
Bayside Solutions is seeking a BioAnalytical Manager III 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.
BioAnalytical Manager III
- 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 BioAnalytical Manager (BAM) provides bioanalytical operational expertise to local (PET) and global (SMT) clinical study teams to implement and execute strategies for anti-drug antibody (ADA) and pharmacokinetic (PK) analysis for all phases of clinical studies for Genentech programs.
- The BAM serves as a single point of contact between scientific functions (BAS, Clinical Pharmacology, DMPK), CROs, and clinical study teams for each clinical study to operationalize sample collection logistics, execute bioanalysis, and facilitate timely delivery of data to internal stakeholders and clinical study teams.
- May work with pharmacology sub-teams to provide input on PK/ADA deliverable timing and to understand clinical program development direction (filings, new studies) to ensure program needs are met.
- Develops and maintains effective, collaborative relationships with study teams, scientific function key stakeholders, data groups, internal outsourcing contacts, and CROs.
- Harmonizes sample collection and handling instructions per bioanalytical strategies and assay requirements to ensure they are included in clinical site lab manual. Facilitate resolution of sample and data discrepancies and disposition of samples throughout the study lifecycle.
- Authors and reviews relevant section of study related documents (i.e., central lab SOWs, study protocols/ICFs, bioanalytical reports, etc.).
- Develops study-specific sample and data flows plans with stakeholders (e.g. BAMP). Develops and manages timelines for bioanalytical labs to ensure samples are tested according to protocol and data is transferred in the specified format per study team timelines.
- Assists function with outside spend (PVC) budget planning and management of actual spend (invoices, PO) for studies.
- Contributes to identification of bioanalysis CROs and set up of contracts for bioanalysis, working with internal contacts. Through CRO Central Point of Contact (CPoC), manage CRO deliverables and performance, ensuring all deliverables are met per SOWs and study timelines. Provide inputs on CRO performance, escalating concerns as appropriate.
- May assist with training and participate on organizational initiatives to support business needs.
- Applies relevant regulatory compliance and internal business standards in the performance of job responsibilities (e.g. eTMF, RACT, Maintenance of Study Tracking Documentation).
Summary of Qualifications:
- Bachelors, M.S., or Ph.D. in biology, chemistry, or related scientific discipline. Project management certification desirable.
- In general, 8 plus years of professional experience in pharmaceutical or biotechnology industry that includes experience related to bioanalysis and sample handling, CRO management, and/or clinical development/operations.
- Working knowledge of ICH GCP.
- Highly effective verbal and written communication.
- Demonstrated ability to influence and collaborate to deliver results in multi-cultural, geographically diverse teams.
- Strong analytical skills to evaluate complex problems for pragmatic solutions.
- Application of independent judgment, with high attention to details.
- Excellent organization and project management skills to independently manage multiple projects with competing priorities.