Job Description
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations 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.
Summary Effective training programs are critical in a regulated manufacturing business and this position plays an essential role in ensuring the training administration for BioMarin manufacturing and support groups are compliant with regards to GxP, regulatory and industry standards and guidelines.
The Training Specialist's primary function is to ensure our learning management system is effective, efficient and functioning correctly. He or she will interact with customers in the business to perform actions in the system and resolve any system issues as needed. They will ensure customers are adequately credited for the training necessary to properly and consistently perform their functions and help identify and implement process improvements that lead to gained efficiencies and reduced costs.
This position reports through the training function within the Business Operations department and supports the Novato manufacturing site and its support groups.
This position is responsible for
- Administration of the Learning Management System (LMS) to ensure seamless customer experience for the users of BioMarin manufacturing and manufacturing support groups
- Provision of training reports in support of audit and inspection
- Leading or assisting department projects as needed
- Owning or assisting department programs as needed
Responsibilities - LMS Administration
- Create and maintain training curricula and training items in association with customer departments/groups
- Assign curricula to newly hired or transferred staff
- Maintain paperless training credit system
- Data enter training records into LMS
- Review training records for compliance with Good Documentation Practices and manage corrections when needed
- Build and integrate multiple types of e-Learning trainings into the LMS
- Maintain creation and delivery of scheduled reports from LMS
- Create and deliver custom reports as requested
- Create, edit and archive documentation as directed by department management
Additional Responsibilities - Triage and process requests submitted to training team
- Participate in internal and external audits and inspections
- Review new/revised procedures (SOPs) and Training Change Requests (TCRs), provide feedback on the contents and assess the training needs and requirements.
- Maintain and update Customer Service platform (ServiceNow) used to submit training team requests
- Support department logistics as needed
- Deliver trainings as applicable
- Interact with customers across manufacturing and support groups to address technical support inquiries and distribute training-related communications
- Train on administrator tools and an ad-hoc and planned basis
- Guide/educate customers in the design of curricula and the associated implementation in the LMS to maximize efficiency and ensure consistency across learning content
Improving Processes
- Identify and recommend process improvements
- Lead or support improvement projects for training systems or programs
Experience Required Skills
Experience with:
- Effective customer service across all levels of business
- Administration of the LMS, preferably ComplianceWire
- Application of data integrity best practices in a corporate environment
- Use of web-based software applications
- Strong attention to detail
Desired Skills:
- 4-6 years experience of professional training experience
- 2-4 years in a regulated environment supporting highly technical processes (e.g. life sciences, energy, aviation, nuclear industries)
- Understanding and familiarity with FDA & European regulatory requirements
- Experience or interest in instructional design and training program development
- Basic/intermediate skills in online training development (e.g. Articulate 360, Camtasia, etc.)
- Excellent written and verbal communication skills
- Ability to comprehend technical information related to equipment, process and regulatory expectations
- Organizational skills to coordinate multi-discipline projects
- Problem solving and analytical skills
Familiarity with:
- Biotech, Pharmaceutical and/or Medical Device Industry
Proficiency in:
- Microsoft Office Suite (Excel, Outlook, Sharepoint, Visio, Word, Teams, OneNote)
- Skype or Zoom
EDUCATION
Bachelor’s Degree in a technical discipline preferred (biological sciences preferred, but not required)
Onsite Requirement: - This is a hybrid position with a requirement for onsite presence at least two days a week in Novato CA.
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.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Job Tags
Worldwide, 2 days per week,