Scientist II / Senior Scientist I, Assay Diagnostics and Lifecycle Management (IVD/LCM)

Location:  San Rafael, California Category: Research

Description

Scientist II/Senior Scientist I, Assay Diagnostics and Lifecycle Management (IVD/LCM)

SUMMARY DESCRIPTION:

The Scientist II or Senior Scientist I in the Assay Diagnostics and Lifecycle Management (IVD/LCM) group of BioAnalytical Sciences is responsible for the oversight of the organization, review and performance activities required for testing of human and animal specimens associated with one or more project in drug or diagnostic development or in a post-marketing setting, according to applicable GLP regulations. Understands company goals and exercises judgement consistent with company practices and policies and is capable of anticipating the technology and resource needs required to meet those goals. Has advanced project management skills and makes project proposals and regular contributions of constructive advice. 

Responsibilities include oversight of multiple projects, both outsourced to Contract Research Organizations (CROs) and internal to BMRN. This includes coordinating project resources for assay characterization and validation, SOP development, sample testing and report generation to ensure timely transmission of data to attain company goals. Interaction with GLP Compliance as well as other departments within BioMarin. Also interact frequently with scientific, project management, and business development contacts at CROs. Manage assay development, validation, and data monitoring activities for bioanalytical assays at CROs. Assist management of bioanalytical activities required for development of in vitro diagnostic assays. Support direct and satellite reports to ensure adequate materials and resources are provided as well as ongoing job-related training and career enhancement opportunities.  Demonstrates effective interpersonal and communication skills and leadership qualities.  Will manage one or more Manager or Senior Research Associate(s) and provide mentoring. Knowledge of GLP and other relevant health authority regulations is required.

 

 RESPONSIBILITIES:

  • Oversight of testing groups supporting multiple drug development projects ensuring GLP and/or medical device compliance in assay validation, assay maintenance, sample handling, sample analysis and result reporting.
  • May represent department on project teams including clinical protocol implementation teams and Research and Early Development (RED) working teams.
  • May perform duties of BioAnalytical Team Lead.
  • Present results, conclusions, and implications to project teams and senior management. 
  • Independently carry out the aforementioned tasks and plan, implement, and complete significant projects with minimum supervision.
  • Participate in scientific meetings and apply project management experience to understand activities and deliverables.
  • Collaborate with the assay strategy and development (ASD) and Bioanalysis (BA) groups to coordinate resources for assay development, characterization, and validation, as well as testing of study samples.
  • Can be a member of the Early Development Team (EDT).
  • Can be functional group representative on project Core Team and Study Execution Team (SET).
  • Oversee and review the performance of GLP-controlled quantitative and semi-quantitative assays on clinical and non-clinical samples such as serum, plasma and urine, including test methods for antibodies, therapeutic proteins, enzymatic activity, and glycosaminoglycan within the bioanalytical laboratory.
  • Ensure assays are performed as needed to meet testing timelines.
  • Lead technical investigations and projects to meet timelines and organizational goals.
  • Participate in preparation or review of SOPs and documents such as validation protocols, validation reports, deviation reports, investigations, ISR reports, Change Requests, and assay SOPs.  Author, revise and review process SOPs and report templates.
  • May author bioanalytical study reports.  May be designated to function as the Principal Investigator (PI) for a specific study and prepare bioanalytical reports for the Study Director.
  • Supervise, train and provide leadership and technical expertise in laboratory procedures for Managers, Research Associates and peer scientists.
  • Interact with BioAnalytical Sciences, BioMarin GLP Compliance, BioMarin Clinical Operations, BioMarin BioMetrics (Clinical Data Management), BioMarin Global Medical Affairs, and Translational Sciences staff to ensure timely transmission of data to study personnel.
  • May function as the primary BAS interface with other departments regarding a designated project or projects.
  • Ensure GLP-compliant sample handling, assay performance, and laboratory operations through adherence to SOPs, and departmental practices and train and supervision of direct reports.
  • Contribute to internal and external inspections and audits, including preparation and execution of corrective actions for observations noted.

SCOPE:

The Scientist II or Senior Scientist I, IVD/LCM, is responsible for efficient and effective GLP laboratory operations.  The scientist has a significant impact on the company’s ability to reach its goals in a timely manner, with respect to delivery of accurate data, generated from validated methods, in support of nonclinical and clinical studies.  Will have an impact on company progress towards drug and diagnostics approval, lifecycle management of approved drug franchises, and future capital investment.

EXPERIENCE:

  • Required: 6-8 years of experience in a bioanalytical research laboratory, or biotechnology company
  • Required: At least 2 years managing a project team
  • Required: Experience with GLP documentation and testing
  • Required: Excellent written and verbal communication skills
  • Required: Demonstrates good interpersonal skills and leadership qualities
  • Essential Functions: Management of personnel in the GLP Laboratory
  • Preferred: Knowledge of medical device regulatory requirement
EDUCATION & EXPERIENCE PER LEVEL:

Scientist 2:

  • PhD or equivalent relevant experience plus 2-5+ years industry experience

Sr. Scientist 1:

  • PhD or equivalent relevant experience plus 5+ years industry experience

WORK ENVIRONMENT / PHYSICAL DEMANDS:

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; biohazardous materials; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration.  The noise level in the work environment is usually moderate.

The employee may frequently be required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

CONTACTS:

  • BioAnalytical Sciences: Senior Director, Director
  • BioAnalytical Sciences IVD/LCM: Senior Scientist I, Manager, Senior Research Associate
  • BioAnalytical Sciences Bioanalysis: Associate Director, Senior Manager, Manager, Supervisor, Associates
  • BioAnalytical Sciences Assay Strategy and Development: Associate Director, Senior Scientist II, Senior Scientist I, Scientist II, Research Associates
  • Translational Sciences: VP, Executive Director, Director, Scientists, Study Monitors
  • Research: Scientists, Research Associates
  • GLP Compliance: GLP/GCP Manager, Associates
  • Clinical Operations: Director, Manager, Associates
  • Global Medical Affairs: Senior Director, Director, Associate Director, Manager
  • Project management internal and external

 SUPERVISOR RESPONSIBILITY:

  • The IVD/LCM Scientist II/Senior Scientist I may directly supervise two or more Managers and/or Senior Research Associates.
~BIO