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.

Responsibilities

• Drive clinical programs, through PPQ, as a Partner Team Lead (PTL).
• Collaborate with cross-functional groups including other Drug Substance modality functions, sister groups in TDS, such as Formulation and Analytical departments, and broader interfacing groups in the wider TOPs organization, especially External Manufacturing, Quality and Supply Chain, as well as enterprise-wide synergies with Research, Regulatory Affairs, Finance, Legal and others.
• Contribute to the group strategy, participating in budget preparation and monitoring, as well as program planning.
• Lead the identification and assistance in selecting new CDMOs, building a deep knowledge of the external landscape.
• Work with the DS team to 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.

Requirements

• 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.

Qualifications

• Agreement to work in a hybrid fashion, spending 2 days per week, on average, at the local BioMarin site.
• Travel: 20% - 30%.

Skills

• 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.

Benefits

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.

Pay

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Schedule

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Benefits

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Company Information

Biobran 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 Biobran is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

Equal Opportunity Employer

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.

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.