Scientist 2, Assay Strategy & Development

Who We Are

From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.

Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

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 or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients’ lives.

The Assay Strategy and Development group within Translational Sciences develops analytical methods for the detection of drugs, antibodies to therapeutics, and biomarkers in biological matrices to support projects through multiple stages of development. We are searching for a talented and highly motivated Senior Scientist to lead a bioanalytical team that will be responsible for the generation of data to enable the successful development of pre-clinical and clinical programs. The candidate will be responsible for the development and oversight of assays for diverse modalities, which may include gene therapies, monoclonal antibodies, oligonucleotides, biologics, and small molecules. Candidates should be familiar with guidance documents for regulated sample testing and should have extensive experience developing bioanalytical methods.

The successful candidate will participate in programs that range from exploratory in vitro and animal studies to non-clinical efficacy and safety studies, and clinical trials. You will be responsible for developing new methods, evaluating novel technologies, and conducting translational research internally at the BioMarin Research Center and externally in partnership with contract research organizations. This position offers a unique opportunity to interact with scientific and business colleagues across many functional areas, including Research, Translational Sciences, Regulatory Affairs, and Clinical Sciences.

This Senior Scientist position will report to a Director in the Assay Strategy and Development group and will have the opportunity to advance our most promising pipeline programs to treat rare genetic diseases.

RESPONSIBILITIES

• Directs and trains others to lead the development and validation of quantitative and semi-quantitative bioanalytical methods to support pharmacokinetic, pharmacodynamic, biomarkers, and immunogenicity assessments. Techniques may include (but are not limited to) ELISA, ligand binding assays, polymerase chain reaction (qPCR and ddPCR), single-cell sequencing, sequence-tagged molecular tracing, cell-based and ex vivo culture assays.
• Develops new techniques or brings in new technologies to enhance the analytical capabilities of the group.
• Plans and executes biomarker assay strategy for non-clinical and clinical studies.  Presents results, conclusions, and implications to project teams and senior management. Trains other scientists to follow suit.
• Oversees internal and external development and validation of a variety of bioanalytical methods to detect drug, antibodies to protein therapeutics, and biomarkers in biological matrices.
• Maintains a detailed awareness of industry guidance and standards for assay validation and performance.
• May serve as Principal Investigator for GLP assays, participate in audits and inspections, and adhere to regulatory compliance standards.
• Oversees technology and process transfers between groups and vendors.
• Authors, reviews, and contributes to non-clinical and clinical study protocols, regulatory reports, and bioanalytical sections in regulatory submissions.
• Authors, reviews, and approves reports and documents such as validation protocols, validation reports, and sample analysis reports.
• Independently carries out the aforementioned tasks and plans, implements, and completes significant projects with very little supervision.
• Manages and mentors PhD-level scientists and research associates; establishing high performance through others.
• Participates in departmental and external scientific meetings and produces original peer-reviewed publications.
• Serve as an expert liaison to other departments.
• Other duties as assigned.

SCOPE

The Senior Scientist is responsible for efficient and effective drug development and laboratory operations. The Senior Scientist is expected to consult with Bioanalytical Sciences Leadership on the prioritization of resources across programs to achieve Early Development Team and corporate objectives.  The Senior Scientist has a significant impact on the company’s ability to reach its goals in a timely manner, with respect to delivery of developed and validated methods to support preclinical and clinical studies.

EDUCATION

• Required: Doctorate (Ph.D.) degree with postdoctoral fellowship and 3+ years of experience in a bioanalytical research laboratory or biotechnology company.
• Experience in managing two or more individuals
• Experience with GLP or GMP documentation.
• Strong written and verbal communication skills.

EXPERIENCE

• Doctorate (Ph.D.) degree with postdoctoral fellowship and 3+ years of experience.  For a total of 5+years.
  Extensive technical expertise and broad scientific knowledge in the bioanalytical field.

WORK ENVIRONMENT

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; 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.

EQUIPMENT

Experience with laboratory equipment and software required for translational research, may include immunoassays, cell culture, mass spectrometry, and/or chromatography.

Windows network or Mac environment, MS Office, etc.

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.