DESCRIPTION

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 Chemistry department, a part of Process Sciences within TechOps, supports all assay needs in Tech Ops. Our 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, we assess the capability of our processes by analyzing in-process samples all the way from bioreactors through purification steps to the drug substance and developrelease assays for transfer to Quality. 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.

SUMMARY

The Analytical Chemistry department at BioMarin Pharmaceutical Inc. is seeking aScientist 2to join a method developmentteam focused on supporting genetherapy clinical programs. The successful candidate will be a self-motivated and critical thinker who has proven ability to work in a multi-disciplinary and fast-paced environment, and solid communication skills.

The candidate will be responsible for developing new AAVanalytical methods with a focus on molecular biology and PCR-based techniques.  They will develop and qualify methods,managesample testing, and compile and communicate results. The selected candidate should possess excellent organizational, analytical and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.

An ideal candidate will have significant experience in molecular biology and PCR-based assays, analytical method development,and data handling. A good scientific understanding of protein chemistry and biochemistry is essential. Hands-on experience in AAV analytics and a prior knowledge of ICHand regulatory submission is a plus.

RESPONSIBILITIES

• Execute relevant experiments to support development of analytical assays and sample testing and for AAV gene therapies in the clinical pipeline
• Develop analytical methods using molecular biology techniques, PCR, dPCR, multiplex dPCR, electrophoresis, and HPLC
• Execute relevant AAV nucleic acid characterization experiments to support manufacturing process development
• Provide concise and quantitative analysis of data and interpretation of experimental results
• Ensure laboratory equipment has current calibration and preventative maintenance documentation
• Report progress to the manager on a regular basis on each program
• Write up methods, development reports, qualification reports, results & share with collaborators and supervisor; present data proactively and regularly in group meetings; communicate plans and results to collaborators and manager iteratively
• Catalogue data/reports electronically in an accessible manner for inspections.

EXPERIENCE

Required Skills:

• Good understanding of nucleic acid and protein chemistry, structure, and function
• Knowledge in standard nucleic acidmolecular biology analysis methods (e.g.Primer Design, PCR, ddPCR, electrophoresis, CE, HPLC)
• Collaborative skills to work in a cross-functional environment
• Excellent communication, collaboration and writing skills
• Proven data analysis, interpretation and scientific communication skills
• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment

Desired Skills:

• Experience inAAV analytics
• Knowledge of biopharmaceutical development
• Experience with method qualification and transfer
• Knowledge of ICH and regulatory submissions

EDUCATION

Ph.D. degree in biological sciences, biochemistry, or chemistry and at least 2 yearsof relevant post graduate experience

WORKSTYLE:  
For this role, a minimum of 2 days per week onsite is required.  There is a laboratory component to the role, however, and onsite presence for lab work or lab oversight will be driven by the project needs.  Some weeks will require just the minimum 2 days onsite, some weeks may require 5 days onsite. 

EQUIPMENT

Thermocyclers, digital droplet generators, HPLC, electrophoresis systems, CE, SDS-PAGE, MALS

CONTACTS

Will report to aPhDDirector in Analytical Chemistry

SUPERVISOR RESPONSIBILITY

May supervise, mentor, and manage Research Associates