Job Description
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\u2019s 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\u2019s 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\u2019 lives. SUMMARY: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.\u00A0 Additionally, CPDT aims to ensure an end-to-end chemical and manufacturing processes development for small molecules and oligonucleotides drug substances.\u00A0 In addition to in-house product development, CPDT also engages in collaborative partnership with contract manufacturing organizations (CMOs) to expedite development of selected drug product candidates. Responsibilities:This individual contributor will work in the CPDT group to assist in the advancement of BioMarin\u2019 s therapeutics for clinical evaluation and potential commercialization. In collaboration with a cross functional teams, key stakeholders as well as external partners, the individual will establish, monitor, and manage project milestones while ensuring compliance with BioMarin\u2019 s quality standards.\u00A0As the role cuts across formulation and device development, working knowledge of manufacturing and fill finish processes for small molecules, biologics, oligonucleotides and or gene therapy drug products is ideal.The position requires the following core competencies:\u2022Understanding of quality systems and GMP processes\u2022Working knowledge of drug product development process\u2022Project management expertise\u2022Organizational and communication skills \u00A0\u2022Negotiation and influencing skillsAdditionally this individual will: Facilitate selection, establishment, maintenance and decommissioning of strategic CMO partners Assist with contract and QTA negotiations as well as compliance audits Provide quality oversight for outsourced manufacturing, testing, packaging, and release procedures/activities Review and approval of Master and executed batch records as well as other GMP documents Ensure projects are executed in alignment with BioMarin\u2019s quality standards and manage their timely completionWork with subject matter experts to support the design/review/approval of development study documents (i.e. prototype screening, characterization, stability, fill-finish compatibility etc.)Manage technology transfer activities to and between contractor sites, encompassing process, analytical and logistical aspectsEvaluate contract manufacturing organization for fit with BioMarin development project requirements by leveraging knowledge on contractors\u2019 landscape through interaction with candidate organizations, site visits and attendance at trade shows.Coordinate assessments of process changes, change requests, deviation and out of specification findingsEnsure quality issues are investigated and appropriate corrective actions are implementedPrepare and deliver effective oral presentations at relevant department and cross functional meetingsManage change requests, deviations, CAPAs on TrackWiseManage CMO meetings and project directoryProvide Person in Plant (PIP) oversight for clinical CMOs, as neededInteract with various internal and external organizations.\u00A0 Engage with members of Chemical, Drug Product and Device Technologies, Analytical Sciences, Legal, Supply Chain, Clinical Operations, Global External Operations, Quality Control, Manufacturing, Regulatory, and Contract Manufacturing, Purchasing groups to jointly advance compounds through product development process.\u00A0 Interact with external parties (CMOs, contract laboratories, equipment Vendors, excipient suppliers etc.)\u00A0Requirements:4 years of experience (2 years with Masters) with 0-2 years of supervisory role in pharmaceutical or biotech setting.Experience managing a lab, preferred.Able to work at the Novato, CA site a minimum of 2 days a week.\u00A0Excellent interpersonal, verbal, and written communication skillsStrategic/critical thinking and problem-solving skillsUnderstanding of drug product development and GMP processesAbility to facilitate meetings, take accurate notes and communicate commitmentsWork collaboratively and effectively in cross-functional teamsPeople management skills\u2014efficiently leverage resources to meet project milestonesProficient with MS Word, Excel, and PowerPointExperience with managing quality investigationsStrong leadership and PO generation and accrual management.Technical expertise in drug product and device development, preferred.Knowledge of risk management tools as Fishbone, Failure Mode Effects Analysis, etc, preferred.Experience with oversight of phase appropriate GMP requirements during early phase development, preferred.Proficiency with eQMS (TrackWise) and eCDMS (Veeva) is preferredExperience establishing best practice processes, a plus 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.
