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. Trains and mentors other employees. Additionally, this role may research and implement new methods and technologies to enhance operations.
Efficiently plans and conducts experiments with an increased degree of independence. Prepares research summaries and reports. Experienced with a wide variety of analyses and techniques. Understand principles of and uses safe laboratory work practices. Interacts with clients and participates in FDA and/or client audits.
Maintains professional knowledge through familiarity with scientific literature. Works on problems of diverse scope. Ability to independently plan and schedule experiments. Interprets results from experiments and plans follow up experiments to achieve project objectives. Ability to organize the routine work with minimum supervision. Properly evaluate and interpret generated data. Ability to troubleshoot.
Demonstrates strong understanding of compliance, provides input in site policy regarding compliance questions, ensures that client requests are within the boundaries of compliance.
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
Routinely participates in compliance meetings to ensure that client requests are within boundaries of compliance
Proficient with a broad range of laboratory techniques and actively investigate new technologies
Attend and may participate in national and international scientific meetings
Independently plan, perform and analyze experimental results in a timely manner
Draft and execute validation protocols for analytical methods
Perform and review data analysis and draft reports for analytical method development and validation
Demonstrate ability to correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up and supervision
Identifies and troubleshoots analytical problems with instrumentation, general chemistry, test methodology and samples submitted
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.
May act as a team /project lead supporting scheduling of project tasks and deliverables
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
Strong understanding of 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 and may mentor others regarding 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
Effectively and routinely provides training.
Actively participates in recruiting efforts
Routinely prepares well written and organized development reports
Performs other related duties as assigned.
Qualifications
B.S./B.A. Chemistry with 10+ years of experience in related industry or MS with 6+ years related experience or PhD with 2+ years related experience
