Bioprocessing Specialist & Permanent Inspection Read Lead Supply chain

Location Cork, Ireland Workstyle Onsite Only Apply

Who 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)

Closing Date: Friday 13th June 2025

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.

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