Manufacturing Manager - Support ServicesLocation Cork, Ireland Apply
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.
Reporting to the Manufacturing Director, the Manufacturing Manager 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 Drug Substance material.
In Manufacturing, there will be a number of Manager positions, each responsible for one of the following areas:
- Upstream, Downstream, Support Services, MPEG (Manufacturing Process Engineering Group) or MPI (Manufacturing Process Implementation).
- MPEG are responsible for the equipment and automation used in the manufacturing areas including troubleshooting, updating and implementing safety/cost/process improvement projects in MFG. MPEG will grow and master manufacturing by delivering quality process engineering improvements as a high-performing team.
- MPI are responsible for the introduction of a new product to Shanbally from MFG perspective and also the introduction of any new major processes or systems into manufacturing.
Managers will be responsible for the colleagues (Process Engineers, Biotechnicians, BioProcess Specialists (BPSs) and/or Shift Leads) that exist in the respective group.
Main areas of responsibility:
• Lead and support the MFG team in the manufacturing of drug substance material under cGMP conditions
• Support and partner closely with other manufacturing managers, process engineers, biotechnicians and other colleagues to ensure master batch records, SOPs and other documents are current and compliant under cGMP conditions – ensure manufacturing systems and practices are consistent throughout the organization
• Lead and support daily operation of manufacturing processing systems and partner with plant engineering colleagues to ensure equipment is reliably maintained and within appropriate calibration
• Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing
• Instil the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence
• Represent Manufacturing group as necessary at critical meetings
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
• Coach, mentor and train biotechnicians, BPSs and process engineers on manufacturing processes, use of operational excellence tools, and high performance team behaviours
• Participate and support plant optimization that helps create a strong value proposition for future investment
Participate in budget planning process - identify and communicate capital equipment, facility, staffing and contract service requirements is preferred.
Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering or related field or equivalent experience is preferred.
• Past experience and demonstrated ability to successfully influence team performance in a high performance team is strongly preferred.
• Demonstrated experience working with MFG processes in production environment including hands on experience in any/all:
o Cell culture bioreactor, seed lab and harvest operations or
o Chromatography, ultra-filtration, and other purification unit operations or
o Support services unit operations; media/buffer preparation, autoclave and parts washer
• 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.
Should be proficient in the operation of all equipment used in the respective functional area of responsibility.
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.
The Manager will typically have ~5-30 direct reports depending on the group/product/project they are managing.
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.