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.
·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
oSupport the closure of Manufacturing owned Quality Records (deviations, change requests)
Required Skills:
4-6 years Manufacturing Experience 2+ years Leading a team
Familiarity with manufacturing software, Chrome skids, TFF skids
Delegating work, leading a team, following production schedule
Desired Skills:
4-6 years Manufacturing Experience 2+ years Leading a team
Experience with Oracle, MES, Microsoft Teams, strong communication skills
EDUCATION
BA/BS desired not required
EQUIPMENT
Chromatography Skids, TFF skids, buffer tanks, Labwashers, Autoclaves
CONTACTS
Will interact with Manufacturing, Automation, Facilities, Instrumentation, QA, QC, Validation
SHIFT DETAILS
This position is for the Back half Day shift Wed/Thurs-Sat 6am-7pm
ONSITE, REMOTE, OR FLEXIBLE
Onsite only
TRAVEL REQUIRED
None
In the U.S., the salary range for this position is $ 95,000 to $ 142,600 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.