Senior Scientist, Analytical Development Job Description Template
Our company is looking for a Senior Scientist, Analytical Development to join our team.
Responsibilities:
- Provides summary presentations and detailed reports to internal and external stakeholders;
- Creates method development reports, qualification protocols and reports, and control strategy documents;
- Performs analytical development activities to support development of cannabis ingredients and formulation excipients;
- Provides subject matter expertise to support high visibility projects;
- Develops advanced analytical methods using strong technical skills and literature search;
- Routinely collaborates with Research, Development, Manufacturing and Regulatory teams;
- Partners with affiliates in activities including technology transfer, data trending, method qualifications and reference standards;
- Generates high quality documentation to support license applications, patent filings and publications;
- Optimizes and qualifies methods for further validation per ICH and FDA guidelines.
Requirements:
- This position typically requires a PhD and 2+ year experience in the biotechnology/biopharmaceutical industry or;
- MS and 6+ years’ experience in the biotechnology/biopharmaceutical industry or;
- BS and 10+ years’ experience in the biotechnology/biopharmaceutical industry;
- Experience in advanced MS techniques, including QQQ and/or QTOF strongly preferred;
- Advanced degree in Chemistry, Analytical Chemistry, or related field (a Doctorate degree is preferred);
- Master’s degree with 5+ years or Doctorate degree with 2+ years of relevant industry experience in analytical development;
- Knowledge of relevant FDA and ICH guidance documents. Experience working in a GxP setting is a plus;
- Experience authoring technical development reports and regulatory documents;
- Track record of learning and acting on dynamic information in a fast-paced environment;
- Excellent oral and written communication skills and organizational skills;
- Knowledge of nanoparticle products, different dosage forms, and standard methods of analysis of these products;
- The person in this position needs to occasionally move about inside the office to access file cabinets, office machinery, etc;
- Must be able to remain in a stationary position 75% of the time;
- Constantly operates a computer and other office productivity machinery;
- Frequently communicates with other employees/customers. Must be able to exchange accurate information in these situations.