Manager, Global MSAT Process Validation
Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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.
This position reports to the Sr. Director, Head of Global Process Validation and is responsible for multi-modality process validation activities in a cGMP environment. This position will coordinate and manage process validation projects related to the implementation of new manufacturing processes, changes to existing processes, and technology transfers according to the three phases of process validation. Process validation activities may include drug substance manufacturing processes, drug product filling processes, process simulations (media fills), filtration, mixing, sterilization, lyophilization, blending, tableting, powder filling, and packaging, and completion of validation impact/risk assessments and evaluations, etc.
Experience with various stages of clinical and commercial manufacturing in a quality and/or technical development roll is preferred. Experience with defining process validation requirements, experiment/studies, and defining acceptance criteria is necessary. Understanding and experience with change control and Health Authority requirements are highly recommended. Health Authority regulatory submissions and inspection experience is highly favorable.
The position organizes manages and performs process validation activities with minimal supervision within a cross-functional cGMP environment while fostering a collaborative Team environment. Other responsibilities of this position include project management, protocol generation, protocol execution, final summary report generation, CTD module generation and review, and other duties as assigned.
- Perform process validation activities related to BioMarin’s drug substance and drug products, through defined clinical and commercial stages.
- Execute (protocol generation, execution, and final validation package preparation) process validation activities related to the implementation of process changes and new processes while exercising judgment within broadly defined procedures and practices to establish acceptance criteria, identification, and implementation of solutions to meet BioMarin and Agency requirements.
- Assist with preparation of regulatory filings, with answering questions from health authority agencies, and with presentations of materials during regulatory inspections/partner audits.
- Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
- Determine methods and procedures on new assignments independently and in accordance with developed practices and procedures.
- May oversee and manage the activities of sub-teams.
- Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
- Lead and represent GMSAT Process Validation in multi-departmental meetings & project teams.
- Identifies and implements improvements to Process Validation systems (department level impact).
- Generation of process validation master plans, core validation master plans and additional supporting documentation.
- Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal BioMarin laboratories.
- Coordination of process validation activities involving cross-functional, multi-departmental teams including Manufacturing (contract), Manufacturing Sciences, Technical Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
- Other duties as assigned
The candidate will have a significant role in the approval of documentation and support for release of manufacturing systems and processes for cGMP use. This position is required to successfully complete projects in a timely manner supporting company goals and objectives. Decisions made by this position can significantly affect project timelines and the ability to manufacture drug substance/drug product meeting BioMarin and Regulatory Agency requirements.
Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
Training in project management is preferred
- 10+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
- 2+ years experience in a position utilizing formal project management a plus.
- Experience with Fill/Finish processes including aseptic filling and lyophilization.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate.
- Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in presenting or defending departmental functions in audits or regulatory inspections
- Understanding and demonstrated involvement with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.
- Proficiency with technical summary report generation required.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications is highly useful.
WORK ENVIRONMENT / PHYSICAL DEMANDS
This function will perform majority of work in an office setting, reviewing documents, participating in meetings, authoring documents. This function may perform up to 60% of its functions at a computer terminal.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; high pressure and temperature utility systems, risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The ability to perform gowning activities and enter the manufacturing plant is preferred, but not required.
This position requires ability to utilize a computer to perform tasks.
This position will require interaction with multiple levels (from technicians up through Sr. Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Technical Development, Facilities, Regulatory Affairs, Accounting, and People Resources.
This position may have up to 6 direct reports (including consultant support)
Demonstrated proficiency and experience in developing and maintaining validation department within cGMP expectations for the manufacture of drugs at BioMarin.
Demonstrated proficiency and experience in maintaining and defending validation systems satisfying regulatory inspection scrutiny
Demonstrated proficiency and experience in managing projects requiring multi-departmental coordination.
Demonstrated experience and knowledge of multi-departmental functions and issues (understanding the organization).Successfully achieving project goals and meeting company deadlines in timely and cost-effective manner.
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.