Scientist, Chemical Development and Manufacturing

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.

Scientist, Chemical Development & Manufacturing - Cork or Dublin

Hybrid Role - 2 days per week onsite

About the Opportunity:

This exciting role has emerged due to significant growth in the Synthetic Drug Substance group. Our pipeline consistently features new and diverse programs, which require development and manufacturing leadership throughout the full product lifecycle. The Synthetic Drug Substance 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.

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.

Leadership Responsibility:

• Through cross functional team engagement, establish and monitor program and project timelines, maintaining tight coordination with interfacing functions, to ensure continued, on time supply of drug substance, through alignment with clinical development milestones and commercial supply requirements.
• Help identify new synthetic routes, process improvements, coordinate technology transfer, while monitoring ongoing improvements at the CDMOs.
• Communicate and coordinate internal evaluation of process changes, change requests, deviations, and OOS findings. Coordinate with BMRN and contractor QA groups to ensure timely evaluation and approval of master and executed batch records, as well as other cGMP documents. Create justifications for changes, which would typically be driven by cost-of-goods, product quality, streamlined procedures and/or logistical simplicity.
• Coordinate with CDMO and BMRN quality and regulatory personnel to support regulatory submissions, to implement new procedures. Contribute to and co-author regulatory filings and other HA communications.
• Drive new CDMO identification and participate in cross functional evaluation, selection and on-boarding.
• Acquire and share knowledge of the contract manufacturing landscape, through interaction with candidate organizations, speculative site visits and attendance at trade shows.
• The position will also serve person-in-the-plant responsibilities, for both critical and routine production activities and will involve interaction with contractor technical staff, for the development and optimization of chemical processes.
• Participate in cGMP compliance audits, as a technical subject matter expert.
• Periodic in person visits to other BioMarin locations, to ensure continued connectivity and alignment, across the internal network.
• Remain up to date with academic and industrial advances, through networking, literature familiarity and conference attendance.
• Lead at the forefront of synthetic chemistry innovation, to ensure new technologies are identified, evaluated and implemented, positioning TDS centrally for cutting edge initiatives. Share learnings at appropriate platforms.

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. #J-18808-Ljbffr