Company : Cambrex
Country: United States
Location : High Point, North Carolina
Post: Thu, 21 Sep 2023 19:31:42 GMT
Expires: Thu, 19 Oct 2023 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Overview:
With minimal supervision: perform analytical testing on reference standards and drug substance following established methods under GMP conditions. Maintain laboratory notebook and perform some data review. Maintain lab instruments with support. Ensure compliance with applicable company SOPs and regulatory guidance.
With some supervision: conduct method validation and method transfers; support laboratory investigations, author reports.
Responsibilities:
Perform analytical testing utilizing established methods.
Maintain and review notebook and data entries.
Write reports and similar documents
Conduct reference standard characterizations
Conduct analytical methods validation, and transfers
Maintain equipment.
Responsible for laboratory upkeep (supplies, chemicals, cleanliness, safety).
This position works with and handles hazardous materials and wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes.
Write protocols and analytical procedures.
Qualifications:
Minimum BS/BA in Chemistry or related field with 6 years experience in a laboratory environment or MS in Chemistry or related field with 2 years experience.
Fundamental Understanding with some of the following analytical technologies:
Titrations (manual and automated)
Basic wet chemistry
FTIR, NMR, XRPD, HPLC, GC
Working knowledge of other analytical equipment common to the pharmaceutical industry
Competencies:
Analytical Chemistry Knowledge: Some understanding of the principles of Analytical Chemistry, able to execute protocols
Cross Discipline Knowledge: Early practical industry exposure to cross functional technical departments, including organic chemistry, works with QC/PSG for transfer
GMP/Regulatory Knowledge: With less manager supervision, able to better understand need for SOPs and basic regulatory guidance, knowledgeable of AD requirements
Instrumentation: Basic understanding of key analytical R&D equipment, can operate independently once instructed, solid LC/GC
Communication: Good oral and written communication skills within group
Problem Solving: May be asked to support peer-led laboratory investigation process with manager support
Time Management: Ability to handle key assignments, with supervision
Leadership: Shares ideas with peers
Technical Documentation and Review: Ability to keep a good laboratory notebook and perform data entry, compliance with GDP, review notebooks and spreadsheets
External Influence: Ability to work within a matrix team
Industry Credibility and Rapport: Willing to learn and grow within the local Cambrex Team
Operational Excellence: Strives to engage in group/team improvement projects
Change Orientation: Able to understand the importance of Cambrex initiatives
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