Senior Scientist 2, Chemical Development & Manufacturing

About the role

This exciting role has emerged due to growth in the Chemical 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.

Responsibilities

• Drive clinical programs through PPQ as a Partner Team Lead (PTL).
• Engage in cross-functional collaboration across modality functions, sister groups in TDS (e.g., Formulation and Analytical), External Manufacturing, Quality, Supply Chain, and enterprise-wide groups (Research, Regulatory Affairs, Finance, Legal).
• Manage project management activities with Contract Manufacturing and Development Organizations (CDMOs), leveraging strong written, communication, and leadership skills.
• Contribute to group strategy by participating in budget preparation and monitoring, as well as program planning.
• Identify and assist in the selection of new CDMOs, building deep knowledge of the external landscape.
• Drive the strategy and performance of the CDMO network and internal functions to deliver enterprise and group goals.
• Anticipate scientific, business, and program challenges and work cross-functionally to solve problems.
• Manage drafting and delivery of 3.2.S filing sections and address HA questions in appropriate sections.
• Conduct periodic in-person visits to BioMarin and CDMO locations to ensure connectivity and alignment across the internal network and person-in-plant support.
• Lead internal synthetic chemistry innovation by identifying, evaluating, and implementing new technologies to position TDS for cutting-edge initiatives and early adaptation.
• Share learnings at appropriate platforms.

Requirements

• Bachelor’s, Master’s, or PhD in Chemistry or Chemical Engineering; post-doctoral experience is an advantage.
• Combined minimum of 9 years of related experience in synthetic molecule, drug substance development environments, and CMC drug substance program management.
• Working knowledge of pharmaceutical regulatory requirements and solid cGMP skills.
• Excellent written and oral communication skills; expectation to present frequently at in-house forums.
• Demonstrated capability to handle multiple programs and projects simultaneously.
• Willingness to work in a hybrid fashion, spending on average 2 days per week at the local BioMarin site.
• Travel: 20% – 30%.

Nice to have

• Experience in oligonucleotide development and/or manufacture.
• Familiarity and/or working with ERP and quality documentation systems.

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.