Description

Area Lead, Manufacturing

ROLE

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.

KEY 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

-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 complex 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


Technical Documentation

-Provide feedback and/or suggested changes to operational procedures

-Assist in the incorporation of new technologies, practices and standards into procedures

-Capable of writing and reviewing process documents


Quality and Compliance

-Complete understanding and adherence to cGMP’s as related to commercial operations

-Support the closure of manufacturing discrepancies and change requests

-Experience with business systems (Process historian, LIMS, Trackwise, ERP, MES, etc.)


EXPERIENCE

5+ years of relevant industry experience

Demonstrated technical expertise in downstream processing

Working knowledge of process automation and associated process equipment

Proven organizational, shift leadership and communication skills

Identify and drive opportunities for process optimization

Ability to manage work, actions and expectations is essential

EDUCATION

B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.

Shift Details: Wednesday/Thursday – Sunday nights, 6PM – 7AM. Wednesday is rotating.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.