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 DescriptionThis Scientist role 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 HPLC, GC, and non-chromatographic 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, KF, titrations, and a variety of instrumental and wet chemical techniques. Other duties may involve analytical method modification, development, and validation. The Scientist 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
- Independently Develop and validate the methods as per the regulatory guidelines for the Raw materials, In process and final drug substance candidates.
- Strong knowledge as per the ICH Guidelines conducting Method validations, method verifications and method transfers.
- Strong knowledge in chemistry and empower software and advanced skills in Analytical Instrumentation.
- Handling FDA deficiencies with the current regulatory trends. Develop an understanding of R&D team goals and work effectively toward achieving them in a multidisciplinary team environment.
- Prepares SOPs, test methods, and other GMP documentation. Reviews data generated by other analysts.
- Interfaces with internal and external clients.
- To carry out any other duties which are within the employee's skills and abilities whenever reasonably instructed.
- Effectively communicate own and/or team's work and deliver project updates to senior level management clearly in oral and written forms in the context of project goals
Special Factors
- While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
- Specific vision abilities include: near, distance, peripheral, color perception, and the ability to adjust focus.
- Must be able to perform fine motor functions, such as accurately weighing and transferring small amounts of chemical compounds.
- Must be able to handle chemicals, including potent and toxic ones in a safe manner, while wearing appropriate personal protective equipment.
- Moderate travel may be necessary for technical meetings, customer visits, and supplier contacts.
Qualifications
- PhD in Analytical Chemistry or equivalent with a minimum of 3 years' experience in a GMP environment.
- MS in Analytical Chemistry or equivalent with a minimum of 6-8 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 3 years' experience in method development and validation for Active Pharmaceutical Ingredients (APIs).
- Experience with cGMP with knowledge of SOP
- Familiar with USP, EP, and ICH guidelines
- Experience with Process Development of APIs
- Experience with HPLC, GC, spectroscopy, and wet chemistry
- Experience in small molecules, peptides, ADC's and Oligonucleotide method development and validation
- Experience with GC-MS, LC-MS, NMR, XRPD, ciEF, and CE-SDS, ICP, and IC
- Experience mentoring staff members in an analytical department
- Formal project management training
- Experience with writing method validation protocols and reports
- Experience with Microsoft Office and other complex computer software (UPLC, Empower 2)
- Excellent analytical, written and verbal communication skills
- Ability to lead projects and provide direction to various levels of BS 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 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.