Bio Analytical Manager

At Roche, 88,500 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 35 years, using human genetic information to develop novel medicines for serious and life-threatening diseases.

BioAnalytical Manager (BAM) provides bioanalytical operational expertise to local (PETs) and global (SMTs) 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. 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.

* Works with pharmacology sub-teams to understand program development direction and deliverable requirements for program decisions and regulatory filings to ensure program needs are met with timely data delivery * 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 manual. Facilitate resolution of sample and data discrepancies and disposition of samples throughout the study * 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. Develop and manage 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 with outside spend (PVC) budget planning and manage actual spend (invoices, PO) for studies * Identifies CROs for bioanalysis. Sets up and manages lifecycle of CRO contracts for bioanalysis, working with GPPS and scientific functions. Manage CRO deliverables and performance, ensuring all deliverables are met per SOWs. Provide input on CRO performance and manage escalation as needed * May assist with training of new or less experienced peers and participate on organizational initiatives to support business needs * Applies relevant regulatory compliance and internal business standards in the performance of job responsibilities

* 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 **Education and Experience Requirements:** * Bachelors or higher degree in biology, chemistry, or related scientific discipline. Project management certification desirable * 5 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