Analytical Development, Principal Scientist I

Job Title: Analytical Development, Principal Scientist I
Location (On-site, Remote, or Hybrid?): Charles City, IA
Contract Duration: PERM

Job Description
The Principal Scientist I will provide technical support for multiple project teams. This individual will evaluate and interpret analytical results, develop, validate and transfer analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks.


Duties and Responsibilities:

• Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
• Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
• Perform analytical chemistry assays based on new and existing methodologies
• Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
• Write technical reports to document analytical methods
• Maintain laboratory notebooks documenting work
• Maintain compliance with GMP SOPs and DEA regulations
• Transfer documented analytical methods to the QC and Process Support Group departments
• Set up new or existing analytical methods for compound identification, purity and potency testing.
• Coordinate off-site testing as necessary
• Conduct testing of analytical samples for the Chemical Development Department as needed.
• Qualify reference materials.
• May also perform other duties as required.

Skills and Competencies:

• Analytical Chemistry Knowledge: Beginning to demonstrate an understanding of advanced theories in Analytical Chemistry and method development.
• Cross Discipline Knowledge: Higher level 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 programs; Some ability 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 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 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 system level changes/initiatives.

Education, Experience, and Licensing Requirements: required and preferred

• Ph.D. in Chemistry or related field with minimum 8 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 12 years of experience in lab environment, pharmaceutical experience preferred.
• Demonstrated ability to transfer processes to commercial scale manufacturing.
• Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.