Sr. Principal Analytical Scientist - ARD

Company Description
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Job Description
The Principle Analytical Scientist is Responsible for the implementation, development, validation and of analytical test methods in support of process research, discovery research, cGMP production, and stability testing, with particular emphasis on LC, LC-MS, GC, and GC-MS methods. The primary responsibility is testing support for production and process development teams.
Major support functions include sample analysis by a variety of analytical techniques including HPLC, GC, LC-MS/MS, GC-MS, ICP-MS, CE, SEC-MALS, NMR, KF, titrations, and a variety of instrumental and wet chemical techniques. Other duties may involve analytical method modification, development, and validation. The incumbent will function as the primary contact on one or more chemical development projects. In-depth involvement with the project team concerning the chemistry of the project and analytical chemistry needs is expected.
Key Responsibilities / Accountabilities

• Develop and validate new analytical procedures. Independently, detects and solves complex problems of high technical difficulty.
• Prepares and reviews scientific reports.
• Interfaces with internal and external clients.
• Analyze research and production samples. Reviews data generated by other analysts.
• Documents all analyses per SOPs.
• Prepares SOPs, test methods, and other GMP documentation.
• Applies knowledge and expertise from multi-disciplines (including QA, QC, Analytical and production) to achieve project goals.
• Applies knowledge and expertise from multi-disciplines (including QA, QC, Analytical and production) to achieve project goals.
• Conducts investigations independently.
• Troubleshoots analyses and instruments.
• Supports qualification of reference materials.
• Conduct training on all analytical chemistry and cGMP procedures.
• To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.
  

Qualifications

• PhD in Analytical Chemistry or equivalent with a minimum of 8 years’ experience in a GMP environment.
• MS in Analytical Chemistry or equivalent with a minimum of 10 years’ experience in a GMP environment.
• BS in Analytical Chemistry or equivalent with a minimum of 12 years’ experience in a GMP environment.
• Minimum of 8 years’ experience in method development and validation for Active Pharmaceutical Ingredients (APIs). Experience with Process Development of APIs.
• Experience with LC, GC, GC-MS, LC-MS/MS, SEC-MALS, CE, IC, spectroscopy, and wet chemistry.
• Experience in Antibody drug conjugates (ADC) testing.
• Experience with writing method validation protocols and reports.
• Experience with Microsoft Office and other complex computer software
• Excellent analytical, written, and verbal communication skills.
• Ability to lead projects and provide direction to various levels of analytical Chemists and Scientists.
• Ability to work independently and in a team environment
• Effective communication with clients
• Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents
• Ability to write clear and concise technical reports, business correspondence and procedure manuals.
• Ability to positively resolve conflict.
  

Additional Information
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .