Senior Scientist 2

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

The Sr. Scientist II 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. For this position, Titrations, CKF/KF, dissolution and/or CCIT based methodologies are commonly employed in the described compendial testing. Other key methodologies applied include:  TLC, HPLC, GC, UV.

On-Site Expectations

• 100% on-site position.
• 2nd Shift: Monday - Friday, 3:00pm - 11:30pm.

Responsibilities

• Combination of basic and advanced skills in multiple techniques: Titrations, assays (potencies, related substances), dissolution, moisture content, identification, CCIT and other various analytical techniques related to USP, EP, JP compendia.
• A subject matter expert (SME) in few core techniques, such as CCIT, Titrations, HPLC, GC, Dissolution.
• Achieves results by solving problems of a diverse scope by independently looking for solutions and reaching with minimal guidance.
• Leads initiatives outside of standard work function.
• Writes methods, test procedures, protocols and reports.
• Able to do advanced troubleshooting of systems.
• Independently performs/writes investigations and work with quality to complete.
• Executes complex method development/validation/ verifications and routine testing with little to no assistance.
• Actively seek to expand their working knowledge of routine instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor instructions.
• Analyzes information for technical correctness and accuracy.
• Complies with applicable GMPs, peer checks information and signs for GMP review. Brings aberrant information to the attention of supervisor.
• Participates in company sponsored training and maintains current status of certifications and is a certified trainer on several advanced techniques. Actively conducts training for others and identifies potential training improvements or modernizations. Maintains a safe, clean, and organized work environment free of safety hazards.
• Suggests and helps implement improvements for safety, work quality, and productivity.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Routinely provides results for client review and discusses results with clients directly.
• Seeks to cultivate mentorship, build leadership skills and foster a culture of “Team First” by being a mentor for new hires and helping set them up for success in the company.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Chemistry or a related field with with at least 10 years industry experience, a Master’s degree with at least 6 years of experience, or a PhD with at least 4 years of experience is required.
• Prior laboratory experience or work experience in Pharmaceutical, CDMO, or cGMP required.

Knowledge, Skills, and Abilities

• Demonstrated hands-on experience performing compendial and raw material testing within a pharmaceutical, biotechnology, or CDMO environment required. 
• Strong knowledge of USP, EP, and JP compendial requirements and their application to pharmaceutical raw material and finished product testing.
• 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.
• Excellent knowledge of Laboratory Documentation is required.
• Strong knowledge of cGMP in a pharmaceutical or regulated environment 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 the 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.