Scientist, Chemical Development and Manufacturing

at  Biomarin

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’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.

MINIMUM REQUIREMENTS:

• Bachelors, Masters or PhD level in Chemistry or Chemical Engineering.
• Post-doctoral experience would be an advantage, while business, leadership training or related training credentials, would be desirable.
• A minimum of 4 years of related experience is required in synthetic molecule, drug substance operations, in either manufacturing or R&D environments.
• Process engineering and/or organic chemistry, at both the research level and in large-scale GMP production.
• 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.
  Travel: 20% - 30%. This would arise from time spent on European contractor sites, BMRN facilities, such as those in Marin County and Ireland, as well as possible visits to raw material suppliers in Asia.

DESIRABLE SKILLS AND EXPERIENCE

• .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.
  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

RESPONSIBILITIES:

• Functioning in the Synthetic Drug Substance group, which is part of the Technical Development & Services organization, the role provides day-to-day oversight and management for synthetic molecule, drug substance contract manufacturing activities, throughout the product lifecycle. As such, handovers from the Research organization and ultimately, transfer to Global External Operations, are habitual.
• Cross functional cultures are critical to the role, where connectivity, often through matrix-driven program teams, form a mainstay of day to day activity. Interfacing groups include other Drug Substance modality functions, sister groups in Technical Development Services, including Drug Product & Device Development and Analytical Sciences, interfacing groups in the wider Technical Operations (TOPs) organization, especially Global External Operations, 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 with Contract Manufacturing and Development Organizations (CDMOs), will draw upon excellent written and communication skills, as well as strong leadership behaviours.
• Contribute to the group strategy, participating in budget preparation and monitoring, as well as program planning.