Scientist I (ARD)

Cambrex•Durham, NC

About The Position

Execute analytical methods and provide general analytical support, including release and stability testing of drug substances and drug products. The role organizes routine work with supervision and evaluates and interprets generated data. Work involves problems of basic to moderate scope requiring review of identifiable factors, with judgment exercised within defined procedures and practices. The Scientist I performs laboratory testing and documentation under cGMP requirements, maintains familiarity with instrumentation and analytical methodologies, and communicates results and issues to supervisors and senior staff. The role works under direct supervision and may assist with investigations, technical documents, and development reports. The position regularly involves use of hands and arms, talking, hearing, and smelling; frequent sitting; and occasional standing, walking, and stooping. It requires regularly lifting or moving up to 10 pounds and occasionally up to 25 pounds. The work environment is usually very quiet, with occasional exposure to moving mechanical parts and vibration. Little to no travel is expected.

Requirements

B.S. or B.A. in Chemistry and at least 2 years of experience in a related industry.
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.
Ability to comply with SOPs and basic regulatory requirements.
Working knowledge of scientific concepts, principles, and procedures.
Good understanding of current FDA and cGMP regulations.
General knowledge of chemistry and scientific calculations.
Hands-on experience with analytical techniques such as HPLC and GC.
Basic computer skills and ability to operate laboratory equipment and computers.
Ability to take direction from experienced scientists and contribute in a team environment.
Good problem-solving skills and attention to detail.
Ability to repeat and follow detailed scientific procedures with supervision.
Ability to clearly present results verbally in group meetings and in written progress reports.
Good interpersonal skills and willingness to ask questions about procedures and concepts.
Aptitude and willingness to gain skills and knowledge in support of GMP regulations.
Good written and verbal communication skills.
Familiarity with Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel.

Responsibilities

Execute analytical methods for in-process control, release testing, and stability monitoring of bulk drug substances and drug products under cGMP guidelines.
Maintain working knowledge 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.
Set up instrumentation for testing according to written test methods, with little to no supervision.
Ensure compliance with cGMP and other regulatory guidelines.
Analyze information for technical correctness and accuracy.
Compile, maintain, interpret, and extrapolate analysis results and communicate them to the supervisor.
Perform routine laboratory procedures in a timely and efficient manner and gain familiarity with analytical techniques.
Participate in cGMP activities and comply with current safety, health, and environmental programs.
Maintain laboratory equipment and supplies as directed, and keep a clean and safe workspace.
Maintain laboratory notebooks and computer files, including LIMS, according to accepted practices.
Support peer-led laboratory investigations with assistance.
Participate in group and project meetings, technical discussions, brainstorming sessions, and seminars as required.
Enter project hours promptly and update project status in tracking and timekeeping systems.
Show initiative and interest in learning new techniques and tests; communicate issues or challenges to senior staff or management.
May review data acquired by others and witness others’ notebooks.
Assist with technical documentation, including OOS and atypical investigations, deviations, and CAPAs.
Assist with writing SOPs, methods, qualification protocols, and other standard documents as directed.
Prepare well-written and organized development reports with guidance.
Perform other related duties as assigned.