Standards and Stability Analytical Chemist

Corden Pharma - A Full-Service CDMO• Boulder, CO, US, CO

9d•$78,000 - $95,500

About The Position

This is an intermediate-level technical professional role within the Quality Team. The Standards and Stability Analytical Chemist performs analytical work accurately and independently to qualify standards and ensure reference materials are available for cGMP analytical testing supporting Research and Development, Quality Control, Manufacturing, and external clients. The role supports the Stability Program by coordinating study initiation, pull schedules, packaging, labeling, and analytical testing. It also supports laboratory investigations and the compilation of stability data and results. The chemist is accountable for ensuring that stability samples are properly packaged, exposed to appropriate conditions, tested, and reported in accordance with cGMP requirements. The position supports 24/7 stability monitoring and testing, and the incumbent must be willing to work weekends and/or nights. Work is performed in a quality-controlled pharmaceutical manufacturing environment, following cGMP, safety, environmental, and chemical hygiene requirements. Actual pay is based on skills and experience.

Requirements

Bachelor's degree from a four-year college or university and two years of related experience and/or training, or an equivalent combination of education and experience.
Ability to read and comprehend simple instructions, short correspondence, and memos; write simple correspondence; and present information effectively in one-on-one and small-group situations.
Ability to perform routine analytical chemistry calculations, including concentration, percentage, parts per million, and relative standard deviation calculations.
Ability to interpret results from analytical techniques including FTIR, HPLC, UPLC, GC, UV, and titrations, and conduct out-of-specification investigations when required.
Ability to solve practical problems and interpret written, oral, diagrammatic, or schedule-based instructions while working under cGMP standards.
Analytical skills and knowledge of general or organic chemistry.
Good communication and computer skills.
Attention to detail.
Ability and willingness to support 24/7 stability monitoring and testing, including working weekends and/or nights.
Ability to meet the physical demands of the role, including occasionally lifting and/or moving up to 50 pounds.

Responsibilities

Perform routine and non-routine testing on a variety of samples, including stability studies and standard characterization or qualification testing.
Perform equipment calibration, titrant standardization, and stability chamber monitoring and preventive maintenance.
Identify and perform basic troubleshooting of QC laboratory instruments, and communicate problems and solutions related to processes, procedures, and materials.
Investigate anomalous test results at a basic level and take corrective action.
Maintain laboratory cleanliness and organization in accordance with safety, regulatory, chemical hygiene, and cGMP policies.
Complete daily recordkeeping in SAP and LIMS, enter material status changes, and initiate incident reports.
Manage the generation and accumulation of hazardous and non-hazardous waste.
Attend and participate in Quality, Research and Development, team huddle, and cross-functional team meetings, and develop team skills.
Apply cGMP practices when conducting stability testing and standards characterization or qualification testing.
Package stability samples and standard materials using appropriate verified materials.
Author technical documents for the Standards and Stability Programs, including protocols and reports.
Perform critical and time-sensitive testing, including testing involving high-potency materials and difficult methods.
Troubleshoot analytical techniques such as UPLC/HPLC, GC, FTIR, UV/Vis, Karl Fischer titrations, and other wet chemistry techniques.
Support laboratory investigations and assist investigators in determining root cause.
Conduct thorough data review in accordance with good documentation practices.
Work independently without frequent supervisory oversight.
Perform job duties safely and take personal responsibility for workplace safety and environmental aspects of work.

Benefits

401(k) matching: Corden Pharma contributes 100% of the first 6%; 100% vested after two years of service.
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Paternal Leave
Tuition Reimbursement
Wellness Program
Vacation: three weeks in the first year
Vision Insurance