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Senior Scientist
1 month ago
Job Summary:
A Senior Scientist for Extractables and Leachables is accountable for driving results in a fast-paced environment by executing non-routine studies and other protocol driven work in support of the Extractables & Leachables group. The Senior Scientist will routinely lead projects to completion. Perform LC/MS and/or GC/MS analysis in a GMP environment.
On-Site Expectations:
- 100% on-site position.
Responsibilities:
- Communicates and collaborates directly with clients to develop scientifically sound experimental approaches for each study performed.
- Performs LC/MS, GC/MS, and/or ICP/MS analysis for extractables/leachables.
- Generates clear and concise reports for protocol driven projects.
- Performs laboratory analysis of pharmaceutical and biopharmaceutical products utilizing analytical instrumentation, analyzes and documents data in accordance with Alcami SOPs.
- Interacts with team members and management to discuss data and project progress.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Other duties as assigned.
Qualifications:
- B.S./B.A. Chemistry or related field with 12 years of experience in related industry or MS with 8 years related experience or PhD with 5 years related experience required.
- Previous experience working in a cGMP environment with in-depth knowledge of cGMP and other applicable regulatory requirements.
- Previous experience within CMO, or CDMO preferred.
Knowledge, Skills, and Abilities:
- Working knowledge of Mass Spectrometry required.
- Working knowledge of HPLC and Gas Chromatography required.
- Working knowledge of spectral identification of molecules strongly preferred
- Working knowledge of cGMP in a pharmaceutical or regulated environment preferred.
- Awareness of cUSP and Regulatory Guidelines preferred.
- Excellent verbal communications and presentation skills required.
- Excellent time management and organization skills required.
- Excellent knowledge of Laboratory equipment and safety required.
- Good problem solving and trouble shooting ability required.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
Travel Expectations:
- Up to 5% domestic travel.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
