Associate Scientist, Analytical Chemistry

Alcon•Durham, CA

5d•Onsite

About The Position

At Alcon, the Associate Scientist, Analytical Chemistry performs analytical testing of drug substances and drug products for potential ophthalmic medicines. The role analyzes materials throughout pharmaceutical product development, including starting materials, intermediates, drug substances, and drug products. Testing may include sample, release, stability, structural, and in-process control analyses. The Associate Scientist generates analytical data, troubleshoots issues, and collaborates on the development and validation of analytical methods, including stability-indicating HPLC, GC, and Karl Fischer methods. The role also performs compendial methods, supports phase-appropriate validation and stability protocols, executes stability studies, compiles and reviews laboratory data, and contributes to investigations and technical and regulatory documentation. Work is conducted in compliance with cGMP, safety, and regulatory requirements.

Requirements

Bachelor’s degree or equivalent years of directly related experience; alternatively, high school education plus 8 years of experience or an associate degree plus 4 years of experience.
Fluent ability to read, write, understand, and communicate in English.
Bachelor of Science or Bachelor of Arts in Chemistry or a related discipline with at least 5–8 years of relevant experience.

Nice To Haves

Strong laboratory skills in analytical testing for small molecules.
Experience with HPLC/UPLC, GC, GC with headspace, Karl Fischer, FT-IR, and physical testing such as pH, HIAC, and viscosity.
Ability to work comfortably in a fast-paced environment and flex activities and priorities rapidly.
Goal-oriented approach and excellent written and oral communication and organizational skills.
Ability to work effectively in teams.
Experience with Empower software and electronic notebooks (ELN).
Experience with analysis and/or analytical development for sterile solutions.

Responsibilities

Analyze drug substances, drug products, and materials at all stages of pharmaceutical product development, including sample, release, stability, structural, and in-process control analyses.
Generate analytical data using new and existing methods and troubleshoot issues.
Collaborate with others to develop and validate analytical methods, including stability-indicating HPLC, GC, and Karl Fischer methods.
Perform and verify compendial methods.
Assist with the design and execution of clinical phase-appropriate method validation and stability protocols.
Execute stability studies supporting development of new drug substances and drug products.
Compile laboratory data and assist with investigations of aberrant and out-of-specification results.
Author technical documents, including method development and validation reports, stability reports, and certificates of analysis, with assistance.
Maintain laboratory records and peer-review laboratory data.
Schedule work activities with supervision and maintain laboratory supplies and equipment.
Author and/or review standard operating procedures for analytical testing and reporting.
Collaborate on investigational studies to address specific issues.
Conduct work in compliance with cGMP, safety, and regulatory requirements.
Assist in authoring regulatory documents.
Monitor and evaluate completion of tasks and projects.
May assist in preparing budgets for laboratory equipment.