Sr. Scientist II (ARD)

Cambrex•Durham, NC

About The Position

The Sr. Scientist II executes analytical methods and provides analytical support, including release and stability testing of drug substances and drug products. The role independently organizes routine work and evaluates, troubleshoots, and interprets data, with demonstrated understanding of method development and qualification and validation principles. It routinely interacts with clients to discuss data and methods, and works on moderately complex problems requiring analysis of identifiable factors and judgment within defined procedures and practices. The position develops and evaluates methodologies, designs and implements experiments, operates and troubleshoots laboratory instrumentation, maintains compliant records, and contributes to technical documentation. It supports cGMP compliance, project delivery, laboratory safety, training, and communication of analytical results. The role may lead sample projects, support project scheduling, mentor team members, participate in client meetings, and advise clients on site procedures.

Requirements

Bachelor of Science or Bachelor of Arts in Chemistry with 8 or more years of related-industry experience; alternatively, a master's degree with 4 or more years of related experience, or a Ph.D. with 0 or more years of related experience.
Working knowledge of experimental design, including chemistry supporting method development.
Working knowledge of advanced laboratory techniques and exposure to cross-functional techniques, including organic chemistry.
Subject-matter expertise in one or more instruments, such as GC, LC, dissolution, or TGA/DSC.
Ability to comply with SOPs and understanding of regulatory compliance.
Working knowledge of scientific concepts, principles, and procedures.
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 with analytical techniques such as HPLC and GC.
Strong computer skills and ability to operate laboratory equipment and computers.
Ability to take direction from experienced scientists and contribute to a team.
Ability to effectively train and mentor others.
Good problem-solving skills, attention to detail, and ability to repeat and follow detailed scientific procedures.
Ability to present results clearly verbally in group meetings and in written progress reports, and routinely present findings to clients.
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.
Independently develop and evaluate methodologies and design and implement experiments.
Participate in experimental design, including development of methods and testing requirements to demonstrate method suitability.
Maintain compliant records with little or no supervision and write technical documents with assistance.
Use and maintain instrumentation, equipment, and scientific methodologies required for 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 and troubleshoot laboratory instrumentation as needed.
Lead a sample project with assistance; may participate in client-level meetings with approval, lead and develop team members, advise clients on site procedures, and support scheduling of project tasks and deliverables.
Ensure compliance with cGMP and other regulatory guidelines.
Analyze information for technical correctness and accuracy; compile, maintain, interpret, and extrapolate analytical results and communicate them to a supervisor.
Perform routine laboratory procedures in a timely and efficient manner and gain familiarity with analytical techniques.
Participate in cGMP activities, provide input on SOPs and client questions, and maintain laboratory equipment and supplies as directed.
Support peer-led laboratory investigations with assistance.
Maintain a clean and safe workspace and maintain laboratory notebooks and/or computer files, including LIMS, according to accepted practices.
Participate in group and project meetings, attend seminars as required, enter project hours promptly, and update project status in tracking or timekeeping systems.
Participate in and comply with safety, health, and environmental programs.
Show initiative and interest in learning techniques and tests, participate in technical discussions and brainstorming, and communicate issues or challenges to senior staff or management.
Review test data acquired by others and witness others' notebooks as needed.
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.
Provide training and, with guidance, prepare organized development reports.
Perform other related duties as assigned.