Cambrex ยท 1 day ago
Principal Scientist 2 - ARD
High Point, NC
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 2 - ARD will independently conduct development and optimization for methods, maintain laboratory notebooks, and lead larger scope projects while ensuring compliance with regulatory guidelines.
AnalyticsBiotechnologyInnovation ManagementManufacturingMarket ResearchPharmaceutical
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
Write SOPs, CAPAs, and similar documents
Perform laboratory investigations
Lead laboratory investigations for Analytical and QC
Lead 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
Qualification
Required
Ph.D. in Chemistry or related field with 8 years minimum experience or M.S. in Chemistry or related field with 12 years minimum experience or B.S. degree in Chemistry or related field with 16 years minimum experience in a laboratory environment
Strong understanding of advanced theories in Analytical Chemistry and method development
Higher level of understanding of the principles of cross-functional departments, including organic chemistry and engineering
Strong understanding of the GMP landscape and fundamental understanding of the industrial regulatory landscape; Good understanding of site SOPs and regulatory CMC concerns and can answer client questions and help them develop their clinical package
Advanced knowledge of HPLC, GC, MS, and ability to train and troubleshoot problems with equipment (and help others)
Excellent written and oral communication skills, often leading technical calls with clients
Demonstrated ability to perform root cause analysis and solve problems
Very good organizational skills and time management. Able to work on several key items at once including two or more medium complexity projects at once
Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up
Strong ability to generate key technical documents with minimal RFT issues and to review documents for others. Basic ability to write new SOPs
Strong demonstrated ability to independently steer client or technical teams; ability to redirect and point out scope change; good ability to work with site leadership team and steer local initiatives
Demonstrated reputation as a leader within the Cambrex Analytical community. Good publication record, where possible, and strong contributions to the Cambrex portfolio
Demonstrated ability to participate and share leadership on local OE initiatives
Demonstrated contribution of input and ideas for larger Cambrex system level changes
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
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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