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Role Summary
BioMarinโs Technical Operations group is responsible for creating drugs for use in clinical trials and for scaling production for the commercial market. This role builds and maintains BioMarinโs manufacturing processes and sites, provides quality assurance and quality control to meet regulatory standards, and coordinates procurement and the worldwide movement of our drugs to patients. Shift: Back half Day shift, Wed/Thu-Sat 6am-7pm; Onsite only.
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)
Qualifications
- Required: 4-6 years Manufacturing Experience
- Required: 2+ years Leading a team
- Required: Familiarity with manufacturing software, Chrome skids, TFF skids
- Required: Delegating work, leading a team, following production schedule
- Preferred: 4-6 years Manufacturing Experience
- Preferred: 2+ years Leading a team
- Preferred: Experience With Oracle, MES, Microsoft Teams, Strong Communication Skills
Skills
- Experience with process automation and functionality
- Strong communication skills
- Familiarity with manufacturing software, Chrome skids, TFF skids
Education
- BA/BS desired not required
Additional Requirements