Sr. Scientist I (ARD)

About the role

You will be responsible for executing analytical methods and providing general analytical support, including release and stability testing of drug substances and drug products, under cGMP guidelines. You will also develop and evaluate methodologies, design and implement experiments, and interact with clients to discuss data and methods.

Responsibilities

• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products
• Develop and evaluate methodologies, design and implement experiments
• Maintain compliant records with little or no supervision
• Able to write technical documents with assistance
• Interact with clients to discuss data and methods
• Set up various instrumentation for testing according to written test methods and with little to no supervision
• Troubleshoot laboratory instrumentation as needed
• Lead a sample project with assistance
• Support peer-led laboratory investigations process with assistance
• Maintain a clean and safe work-space
• Participate in group and project meetings as required
• Attend seminars as required
• Participate in and comply with all current safety, health and environmental programs
• Analyze information for technical correctness and accuracy
• Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor
• Support writing technical documentation such as OOS, atypical investigations, deviations and CAPAs
• Support writing standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed
• Provide input on SOPs and client questions
• Prepare well written and organized development reports
• Perform other related duties as assigned

Qualifications/Skills

• Working knowledge of experimental design, including chemistry supporting method development
• Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC
• Understanding of the chemical properties relating to method development, qualification / validation and troubleshooting
• Compliance to SOPs and basic regulatory compliance
• Active engagement with team and support for process improvements
• Strong understanding of current FDA and cGMP regulations
• General knowledge of chemistry and scientific calculations
• Hands-on experience in analytical techniques such as HPLC, GC, etc
• Basic computer skills
• Operate laboratory equipment and computers
• Contribute in a team environment
• Good problem-solving skills
• Good attention to details
• Able to repeat and follow detailed scientific procedures with supervision
• Able to clearly present results verbally in group meetings and in written progress reports
• Good interpersonal skills and willingness to ask questions about procedures and concepts
• Aptitude and willingness to gain more skills and knowledge in support of GMP regulations
• Good written and verbal communication skills
• Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel
• Aptitude and willingness to gain more skills & knowledge
• Good attention to detail and good problem-solving skills

Education, Experience & Licensing Requirements

• S./B.A. Chemistry with 6+ years of experience in related industry or M.S. with 2+ years related experience

Travel

Not applicable

Physical Demands

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 occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.

Environment and Protective Equipment

The work environment characteristics described here are representative of those an employee encounters while performing 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 occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.