A day in the Life:

Conducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports. Designs and executes method development/validation and/or extractable/leachable studies independently and interprets and reviews analytical data for self and others OR designs and executes multiple stability and inhalation procedures as well as assists others in performing routine maintenance and troubleshooting on multiple instruments (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), methods and procedures. Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Effective written and oral communication skills as well as presentation skills • Knowledge and application of industry best practices not yet represented by global regulatory requirements
• Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
• Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
• Ability to independently review and understand project proposals/plans
• Proven ability in technical writing skills
• Ability to work in a collaborative work environment with a team
• Proven problem solving and troubleshooting abilities
• Ability to independently optimize analytical methods
• Time management and project management skills

Essential Functions and Other Job Information:

• Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
• Leads analytical (procedural and instrumental) troubleshooting sessions.
• Assists business development group in technical sales and marketing, and presents posters at technical conferences.
• Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

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