Sr. Scientist I (ARD)

Cambrex; Durham (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Healthcare

Life insurance

Retirement plan

Job summary

Cambrex in Durham, NC is seeking a hands-on analytical chemist to perform testing of raw materials, intermediates, and drug substances for late-stage clinical and commercial programs. The role centers on HPLC/UPLC analysis with opportunities to use GC, KF, IC, and related methods, and requires strong data integrity and adherence to cGMP.

Responsibilities include method development, transfers, validation support, maintaining compliant records, writing technical documents, and collaboration with a

Qualifications

• Bachelor’s degree in Chemistry or a related scientific discipline; required minimum experience in GMP environments.
• Hands-on familiarity with analytical techniques used in drug substance testing (HPLC, GC, KF, IC).
• Experience with method development, validation, and troubleshooting in a regulated lab.
• Strong data integrity, documentation, and ability to work in a team.

Responsibilities

• Perform analytical testing of raw materials, intermediates, and drug substances under cGMP guidelines.
• Lead/participate in method development, transfers, and validation activities.
• Maintain compliant records and write technical documents with guidance.
• Operate instrumentation (HPLC/UPLC, GC, KF, IC) and analyze data.
• Assist with SOPs, CAPAs, and client communications as needed.

Skills

Analytical techniques

HPLC

Experimental design

Regulatory compliance

FDA/cGMP knowledge

Education

Bachelor’s degree in Chemistry or related

Master’s degree in Chemistry or related

Tools

Empower

ChemDraw

MS Office

Job description

You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

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

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.

Job Overview

This role is a hands-on laboratory position focused on performing analytical testing of raw materials, intermediate materials, and drug substances supporting late-stage clinical and commercial pharmaceutical programs. Approximately 80% of the role is dedicated to laboratory bench work, with a strong emphasis on generating high-quality, accurate, and compliant analytical data.

Primary responsibilities include release testing, in-process and homogeneity testing, stability testing, and reference standard qualification activities using a variety of analytical techniques. The role is heavily focused on HPLC/UPLC analysis, with additional opportunities to utilize GC, Karl Fischer (KF), ion chromatography (IC), and other analytical methods.

The successful candidate will also support method transfers, validation activities, troubleshooting, and continuous improvement initiatives aimed at optimizing analytical methods and supporting method lifecycle management.

Candidates should possess strong attention to detail, adaptability in a dynamic laboratory environment, and a collaborative, team-oriented mindset.

Experience with chromatography systems and data management software such as Empower is highly desirable. Team members typically develop expertise in liquid chromatography techniques first, with opportunities to expand into GC, KF, and other analytical platforms based on project and business needs.

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.
• 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
• 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
• Provides input on SOPs and client questions
• With guidance, prepares well written and organized development reports
• Perform other related duties as assigned.

Qualifications/Skills

• Working knowledge of experimental design, including chemistry supporting method development
• Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC.
• Working exposure to cross functional techniques including organic chemistry.
• Understands the chemical properties relating to method development, qualification /validation and troubleshooting.
• Able to comply to SOPs and basic 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
• General knowledge of chemistry and scientific calculations
• Hands on experience in analytical techniques such as HPLC, GC, etc
• Basic computer skills
• Ability to operate laboratory equipment and computers
• Ability to take direction from experienced scientists and contributes in a team environment
• Good problem-solving skills
• Good attention to details
• Can repeat and follow detailed scientific procedures with supervision
• 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

• Bachelor’s degree in Chemistry or a related scientific discipline with a minimum of 6 years of relevant pharmaceutical, biotech, or analytical laboratory experience; or
• Master’s degree in Chemistry or a related scientific discipline with a minimum of 2 years of relevant pharmaceutical, biotech, or analytical laboratory experience.
• This position is designed for candidates with significant hands‑on laboratory testing experience in a GMP‑regulated environment.

Supervision Received

Works under limited supervision.

Physical Demands, Work Environment, And Travel

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.

Benefits

• 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!

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Aff…