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.
The Technical Writer is responsible for ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies, and safety practices.
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.
- Provide technical and cGMP expertise for all aspects of technical writing and testing documents. May contribute to QC data review and / or verification in support of method studies.
- Provide technical expertise for all aspects of testing, method validation, transfer and lifecycle management.
- Coach and develop individuals within the group.
- Responsible for inter-team and inter-department collaboration
- Collaboration with QC Analysts, Associates, Scientists, Laboratory Manager to ensure successful QC Laboratory studies and method implementation.
- Develop and maintain both internal and external relationships
- Contributes to authorship of regulatory submissions; presents work to cross-functional teams as required.
- Author, review and approve documents such as standard operating procedures, protocols, reports, master plans, policies, and investigation or change request records.
- Interact with development laboratories and provide guidance for qualification and transfer of methods.
- Ensure the team is compliant to GXP and safety and environmental standards.
- Participate and ensure support for cross-functional teams.
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
- Lead and implement initiatives that add value to the QC and global operations.
- Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
- Other job responsibilities as assigned.
- Minimum 3 years of experience in Quality Control or similar environment
- Sound knowledge of ICH and FDA guidance documents for analytical methods
- Proven technical writing experience
- Proficiency with Trackwise or QMS and Office365 preferred
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.