Area Lead, Downstream Manufacturing - United States
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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.
BioMarin leads the biotechnology industry in delivering therapies for chronic and degenerative genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. BioMarin will continue to focus on advancing therapies that are the first or best of their kind and make a big difference in improving patients' lives.
BioMarin’s Novato commercial manufacturing facility produces recombinant enzyme replacement therapies using perfusion based mammalian cell culture processes and multiple column purification systems. Under direction of area management, the Manufacturing Area Lead will be responsible for leading a shift of individuals in the production of commercial products in the Purification area. The Area Lead is accountable for the daily coordination of the activities of the staff, monitoring the maintenance of production equipment and facilities in the Purification Suite, overseeing complete documentation of all required production activities and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices. The position will require shift work, potentially including weekends, off hours and holidays.
Responsible for daily operations on the production floor, including scheduling, staffing, training, material use and troubleshooting to ensure that all operations are in full quality and safety compliance.
Technical proficiency in area of responsibility and ability to provide technical instruction and training to staff and team
Identify issues, troubleshoot and support resolution with support groups
Perform operational tasks in respective work area
Accountable for the daily operations in Purification which requires a high level of communication to make appropriate decisions, troubleshoot process and equipment malfunctions, and schedule adherences with minimal oversight
Accomplishes tasks through direct and effective coordination
Provides direction and hands-on training to staff
Involved in the management of staff with Supervisor
Embodies department values and sets the standards for others to operate
Fosters an environment of compliance, work ethics and development
Ability to take on moderate level projects
Effective interaction with peer Area Leads across manufacturing to create alignment and improvement
Partners with support groups (Facilities, Validation, Quality, etc.) to complete scheduled activities and non-routine activities right-first-time.
Strong knowledge and experience in all aspects process theory, equipment, and compliance
Ability to identify issues, troubleshoot 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
Proven experience with purification process, theory and equipment
Experience with process automation and functionality
Assist with creating, revising, reviewing and approval of documentation including SOPs, Batch Records and logbooks
Support the closure of Manufacturing owned Quality Records (deviations, change requests, etc.)
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
B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.
No direct reports. Area Lead is involved in the management of staff with Supervisor.
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.
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
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.