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. 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.
- Able to apply prior knowledge to accurately interpret structural data.
- Good understanding of the functional chemistry affecting analytical technique
- Ability to help identify risks for regulatory compliance or violation of site SOP
- 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
- Routinely leads and develop other team members.
- May advise clients on site procedures.
- Routinely acts 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
- Ability to author and review key technical documents with minimal RFT errors and can write new SOPs with manger assistance
- 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
- May lead key operational excellence initiatives
- 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/Skills
- Working knowledge of experimental design, including chemistry supporting method development
- Good grasp of advanced scientific/technical reading, writing and verbal communication skills
- Regularly conceives and applies innovative, technical solutions to a variety of problems
- Effective independent researcher
- Can articulate and evaluate project concepts and strategy
- Operates with substantial latitude for independent actions and decisions relating to technical problems and procedures
- Recognized as a technical resource in a related area
- Expert in related technologies
- Demonstrated continued development in a relevant area of CMC
- Working knowledge of advanced laboratory techniques
- Working exposure to cross functional techniques including organic chemistry.
- Subject matter expert in one or more instruments (i.e. GC, LC, dissolution, TGA/DSC)
- Able to comply to SOPs and have understanding of 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
- Strong knowledge of chemistry and scientific calculations
- Hands on experience in analytical techniques such as HPLC, GC, etc
- Strong computer skills
- Ability to operate laboratory equipment and computers
- Ability to take direction from experienced scientists and contributes in a team Environment
- Ability to effectively train and mentor others
- Good problem-solving skills
- Good attention to details
- Can repeat and follow detailed scientific procedures
- 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
B.S./B.A. Chemistry with 12+ years of experience in related industry or MS with 8+ years related experience or PhD with 4+ years related experience
Supervision Received
Works under general supervision.
Physical Demands, Work Environment, and Travel
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 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, The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required.
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.
Travel:
Little to no expected travel time
