Description

Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

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.

Bioprocess Specialist – Packaging Operations

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.

Packaging BPS - Projects
Closing Date: 30th January 2023
 

The Bioprocess Specialist – Packaging Operations reports to the Packaging Operations Manager and works in a team environment that will be committed to continuous improvement, process understanding, personal development and demonstration of production techniques that will result in agile and compliant packaging operations.

Main areas of responsibility

 

• Support for the Voxzogo DCC (Dual Chamber Cartridge) project. (Capital Investment of ~$20m) and support for the Suite 2 Palynziq Expansion. (Capital Investment of ~$8m). This role will support new equipment introduction and start-up of a commercial packaging facility and report to the Packaging Project Lead until commercial operations handover.
• Support the packaging line commissioning and qualification team from FAT through SAT, IOQ, Characterisation and PQ as required.
• Support and partner closely with peer groups to develop master batch records, SOPs, training records and other documents and ensure they are compliant under cGMP conditions – ensure Manufacturing systems and practices are consistent throughout the organization
• Own, investigate, write and approve associated deviations as well as support & coach

Packaging Technicians in these functions – ensure adoption of ‘zero late’ mentality in

meeting timelines.

• Ensure areas meet compliance standards and audit areas against standards - highlight any issues and work proactively with the area team and others to ensure resolution.
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory complian
• Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of and validation efforts required for commercial manufacturing and ongoing revalidation.

• 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
• Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high-performance team behaviour
• Supervise, and perform as needed, employee training in Packaging

 

EDUCATION AND EXPERIENCE

 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)
• At least 3 years experience in a regulated manufacturing environment with excellent knowledge of packaging operations
• Strong knowledge of cGMPs (US & EU), ISO, ANSI and other regulatory agency standards and requirements applicable to packaging operations
• Experience of successfully contributing to a startup operation highly desirable
• Experience in device assembly, secondary packaging and labelling and serialisation beneficial

• 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.