Sr. Scientist II - Analytical Testing , HPLC , GMP

Sr. Scientist II
- Analytical Testing , HPLC , GMP

Location:

US-NC-Durham | :  | Category:
Analytical | Position Type:
Full-Time |

Working Hours:

1st

Shift: Monday
- Friday, 8:00am - 5:00pm

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. A Sr. Scientist II will routinely lead method development/method validation projects. For this position, HPLC, dissolution and/or GC based methodologies are commonly employed in the described testing. Other key methodologies applied include: CKF/KF, MS, ICP‑MS, Particle Size, CCIT, UV.

• 100% on‑site position.
• 1st
  
  Shift: Monday
  - Friday, 8:00am - 5:00pm.

• Combination of basic and advanced skills in multiple techniques: residual solvents, assays (potencies, related substances), dissolution, elemental impurities, moisture content, identification, and other various analytical techniques.
• A subject matter expert (SME) in few core techniques, such as HPLC, GC, MS, ICP‑MS, 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 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.

• Bachelor’s degree in Chemistry or a related field with at least 10 years of 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.

• Hands‑on HPLC and GMP experience required.
• 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 preferred.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

• 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…