Bioprocessing Specialist & Permanent Inspection Read Lead Supply chain
Location Cork, Ireland Workstyle Onsite Only ApplyWho We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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.
Bioprocess Specialist & Permanent Inspection Readiness Lead
Location: Cork, Shanbally (Onsite role)
SUMMARY DESCRIPTION
The overall Supply Chain Operations (SCO) department is responsible for the site planning & scheduling, Raw Materials Purchasing, Oracle recipe management, VMI (Vendor Managed Inventory), Materials management, Warehouse, Dispensing/Sampling and Shipping to customers.
Reporting to the Supply Chain Operations Manager of the functional area, the primary role of the SCO BPS & PIR Lead is to provide SCO technical leadership and lead permanent inspection readiness within SCO. The lead will be committed to team development, continuous improvement and compliance. A high level of initiative, influencing and questioning skills are key role requirements, as well as excellent organisational skills.
Main areas of responsibility:
Compliance Leadership:
- Lead, own, investigate, write and approve investigations and CAPA implementation on site QMS system
- Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
- Develop, define scope, and support the implementation of technical solutions under the guidance of site change control systems
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
- Ensure areas meet compliance standards and highlight any issues and work proactively with the area team and others to ensure resolution
- 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
- Provide guidance on compliance and regulations and build competency within the Supply Chain Operations (SCO) team
- Develop and maintain an internal compliance programme within SCO
- Anticipate questions and focus areas related to ICH and Annex 1 guidelines
- Foster high expectations and unrelenting persistence towards continued audit success
- Generate responses to audit findings
- Lead and participate in self-inspections and compliance walk-throughs of all SCO areas
- Demonstrate a strong task focus. Use data analysis to identify problem areas and drive implementation of improvements and initiatives.
- Liaise with site and global support teams to share learnings and implement improvements at a company wide scale
- Responsible for reporting, monitoring and improving compliance metrics for SCO team
- Demonstrate a quality focused approach to decisions in SCO. Consider site wide impact and solutions to issues/decisions
- Use risk assessment and problem-solving tools to contribute to quality / compliance-related investigations / continuous improvements initiatives
Team Leadership:
- Foster a safety and quality focused environment through inspection readiness coaching support
- Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high-performance team behaviours
- Supervise, and perform as needed, employee training in SCO
- Effectively and consistently prioritise and delegate daily assignments and projects to technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule
- Report, monitor and improve compliance metrics within SCO
- Lead effective documentation lifecycle management for SCO
- Lead preparation for regulatory and corporate audits
- Create a permanent audit readiness state and a zero-late mindset
- Implementation of projects and initiatives to improve compliance metrics and audit preparedness
- Develop effective working relationships with key stakeholders across site
Skills
- Demonstrated experience working with MFG processes, device assembly and secondary packaging operations in a cGMP environment
- Past experience and demonstrated ability to successfully influence team performance in a high performance team is preferred
- Demonstrate strong communication skills and the ability to interact across cross-functional teams
- Track record of embedding a strong Quality and Safety culture
- Strong process knowledge of quality systems
- Excellent project management skills
- Proven ability to lead and deliver on multiple and agile and flexible to work on multiple initiatives
- Strong continuous improvement focus
- Strong collaboration skills
- Experience with site regulatory inspections and direct interaction with regulatory inspectors
- Highly developed organizational and leadership skills
Equipment
- Should be proficient in the operation of all equipment used in the respective functional area of responsibility.
Education
- Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering or related field or equivalent experience in a GMP environment is preferred.
- Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework).
Experience
- At least 3 years experience in a regulated manufacturing environment with excellent knowledge of quality systems.
- Demonstrated ability to partner with other functional groups to achieve business objectives.
- Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to material operations in a pharmaceutical production facility.
- Strong communication and interpersonal skills – oral, written and formal presentation skills.
- Creative problem solving skills.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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.
Equal Opportunity Employer/Veterans/Disabled
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.