Senior Scientist 3 - Extractables & Leachables

 

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 Sr. Scientist III - Extractables & Leachables 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 Sr. Scientist III - Extractables & Leachables will routinely lead method development/method validation projects. LCMS and GCMS based methodologies are commonly employed in the described testing. Detailed understanding of the theoretical basis of the methods/experiments along with ability to troubleshoot equipment are also required. The incumbent will work on extremely complex problems in which analysis of situations or data requires an evaluation of tangible and intangible variables.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:30am - 5:30pm.

Responsibilities

• Uses advanced skills in multiple techniques, to include assays (potencies, related substances), dissolution/drug release, residual solvents, elemental impurities, moisture content, identification and various other wet chemistry based measurements.
• Develops and validates methods, test procedures, protocols, and reports.
• Understands the theoretical basis of methods/experiments.
• Maintains strong knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Analyzes information for technical correctness and accuracy.
• Evaluates and interprets data.
• Achieves results by solving problems of a diverse scope.
• Interacts with clients and participates in regulatory agency and/or client audits.
• Leads investigations and root cause analysis.
• Drives initiatives outside of standard work function.
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Safely handles potent compounds.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Performs one or more of the following techniques: Extractions, GCMS, and LCMS
• Evaluates and interprets generated data.
• Analyzes information for technical correctness and accuracy.
• Understands the theoretical basis of methods/experiments.
• Performs technical review of common laboratory data.
• Performs GMP review of solutions and wet chemical analyses.
• Performs technical review of typical laboratory data and HPLC analysis.
• Writes test procedures, protocols, and reports.
• Maintains laboratory stock of reagents, clean glassware, and removes expired solutions.
• Solves problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Assists in removal of hazardous waste, routine equipment cleaning and restocking of consumable products and reagents.
• Effectively uses various laboratory software packages (Empower3, ProCal, Master Control, ELN, etc.).
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Chemistry with 15+ years of experience or Master’s degree with 11+ years of experience, or Ph.D. with 7+ years of experience required.
• 2+ years of experience in Pharmaceuticals drug product development under cGMP is required.
• CDMO experience is preferred.

Knowledge, Skills, and Abilities

• 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.

Travel Expectations

• Up to 5% travel required.

Physical Demands and Work Environment

The physical demands and work environment 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 stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk, sit, climb, or balance 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 occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock 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, half face and full-face respirator, lab coats, full protective body coverings, various types of gloves, etc.