TALENT PIPELINE - Scientist II (Analytical R&D)- Future Opportunities

Responsibilities

• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines
• 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
• Performs 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
• Responsible for ensuring compliance with cGMP and other regulatory guidelines
• Analyzes information for technical correctness and accuracy
• Compiles, maintains, interprets and extrapolates data on results of analysis and communicates these results to supervisor
• Performs routine laboratory procedures in a timely and efficient manner
• Gains familiarization with analytical techniques
• Supports cGMP activities
• Maintains laboratory equipment and supplies as directed
• Maintains a clean and safe work-space
• Maintains laboratory notebook and/or computer files (i.e. LIMS) according to standard, accepted practices
• Participates in group and project meetings as required
• Enters project hours promptly and updates project status on appropriate tracking and/or timekeeping systems
• Attends seminars as required
• Participates in and complies with all current safety, health and environmental programs
• Shows initiative and interest in learning new techniques and tests
• Communicates issues or challenges to senior staff and/or management
• Reviews test data acquired by others and witnesses others’ notebooks
• Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs
• Assists with writing standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed
• With guidance, prepares well written and organized development reports
• Performs other related duties as assigned.

Qualifications

• 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
• 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
• 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
• Good 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
• Able to clearly present results verbally in group meetings and in written progress reports
• 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 4+ years of experience in related industry or MS with 0+ years related experience
• Supervision Received
• Works under limited supervision