Head Of MPI Operations - 12 Month Assignment
Hiring Manager: Shaun O'Neill ([email protected])
Description
Who We Are
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.
Head of MPI Operations - 12 Month Assignment
Location - Hybrid, Shanbally
Closing date for applications 31st October 2024
RESPONSIBILITIES
Reporting to the Manufacturing Director, the Head of MPI Operations will work in a team environment that is aligned with the manufacturing value stream, and will be committed to continuous improvement, process understanding, personal development, and demonstration of production techniques that will result in agile and compliant manufacture of Biomarin Products.
Main areas of responsibility:
Ensure all key safety & quality operational metrics are managed effectively through the standard timelines and DMS.- Post campaign analysis/lessons learned & campaign Readiness.
- Audit readiness standardization.
- Analytical Equipment System Owners.
- Spec support/SCN.
- Drafting, Updating & coordinating Technical Documentation.
- Leader sits on Site E2E Flow Support Team to ensure connectivity with all key functions on site.
- New Process Implementation.
- CI Ideas implementation.
- Ops lead for CAPEX, OPEX & Technology projects.
- Developing LRP business cases/Project business cases development.
- Process optimization & yield improvements in partnership with MSAT.
- Value capture and reporting.
- Coordinate the execution of Network Assessments as required in line with Network Strategy requests.
- Represent the different Operational areas of DS/DP/PKG with a view to maximize the manufacturing capacity and utilization.
- Key partner team for new product introduction across the different Operational areas of DS/DP/PKG.
- Deliver Manufacturing Operational Readiness Plans for key projects related to Tech Transfer, Capital and Site Strategic projects.
- Participate in budget planning process - identify and communicate capital equipment, facility, staffing and contract service requirements is preferred.
SCOPE
The MPI role will support Operations across the Drug Substance, Drug Product & Secondary Packaging Operational areas within the broader Manufacturing Operations function within the Shanbally site to support End to End Operations.
The MPI role will support Operations across the Drug Substance, Drug Product & Secondary Packaging Operational areas within the broader Manufacturing Operations function within the Shanbally site to support End to End Operations.
This role will lead a team of direct reports and a form part of a team of cross functional leaders to ensure seamless coordination and execution across the organisation, while also holding end to end leadership team responsibility to drive and optimize business performance ensuring seamless coordination and execution across the business.
EDUCATION
Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or biosystems engineering, or related field or equivalent experience is preferred.
Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or biosystems engineering, or related field or equivalent experience is preferred.
EXPERIENCE
Leadership experience within the GMP operational environment with strong demonstration of Decision Making, Influence & Collaboration, Agility and Leadership at the appropriate Level
Past experience and demonstrated ability to successfully influence team performance in a high-performance team is strongly preferred.
Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams.
Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
Experience with regulatory inspections and direct interaction with regulatory inspectors.
Demonstrated project management of resources, schedule and equipment is strongly preferred.
Track record of embedding a strong Quality culture. Trackwise experience preferred
Highly developed organisational and leadership skills.
Process development and/or technology transfer experience preferred.
CONTACTS
Work closely with Manufacturing, Validation, EHS, Automation, Manufacturing Science and Technology Group, Quality Operations and Facility Services personnel to ensure timely closure of Manufacturing challenges and implement effective CAPAs.
Work closely with Manufacturing, Validation, EHS, Automation, Manufacturing Science and Technology Group, Quality Operations and Facility Services personnel to ensure timely closure of Manufacturing challenges and implement effective CAPAs.
SUPERVISOR RESPONSIBILITY
The Manager will typically have ~5-15 direct reports depending on the group/product/project they are managing.
The Manager will typically have ~5-15 direct reports depending on the group/product/project they are managing.
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.