Scientist I/II

Location:  Novato, California Category: Process Science

Description

 

DESCRIPTION

 

BioMarin Pharmaceutical Inc. is a 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 Tech Ops, supports all assay needs in Tech Ops. Our scientists and associates are experts in analytics of small molecules, peptides, complex glycosylated enzymes, PEGylated proteins 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 processes by analyzing in-process samples all the way from bioreactors through purification steps to the drug substance and build release 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 is seeking an experienced analytical chemistry and separations expert at the Scientist I/II level to join a mass spectrometry-based team focused on supporting small molecule, recombinant protein, and gene therapy programs. The successful candidate will be a self-starting, independent, and agile scientist who enjoys working in a multi-disciplinary and fast-paced laboratory. The primary set of responsibilities will be liquid chromatography-based product characterization and analytical method development to support clinical-phase development and commercial process investigations/optimizations. Super-user responsibility for an LC-MS/MS (Agilent 6550) instrument is required. While the current need is for an individual contributor in the lab, there may be opportunities to develop platform or team leadership/management responsibilities.

 

 

RESPONSIBILITIES

 

  • Develop and/or execute qualitative and quantitative analytical methods to support small molecule, peptide, and protein characterization and process development needs in a CMC environment
  • Aligns prioritization of projects with manager but works independently to design/execute experiments and interpret/communicate results
  • Understands program needs and takes responsibility for delivery of results and proactively plans work and resources to meet tight timelines
  • Report progress to the manager on a weekly basis and to the larger mass spectrometry or AC group on a monthly basis
  • Assay development, qualification, and transfer to Assay Services or Quality Control as needed
  • Engage with staff from Analytical, Process Development, Process Analytics, Manufacturing, and Research with enthusiasm and collegiality
  • Record work/data/reports in an Electronic Laboratory Notebook in a clear and accessible manner for inspections
  • Train colleagues and associates as needed

 

 

 

 

 

 

EXPERIENCE

 

Required Skills:

  • Expertise in separations science, including but not limited to: RP, IC, SEC/GPC, HILIC, and HIC
  • Expertise in mass spectrometry, including ESI, EI, and MALDI ionization with a range of mass spectrometer designs (Q-TOF, Orbitrap, QQQ), and standard chromatographic detectors (UV, FLR, ELSD, CAD, RI, MALS)
  • Experience with peptide, disulfide, and/or glycan mapping method development/execution
  • Proven technical skills in a cross-functional and collaborative environment
  • Competency in method development, qualification, stability/forced degradation studies and technology transfer
  • Outstanding oral communication, collaboration, and technical 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:

 

  • Proficiency in GC-FID/MS and/or ICP-MS/AES
  • Understanding of ICH, USP, Ph Eur, FDA and relevant guidelines for CMC development

 

 

 

EDUCATION

  • Ph.D. in chemistry with >2 years of biopharma/biotech experience or solid record of publications related to the technical skills described for this position
  • M.S. in chemistry with >5 years of direct therapeutic protein characterization experience including peptide, disulfide, and glycan mapping method development and GC-MS or ICP-MS method development
  • B.S. in chemistry with >8 years of direct therapeutic protein characterization experience including peptide, disulfide, and glycan mapping method development and GC-MS or ICP-MS method development

 

 

EQUIPMENT

Operation of standard analytical chemistry instruments as described above

 

CONTACTS

Will report to a Sr. Scientist

 

SUPERVISOR RESPONSIBILITY

None