Manufacturing Area LeadLocation Novato, California
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.
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.
The successful candidate will be a key member of the team to design and implement a FVIII Gene Therapy production area.
The position may require off hours support as required. The position will require shift-work, potentially including weekends, off hours and holidays. The successful candidate will be a key contributor in the development of a new Gene Therapy Product.
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.
- Experience in inspection of finished product, labeling, and vial reconciliation requirements
- Reviews schedules and manages tech transfer, and assembly operations as required
- Experience in aseptic processing, environmental controls and automated filling systems
- Review batch records and provide oversight for all specified manufacturing operations undertaken
- Responsible for oversight of routine operations on the production floor; including scheduling, training, material use, and troubleshooting to ensure all operations are in full compliance with regulatory and safety guidelines
- Demonstrate a high level of understanding and experience with fill finish technologies, automation controls, and compliance
- 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
- Broad knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation
- Ability to understand, apply, and evaluate basic chemistry, biology and scientific principles as appropriate for the position
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, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.