Cambrex
Principal Scientist II (ARD)
US-NC-Durham
Job ID: 2024-3632
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.
Provides leadership and mentoring across the analytical team and to other functions. Leads and
/or provides input to higher level initiatives. 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
Independently develop and evaluate methodologies, design and implement experiments.
- Able to apply prior knowledge to accurately interpret structural data.
- Good understanding of the functional chemistry affecting analytical technique
- Ability to help identify risks for regulatory compliance or violation of site SOP
- 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
- Routinely participates in compliance meetings to ensure that client requests are within
boundaries of compliance
- Proficient with a broad range of laboratory techniques and actively investigate new
technologies
- Attend and may participate in national and international scientific meetings
- Independently plan, perform and analyze experimental results in a timely manner
- Draft and execute validation protocols for analytical methods
- Perform and review data analysis and draft reports for analytical method development
and validation
- Demonstrate ability to correctly analyze data/results and interpret outcome of
experiments and to propose appropriate follow-up and supervision
- Identifies and troubleshoots analytical problems with instrumentation, general chemistry,
test methodology and samples submitted
- 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
- Routinely leads and develop other team members.
- May advise clients on site procedures.
- Routinely acts 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
- Strong understanding of the use of analytical techniques to characterize materials
- Participate cGMP activities
- Provides input on SOPs and client questions
- Ability to author and review key technical documents with minimal RFT errors and can
write new SOPs with manger assistance
- 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
- May lead key operational excellence initiatives
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
- articipates 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 and may mentor others regarding 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
- Provides input on SOPs and client questions
- Effectively and routinely provides training.
- Actively participates in recruiting efforts
- Routinely prepares well written and organized development reports
- Performs other related duties as assigned.
Qualifications
B.S./B.A. Chemistry with 14+ years of experience in related industry or MS with10+
years related experience or PhD with 6+ years related experience
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