Position will conduct development and optimization for methods that have a starting point and/or information regarding some or all parameters 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. Troubleshoot HPLC and GC issues. Work with Process Chemistry department to support analytical needs for process development and manufacturing. Ensure compliance with applicable Company SOPs and regulatory guidances.

With minimal support, perform laboratory investigations and non-routine project work including QC issues, participate in larger scope projects, author analytical procedures, protocols, and reports.

With some support, conduct method development on methods where no starting point is given, conduct method optimization and development on LC/MS and GC/MS. 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.

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.
• Perform laboratory investigations.
• Lead laboratory investigations for Analytical and QC with support.
• Participate in 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: Strong understanding of the principles of Analytical Chemistry with some practical laboratory experience.

Cross Discipline Knowledge: Good understanding of the principles of cross-functional departments, including organic chemistry and engineering

GMP/Regulatory Knowledge: Demonstrated understanding of GMP as it relates to current work; With less manager input, can help to advise clients on key regulatory strategies

Instrumentation: Demonstrated ability to use, train and investigate root cause issues with with HPLC, GC, good understanding of MS

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: Good understanding of time management and can self-organize with or without supervision

Leadership: Strong demonstration of sharing key ideas across the group

Technical Documentation and Review: Ability to write and review technical documents with minimal RFT errors

External Influence: Actively participates in regular internal project team meetings, including submission of key technical reports; organizes group level initiatives within the larger scientific team

Industry Credibility and Rapport: Known as a solid scientific contributor within the site

Operational Excellence: Able to support key OE initiatives

Change Orientation: Locally supports changes associated with larger Cambrex initiatives

Education, Experience & Licensing Requirements

Ph.D. in Chemistry or related field with 2 years minimum experience 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

Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is divided between performing in an office setting and walking in/out of the laboratories, standing for extended periods of time. Walking and standing are required.  Position also requires visual acuity, talking, computer typing.