Clinical Trials Assistant Jobs in Santa Rosa, CA

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.

SeniorScientist 2, Chemical Development & Manufacturing

This exciting role has emerged due to growth in theChemical Development & Manufacturing group, which is part of the Drug Substance Technologies (DST) function in the Technical Development & Services (TDS) organisation. Our pipeline consistently features new and diverse programs, which require development and manufacturing leadership throughout the full product lifecycle.

The Chemical Development & Manufacturing group leads the CMC development for all synthetic chemistry programs across Technical Operations (TOPS); while the diversity of modalities are continuing to grow, small molecules, oligonucleotides, peptides and PEGs are firmly established. A wonderful opportunity for a team player, with appropriate scientific skills and experience, as well as an energetic, growth mindset, to join an established, high functioning team.

The role involves driving clinical programs, through PPQ, as aPartner Team Lead (PTL).

Cross functional collaboration behaviors are critical to the role, where connectivity forms a mainstay of day to day activity. Interfacing groups include other Drug Substance modality functions, sister groups in TDS, including Formulation and Analytical departments.

Broader interfacing groups in the widerTOPs organization are also in play, especially External Manufacturing, Quality and Supply Chain, as well as enterprise-wide synergies with Research, Regulatory Affairs, Finance, Legal and others.

Project management, especially with regard to active programs withContract Manufacturing and Development Organizations (CDMOs), will draw upon excellent written and communication skills, as well as strong leadership behaviors. Contribute to the group strategy, participating in budget preparation and monitoring, as well as program planning.

Leadership Responsibility:

Through cross functional team engagement, collaboratively working on the technical team, ultimately to meet Enterprise-wide program timelines, including:

• Identify and assist in selection of new CDMOs, building a deep knowledge of the external landscape.
• Together with the DS team, drive the strategy and performance of the CDMO network, as well as the internal functions, to deliver enterprise and group goals.
• Anticipate scientific, business and program challenges, while working cross functionally to solve problems.
• Manage drafting and delivery of 3.2.S filing sections and address HA questions, in appropriate sections.
• Periodic in person visits to other BioMarin and CDMO locations, to ensure continued connectivity and alignment, across the internal network and Person-in-plant support, respectively.
• Play a part at the forefront of internal synthetic chemistry innovation, to ensure new technologies are identified, evaluated and implemented, positioning TDS centrally for cutting edge initiatives and early adaptation. Share learnings at appropriate platforms.

Must have: Minimum Requirements:

• Bachelors, Masters or PhD level in Chemistry or Chemical Engineering. Post-doctoral experience would be an advantage, while business, leadership or related training credentials, would be desirable.
• A combined minimum of 9 years of related experience is required in synthetic molecule, drug substance development environments and CMC DS program management.
• Working knowledge of pharmaceutical regulatory requirements, as well as solid cGMP skills.
• Excellent written and oral communication skills; expectation to present frequently, at in- house forums.
• Demonstrated capability at handling multiple programs and projects, at the one time.
• Agreement to work in a hybrid fashion, spending 2 days per week, on average, at the local BioMarin site.
• Travel: 20% - 30%.

Nice to have:

• Experience in Oligonucleotide development and/or manufacture, would be an advantage.
• Familiarity and/or working with ERP and quality documentation systems are desirable but not required.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.