Sr. Associate, QC GTAT
Location Novato, California Apply
Who We Are
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.
ROLE
The GTAT Senior Associate is responsible for providing technical strategy and leadership relative to the performance, validation, optimization, development, troubleshooting, and transfer of molecular biological, biochemical and chemical evaluations for drug substance, drug product under cGMP guidelines and procedures. The GTAT Senior Associate is expected to provide strong cGMP knowledge and guidance to team members and will aid in solving lab issues as needed. The GTAT Senior Associate is responsible for supporting training to site QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods, and authoring or supporting the preparation of regulatory submission documents and, where required, supporting the on-time release, stability, and non-routine testing of pharmaceutical drug substances and drug product. Strong written and verbal communication skills are essential.
Analysis, interpretation and presentation of laboratory results and conclusions, being a key subject matter expert for regulatory inspections, training and educational development of other staff are also expected.
KEY RESPONSIBILITIES
• Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
• Contribute to analytical strategy for method optimization and implementation in QC. Partner with Analytical Sciences and site QC to ensure streamlined transfer of knowledge.
• Become Subject Matter Expert in analytical methods including: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, PCR, etc.
• Provide technical expertise for analytical methods in QC, support the maintenance of method, and analytical equipment implementation.
• Analyze, trend, and review method results during transfers, validation, and implementation of methods.
• Experimental design, execution, and report writing—often for direct submission to pharmaceutical regulatory agencies
• Develop, optimize, validate and troubleshoot analytical test methods
• Draft and revise QC SOPs for implementation into QC; may contribute to data review and approval of results and training of site QC analysts and data reviewers.
• Initiate and/or act as investigator/owner for validation discrepancy investigations, deviations, and related corrective and preventative actions. Complete records in timely manner.
• Expected to provide technical and cGMP knowledge and guidance to the entire team
• Maintain the laboratory in an inspection-ready state including support of equipment management
• Interact directly with regulatory agency inspectors during audits
• Interface with other BioMarin departments (MSAT, QCAT, Technical Development, Quality Assurance, etc.) and contractors as necessary
• Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
• Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
• Other duties as assigned
EDUCATION AND EXPERIENCE
BA/BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 10+ years professional experience)
MS/PhD in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 5+ years professional experience).
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.
In the U.S., the salary range for this position is $ 91,200 to $ 136,800 per year, 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. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
Apply 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.
ROLE
The GTAT Senior Associate is responsible for providing technical strategy and leadership relative to the performance, validation, optimization, development, troubleshooting, and transfer of molecular biological, biochemical and chemical evaluations for drug substance, drug product under cGMP guidelines and procedures. The GTAT Senior Associate is expected to provide strong cGMP knowledge and guidance to team members and will aid in solving lab issues as needed. The GTAT Senior Associate is responsible for supporting training to site QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods, and authoring or supporting the preparation of regulatory submission documents and, where required, supporting the on-time release, stability, and non-routine testing of pharmaceutical drug substances and drug product. Strong written and verbal communication skills are essential.
Analysis, interpretation and presentation of laboratory results and conclusions, being a key subject matter expert for regulatory inspections, training and educational development of other staff are also expected.
KEY RESPONSIBILITIES
• Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
• Contribute to analytical strategy for method optimization and implementation in QC. Partner with Analytical Sciences and site QC to ensure streamlined transfer of knowledge.
• Become Subject Matter Expert in analytical methods including: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, PCR, etc.
• Provide technical expertise for analytical methods in QC, support the maintenance of method, and analytical equipment implementation.
• Analyze, trend, and review method results during transfers, validation, and implementation of methods.
• Experimental design, execution, and report writing—often for direct submission to pharmaceutical regulatory agencies
• Develop, optimize, validate and troubleshoot analytical test methods
• Draft and revise QC SOPs for implementation into QC; may contribute to data review and approval of results and training of site QC analysts and data reviewers.
• Initiate and/or act as investigator/owner for validation discrepancy investigations, deviations, and related corrective and preventative actions. Complete records in timely manner.
• Expected to provide technical and cGMP knowledge and guidance to the entire team
• Maintain the laboratory in an inspection-ready state including support of equipment management
• Interact directly with regulatory agency inspectors during audits
• Interface with other BioMarin departments (MSAT, QCAT, Technical Development, Quality Assurance, etc.) and contractors as necessary
• Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
• Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
• Other duties as assigned
EDUCATION AND EXPERIENCE
BA/BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 10+ years professional experience)
MS/PhD in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 5+ years professional experience).
Required Skills:
Experience in QC Method Development, Validation, Transfer and Optimization
Strong knowledge of Regulatory Compliance requirements and experience with Audit and Site Support
Experience in Process Improvement projects
Desired Skills:
Data analytics and statistical analysis
Project management and planning
Training and mentoring junior team members
Experience working cross functionally, supporting global teams
SHIFT DETAILS
Days, Monday to Friday
Candidate would be expected to be on site for 2-3 days per week on average (varies depending on what they are required to work on each week)
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.
In the U.S., the salary range for this position is $ 91,200 to $ 136,800 per year, 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. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.