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Senior Scientist II / Associate Director MSAT Cell Culture

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. 

MSAT Cell Culture Team Leader

SUMMARY DESCRIPTION
BioMarin has 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.
MSAT (Manufacturing Sciences and Technology) provides scientific and technical leadership for addressing process robustness, process understanding and process optimization opportunities in clinical and commercial manufacturing of biopharmaceutical processes. 
The successful candidate will be a person passionate about science and about leading others to successfully meet business objectives.
This person plays a leading role in troubleshooting processes, building a detailed understanding of them, and driving process robustness and optimization by setting clear objectives and empowering their team.  This position involves close collaboration within MSAT, Process Development, Manufacturing, Quality Control, and Quality Assurance groups.  
This position requires advanced technical expertise in mammalian cell culture processes, protein product quality attributes, associated scientific areas and advanced data analysis skills.  Of equal importance is the ability to lead and develop people. 

The successful applicant:
• Is a recognized subject matter expert within the company and considered for leadership roles within multidisciplinary project teams.
• Makes use of scientific expertise and understanding of the organization to develop and contribute to complex company objectives.
• Has demonstrated effectiveness and creativity in meeting objectives on multiple projects or initiatives. Regularly contributes proposals and influences decision-making within technical teams and at a site or division level.
• Acts independently in selecting scientific approaches and defining acceptance criteria. Has contributed to the field through patents, publications, presentations, or regulatory submissions.

RESPONSIBILITIES
• Leading, mentoring and development of staff is a critical part of the responsibility, with an aim to empower team members to a level commensurate with their skills and experience.
• Provide scientific leadership for the site and company with the aim to ensure steady product supply, process robustness and a focus on cost of goods reduction.
• Scale-up through technology/process transfer to clinical and commercial manufacturing.
• Establish and maintain scaled-down models of cell culture and harvest production processes.
• Utilize fundamental engineering principles relevant to bioprocess unit operations for scale-up and technology transfer.
• Effective communication with team members and stakeholders is a must.
• Define small-scale validation studies.
• Define strategic priorities for continuous improvement of manufacturing operations.
• Skilled in applying design of experiments principles to screening and process characterization studies.
• Ensure accurate and complete documentation of any scientific experimental plan, data and report.
• Lead Process characterization and range-finding experiments for current and new processes.
• 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.

EDUCATION
PhD in biochemistry, biochemical engineering, or the biological sciences, with a minimum of 8+ years relevant industry or related experience in process development/manufacturing sciences; Or MSc. with 12+ years relevant experience.  Understanding of GMP’s and the links to commercial and clinical processes is important.

EXPERIENCE
Should have 8+ years of relevant industry experience and demonstrated advanced expertise in cell culture processes. Must have strong communication skills and leadership experience.
• Demonstrated skill in biopharma cell culture and analytical techniques.
• In-depth knowledge of cell culture associated technologies and scale-up considerations.
• Experienced in the operation and analysis of purification systems at various scales.
• Experienced in cGMP and large-scale manufacturing equipment and practices and with the transfer of technology to cGMP operations.
• Experience in effectively managing scientific groups and projects.
• Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment.
• Demonstrated skill in leading project teams tasked with resolving complex production related issues.
• Experience leading, mentoring and developing others.

WORK ENVIRONMENT / PHYSICAL DEMANDS
Laboratory work and manufacturing support activities 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 cell culture and/or purification, as well as analytical instruments typical in biopharmaceutical labs and manufacturing

CONTACTS
• MSAT
• Manufacturing
• Quality and Validation
• Quality Control
• Process Sciences
• Facilities Services
• Regulatory Affairs
• Supply Chain

SUPERVISOR RESPONSIBILITY
Leads a team of scientists and engineers.

COMPETENCIES REQUIRED
• Technical Knowledge & Expertise                               
• Business Acumen        
• Critical Thinking & Evaluation                                     
• Influencing                                                                 
• Organisational Awareness                                          
• Performance Management                                         
• Self-Knowledge
• Talent Acquisition and Development 


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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