Cambrex ยท 1 day ago
Analytical Development, Principal Scientist I
Charles City, IA
Full-time
Onsite
Lead/Staff
8+ years expCambrex is a leading global contract development and manufacturing organization that provides drug substance development and manufacturing across the entire drug lifecycle. The Principal Scientist I will provide technical support for multiple project teams, evaluating and interpreting analytical results, and developing and validating analytical methods for APIs and raw materials while ensuring compliance with cGMP guidelines.
AnalyticsBiotechnologyInnovation ManagementManufacturingMarket ResearchPharmaceutical
Hiring Manager
Rob Duncan
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
Qualification
Required
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
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 Cambrex 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 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
Benefits
Healthcare
Life insurance
Planning for retirement
Company
Cambrex
Cambrex is a small molecule company that offers drug substance, drug product, and analytical services.
1001-5000 employees
H1B Sponsorship
Cambrex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (19)
2023 (16)
2022 (15)
2021 (7)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
unknown2019-08-07Acquired
1987-10-02IPO
Leadership Team
Tom Loewald
Chief Executive Officer
Robert Green
EVP & Chief Financial Officer
Recent News
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