Job Details
Our client is a global leader in the development and manufacturing of specialty pharmaceutical drug products, including oral and mucosal thin films and transdermal patches.
The Sr. Analytical Scientist will be responsible for the design and development of new products, innovation of new technologies, and improvements to existing products. This position will report to the Director of Product and Process Development.
RESPONSIBILITIES:
- Develop project designs and strategies aligned with application requirements, sharing them with the project team and relevant stakeholders.
- Creating formulations and product constructions, selecting raw materials, conducting experimental evaluations, and setting specifications for multiple projects concurrently
- Perform experiments at lab and production scales, drawing conclusions from technical data analysis and literature references.
- Define test methodologies, prepare samples, and conduct tests on raw materials, intermediates, and finished products to support programs.
- Anticipate and address potential technical issues during development, efficiently troubleshooting and solving problems.
- Contribute to the design and specification of production-scale processes and validation.
- Collaborate with cross-functional teams to develop and commercialize new drug delivery products
- Conduct research on literature and patents to ensure project feasibility and compliance.
- Interact with customers and colleagues and contribute to the patenting of technology
QUALIFICATIONS:
- Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or Polymer/Materials Science
- Minimum 3 years of Pharma Industry experience
- 7+ years of laboratory experience, preferably in research.
- Must have forced degradation, HPLC, MS, and method development experience.
- Proficiency in polymer formulation and mixing processes for drug delivery, with coatings experience preferred.
- Knowledge of cGMP, 21CFR Part 211, QbD, PAT, ICH, and ISO standards.
- Familiarity with chemical analytical techniques and statistical experimental methods.
This role is 100% onsite. Relocation assistance will be provided