Scientist II (ARD)

Cambrex•Durham, NC

About The Position

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 with supervision and to evaluate and interpret generated data. Works on problems of moderate 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.

Requirements

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
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
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
Can repeat and follow detailed scientific procedures with supervision
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.
B.S./B.A. Chemistry with 4+ years of experience in related industry or MS with 0+ years related experience

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
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
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
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
With guidance, prepares well written and organized development reports
Performs other related duties as assigned