What are the responsibilities and job description for the Principal Scientist II - Extractables & Leachables position at Alcami Corporation?
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
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Job Summary
A Principal Scientist II - Extractables and Leachables (E&L) is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. A Principal Scientist II will routinely lead method development/method validation projects. The Principal Scientist II will support Extractables and Leachables (E&L) testing for pharmaceutical products. This role focuses on trace level analysis to identify compounds that may leach from manufacturing components and container closure systems into liquid formulations, supporting patient safety and regulatory compliance.
This is a hands on, mass spectrometry driven position emphasizing method development and GMP rigor.
On-Site Expectations
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.
Are you interested in joining our team?
Job Summary
A Principal Scientist II - Extractables and Leachables (E&L) is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. A Principal Scientist II will routinely lead method development/method validation projects. The Principal Scientist II will support Extractables and Leachables (E&L) testing for pharmaceutical products. This role focuses on trace level analysis to identify compounds that may leach from manufacturing components and container closure systems into liquid formulations, supporting patient safety and regulatory compliance.
This is a hands on, mass spectrometry driven position emphasizing method development and GMP rigor.
On-Site Expectations
- 100% on-site position.
- 1st Shift: Monday - Friday, 8:00am - 5:00pm.
- Execute extractables and leachables studies to identify potential migrants from packaging and manufacturing materials
- Develop, optimize, and validate chromatography and mass spectrometry based methods for trace analysis
- Interpret complex analytical data and support identification of unknown compounds
- Generate and maintain GMP compliant documentation, protocols, and reports
- Participate in client interactions, audits, and technical discussions
- Support investigations, deviations, and root cause analyses
- Other duties as assigned.
- LC/MS for nonvolatile compounds
- GC/MS (direct injection and headspace) for semi volatile and volatile compounds
- ICP-MS for elemental impurities (supporting scope)
- Bachelor’s degree in Chemistry, Biology, or related field with 18 years GMP related experience; OR Master’s degree in related field with 14 years related experience; OR PhD in related field with 13 years related experience.
- Experience in Pharmaceutical, CDMO, or cGMP preferred.
- Excellent verbal and written communication and documentation skills required.
- Excellent detail orientation and organizational skills required.
- Excellent problem-solving and basic trouble-shooting ability required.
- Excellent knowledge of laboratory equipment and safety required.
- Expert knowledge of Laboratory Documentation is required.
- Ability to develop and implement new methods/processes required.
- Ability to plan and manage multiple tasks for timely achievement of results.
- Working knowledge of cGMP in a pharmaceutical or regulated environment required.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
- 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 (LC/MS or GC/MS).
- Experience identifying unknown peaks using mass spectral data.
- Familiarity with trace analysis and regulatory expectations for E&L.
- Up to 5% domestic travel.
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.