Scientist 2 - Chemical, Drug Product and Devices Technologies (CPDT)Location Novato, California Workstyle Open to Hybrid Apply
Title:Scientist 2 - Chemical, Drug Product and Devices Technologies (CPDT)
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.
The Chemical, Drug Product and Devices Technologies (CPDT) group, which is under the Technical Development organization, contributes to and aligns with BioMarin's mission of developing and commercializing innovative biopharmaceuticals for serious diseases and medical conditions. The CPDT group leads the development of stable, reproducible, and scalable drug products and devices that are safe for non-clinical, clinical, and commercial use. Additionally, CPDT aims to ensure an end-to-end chemical and manufacturing processes development for small molecules and oligonucleotides drug substances. In addition to in-house product development, CPDT also engages in collaborative partnership with contract development manufacturing organizations (CDMOs) to expedite development and fill finish of selected drug product candidates.
This Scientist 2/People Leader (managing 1-2 Research Associates) will work in the CPDT group to assist in the advancement of BioMarin’s therapeutics for clinical evaluation and potential commercialization. They will perform formulation development screening studies and develop clinical/commercial formulations and fill/finish processes for drug products. Theywill also define appropriate primary packaging and delivery devices for the finished drug product as needed. Experience in formulation of monoclonal antibodies through selection of appropriate buffer systems, stabilizersand storage conditions is preferred. The candidate is a highly motivated and responsible for leading formulation and process development activities for biologic drug candidates. This will include biophysical characterization of drug candidates, designing/conducting stability studies on prototype formulations and performing development work to support fill/finish processdesign and tech transfer to CMOs. In addition, the candidate should have experience with parenteral formulation development and manage early phase programs which requires working with CROs and CMOs for development of an appropriate drug product formulation, selection of suitable primary packaging and manufacturing of early phase clinical drug products.To accomplish these tasks, the selected candidate should preferably possess the skills to utilize a diverse array of analytical instruments to characterize protein molecules and the experience with drug- device combination product development. The ideal candidate is a self-starter familiar with the literature and keeps up with new developments in the field and is thus able to identify opportunities for innovation.
Working closely with a cross functional internal team as well as external partners, the individual will establish, monitor, and manage project milestoneswhile ensuring they meet BioMarin’s quality standards and are executed in a timely manner.
The position requires the following core competencies:
- Possess technical expertise in biophysical characterization of drug candidates,designing/conducting stability studies on prototype formulations and performing development work to support fill/finish process design.
- Familiarity with quality systems and GMP processes
- Organizational and communication skills
- Characterize the physicochemical properties of protein drug candidate compounds.
- Develop non-clinical formulations for efficacy and toxicology studies, perform formulation development screening studies and develop clinical/commercial formulations and fill/finish processes for biologic protein products
- Design and execute in-house laboratory studies and manage technical work at contract manufacturing partners
- Drive and/or impact projects of complex nature; design and execute experimental protocols for wide variety of projects independently
- Anticipate technology resources, introduce and/or invent new methodologies
- Participate in leading sub-team meetings to investigate drug product fill finish issues, troubleshoot formulation issues, and propose preventive/corrective actions to resolve issues related to formulation
- Lead, Supervise and/or train Sr. Research Associates and Research Associates
- Maintain Good Documentation and Assist in the preparation of presentations, patents, IND and BLA/NDA Documentation.
- Provide technical subject matter expert input to facilitate establishment and maintenance of CMO partners
- Participate in evaluation of CMO’s fit with BioMarin development requirements by evaluating contractors’ capability and capacity by engaging with candidate CMOs, site visits and attending trade shows
- Along with internal and CMO organizations,review Master batch records as well as other GMP documentsas a technical subject matter expert for drug product fill finish operation
- Technical oversight ofearly phase projectexecution, work with internal and externalpartners to ensure their timely completion
- Responsible fordrug product technology transfer activities to and between contractor sites or to internal partners
- Prepare and deliver effective oral presentations at relevant cross functional meetings.
- Provide Person in Plant (PIP) oversight for clinical CMOs for projects duringearly phase product development
- Excellent interpersonal, verbal, and written communication skills
- Strategic/critical thinking and problem-solving skills
- Understanding of drug product development and GMP processes
- Work collaboratively and effectively in cross-functional teams
- Proficient with Microsoft suite (MS Word, Excel, and PowerPoint)
- Experience with managing quality investigations
- Strong leadership and financial acumen
- Flexibility – Agile and ability to pivot quickly as needed when priorities changed
- Technical expertise in parenteral drug product and device development
- Oversight of phase appropriate GMP requirements during early phase development
- Ph. D degree in Pharmaceutical Sciences, Biochemistry, Biophysical Chemistry, or related scientific discipline with 5 years or MS with 8 years.
The individual is expected to interact with various internal and external organizations. Internally, the individual will engage with members of, Technical Development (cell culture, purification, chemical, drug product and device, and analytical science), CMC project management, Discovery & Research,Legal, Global External Organization, Quality Control, Validation, Quality Assurance, Manufacturing, Regulatory, and Contract Manufacturing, Manufacturing Science and Technology and Purchasing groups to jointly advance compounds through product development process. Additionally, the individual is expected to interact with external parties such as CMOs, contract laboratories, equipment vendors, excipient suppliers,etc.
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, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.