(Urgent Search) BioProcess Specialist, Supply Chain Operations

Overview

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. 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.

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. Come join our team and make a meaningful impact on patients’ lives.

Duties

SUMMARY DESCRIPTION

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 Bioprocess Specialist (BPS) is to provide technical leadership and support for Warehouse operations team including shipping/receiving, sampling and weigh/dispense activities. The BPS 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. The role presents a great opportunity for a candidate with technical experience within operational roles in Biopharmaceutical industry.

Main areas of responsibility:

- Provide technical leadership and be SME for warehouse operations team on all areas including Shipping/Receiving, warehousing, weigh/dispense and sampling.
- Lead and implement continuous improvement initiatives that add value to Supply Chain Operations.
- Support and partner closely with internal customers to ensure all operational activities are current and comply with cGMP conditions.
- Support and partner closely with peer groups to ensure SOPs, training records and other documents are current and compliant under cGMP conditions.
- Own, investigate, write and approve associated deviations as well as supporting and coaching Biotechnicians in these functions.
- Lead the execution of Supply Chain Operations readiness plans for manufacturing campaigns for new and existing products.
- Lead and support business process excellence implementation within Supply Chain Operations (e.g. 5S, SMED, Leader Standard Work, PPM & Standard work).
- Initiate and lead productivity and value enhancement projects for Supply Chain Operations.
- Support all infrastructure enhancement projects related to the Supply Chain Operations (SCO): warehouse storage areas, dispensary and sampling operational areas.
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
- 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.
- 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 behaviours.
- 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.
- Effectively and consistently prioritise and delegate daily assignments and projects to the technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.
- Supervise, and perform as needed, employee training in Warehouse Operations.

Skills

- Strong technical knowledge of warehouse operations including weigh/dispense and sampling activities.
- 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 manufacturing systems including MES, SAP and 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 organisational 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 Biopharmaceutical or manufacturing environment with excellent knowledge of manufacturing systems and processes.
- 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.
- Excellent problem-solving skills and experience in leading investigations.

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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