Research Associate 2, Drug Product development DPDT

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. 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. Come join our team and make a meaningful impact on patients' lives.

SUMMARY
The Research Associate 2 role will support the team by generating high quality data while executing both routine testing and more complex, exploratory research projects. In addition, the candidate is expected to lead certain aspects of projects independently including experimental design, execution, interpretation of results, drafting of technical documents, and communication of data to stakeholders through oral presentations

Responsibilities/ideal skills:

• Conduct preformulation characterization and formulation development studies including routine and non-routine laboratory activities under general supervision.
• Execute assigned laboratory experiments to support project goals. Conduct compatibility and stability studies under general supervision.
• Perform assigned assays to characterize drug substances and formulations.
• Familiarity with the set-up, maintenance and calibration of equipment and instrumentation to support projects is preferred.
• Trouble shoot equipment and coordinate repair if needed.
• Assist in tech transfer to internal and external manufacturing organizations.
• Contribute to the planning of the experimental studies.
• Conduct compatibility and stability studies under minimal supervision.
• Assist in tech transfer to internal and external manufacturing organizations.
• Assist in the development and characterization of formulations.
• Utilize a diverse array of analytical instruments and methods to characterize proteins and oligonucleotides
• Provide formulation support to R&D for drug safety and pharmacological studies in animal models
• Disseminate research and development work in writing or oral presentation as needed
• Maintain good documentation and assist in the preparation of presentations, patents, IND and BLA/NDA documentation
• Expected to adhere to Good Scientific Practices, and SOPs
• Lead and manage day-to-day activities of specific lab(s)
• Develop procedures to improve workflows and processes
• 
  

REQUIRED SKILLS

• Hands on experience with HPLC and several other analytical assay methodologies are required.
• Formulation development experience is preferred.
• Experience in pharmaceutical/biotech industry is required.
• Experience with the setup, maintenance and calibration of equipment and instrumentation to support projects is preferred.
• Attention to detail and effective organizational skills
• Able to use computers effectively for data analysis and presentation
• Ability to work in a fast pace and dynamic environment
• Excellent communication skills, strong ability to present results in both oral and written formats
• Be a team player

Experience/Education

BS in physical/Chemical/Biological/Life Science with over 2- 4 years' experience or M.S. with over 0-2 years' experience.

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.