Endocyte welcomes those who thrive on new challenges, value creativity, enjoy an entrepreneurial environment, and share our vision for developing new and better medicines.
If your qualifications and interests match one of our open positions, please send us your résumé.
Attn: Human Resources
3000 Kent Avenue
West Lafayette, IN 47906
Endocyte is currently seeking candidates for the following position:
Endocyte is currently seeking a detail-oriented and professional Analytical Chemist to add to its team. The Analytical Chemist is responsible for developing and validating analytical procedures to evaluate the physical and chemical characteristics of raw materials, intermediates, APIs, and drug products. This position will also provide support for the development of new drug products. The incumbent documents these activities and formalizes analytical methods to be utilized in the future assuring regulatory compliance and transferability. These activities support drug development efforts for APIs and drug products.
As an Analytical Chemist with Endocyte, your essential responsibilities will include:
Analytical method development, validation and optimization
- Researches and develops new analytical methods required to evaluate formulations and new materials in support of development chemists’ efforts (e.g., identification, characterization, degradation studies)
- Researches and develops new analytical methodology required to establish the physical and chemical characteristics of raw materials, intermediates, APIs, and drug products (e.g., identify, purity, potency, appearance)
- Reviews current approved analytical protocols and test procedures for process improvement opportunities and/or new or revised regulatory requirements. Develops revised methodology where appropriate
- Performs qualitative and quantitative analytical tests utilizing approved protocols and test procedures to support the receipt and release of raw materials, intermediates, APIs and drug products and/or to evaluate unknowns, new materials, and/or new formulations in support of development chemists’ efforts (e.g., identification, characterization, degradation studies)
- Performs qualitative and quantitative analytical tests utilizing approved protocols and test procedures to establish and maintain reference and working standards required for the evaluation of APIs and drug products. This includes the characterization, potency, moisture, and purity of reference standards and the preparation, packaging, testing, and inventory maintenance of working standards. Supports vendor contracted to manufacture standards as appropriate
- Performs qualitative and quantitative analytical tests utilizing approved protocols and test procedures in support of stability testing for APIs and drug products
- Supports external laboratories contracted to perform qualitative and quantitative analytical tests using approved protocols and test procedures. This includes supplying protocols, procedures, standards, and samples; reviewing and distributing results
Analytical methods and results documentation
- Documents laboratory activities and maintains laboratory notebook
- Formalizes analytical methods to be utilized in the evaluation of raw materials, intermediate, APIs, and drug products and creates protocols and test procedures to be followed in future testing
- Assures that the protocols and test procedures are transferrable and compliant with regulatory requirements
- Creates, reviews, and/or revises laboratory SOPs when appropriate
- Follow company/departmental policies, procedures and SOPs
- Special projects as requested
B.S. or M.S. in Analytical Chemistry/Pharmaceutical Science or related field with a minimum of 5+ years experience in a pharmaceutical analytical laboratory setting.
- Knowledge and understanding of a variety of analytical techniques including UPLC/HPLC, LC/MS, GC, UV-Vis Spectrophotometry, infrared spectroscopy, and Karl Fischer titration
- Familiarity with pharmaceutical development for sterile, parenteral products
- Familiarity with cGMP regulations and FDA and ICH guidelines
At Endocyte, we know technology drives succss, but people are the heart of that achievement. We are committed to nurturing an atmosphere where creative thinking thrives and employees develop their full potential. Every day, at all levels of the organization, we work to make each individual feel included and appreciated. Endocyte is proud to offer comprehensive and competitive benefit programs, designed to meet its employees’ needs and those of their families.