Supports the Quality Management System (QMS) and Document Management System (DMS) in a GMP regulated environment, ensuring compliance with SOPs, GMP/GLP standards and client requirements.
Compensation
The hiring range in Colorado for this position is $93,750/year - $108,750/year and is eligible for a 4% annual target bonus.
Responsibilities
Perform independent quality evaluation and release of support documentation, materials, products, equipment, and/or facilities
Ensure testing/manufacturing performed per approved SOPs/methods/protocols and comply with specifications
Participate in internal, client and/or regulatory audits
Support quality events and root cause analysis
Develop, implement, and maintain procedures and policies to comply with FDA, EU, and ICH requirements
Senior Scientist responsible for method validations, transfers, and verifications on APIs and finished products, applying GMP and leading analytical investigations.
Responsibilities
Perform method validations, transfers, and verifications on APIs and finished products
Apply GMP principles in all responsibilities
Conduct analytical investigations using HPLC, GC, UV/Vis, and dissolution techniques
Troubleshoot instrumentation and coordinate with vendors
Train and mentor junior staff in laboratory procedures
Execute analytical techniques in support of method validation for Active Pharmaceutical Ingredient manufacturing.
Compensation
The full-time equivalent pay range for this position is $85,840.00 - $134,125.00/yr plus eligibility for bonus, stock and benefits.
Responsibilities
Design and conduct laboratory scale experiments using analytical instrument platforms such as HPLC/UPLC, HPLC-MS, ICP-MS, IC, GC, GC-MS, UV, Karl Fischer
Author method validation protocols and reports with adherence to ICH guidelines and internal Agilent standard operating procedures (SOPs)
Design and safely conduct laboratory scale experiments using current best practices for API testing
Properly record and summarize experiments in notebooks and reports and construct research summaries to present to internal teams
Maintain process compliance integrity by adhering to SOPs and current good manufacturing practices (cGMP) as appropriate
Requirements
Bachelor's degree (B. S.) or equivalent in chemistry, or related applied science field
Nice to have: Experience with IC, GC, GC-MS, UV, Karl Fischer
Nice to have: Experience working in a cGMP regulated environment
Nice to have: Knowledge of analytical test methods used in the testing of oligonucleotide API or related molecules
Support the Chemistry lab start up and perform qualification and routine testing to support the Holly Springs Facility, including writing procedures, executing system qualification, method transfers, and supporting computerized systems.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 62,571.90USD -84,656.10 USD
Responsibilities
Participating in the QC Chemistry start up activities including execution of system qualification and validation and method transfers.
Working collaboratively with site teams to establish work order and PM system for laboratory equipment.
Assisting with creating and collaborating on Data Integrity Assessments for computerized lab systems.
Review and Approve QC method executions for GMP and Stability support.
Assisting with procurement activities for consumables and critical reagents for routine lab activities.
Requirements
High school/GED
Associate's degree
Bachelor's degree
Nice to have: degree in a related scientific field such as Chemistry, Biochemistry, Physics or Chemical Engineering
Nice to have: 4+ years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry
Execute analytical techniques in support of method validation for API manufacturing.
Compensation
The full-time equivalent pay range for this position is $85,840.00 - $134,125.00/yr plus eligibility for bonus, stock and benefits.
Responsibilities
Design and conduct laboratory scale experiments using analytical instrument platforms such as HPLC/UPLC, HPLC-MS, ICP-MS, IC, GC, GC-MS, UV, Karl Fischer
Author method validation protocols and reports with adherence to ICH guidelines and internal Agilent standard operating procedures (SOPs)
Design and safely conduct laboratory scale experiments using current best practices for API testing
Properly record and summarize experiments in notebooks and reports and construct research summaries to present to internal teams
Maintain process compliance integrity by adhering to SOPs and current good manufacturing practices (cGMP) as appropriate
Requirements
Bachelor's degree (B. S.) or equivalent in chemistry, or related applied science field
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