Scientist I / Scientist II Location Novato, California Apply
Job Requisition for Scientist I / Scientist II
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.
The selected candidate will be responsible for all pre-formulation/formulation activities associated with small molecule lead optimization and subsequent preclinical/clinical/commercial development. Success in this position requires a highly motivated individual who can provide leadership through previous experiences in the lab to coordinate and oversee activities with contract research organizations. The qualified candidate will have proven experience in developing parenteral and solid oral dosage formulations and possess excellent inter-personal skills to effectively work in a team-based environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Evaluate the selection of vehicles, excipients and/or new technologies appropriate to prepare formulations of investigational small molecules for in vivo studies.
Evaluate physical/chemical characteristics of small molecules as they relate to formulation investigations like pH, pKa, solubility, pH-solubility profile, particle size, solid and solution state stability studies, dissolution characteristics and polymorphism.
Critically evaluate data sets from multiple study designs to establish predictive strategies to rank order small molecules from clinical candidacy and support preclinical/clinical development of the selected candidate.
Primarily an individual contributor,capable of working independently with minimal supervision.Keeps up with new developments in field and is familiar with the scientific literature.
Identify opportunities for innovation and capable of generating quality scientific publications with limited assistance from coworkers. Takes primary responsibility for a wide variety of development projects, including shared responsibility for complex projects; carries out experimental work to meet project goals and timelines.
Develop a detailed understanding of product and process development, validation, GMP, and process transfer.
Plan & manage the technical and business activities associated with execution of formulation and process development, scale-up and technology transfer activities, via collaboration with multiple disciplines within BioMarin and with external contract research/development organizations.
Participate in internal and external scientific meetings.
Possess advanced skills in experimental design, data analysis, and data presentation. The candidate should be able to integrate experimental design expertise with technical knowledge.
Responsibilities include but not limited to managing the preparation, review and approval of a broad spectrum of technical documents such as MBRs, specifications, protocols, development reports etc. at contract vendors and at BioMarin. Additionally, the candidate will generate appropriate sections of drug product CMC dossier for regulatory submissions (IND/NDA, CTA/MAA).
Demonstrating experience of leading a development group of 1 or more research associates, and balance the scientific and the supervisory responsibilities is a plus.
BS degree in related discipline with 8 -12 +years of related experience; or,
MS degree in related discipline and 5 8 +years of related experience; or,
PhD in related discipline and 2 5 +years of related experience, or;
Equivalent combination of education and experience.
Strong experience with parenteral and solid dosage pre-formulation and formulation development
Experience in formulation characterization & analytical instrumentation.
Experience in authoring development reports, scientific publications, and/or patents that demonstrate significant scientific contributions to company technologies, processes, and/or products.
Knowledge of basic pharmaceutics principles, an understanding of the role pre-formulation plays in the drug discovery/lead optimization.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Has complete understanding and wide application of technical principles, theories, concepts and techniques.
Has good general knowledge of other related disciplines.
Possesses strong analytical skills, includinggood verbal and written communications skills.
Beginning to develop people and project management skills to allow large multi-department projects to be carried out efficiently.
Proficient with broad use computer applications such as MS Office and specialized statistical software applications as needed for job.
Works on very complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Creates formal networks involving coordination among groups.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.