Area Lead, Manufacturing

Location:  Novato, California Category: Manufacturing

Description

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.

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. Come join our team and make a meaningful impact on patients’ lives.

RESPONSIBILITIES

The Fill Finish Lead is responsible for ensuring department floor operations; ensuring safety and compliance with cGMP's maintained at all times. Ensures the efficiency of materials, processing requirements, equipment function, and personnel training for day to day operations. As a leader for a Manufacturing shift, provides tactical leadership so that mission, vision, and department objectives are met.

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

Business

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

Other duties as assigned


EDUCATION

  • Bachelor’s degree in science related area or engineering or Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry

 
WORK ENVIRONMENT/PHYSICAL DEMANDS

  • Consists of strenuous, repetitive work. The following list of physical movements maybe used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
  • Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
  • May require work around loud equipment.
  • The use of personal protective equipment will be required.
  • Requires various shift based work and off hours
  • Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.


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.