Sr. Research Associate I, Tech Ops

Location:  Novato, California Category: Technical Development

Hiring Manager: Deepshika Gilbile ([email protected])

Description

About Technical Operations

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. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

JOB DESCRIPTION 
The selected candidate will work in the Separations and Biophysical Assays team within the Analytical Sciences group to assist in the advancement of BioMarin's therapeutics for clinical evaluation and potential commercialization. The candidate will be responsible for development and qualification of new biophysical/ biochemical assays, provide routine testing and characterization support to partner groups to help with early candidate selection, process development, and drug substance and drug product process characterization.
 
The ideal candidate will have hands-on experience working with a variety of modalities including but not limited to proteins, peptides, protein-conjugates, enzymes, RNA-based and AAV-based biologics with a focus on method development and in-depth characterization. The ideal candidate will be able to perform quality work under limited supervision, apply problem solving techniques to maintain accurate results, promote improvements, and assure a safe, stable, on-target operation within the laboratory. The selected candidate should possess excellent analytical, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.
RESPONSIBILITIES
Primary responsibility is to support the Separations and Biophysics group within Analytical Sciences
  • Be a hands-on presence in the laboratory, supporting biophysical/ biochemical assay development and qualification using HPLC, MALS, DLS, AUC, DSF  CD, DSC, etc for various modalities.
  • Provide routine analytical characterization & testing support to partner groups including Upstream and Downstream PD, Formulations, and Research & Early Development (RED).
  • Document experimental results in the company electronic lab notebook (Benchling), author procedures, and contribute to technical documentation (test methods, development reports).
  • Actively participate in the operational aspects of the laboratory by conducting safety inspections, lab organization, ordering supplies, and performing routine equipment maintenance.
  • Present scientific literature and results from ongoing studies at group meetings and other discussion forums at the company.
  • Other duties as assigned. 
Skills 
Required Skills: 
  • Hands-on experience in the biotechnology industry or academic setting with a broad range of analytical techniques focused on protein, peptide, protein-conjugates, RNA-based and/or virus-based analytical testing and characterization is required.
  • Experience with biophysical and biochemical characterization methods is required:
  • Light scattering methods (MALS, DLS)
  • Analytical Ultracentrifugation (AUC)
  • Experience with chromatographic purification methods (HPLC, UPLC, CE)
  • Spectroscopic methods (UV, CD, fluorescence, FRET, FRAP)
  • Thermodynamic methods (DSC and ITC)
  • Label-free binding methods (BLI/Octet, SPR)
  • In-depth technical understanding of all aspects of analytical testing, phase appropriate regulatory requirements, method qualifications and method transfers.
  • Ability to independently troubleshoot issues, ideate and develop insights to technical challenges and propose solutions to solve them.
  • Demonstrates attention-to-detail and “right-the-first time’ approach
  • Excellent written and oral communication skills, with the ability to communicate complex information. Be able to present data/ideas to functional and cross-functional teams.
  • Ability to influence others effectively and develop collaborative relationships with partner teams.
  • Familiar with use of statistical software, electronic document management, and laboratory information management.
  • Ability to effectively analyze complex problems and present results effectively within and beyond the department
  • Ability to flexibly adapt to changing business needs and meet timelines.
  • Strong organizational skills with the ability to effectively multi-task and prioritize.
Desired Skills: 
  • Experience in method development, qualification, and transfer to/from other laboratories such as development, quality control.
  • Knowledge of biopharmaceutical process development is a plus.
  • Experience with automation is a plus.
  • Experience working in a cross-functional environment.
  • Good understanding of root cause analysis methodology.
Education 
  • Bachelor’s degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 6+ years of experience in a Biologics or Pharmaceutical environment.
  • Master’s degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 4+ years of experience in a Biologics or Pharmaceutical environment.
 
WORK ENVIRONMENT / PHYSICAL DEMANDS
  • This role is primarily a laboratory position; contact with chemicals is part of the job.  The role is fully onsite (5 days a week, 8-hour days) with occasional evening or weekend work required. The employee will be trained to use common lab equipment and minimize exposure to hazards.   Desktop or laptop computer work is also a major component of the job.
  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • 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, knee 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
 Analytical laboratory equipment.
CONTACTS 
Other scientists within Purification Process Development, Cell Culture Process Development, Analytic Chemistry, Quality Control, and Formulation; project managers, and laboratory associates.



Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.