Sr. Scientist II (ARD)

About the role

Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Independently develop and evaluate methodologies, design and implement experiments. Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability. Maintain compliant records with little or no supervision. Write technical documents with assistance. Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.

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.
• 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.
• May lead and develop other team members.
• May advise clients on site procedures.
• May act 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.
• Gain familiarization with analytical techniques.
• Participate cGMP activities.
• Provides input on SOPs and client questions.
• 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.
• 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.
• 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 writing 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.
• With guidance, 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.
• Working knowledge of advanced laboratory techniques.
• 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.
• Able 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.
• Strong computer skills.
• Ability to operate laboratory equipment and computers.
• Able 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.
• 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

• S./B.A. Chemistry with 8+ years of experience in related industry or MS with 4+ years related experience or PhD with 0+ years related experience.

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.

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.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.