Scientist II, Analytical Chemistry

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the KindevaAt Kindeva were more than a pharmaceutical manufacturerwe partner with leading pharmaceutical companies to develop and manufacture life-changing therapies that improve the lives of patients around the Kindeva means becoming part of a collaborative team where your work directly supports the successful delivery of therapies from development through commercialization. Youll work alongside experienced scientists and cross-functional teams in a fast-paced highly regulated environment where scientific excellence innovation and collaboration make a meaningful impact every Impact You Will MakeAdvance Science. Deliver Quality. Improve to the Manager Analytical Chemistry the Analytical Chemistry Scientist II supports the development validation and transfer of analytical methods for components excipients drug substances and drug products across multiple stages of pharmaceutical this role youll apply your analytical expertise to generate high-quality scientific data that supports formulation development regulatory submissions technology transfers and commercialization collaborate with scientists formulation development teams quality manufacturing and external partners to develop robust analytical methods troubleshoot technical challenges and ensure laboratory activities are performed in compliance with cGMP GLP and regulatory requirements. Your scientific contributions will help ensure the safety quality and successful delivery of innovative therapies to patients around the this role you will:Develop optimize validate and transfer analytical methods supporting pharmaceutical development and interpret and communicate analytical data to support formulation development regulatory submissions and technical with cross-functional teams to solve complex analytical challenges and support technology transfer compliance with cGMP GLP and company quality standards while producing accurate scientific continuous improvement initiatives that enhance laboratory efficiency analytical capabilities and overall project Testing & Method DevelopmentPerform routine and non-routine testing of raw materials in-process samples drug substances and finished drug products to support formulation and process optimize and validate analytical test methods for components drug substances excipients and drug and report analytical data with a high degree of accuracy and scientific analytical methods and instrumentation proposing and implementing effective qualification of new analytical laboratory & CompliancePrepare technical documents including analytical method protocols validation reports technical reports and and maintain accurate and timely laboratory records in accordance with company policies and regulatory all laboratory work complies with cGMP GLP and company quality in cross-functional project teams and contribute to CMC documentation for regulatory submissions (IND NDA ANDA).Collaboration & Continuous ImprovementSupport method transfer and qualification activities to internal and external laboratories (e.g. CROs CDMOs).Prioritize personal workload to ensure that key objectives are met on time and to continuous improvement projects that improve laboratory effectiveness and qualification of new analytical laboratory creative thinking to generate solutions to complex technical -functional training and execution of activities within the R&D Product Development & Design Team as up to date with industry trends technologies and regulatory changes relevant to analytical other duties as QualificationsDegree in a scientific field:PhD or MS with 0 years of experience; orBS with 3 years of experience; or7 years of experience without a Bachelors attention to detail and scientific to work both independently and collaboratively in a fast-paced in analytical instrumentation and techniques including HPLC GC UV-Vis FTIR Karl Fischer spray testing and related analytical with cGMP ICH and FDA in analytical data interpretation documentation and scientific organizational written and verbal communication to work independently and manage time QualificationsExperience in an FDA-regulated with nasal spray drug products and RequirementsRegularly use hands to handle laboratory materials and a computer for extended periods throughout the effectively by telephone electronic communication and in stand and walk for extended periods of lift and/or move up to 25 proper lifting techniques and remain aware of laboratory and workplace Our One Team MissionAt Kindeva were driven by one mission: improving patients lives through innovation scientific excellence and collaboration. As part of our One Team culture youll work alongside talented colleagues who are passionate about solving complex scientific challenges and advancing pharmaceutical development. If youre ready to make a meaningful impact while growing your career in analytical chemistry we encourage you to apply and join our team.#LI-Onsite#WH