Analytical Development Scientist II

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeAs an Analytical Development Scientist II you will play a critical role in supporting analytical method transfer verification and validation activities for both small molecule and biologic products within a Contract Development and Manufacturing Organization (CDMO) environment. This position contributes to the development and implementation of analytical capabilities while supporting quality control testing technical investigations process transfers and validation activities. You will collaborate closely with the Manufacturing Quality Validation and Technical Operations teams to ensure analytical activities are executed efficiently and in compliance in support of bringing life-changing therapies to patients around the Method Development Transfer & ValidationExecute analytical method transfer verification validation and troubleshooting activities supporting both biologic and small molecule pharmaceutical routine and non-routine analytical testing of raw materials in-process samples finished products stability samples and validation technical investigations specification development regulatory submissions and analytical activities associated with cleaning validation and manufacturing Operations & Continuous ImprovementSupport the implementation qualification and maintenance of analytical instrumentation and laboratory and implement opportunities to improve analytical methods laboratory processes efficiency compliance and overall testing technical expertise across a variety of analytical and biochemical techniques while supporting laboratory best practices and data integrity -Functional Collaboration & Technical SupportCollaborate with Quality Control Manufacturing Quality Assurance Validation and Technical Operations teams to support routine operations and project technical guidance and training to laboratory personnel as and revise analytical methods protocols reports Standard Operating Procedures (SOPs) and other technical documentation while maintaining compliance with current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs).Support occasional off-shift weekend or manufacturing-related activities as business needs degree in Chemistry Biochemistry or a related scientific field with 5 years of relevant industry experience; Masters degree with 3 years of relevant industry experience; or Ph.D. with 2 years of relevant industry experience. Equivalent combinations of education training and experience may be supporting Quality Control or Analytical Development activities within GMP-regulated pharmaceutical biotechnology or CDMO environments including biologics (proteins peptides monoclonal antibodies) and small molecule pharmaceutical -on experience performing analytical method transfer method validation compendial verification troubleshooting and analytical testing using techniques such as HPLC UPLC LC-MS GC-MS FTIR SDS-PAGE ELISA Western Blot protein concentration assays Karl Fischer titration pH analysis and general wet chemistry with chromatography data systems and laboratory software platforms including Empower and Chromeleon along with a strong understanding of cGMP regulations FDA and ICH guidance method validation principles data integrity requirements and laboratory safety ability to troubleshoot analytical issues critically evaluate data perform statistical calculations generate technical reports protocols SOPs and other scientific documentation while providing scientifically sound recommendations and verbal and written communication skills with the ability to collaborate effectively across cross-functional teams manage multiple priorities and meet deadlines in a fast-paced pharmaceutical manufacturing RequirementsSpecific vision requirements include close vision distance vision color vision and the ability to adjust to use computers and laboratory systems for extended periods of to follow all cGMP laboratory and safety wear required personal protective equipment (PPE) and perform assigned work to use proper lifting techniques and remain aware of workplace occasionally lift and/or move up to 25 to support occasional weekend off-shift or manufacturing support activities as business needs require.#LI-Onsite