Cmc Project Manager Jobs in Santa Rosa, CA (NOW HIRING)

Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people's lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Technical Operations
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.

• Experience leading multi-disciplinary team and providing oversight of cross-functional activities within the team,tobring about the successful planning, monitoring, and executing of deliverables.
• Experience with designingparenteralformulation screening and optimization studies, experience in gene therapy drug product development is preferred.
• Hands-on experience in solid oral dosage form development, including pre-formulation and formulation of tablets, capsules, and oral solutions.
• Experience withparenteraldrug product formulation development, characterization, testing, quality risk assessment and CMC regulatory guidance and filings.
• Strong leadership and team management skills. A strong team player with good collaborative and people skills.
• Strong organization and prioritization skills, ability to facilitate and drive program forward
• Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Highly motivated with the ability to resolve technical issues, develop and implement corrective solutions, be able to quickly adapt and respond effectively to changes
• The candidate will have a broad knowledge of regulatory, scientific, and technical issues concerning drug development applications.
• Experience in authoring/reviewing CMC sections for regulatory filings with health authorities.
• Excellent technical writing skills, experience authoring/reviewing development reports, batch records, regulatory filings, or other documents.

• Solid understanding and familiarity with pharmaceutical characterization and testing equipment such asHPLC(RP-HPLC,SEC,ion exchange chromatography),DSC, UV spectrophotometry, particle size measurement techniques, DLS, Differential Scanning Fluorimetry (DSF),and so on.
• Operational knowledge and experience withsmall molecules, oligos and peptidesfill finish operation and tech transfer.
• Familiarity with parenteral dosage forms, manufacturing processes, and packaging components is a plus
• Critical thinking and evaluation
• Influencing
• Organizational Awareness
• Performance Management
• Self-Knowledge