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Director – Sterile DP Manufacturing Operations

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. 

Having just obtained approval to establish internal Sterile Drug Product Filling operations at the Shanbally site, we at BioMarin are now looking to commence hiring for key technical and leadership positions.  Initially these roles will support the capital project execution, product transfers and operational readiness activities before moving into routine operational support. This facility will contain a state of the art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and commercial filling for the majority of the BioMarin biologics product portfolio.


Role Summary

BioMarin has a high-performing, team based organisation, 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 organisational skills.

The Director – Sterile DP Manufacturing Operations is a member of the Site Leadership team with accountability for the site Sterile Drug Product Manufacturing operations. Key aspects of this role include, program leadership to ensure successful startup of Sterile Drug Product Manufacturing operations, hiring and onboarding a strong sterile operations team and successful integration of sterile manufacturing operations into current Site operations and culture.

Once start up is complete the Director – Sterile DP Manufacturing Operations will have accountability for delivery of sterile drug product from the Shanbally facility across, component preparation, sterile filling and visual inspection operating units.

The Director – Sterile DP Manufacturing Operations will report to the VP Operations, Shanbally Site.

Role Responsibilities

  • Responsible for operation of dynamic, safe, high quality, and cost effective manufacturing facility
  • Recruit, develop and lead a clinical and commercial sterile DP manufacturing department which will ensure facility meets all cGMP operation requirements at all stages including start-up and validation of the facility.
  • Post start up, direct the manufacture of sterile filled drug products, syringes and vials, on the flexible Sterile filling line at Shanbally.
  • Serve as member of the Shanbally Site Leadership Team and contribute to the overall leadership and management of the site.
  • Lead the budget planning process for manufacturing including capital equipment, facility, staffing needs and contract service requirements.
  • Implement and manage a Site Readiness process that will ensure all operations adhere to and meet the project start up schedule and deliver key milestones.
  • Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements.
  • Responsible for managing all aspects of a high performance team.
  • Instill the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.
    • Ensure adherence to high standards of quality and support of a science and risk based quality culture.
    • Ensures relevant metrics are in place to effectively monitor and report out on operational performance and identify/implement improvement opportunities quickly.
    • Ensures that all manufacturing methods and practices are consistent with industry and BioMarin standards.
    • Ensures that colleague training programs are suitable and effective to support cGMP requirements.
    • Build focus and engagement by fostering opportunities for ownership, impact and continual professional development.

    Work Environment / Physical Demands

    Travel:   20%

    This would arise from time spent primarily at equipment manufacturers for design, engineering runs and FATs. Other travel would include the BioMarin facilities in Marin County, US.

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Education Required

    • Degree in Science / Engineering, Operations Management, or Industrial Engineering required
    • Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework)
    Experience Required
    • 15 years of directly related experience and at least 8 years in a aseptic drug product manufacturing environment.
    • Experience in drug product packaging and labelling beneficial
    • 5+ years of experience leading direct reports
    • Demonstrated ability to partner with other functional groups to achieve business objectives required
    • Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility.
    • Experience successfully leading a start up operation preferred
    • Strong communication skills – Oral, written and formal presentation skills with senior management, middle management and line staff
    • Creative problem solving skills
    • Comfortable and effective working indirectly through others

    Leadership Behaviors and Personal Competencies:

    Collaboration

    • Builds partnerships and works collaboratively with others to meet shared objectives.
    Communicates Effectively
    • Develops and delivers communications which convey a clear understanding of the unique needs of different audiences;
    • Skilled influencer; able to distill complex concepts into concise, salient points.
    Ensures Accountability
    • Holds self and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.
    Develops Talent
    • Develops people to meet both their career goals and the organization’s goals through coaching, feedback, exposure and stretch assignments;
    • Effectively develop successful leaders and high performing teams.
    Drives Vision and Purpose
    • Paints a compelling picture of the vision and strategy which motivates others to action.
    Strategic Thinking
    • Understands interdependencies, trends, issues and opportunities; able to synthesize complex information and translate into mid to long-range goals and plans.
    Interpersonal Effectiveness
    • Credible, trustworthy and empathetic leader; calm under pressure; can do attitude; relates openly and comfortably with diverse groups of people.
    Agility and Flexibility
    • Handles multiple projects and priorities simultaneously; operates effectively, even when things are not certain or the way forward is unclear.
    Versatility
    • Able to work in a variety of roles and settings, with a diverse group of people and/or functions.
    Results Orientated
    • Able to prioritize and focus on the few critical objectives;
    • Design simple, flexible organizational structures and systems that can align and adapt with evolving strategy.
    High Ethical Standards and Integrity

    Learning Orientation

    • Effectively adjusts to new, changing and unpredictable situations; able to learn new things quickly and easily; solicits and responds to feedback and coaching



    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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