Senior Scientist 1 - ARD

Cambrex; High Point (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Cambrex in High Point, NC seeks a Senior Scientist 1 - Analytical R&D to independently perform analytical testing on reference standards and drug substance under GMP conditions. You will maintain notebooks, review data, and ensure instrument maintenance.

With minimal supervision, you will conduct method validation and transfers, perform investigations, participate in larger scope projects, and train colleagues, contributing to quality and regulatory compliance within a collaborative team.

Qualifications

• Analytical chemistry knowledge with practical lab experience.
• Cross-functional understanding including organic chemistry.
• GMP regulatory knowledge with SOP/regulatory guidance familiarity.
• Experience with HPLC, GC and related instrumentation.
• Strong written and oral communication skills.
• Ability to lead investigations with supervisor support.

Responsibilities

• Perform analytical testing using established methods.
• Maintain and review notebooks and data entries.
• Write reports, protocols and similar documents.
• Conduct reference standard characterizations.
• Perform method validation and transfers.
• Carry out laboratory investigations.
• Participate in larger scope projects.
• Train laboratory colleagues.
• Maintain equipment and lab safety.
• Handle hazardous materials and waste, recognizing emergencies.
• Occasionally perform method development with support.

Skills

Analytical Chemistry

Cross Discipline Knowledge

GMP/Regulatory Knowledge

Instrumentation

Communication

Problem Solving

Time Management

Leadership

Technical Documentation

External Influence

Industry Credibility

Operational Excellence

Change Orientation

Education

Ph.D. in Chemistry or related field

M.S. in Chemistry or related field with 6 years minimum experience

B.S. degree in Chemistry or related field with 10 years minimum experience

Tools

HPLC

GC

FTIR

NMR

XRPD

GC/MS

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

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

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.

Job Overview

Senior Scientist 1 - Analytical R&D will independently perform analytical testing on reference standards and drug substance following established methods under GMP conditions. Maintain laboratory notebook and perform data review. Maintain lab instruments. Ensure compliance with applicable company SOPs and regulatory guidance. With minimal supervision, conduct methods validation and method transfers, perform laboratory investigations and non-routine project work, participate in larger scope projects, author protocols and reports. Troubleshoot instrumentation with support.

Responsibilities

Essential Functions:

• Perform analytical testing utilizing established methods.
• Maintain and review notebook and data entries.
• Write reports, protocols and simlar documents
• Conduct reference standard characterizations
• Conduct analytical methods validation, and transfers
• Perform laboratory investigations.
• Participate in larger-scope projects
• Train laboratory colleagues
• Maintain equipment.
• Responsible for laboratory upkeep (supplies, chemicals, cleanliness, safety).
• This position works with and handles hazardous materials and wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes.
• Occasionally, perform method development and pre-validation experiements with support

Qualifications/Skills

Competencies:

• Analytical Chemistry Knowledge: Good understanding of the principles of Analytical Chemistry with some practical laboratory experience.
• Cross Discipline Knowledge: Basic understanding of the principles of cross-functional departments, including organic chemistry
• GMP/Regulatory Knowledge: Demonstrated understanding of GMP; With manager input, can help to advise client inquires related to SOP or regulatory guidance
• Instrumentation: Good fundamental understanding and ability to use/investigate issues with HPLC, GC
• Communication:Good written and oral communication skills, able to handle client requests with manager review
• Problem Solving: Able to solve problems in the workplace and helps to lead investigations with manager support.
• Time Management: Reasonable ability to handle one or more tasks or projects, often with supervision
• Leadership: Shares ideas with peers
• Technical Documentation and Review: Ability to write technical documents with assistance
• External Influence: Occasionally participates in internal project team meetings, as needed; demonstrated ability to work within a team matrix
• Industry Credibility and Rapport: Known as a solid scientific contributor within the department/group
• Operational Excellence: Demonstrated interest in improvement of operational aspects of the group/team
• Change Orientation: Provides constructive feedback for Cambrex Initiatives

Education, Experience & Licensing Requirements

Ph.D. in Chemistry or related field or M.S. in Chemistry or related field with 6 years minimum experience or B.S. degree in Chemistry or related field with 10 years minimum experience in a laboratory environment.

Fundamental Understanding With Some Of The Following Analytical Technologies

• Titrations (manual and automated)
• Basic wet chemistry
• FTIR, NMR, XRPD, HPLC, GC, GC/MS, laser diffraction particle size
• Working knowledge of other analytical equipment common to the pharmaceutical industry

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 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 / affirmative action employer and will consider all qualified applicants for employment without regard to race, colour, 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.