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Principal Scientist II

4 months ago

Durham, North Carolina, United States Cambrex Full time
Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community
We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today

Job 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/Skills

• Working knowledge of experimental design, including chemistry supporting method
development

• Good grasp of advanced scientific/technical reading, writing and verbal communication
skills

• Regularly conceives and applies innovative, technical solutions to a variety of problems

• Effective independent researcher

• Can articulate and evaluate project concepts and strategy

• Operates with substantial latitude for independent actions and decisions relating to
technical problems and procedures

• Recognized as a technical resource in a related area

• Expert in related technologies

• Demonstrates continued development in a relevant area of CMC

• Working knowledge of advanced laboratory techniques

• Working exposure to cross functional techniques including organic chemistry.

• 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

• Ability to read and execute compendial methodologies

• Strong understanding of current FDA and cGMP regulations

• Strong 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

• Ability to take direction from experienced scientists and contributes in a team

environment

• Ability to effectively train and mentor others

• Ability to effective lead teams

• Strong problem-solving skills

• Excellent attention to details

• Can repeat and follow detailed scientific procedures

• 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

• Excellent 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

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

Supervision Received:
Works under general supervision.

Physical Demands, Work Environment, and Travel

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.

While performing the duties of this Job, the employee is regularly required to use hands to
finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is
frequently required to sit. The employee is occasionally required to stand; walk and stoop,
The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally
lift and/or move up to 25 pounds. Specific vision abilities required.

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.
While performing the duties of this Job, the employee is occasionally exposed to moving
mechanical parts and vibration. The noise level in the work environment is usually very quiet.

Travel:

Little to no expected travel time.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.