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 DescriptionThe Senior Analytical Scientist is responsible for the implementation, development, qualification, and validation of analytical test methods in support of process research, discovery research, cGMP production, and stabilitytesting, with particular emphasis on HPLC, GC, LC/MS, GC/MS, NMR, ciEF, and CE-SDS methods. This role's 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, KF, titrations, and a variety of instrumental and wet chemical techniques. Other duties may involve analytical method modification, development, and validation. The incumbent may 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, qualify, validate and transfer the analytical methods as per the regulatory guidelines for small molecules and peptides.
- Perform sample analysis using various analytical techniques (e.g., LC, GC, LC-MS, GC-MS, NMR, ciEF, and CE-SDS etc.), interpret results, and prepare high-quality documentation such as protocols, analytical reports, and summary reports.
- Independently detect and solve complex analytical problems of high technical difficulty.
- Handle FDA deficiencies with the current regulatory trends.
- Prepare SOPs, test methods, and other GMP documentation. Review data generated by other analysts.
- Apply knowledge and expertise from multi-disciplines (including QA, QC, analytical and production) to achieve project goals.
- Conduct investigations independently and troubleshoot analyses and instruments.
- Mentor chemists and scientists. Provide training on all analytical chemistry and cGMP QC procedures.
- Prepare and review scientific reports.
- Contribute to the technical growth of the department and company.
- Interface with internal and external clients.
- Carry out any other duties which are within the employee's skills and abilities whenever reasonably instructed.
Qualifications
- Bachelors in Analytical Chemistry, Chemistry, or a related field with a minimum of 12+ years of work experience in the pharmaceutical industry/GMP environment
- Masters in Analytical Chemistry, Chemistry or a related field with a minimum of 10+ years' experience in the pharmaceutical industry/GMP environment.
- PhD in Analytical Chemistry or a related field with a minimum of 8+ years' experience in the pharmaceutical industry/GMP environment.
- Minimum of 5 years' experience in method development and validation for Active Pharmaceutical Ingredients (APIs).
- Experience with Process Development of APIs.
- Experience with HPLC, GC, GC-MS, LC-MS, NMR, ciEF, CE-SDS spectroscopy, and wet chemistry.
- Experience mentoring staff members in an analytical department.
- Skilled in writing method validation protocols, reports and technical reports.
- Skilled and familiarity with analytical software tools like Empower 3 and DryLab.
- 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, analyse, 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 InformationAll 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.