Analytical Development, Principal Scientist I (HE2026)

Techlink Systems

Charles City, IA 50616, USA

Published: 6/14/2022

Technology

Full Time

Job Description

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

Company DescriptionTechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.

We also have national recruiting

Company Description

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. \r\n\r\nWe serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness. \r\n\r\nWe also have national recruiting