Supervisor, Instrumentation

Novato, CA

Employer:

Description

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.

Supervisor, Instrumentation

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.

SUMMARY

This is a Swing Shift position operating Tuesday - Friday, 14 00 - 00 30. Under direction of the Associate Director, GMP Maintenance and Calibration, the Instrumentation Supervisor will be responsible for leading a team of individuals in the calibration of instruments in the cGXP environment, including Facilities, Quality Control, Validation, and Manufacturing Departments. The Supervisor is accountable for managing the activities of the staff, performing calibrations, writing, and revising calibration procedures and conducting or coordinating department specific training. Additionally, the Supervisor will oversee complete documentation of all required calibration activities and ensure compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), corporate policies and safety practices.

RESPONSIBILITIES

Leadership
- Accountable for the daily operations in Instrumentation which requires a high level of communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight.
- Accountable for all routine calibrations due.
- Accomplishes tasks through direct and effective coordination.
- Provides direction and hands-on training for staff.
- Involved in the management and development of staff.
- Lives department values and sets the standards for others to operate.
- Fosters an environment of compliance, work ethics and development.
Contribution
- Ability to take on moderate level projects.
- Effective interaction with peer Leads across multiple departments to create alignment and improvement.
- Partners with support groups (Manufacturing, Validation, Quality) to complete scheduled activities.
Process Knowledge
- Strong knowledge and experience in all aspects calibration theory, equipment, operation 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 instrumentation process, theory, and equipment.
- Experience with process automation and functionality a plus.
- Assist with review and approval of documentation including SOPs, Work Orders, and logbooks.
- Support the closure of Facilities owned Quality Records (deviations, change requests).
Quality and Compliance
- Complete understanding and adherence to cGMP's as related to Instrumentation.
- Initiate and own required Corrective and Preventative actions and lead change control actions.
- Support the closure of Facilities discrepancies and change requests • Current understanding of FDA and EMEA guidelines, cGMP's.
Business
- Experience with business systems (CMMS, Trackwise , ERP, etc.).
- Support trending and communication of defined department metrics.
- Identify and drive opportunities for process & business optimization.
- Translates company and department goals into actionable objectives for self and staff.

~This role directly handles and/or is in proximity to lentiviral or other viral vector based gene delivery systems.

EDUCATION

High School Diploma is required.
College degree desired.

EXPERIENCE

6+ years of directly related industry experience, including at least 2+ years with proven leadership role.
Ability to independently manage work, actions and expectations is essential.
Demonstrated technical expertise in instrumentation and calibration systems.
Strong organizational, collaborating and communication skills.
May have 5 or more direct reports to supervise.

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

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.

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.

In the U.S., the salary range for this position is $ 84,000 to $ 126,000 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.

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