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Sr Business Analyst, BioAnalysis Operations Information Systems

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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.

As a member of the BioAnalytical Operations-Information Systems (BAO-IS) team you will play a key role in system deployment, validation and business process development. You will have the opportunity to participate in high impact, high visibility projects such as automated data capture and analysis, digital transformation of existing business process and critical laboratory systems validation supporting GxP and R&D laboratory workflows. We are looking for an outgoing, motivated individual who is excited at the prospect of building out new digital infrastructure and taking it from concept through validation and finally deployment to a dynamic team of industry-leading scientific staff.

Responsibilities: 

A Business Analyst 2 performs the following duties in coordination with a manager or Sr. Business Analyst.

  • Perform drafting of project implementation plans, requirement specifications, and execution of test scripts for system validation implementation projects according to applicable GLP and 21CFR11 compliance regulations.
  • Assume Business Process Owner and Subject Matter Expert roles for system validation implementation projects.
  • Prepare controlled documents, process documents, and data reports including but not limited to SOPs, System Design Documents, System Configuration Documents, Data Transfer Specifications.
  • Perform Administrator duties for BAS LIMS, ELN, SDMS, analytical instruments, and other software.
  • Perform Super User functions for BioMarin information and file sharing systems related to BAS (BioAnalytical Sciences).
  • Perform and assist with tasks for implementation and/or validation of new instrument and computer systems, software, and upgrades.
  • Business Process expert for 1 or more GxP validated systems in BAS.
  • Involved in decision making processes for the purchase of new systems.
  • Prepare controlled documents, process documents, and data reports including but not limited to SOPs, System Design Documents, System Configuration Documents, Data Transfer Specifications.
  • Collaborate with BAS Managers and Scientists to improve workflow processes involving LIMS and other computer systems.
  • Collaborate with BAS Managers to develop management metrics derived from computer system usage.
  • Coordinate with BAS personnel for instrument workstation troubleshooting and maintenance.
  • Provide general Training on computer systems as needed.
  • Ensure data integrity and compliant laboratory operations.
  • Participate in internal and external inspections and audits.
  • Any other reasonable activities or duties assigned or required by leadership or management

A Sr. Business Analyst is expected to perform the above duties and the following duties independently with minimal oversight.

  • Manages, administers, supports, and troubleshoots laboratory computerized instruments and information systems per applicable GLP and 21CFR11 compliance regulations
  • Manages and/or supports GxP regulated change control activities
  • Represents BAS in computer systems validation (CSV) activities
  • Manages implementations and upgrades of computer systems and software
  • Able to manage assigned projects from concept to deployment

Education/Experience:

  • Required: Bachelor’s degree in computer sciences, life sciences or equivalent experience with administration of information systems, laboratory information systems; or similar integrated, networked computerized systems; or Laboratory Scientist with laboratory information systems administrator experiences.
  • Preferred: Master’s degree in computer sciences

Business Analyst 2 Requirements:

  • Required: At least 4 years of experience as a Network or Laboratory Information Systems (LIMS, ELN, LES, etc.) Administrator.
  • Required: Excellent writing and verbal communications skills.
  • Preferred: At least 2 years of experience working in a bioanalytical laboratory or 2 years working in a biopharmaceutical company.
  • Preferred: Experience with Good Documentation Practices (GDP).

Sr. Business Analyst Requirements:

  • 4+ years of experience supporting GxP compliant computerized systems, preferably administering Laboratory Information Management Systems (LIMS) and/or Electronic Laboratory Notebook (ELN) software
  • 6+ years of work experience in a biotech or pharmaceutical company, preferably supporting a GxP laboratory
  • Working knowledge and experience with GLPs, 21CFR11, and electronic data handling and security.
  • Experience supporting CSV activities (requirements author, test script execution)
  • Knowledge and experience in GxPs, 21CFR Part 11, and preclinical/clinical drug development.
  • Software Change Control



We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

~BIO

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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