Manager, Gene Therapy Pilot Plant

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.

JOB DESCRIPTION

Responsibilities

The Manager role is responsible for an assigned area within the Gene Therapy Pilot plant. Collaborates with support groups to ensure accurate and smooth process transfer and production. Oversees the planning, implementation and execution of operations for new products and technologies in a cGMP environment.

  • Accountable for plant activities, monitoring processing, maintenance of production equipment and facilities in the manufacturing areas, overseeing complete documentation of all required production activities and ensuring compliance with the Good Manufacturing Practices regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices.
  • Ensures the efficiency of materials, processing requirements, equipment function and personnel performance for the day to day operations.
  • Provide technical expertise to resolve manufacturing issues. Interact with support groups to ensure targets are met and product and process comply with cGMP guidelines.
  • Leading operational staff, developing staff capabilities, creating a culture of safety, maintaining training objectives, compliance and collaboration while implementing process improvements where applicable.
  • Issue deviations and change requests and work with department manager and/or QA professionals to evaluate, process and close records.
  • Sets project timeframes and priorities based on objectives with effective tracking and management of progress

EXPERIENCE

Required Skills:

  • 8 years of directly related industry experience, including at least 2+ years with proven leadership role and 4+ years of cGMP manufacturing experience.
  • Experience with process development, process transfer, validation or gene therapy manufacturing operation is a plus.
  • Strong organizational, collaborating and communication skills

EDUCATION

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

WORK ENVIRONMENT/PHYSICAL DEMANDS

The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

The position may require off hours support as required. The position will require shift work and potentially including weekends, off hours and holidays.



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