Tolmar · 1 day ago
Sr QC Development and Technical Analyst
Fort Collins, CO
Full-time
Onsite
Mid, Senior Level
$95K/yr - $105K/yr
6+ years expTolmar is a pharmaceutical company seeking a Senior QC Development and Technical Analyst who will support the life cycle of chemistry methods. This role involves mentoring QC analysts, leading method transfers, and ensuring compliance with cGMP requirements while contributing to continuous improvement initiatives within the department.
BiotechnologyHealth CareManufacturing
Responsibilities
Function as a subject matter expert for the QC department consistently demonstrating the professional expectations of the department. This includes adherence to compliance, time management, commitment to collaboration with all personnel, effective communication both written and verbal, and embrace challenges with curiosity and enthusiasm
Expertise in performing analyses on a variety of samples using advanced preparation techniques analysis methods and instrumentation
Provide mentorship to QC analysts in all aspects of analyses performed within the QC chemistry laboratory including but not limited to documentation, procedures, regulations, technical understanding and method troubleshooting best practices
Accountable for proper use, care, maintenance, and troubleshooting of instrumentation
Requires the ability to write clear and effective scientific documents and requires the ability to review complex and technical documents
Performs high level method transfers and leads the department in the evaluation and implementation of new technologies. Collaboration with Analytical Development during method development requiring effective communication of commercial QC challenges to ensure validated methods are compatible with commercial testing, previous CAPAs and regulations
Support investigations, provide technical guidance, and perform investigational testing
Provide scientific recommendations to management/technical writers regarding QC procedures requiring the ability to collect recommendations, identify essential steps, ensure the appropriate changes are made, and serve as a technical reviewer for document updates to ensure correct changes are made with scientifically sound justification
Prioritizes tasks and performs job duties with minimal guidance from management. Works to complete tasks in an efficient manner and is a productive member of the department. Contributes to a highly productive environment by avoiding distractions
Support adherence to department budget by identifying alternative cost-saving and compliant materials and equipment during the method development process, where appropriate
Will represent the department by providing accounts and results of method transfer activities and assist with troubleshooting aberrant method transfer results. Understand method development principles (accuracy, robustness, precision, etc.) and provide technical expertise to determine root cause of aberrant method transfer results
Leads implementation of change and demonstrate leadership aptitude in technical functions
Provide support to the department leadership with the implementation of new systems, and continuous improvement efforts. Generates new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements. Understands and processes complex information and exercises sound judgment, considering the situation, the issues, the key players and the levels of authority involved. Proposes courses of action that further the objectives, priorities, and vision of the organization
Accountable for documenting all activities and maintaining records according to good documentation practices
Responsible for acting as a technical reviewer for document updates to ensure changes that are made are justified and scientifically sound
Lead with a compliance mindset
Keeps up to date with regulatory guidelines and their application to the laboratory functions
Perform additional duties as assigned
Qualification
Required
Bachelor's degree in scientific discipline, preferably in Chemistry or Biochemistry
6 or more years of experience in a QC pharmaceutical analytical laboratory position with an emphasis and experience in developing methods using advanced techniques and skilled with complex testing
Advanced knowledge and application of government regulations for drugs or medical devices including GMP, GLP and ICH and their application to laboratory testing and review processes and procedures
Advanced knowledge in the use of USP, NF and other compendia
Highly proficient use of analytical laboratory instruments such as HPLC, FTIR, FTNIR, GPC, GC, and UV-Vis spectrophotometers
Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage
Excellent written and oral communication skills
Ability to interpret, understand and follow analytical procedures and calculations
Demonstration of training and project leadership skills
Ability to train analysts on complex methodology
Expert knowledge in analytical testing of drug substances and formulations
Preferred
Master's degree preferred
Benefits
Bonus Eligible
Benefits information: https://www.tolmar.com/careers/employee-benefits
Company
Tolmar
TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company.
1001-5000 employees
H1B Sponsorship
Tolmar has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (5)
2022 (3)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
A
Anil D'souza
Chief Executive Officer
Gerald Wallner
Data Integrity Manager
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