Scientist 2, Technical DevelopmentLocation Novato, California Workstyle Open to Hybrid Apply
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.
Chemical, Drug Product and Device Technologies (CPDT) is comprised of a team of scientists responsible for Drug Substance (synthetic), Drug Product and Device development. CPDT is responsible for end-to-end development of chemical/synthetic molecules in collaboration with multi-disciplinary partners. CPDT team delivers stable formulations, reliable processes and technologies for drug product, combination products and administration components from early to late stage for all various modalities including oligonucleotides, gene therapy, small molecule, peptides, and proteins. We develop platform strategies to enable fast to patient approaches, including DS and DP development and manufacturing for outsourced programs.
The Chemical, Drug Product and Device Technologies (CPDT) group is seeking a motivated scientist to develop drug products for clinical and commercial application. The selected candidate will develop formulations and fill-finish processes as well as define appropriate primary packaging components and delivery devices for the drug products. The candidate will investigate and resolve issues associated with manufacturing and stability of formulated bulk drug substance and drug product. Experience in formulation development of proteins, gene therapy, and oligonucleotides through selection of appropriate buffer systems, excipients, and storage conditions is preferred. The role requires strong management skills and ability to efficiently collaborate with internal and external teams. The ideal candidate is a self-starter, team-oriented individual who is familiar with scientific literature and keeps up with new development in the field to identify opportunities for innovation.
- Employ advanced skills in the design and data analysis of experimental studies
- Able to integrate experimental design expertise with technical knowledge
- Expeditiously executes experimental work to meet project goals and timelines
- Utilize a diverse array of analytical instruments to conduct physicochemical and biophysical characterization of lead drug candidates
- Provide formulation support to Discovery to support PK, TK, drug safety and pharmacological studies in animal models
- Manage CDMO(s) and collaborate with internal and external teams to develop drug products
- Help define difficulty level to formulate drug candidates into clinical and commercial dosage forms
- Develop formulations and drug delivery systems and support technology transfer to external teams and or organizations
- Support investigation and resolution of issues associated with formulated bulk drug substance and DP production and stability
- Present experimental results and recommendations to project teams, provides updates of project status, risks, and mitigation strategies in the context of overall program goals
- Contribute to scientific publications and author/review appropriate sections of drug product CMC dossier for regulatory submissions (IND/NDA, CTA/MAA).
- Develop protocols for various stability studies in collaboration with team members and external partners to support various programs in early and late-stage development
- Maintain good documentation and assist in the preparation of presentations, patents, regulatory filings (IND, IMPD, BLA/NDA etc.)
- Assume research direction and administration duties in an interdepartmental research team
- Expect to adhere to Good Scientific Practices, and SOPs
- Develop people and project management skills to allow large multi-department projects to be carried out efficiently.
- May lead a group of one or more research associates
- Strong experience with pre-formulation and parenteral formulation development in the areas of protein, oligonucleotide or gene therapy
- Experience in formulation characterization & analytical instrumentation.
- Experience in authoring development reports, scientific publications, and/or patents that demonstrate significant scientific contributions to technologies, processes, and/or products.
- Advanced skills in experimental design, data analysis, and data presentation
- Ability to integrate experimental design expertise with technical knowledge
- Excellent analytical, oral, and written communication skills, as well as a demonstrated ability to operate both independently and in team settings
- Solid understanding with pharmaceutical characterization and testing equipment including HPLC, DSC, UV Spectrophotometry, SEC-MALS, Fluorescence Spectroscopy, MFI, HIAC, SLS, DLS, etc.
- Understanding of drug product development and GMP processes
- Willingness to work on multiple projects
- Proficient with Microsoft suite (MS Word, Excel, and PowerPoint)
- A strong team player with good collaborative and people skills
- Strong organization and prioritization skills, attention to details and ability for in-depth research and analysis
- Highly motivated individual able to resolve technical issues, develop and implement corrective solutions, adapt quickly and respond effectively to changes
- Experience with Gene therapy product development
- Flexible and ability to adapt to changes quickly
Ph.D., in the Pharmaceutical Sciences, Biochemistry, Biophysical Chemistry or related discipline with 2-5 years of experience (8+ years with MS or 12+ years with BS)
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.
In the U.S., the salary range for this position is $ 112,000 to $ 168,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.