Upstream Senior Scientist 1

Upstream Senior Scientist 1

BioMarin

Cork, Ireland

SUMMARY

The Technical Development and Services BCoE lab is seeking an Upstream Senior Scientist 1 to lead and grow a 3+ member team. Reporting to the Head of the BCoE lab, the Upstream Senior Scientist 1 will be a technical leader in Drug Substance Technologies. They will coordinate goals, support resourcing, and lead technical projects supporting commercial manufacturing. This individual will be responsible for overseeing the activities and professional development of a group of junior scientists and research associates as they develop, characterise, and transfer upstream biomanufacturing processes for our biologics pipeline programs. Activities of the team include design and execution of experiments in the laboratory, utilising and refining bench-top bioreactor and fermentor process models, and purification or analytics of intermediate samples to assess performance. The team also participates in process transfer, monitoring, and support efforts to one or more manufacturing sites.

Experience with process development phases, GxP operations, and regulatory expectations is essential for success. Bioreactor/fermentor scale-up and development experience is strongly desired, including understanding of the underlying engineering principles. This individual must be competent with design of experiments, statistical tools for analysis and interpretation of data, and electronic data management systems. The ideal candidate will also have familiarity with different biologics modalities and large-scale production systems for manufacture of therapeutic proteins.

RESPONSIBILITIES

• Leading team of scientists and research associates for upstream activities; this includes planning experiments, communicating company and program priorities, and reviewing data, presentations, and technical reports;
• Directs projects of a complex nature; oversees experimental, tech transfer, and manufacturing support activities and investigations;
• Participate in efforts to define, manage, and/or complete innovation projects that advance technical capabilities;
• Track team progress against project timelines, generate regular status updates and communicate progress, resourcing needs and issues to leadership;
• Foster strong collaborations with peers within TDS;
• Represents BCoE on cross-functional initiatives, e.g. establishing strategies & best practices;
• Design, setup, and oversee evaluation of new process or analytical equipment;
• Generate documentation for experimental reports to support technology transfer and regulatory filings;
• Attend scientific meetings and training courses to gather knowledge on best practices in industry.

EDUCATION

• PhD in Biology or a related field, or equivalent relevant experience, and more than five years of experience in the biotechnology industry; MS with 10+ years; BS with 12+ years.

EXPERIENCE

Required Skills:

• Experience with cell culture processing platforms, including bioreactor/fermentor optimization and scale-up;
• Process characterization and risk assessment experience necessary;
• Ability to perform statistical design of experiments (DoE), data analysis and interpret and present results;
• Clear technical writing and editing to author or oversee generation of technical reports;
• Successful management of scientists, with focus on professional development for employee and fit to organisational needs;
• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment;
• Strong communication skills to articulate activities of team through oral presentations.

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