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Scientist 1 MSAT Process Analytics

Location Cork, Ireland
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. 






SUMMARY DESCRIPTION
BioMarin is a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.
The candidate must think independently, work well in a team environment, and apply management and leadership skills.  He or she must demonstrate strong interpersonal, communication and organizational skills. This is a key role in the Manufacturing Sciences and Technology group.
The MSAT Scientist in this role will be a key provider and source of analytical expertise and technical knowledge to the MSAT group and provide expertise in analytical applications and data interpretation for drug substance and drug product. The role is to provide thought leadership and technical guidance and fulfull a mentorship and coaching role in the MSAT group.
They will provide expertise in developing and troubleshooting analytical methods needed to support protein Purification and Cell Culture processes and provide expert input on product quality and impurity identification and clearance, in the development and/or feasibility studies for manufacturing processes.
The role involves close collaboration with Cell Culture, Downstream and Manufacturing Interface groups in MSAT in addition to groups such and Manufacturing and QC locally and Process Development, Analytical Chemistry and functional groups at other BioMarin locations. The role combines elements of scientific and operational and people leadership.
Furthermore, this position requires a degree of familiarity with quality control and its relationship to cGMP manufacture of therapeutic enzymes.

RESPONSIBILITIES
• In consultation with scientists and project leads, independently develop, qualify and troubleshoot a variety of analytical methods needed to support protein Purification and Cell Culture processes.
• Support MSAT Purification and Cell Culture Process Development activities with analytical testing and data interpretation.
• Develop new techniques, and bring in new technology from the outside, to enhance the analytical capabilities of the group.
• Work with MSAT scientists to identify knowledge gaps and provide analytical solutions to increase process understanding
• Develop the analytical capability of MSAT for characterization, in-process, Drug Substance and Drug Product analyses.
• Develop tool-kit for MSAT, internally and/or with external partnerships, to allow for both routine and non-routine characterization, in-process and quality testing.
• Partner with other members of the team, as well as cross-functionally, to review and investigate analytical data results and trends from the commercial or clinical process, as well as for the lab scale experiments, and present results, conclusions and implications to project teams and stakeholders.
• Interface with other departments, such as QC, Manufacturing and QA regarding a designated project.
• Act as a coach within the MSAT department to enhance the group’s overall process analytics expertise.
• Identify external partners to support testing requirements during process development, protein characterization and manufacturing investigations.
• Prepare SOPs, reports and documents such as characterization protocols, development reports, and testing results data reports.
• Ensure analytical equipment is maintained in a fully functional and calibrated state.
General:
• Independently plan, execute and complete significant projects with minimal supervision.
• Interface with Manufacturing, Quality and Validation, Quality Control, Process Sciences and Facilities Services.
• Review and interpret raw data.
• Maintain excellent documentation of laboratory work.
• Be a team player with excellent communication skills.
• Adhere to all site safety, environmental and industrial hygiene procedures and practices.
• Play an active role in maintaining and enhancing the safety of the workplace and the laboratories.
• May be required to work periodically out of normal business hours
• Prioritize effectively and manage multiple priorities in a fast-pace work environment


EDUCATION
• Bachelor’s degree in biochemistry, biology, analytical chemistry or related field with 10+ years relevant experience; Master’s degree with 8+ years; or Ph.D. with 3+ years.


EXPERIENCE
• Bachelor’s degree in biochemistry, analytical chemistry, biology, biochemical engineering or related field with 10+ years relevant experience; Master’s degree with 8+ years; or Ph.D. with 3+ years.
• Detailed knowledge in bio-analytical science and technologies.
• Detailed working knowledge of protein interactions, analysis and characterization techniques to include UPLC/HPLC – e.g., rpHPLC, SEC, SAX, impurity characterization and clearance techniques, immuno-assay techniques, enzymatic assays and carbohydrate analysis related to in-process and product quality testing.
• Working knowledge of particulate (visible and sub-visible) identification and measurement and Mass Spectrometry techniques.
• Working knowledge of assay transfer, assay development, optimization and qualification.
• Knowledge process sciences relating to cell culture and protein purification technologies at small and or/large scale.
• Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment.
• Demonstrated expertise in planning and designing experimental work and in data analysis and interpretation.
• Demonstrated experience of writing reports and other technical documents, and presenting to groups of technical experts and stakeholders.
• Scientific publications and presentations at technical conferences desirable.

WORK ENVIRONMENT / PHYSICAL DEMANDS
The role of MSAT is to provide excellent scientific and process engineering support to BioMarin’s portfolio of commercial and clinical products. In that regard the work environment is highly varied. Laboratory work will require the use or proximity of chemicals, laboratory and manufacturing equipment and instruments, and mechanical moving parts.  Noise and vibration may be present.

Periodic week-end laboratory work and week-end support work and/or on-call support for Manufacturing will be required.

EQUIPMENT
• Equipment related to analytical testing, as well as cell culture and/or purification equipment typical in biopharmaceutical labs and manufacturing

CONTACTS
• MSAT
• Manufacturing
• Process Development
• Quality Control
• Analytical Chemistry
• Quality and Validation
• Facilities Services

SUPERVISOR RESPONSIBILITY
May be responsible for managing one or more associate scientists.

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.

 We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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