Laboratorios Silanes is hiring an Analytical Innovation Manager to lead and ensure the completion of activities related to the development of new products focused on analytical development. You will guarantee compliance with quality, safety, and efficacy standards established by the company and current regulations.
What You'll Do
- Lead development, validation, and transfer projects for analytical methodologies.
- Ensure regulatory compliance with COFEPRIS, FDA, and other applicable agencies.
- Design, develop, and validate analytical methods under ICH guidelines.
- Coordinate stability studies, dissolution tests, and determination of organic and inorganic impurities.
- Supervise analysis by HPLC, GC, mass spectrometry, UV-Vis, IR, and titrations.
- Manage laboratory resources (supplies, equipment, and budget).
- Lead a direct technical team (starting with 4 direct reports, with projected growth).
- Coordinate relationships with third parties and external laboratories.
- Ensure compliance with timelines, quality of deliverables, and strategic area objectives.
- Plan and manage the development of analytical methods for new products, ensuring they are validatable and robust.
- Manage the analysis of batches for stability and clinical studies.
- Plan and manage verifications and/or validations of analytical methods for raw materials.
- Manage analytical transfers of raw materials according to the new product launch plan.
- Manage the development and validation plan for analytical methods for the quantification of nitrosamines.
What We're Looking For
- Completed bachelor's degree in Pharmaceutical Chemistry Biology, Industrial Pharmaceutical Chemistry, Pharmaceutical Engineering, or related to Pharmaceutical Technology.
- 5 years in project management within the pharmaceutical industry.
- Experience in development, validation, and transfer of analytical methodologies.
- Solid experience in chromatography (HPLC and GC).
- Development and validation of analytical methods.
- Experience in stability studies and dissolution tests.
- Handling of mass spectrometry, UV-Vis, IR, and titrations.
- Laboratory management and personnel management.
- Experience in interaction with third parties and external laboratories.
- Knowledge of national and international regulations.
- English: Intermediate – Advanced.
- Expert knowledge of the different stages of Pharmaceutical Development.
- Expert knowledge of the different studies involved in Product Development.
- Expert knowledge of Good Documentation, Laboratory, and Manufacturing Practices.
- Expert knowledge of Analytical Chemistry and impurities.
Nice to Have
- Master's degree in Science, Chemical Sciences, or related to Pharmaceutical Technology.
- At least 1 year in a similar position.
- Knowledge in different areas of Pharmaceutical Development: formulation development, analytical development, method validation, stability studies, integration of registration files.
- Experience in formulation development.
- Integration of files for health registration.
- Participation in predictive toxicity studies.
Technical Stack
- HPLC
- GC
- Mass Spectrometry
- UV-Vis
- IR
- Titrations
Team & Environment
You will lead a direct technical team, starting with 4 direct reports and with projected growth.
Work Mode
This is an onsite position located at Parque Industrial Toluca 2000.
Laboratorios Silanes is an equal opportunity employer.
