Principal Scientist 1 – ARD Position Available In Guilford, North Carolina

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 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 Principal Scientist 1 – ARD will independently: conduct development and optimization for methods that have no starting point for intermediates and final products. Develop and optimize robust analytical methods for final product that are validatable . Maintain laboratory notebook and perform data review. Maintain lab instrumentation. Conduct method development and optimization on LC/MS and/or GC/MS. Troubleshoot instrument issues. Work with Process Chemistry department to support analytical needs for process development and manufacturing. Ensure compliance with applicable Company SOPs and regulatory guidances . Perform laboratory investigations and non-routine project work including QC issues. Author analytical procedures, protocols, and reports . Act as Analytical lead for internal projects including responsibility for all Analytical aspects of the project from development through technical support of QC for final product release . With minimal support, understand regulatory requirements and recommend Analytical approaches to clients and CHP colleagues. With some support , lead larger scope projects including cross-site projects within Cambrex. Responsibilities + Develop and optimize analytical methods for intermediates and final product. + Maintain and review notebook and data entries. + Write analytical procedures, protocols, reports and similar documents. + Review and revise SOPs. + Perform laboratory investigations. + Lead laboratory investigations for Analytical and QC. + With support l ead larger-scope projects. + Train and mentor laboratory colleagues. + Maintain equipment + This position works with and handles hazardous materials and wastes . Responsible for recognizing emergency situations concerning hazardous materials and wastes .

Qualifications/Skills Analytical Chemistry Knowledge :

Beginning to demonstrate an understanding of advanced theories in Analytical Chemistry and method development

Cross Discipline Knowledge:

Higher level of understanding of the principles of cross-functional departments, including organic chemistry and engineering

GMP/Regulatory Knowledge :

Demonstrated understanding of industrial GMP and practical application to Cambrex programs; some a bility to provide feedback to clients re: clinical strategy

Instrumentation:

Advanced knowledge of HPLC, GC, MS, and ability to train and troubleshoot problems with equipment (and help others)

Communication:

Good written and oral communication skills, ability to communicate with clients without manager supervision.

Problem Solving:

Strong demonstration of problem solving, ability to lead investigations

Time Management :

Able to maintain timeline of key activities and use time efficiently; ability to handle projects without supervision though requires regular check in with manager

Leadership:

Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up

Technical Documentation and Review:

Ability to author and review key technical documents with minimal RFT errors . Can write new SOP with manager assistance .

External Influence:

Ability to lead local project teams and steer clients to desired outcomes; ability to work with management to develop key local laboratory-based initiatives

Industry Credibility and Rapport:

Recognized scientific leader within the Cambrex organization, locally and possibly beginning to extend to other sites

Operational Excellence:

Actively participates in key operational excellence initiatives

Change Orientation:

Active participation and support for implementation of Cambrex system level changes/initiatives Education, Experience & Licensing Requirements Ph.D. in Chemistry or related field with 6 years minimum experience or M.S. in Chemistry or related field with 10 years minimum experience or B.S. degree in Chemistry or related field with 1 4 years minimum e xperience in a laboratory environment . Fundamental Understanding with some of the following analytical technologies: + Titrations (manual and automated) + Basic wet chemistry + HPLC, GC, GC/MS, FTIR , NMR , XRPD , laser diffraction particle size , TLC + Working knowledge of other analytical equipment common to the pharmaceutical industry This position works with and handles hazardous materials and wastes . Responsible for recognizing emergency situations concerning hazardous materials and wastes . 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, 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.