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Director, Analytical Sciences

BioMarin Pharmaceutical Inc.
Novato, California
Start date
Oct 14, 2022

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Information Technology, Business/Data Analytics
Required Education
Bachelors Degree
Position Type
Full time
Biotech Bay

Job Details

Director, Analytical Sciences




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 Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. The Analytical Sciences department supports all assay needs in Tech Ops. Our 50+ scientists and associates are experts in analytics of small molecules, peptides, proteins/enzymes, and gene therapy agents. We develop assays to follow the quality attributes of our products, support IND and BLA applications, and assess the capability of our production processes. We develop release assays and are responsible for lot release and formal stability testing for early-stage clinical programs (tox, development, GMP lots), and support assay transfer to Quality for late-stage programs. We are also instrumental in time-critical analysis support to Manufacturing as needed. Come join our team and make a meaningful impact on patients’ lives.





The Analytical Sciences department at BioMarin Pharmaceutical Inc. is seeking a Director to lead a 12+ member team focused on assay development, routine and early-stage clinical release testing, and quality.  Reporting to the Executive Director of Analytical Sciences, the Director will be a member of the department leadership team and a key liaison with our Quality partners. They will define analytical strategies, ensure GxP release and routine testing in a phase-appropriate manner, and mentor a team of scientists to develop pioneering analytics that provide control over BioMarin’s broad pipeline of clinical programs.




  • In partnership with Research and Clinical, support Analytical Sciences in the definition of Critical Quality Attributes (CQAs) for clinical programs and development analytical strategies for CQA control 
  • Develop analytical strategies for raw materials attribute characterization, assessing analytical needs and designing control strategies in partnership with production teams
  • Lead team development of phase-appropriate procedures and management of critical reagents for early-stage programs
  • Lead team development of phase-appropriate procedures for GLP test article characterization and GMP release testing for early-stage programs
  • Provide oversight and mentorship to the leader and members of the Analytical Sciences Routine Testing group, ensuring GxP-compliant, timely release of clinical material
  • Lead team in development, testing, and transfer of analytical methods for control of clinical gene therapy programs, including techniques such as ddPCR, biolayer interferometry, ELISA, HPLC…
  • Serve as a liaison to our Quality partners, driving alignment on analytical strategies, platforms, and procedures
  • Collaborate with other Analytical Sciences group leaders (e.g. cell-based assays, mass spectrometry, biophysical characterization) in aligning analytical suites for each program
  • Author and review analytical-relevant CMC sections of regulatory filings
  • Track team progress against project timelines, generate regular status updates and communicate progress, resourcing needs and issues to leadership
  • Document experiments, data, and findings electronically in an accessible manner for inspections.




Required Skills:

  • Extensive drug development experience, preferably spanning from early stage to approval
  • Understanding of current ICH guidelines and related industry guidelines and practices, with the ability to apply them to analytical development
  • Extensive experience with analytical method development, qualification, and transfer
  • Strong written communication skills, with the ability to author and review relevant documentation (methods, protocols, reports) and regulatory sections
  • Experience in mentoring scientists
  • Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships
  • Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment


Desired Skills:

  • Experience in gene therapy analytics



Ph.D. in Chemistry, Biochemistry, Biology, or related field, plus 10+ relevant industry experience; or M.S. with 15+ years; or B.S. with 18+ years



Will report to Executive Director of Analytical Sciences and interface with internal department leaders and external partners from Quality, Regulatory, Technical Development, and Research



Will supervise, mentor, and manage a team of Scientists and their reporting Research Associates


PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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


BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

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