Cambrex
Principal Scientist I (ARD)
US-NC-Durham
Job ID: 2024-3634
Type: Regular Full-Time
# of Openings: 1
Category: Analytical
Cambrex - Durham
Overview
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 independently and
to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method
development and qualification / validation principles. Routinely and effectively interacts with
clients to discuss data and methods. Trains and mentors other employees. Additionally, this role
may research and implement new methods and technologies to enhance operations.
Efficiently plans and conducts experiments with an increased degree of independence.
Prepares research summaries and reports. Experienced with a wide variety of analyses and
techniques. Understand principles of and uses safe laboratory work practices. Interacts with
clients and participates in FDA and/or client audits.
Maintains professional knowledge through familiarity with scientific literature. Works on
problems of diverse scope. Ability to independently plan and schedule experiments. Interprets
results from experiments and plans follow up experiments to achieve project objectives. Ability
to organize the routine work with minimum supervision. Properly evaluate and interpret
generated data. Ability to troubleshoot.
Demonstrates strong understanding of compliance, provides input in site policy regarding
compliance questions, ensures that client requests are within the boundaries of compliance.
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
Qualifications- S./B.A. Chemistry with 4+ years of experience in related industry or MS with 0+ years related experience
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.
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