BioMarin Pharmaceutical
Intern, External Quality Strategic Partnerships
BioMarin Pharmaceutical, Novato, California, United States, 94949
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: The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining insight into the pharmaceutical/biotech industry. Over the course of 10 - 12 weeks, our interns gain industry experience while working alongside our talented team on meaningful projects. External Quality supports oversight of the Quality of production processes and in-country release/testing that occur at Contract Manufacturing Organizations (CMO), Contract Development Organizations (CDMO), Business Partners and Contract Testing Organizations (CTO). This position reports to the Quality Strategic Partner Lead in External Quality and will support BioMarin’s engagement with our business partners. This role will collaborate across sites at BioMarin for all aspects of production and support activities related to our business partners.
JOB DESCRIPTION/PROJECT:
Provide support for one or more areas of the Quality Strategic Partner processes, including but not limited to: Key Performance Indicators, Deviation and Change Control Management, document revisions, communication flows, other administrative items. Participate in cross-functional Quality Strategic Partner meetings. Support development and improvement of Partner related processes and procedures, and continuously evaluate and improve practices and systems. Assist in development, implementation, and enforcement of functional processes and procedures. Other duties as assigned.
Required Skills:
Strong ability to comprehend complex information related to biopharmaceutical production. Proficiency with standard software applications, including MS Excel, Word. Exceptional organizational, spelling, grammar and typing skills. Effective leadership and communication skills.
Desired Skills:
Basic understanding of good manufacturing practices (GMP) and working in a regulated environment. Understanding and familiarity with FDA, European, PMDA guidelines. Proficiency in Power BI, SharePoint.
Qualifications/Eligibility:
Student in their 3rd or 4th year of Undergrad or Graduate student pursuing a degree in physical/biological science, financial/accounting, or business. Must be available to work full time, 40 hours a week. Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall term after the completion of the internship OR have graduated within 1 year of the start of the program. Must be able to relocate if necessary and work at the designated site for the duration of the internship for on-site, hybrid roles. Some positions will be open to remote interns, but employee must be within United States borders.
Benefits of a BioMarin Internship:
Paid hourly wage, paid company holidays, and sick time. Apply skills and knowledge learned in the classroom to on-the-job experiences. Comprehensive, value-added project(s). Develop skills specific to your major. Opportunities for professional development by building relationships and learning about other parts of the business. Participate in company all hands meetings, monthly community lunches. Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks. Access to Employee Resource Groups.
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. In the U.S., the salary range for this position is $21 to $30 per hour, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
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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: The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining insight into the pharmaceutical/biotech industry. Over the course of 10 - 12 weeks, our interns gain industry experience while working alongside our talented team on meaningful projects. External Quality supports oversight of the Quality of production processes and in-country release/testing that occur at Contract Manufacturing Organizations (CMO), Contract Development Organizations (CDMO), Business Partners and Contract Testing Organizations (CTO). This position reports to the Quality Strategic Partner Lead in External Quality and will support BioMarin’s engagement with our business partners. This role will collaborate across sites at BioMarin for all aspects of production and support activities related to our business partners.
JOB DESCRIPTION/PROJECT:
Provide support for one or more areas of the Quality Strategic Partner processes, including but not limited to: Key Performance Indicators, Deviation and Change Control Management, document revisions, communication flows, other administrative items. Participate in cross-functional Quality Strategic Partner meetings. Support development and improvement of Partner related processes and procedures, and continuously evaluate and improve practices and systems. Assist in development, implementation, and enforcement of functional processes and procedures. Other duties as assigned.
Required Skills:
Strong ability to comprehend complex information related to biopharmaceutical production. Proficiency with standard software applications, including MS Excel, Word. Exceptional organizational, spelling, grammar and typing skills. Effective leadership and communication skills.
Desired Skills:
Basic understanding of good manufacturing practices (GMP) and working in a regulated environment. Understanding and familiarity with FDA, European, PMDA guidelines. Proficiency in Power BI, SharePoint.
Qualifications/Eligibility:
Student in their 3rd or 4th year of Undergrad or Graduate student pursuing a degree in physical/biological science, financial/accounting, or business. Must be available to work full time, 40 hours a week. Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall term after the completion of the internship OR have graduated within 1 year of the start of the program. Must be able to relocate if necessary and work at the designated site for the duration of the internship for on-site, hybrid roles. Some positions will be open to remote interns, but employee must be within United States borders.
Benefits of a BioMarin Internship:
Paid hourly wage, paid company holidays, and sick time. Apply skills and knowledge learned in the classroom to on-the-job experiences. Comprehensive, value-added project(s). Develop skills specific to your major. Opportunities for professional development by building relationships and learning about other parts of the business. Participate in company all hands meetings, monthly community lunches. Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks. Access to Employee Resource Groups.
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. In the U.S., the salary range for this position is $21 to $30 per hour, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
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