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