Sr. Scientist III - Extractables & Leachables

Alcami Corporation•Wilmington, NC

9d•Onsite

About The Position

The Sr. Scientist III - Extractables & Leachables performs routine and non-routine analytical testing in support of pharmaceutical product development or manufacturing and drives results in a fast-paced environment. The role routinely leads method development and method validation projects, commonly using LCMS- and GCMS-based methodologies. It requires detailed understanding of the theoretical basis of methods and experiments, as well as the ability to troubleshoot equipment and address highly complex problems involving tangible and intangible variables. This is a 100% on-site, first-shift position, Monday through Friday, 8:30 a.m. to 5:30 p.m. The role involves client interaction and participation in regulatory agency and client audits, laboratory data review, investigations, and root-cause analysis. The employee must follow cGMP and other relevant training requirements, maintain a safe and organized laboratory, and safely handle potent compounds. Up to 5% travel is required. The work environment may include exposure to wet or humid conditions, moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, electrical shock risk, and vibration. The noise level is usually moderate. Appropriate personal protective equipment is required for specific job duties. Physical duties include standing, handling and reaching, and occasionally walking, sitting, climbing, balancing, and stooping, kneeling, crouching, or crawling. Lifting requirements include up to 10 pounds regularly, up to 25 pounds frequently, and up to 50 pounds occasionally.

Requirements

Bachelor’s degree in Chemistry with 15 or more years of experience, a master’s degree with 11 or more years of experience, or a Ph.D. with 7 or more years of experience.
At least 2 years of experience in pharmaceutical drug product development under cGMP.
Excellent verbal and written communication and documentation skills.
Strong attention to detail and organizational skills.
Excellent 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.
Hands-on experience with GC and/or HPLC method development and validation.
Strong attention to detail and proficiency with GMP documentation.
Experience with Extractables and Leachables studies.
Mass spectrometry experience with LC/MS or GC/MS.
Experience identifying unknown peaks using mass spectral data.
Familiarity with trace analysis and regulatory expectations for Extractables and Leachables.

Nice To Haves

CDMO experience.

Responsibilities

Perform routine and non-routine analytical testing supporting pharmaceutical product development or manufacturing.
Use advanced skills in multiple 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.
Perform techniques including extractions, GCMS, and LCMS.
Understand the theoretical basis of methods and experiments, and maintain knowledge of instrumentation, equipment, and scientific methodologies.
Analyze information for technical correctness and accuracy; evaluate and interpret generated data.
Perform technical review of common and typical laboratory data, including HPLC analysis, and GMP review of solutions and wet chemical analyses.
Lead method development and validation projects, investigations, and root-cause analysis.
Solve problems of diverse scope and drive initiatives outside the standard work function.
Interact with clients and participate in regulatory agency and client audits.
Maintain a safe, clean, and organized work environment free of safety hazards, and safely handle potent compounds.
Ensure timely completion of work and compliance with cGMP and other relevant company training requirements.
Write test procedures, protocols, and reports.
Maintain laboratory stock of reagents and clean glassware, and remove expired solutions.
Assist with hazardous waste removal, routine equipment cleaning, and restocking consumable products and reagents.
Use laboratory software packages such as Empower3, ProCal, Master Control, and ELN.
Perform other duties as assigned.