Sr. Scientist I - Analytical Testing , HPLC

Alcami Corporation•Morrisville, NC

6d•Onsite

About The Position

A Senior Scientist I performs routine and non-routine analytical testing in support of pharmaceutical product development or manufacturing. Testing commonly uses HPLC, dissolution, and/or GC methodologies, as well as titrations, UV, AA, IR, and other techniques. Methods may be compendial, such as USP or EP, or proprietary methods supplied or developed by the company. This is a 100% on-site, first-shift position, Monday through Friday, from 8:00 a.m. to 4:30 p.m. The role may require up to 5% domestic travel.

Requirements

Bachelor’s degree in Chemistry with 8 or more years of experience, or a Master’s degree with 4 or more years of experience, or a Ph.D. with 2 or more years of experience.
At least 2 years of experience in pharmaceutical drug product development under cGMP.
Hands-on HPLC experience.
Excellent verbal and written communication and documentation skills.
Strong attention to detail and organizational skills.
Strong problem-solving and basic troubleshooting ability.
Excellent knowledge of laboratory equipment and safety.
Expert knowledge of laboratory documentation.
Ability to develop and implement new methods and processes.
Ability to plan and manage multiple tasks to achieve results on time.
Working knowledge of cGMP in a pharmaceutical or regulated environment.
Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.

Nice To Haves

CDMO experience.
Experience with Empower and ELN.

Responsibilities

Use advanced skills across analytical techniques, including assays, dissolution or drug release, residual solvents, elemental impurities, moisture content, identification, and other wet-chemistry measurements.
Develop and validate methods, test procedures, protocols, and reports.
Understand the theoretical basis of methods and experiments.
Maintain knowledge of instrumentation, equipment, and scientific methodologies needed for assigned work.
Analyze information for technical correctness and accuracy; evaluate and interpret data.
Solve problems of diverse scope to achieve results.
Interact with clients and participate in regulatory agency and/or client audits.
Lead investigations and root cause analysis.
Drive initiatives beyond standard work functions.
Maintain a safe, clean, organized work environment free of safety hazards.
Safely handle potent compounds.
Complete work on time and comply with cGMP and other relevant company training requirements.
Perform other duties as assigned.