Lead, Manufacturing (Grave Shift)

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.

Manufacturing Shift Lead Backhalf Graves

SUMMARY

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 individuals 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.

RESPONSIBILITIES

Leadership

• Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight
• Accomplishes tasks through direct and effective coordination
• Provides direction and hands-on training for staff
• Supports the management of staff with supervisor
• Lives department values and sets the standards for others to operate
• Fosters an environment of compliance, strong work ethic and ongoing learning

Contribution

• Ability to take responsibility for moderate level projects
• Effective interaction with peer Leads across manufacturing to create alignment and improvement
• Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities

Process Knowledge

• Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
• Ability to troubleshoot, identify issues and support resolutions with technical groups
• Required to perform ongoing operational tasks in respective work area
• Uses scientific thinking and decision making in daily work

Technical Competency

• Proven experience with relevant process, theory and equipment
• Experience with process automation and functionality
• Assist with review and approval of documentation including Batch Records and logbooks
• Support the closure of Manufacturing owned Quality Records (deviations, change requests)
• Other duties as assigned

EXPERIENCE

Required Skills:

• 2-4 years Manufacturing Experience 0-2 years Leading a team
• Familiarity with manufacturing softwares, Chrome skids, TFF skids
• Delegating work, leading a team, following production schedule

Desired Skills:

• 2-4 years Manufacturing Experience 0-2 years Leading a team
• Desired skills is experience with Oracle, MES, Microsoft Teams, communication with groups

EDUCATION

BA/BS desired not required, 1-2 years leading Manufacturing experience

EQUIPMENT

Chrome Skids, TFF skids, buffer tanks, labwashers, autoclaves

CONTACTS

Will interact with manufacturing, automation, facilities, instrumentation, QA, QC

SHIFT DETAILS

This position is for the Backhalf Graves shift Wed/Thurs-Sat 6pm-7am

ONSITE, REMOTE, OR FLEXIBLE

Onsite only

TRAVEL REQUIRED

None

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.

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.