Job Overview
Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss data and methods. Works on problems of moderate and sometimes advance scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Responsibilities
- Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines
- Independently develop and evaluate methodologies, design and implement experiments.
- Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability.
- Maintains compliant records with little or no supervision
- Able to write technical documents with assistance
- Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks
- Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions
- Sets up various instrumentation for testing according to written test methods and with little to no supervision.
- As needed, troubleshoots laboratory instrumentation
- Leads a sample project with assistance
- May participate in client level meetings, with approval
- May lead and develop other team members.
- May advise clients on site procedures.
- Responsible for ensuring compliance with cGMP and other regulatory guidelines.
- Analyze information for technical correctness and accuracy
- Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor
- Perform routine laboratory procedures in a timely and efficient manner
- Gain familiarization with analytical techniques
- Participate cGMP activities
- Provides input on SOPs and client questions
- Maintain laboratory equipment and supplies as directed
- May support peer-led laboratory investigations process with assistance
- Maintain a clean and safe work-space
- Maintain laboratory notebook and/or computer files (i.e. LIMS) according to standard, accepted practices
- Participate in group and project meetings as required
- Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems
- Attend seminars as required
- Participate in and comply with all current safety, health and environmental programs
- Shows initiative and interest in learning new techniques and tests
- Participates in technical discussions and brainstorming sessions
- Communicates issues or challenges to senior staff and/or management
- May review test data acquired by others and witness others’ notebooks
- Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs
- Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed
- Provides input on SOPs and client questions
- With guidance, prepares well written and organized development reports
- Performs 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.
- Working exposure to cross functional techniques including organic chemistry.
- Understands the chemical properties relating to method development, qualification /validation and troubleshooting.
- Able to comply to SOPs and basic regulatory compliance
- Working knowledge of scientific concepts, principles and procedures
- Actively and positively engages with team and supports process improvements
- Ability to read and execute compendial methodologies
- 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
- Ability to operate laboratory equipment and computers
- Ability to take direction from experienced scientists and contributes in a team environment
- Good problem-solving skills
- Good attention to details
- Can repeat and follow detailed scientific procedures with supervision
- Able to clearly present results verbally in group meetings and in written progress reports
- Routinely and effectively presenting findings to clients
- Good interpersonal skills and is willing 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 MS with 2+ years related experience
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 sit. The employee is occasionally required to stand; walk 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.
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.
