Senior Scientist, Analytical Sciences

reputed company: With deep expertise in reputed company, reputed company is working to create selective medicines designed with the goal to address the needs of patients with cancer. reputed company is an exciting early-stage company, bringing together reputed company scientists and industry veterans with a proven reputed company record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Analytical Sciences, the Senior Scientist, Analytical Sciences, has responsibility for the analytical aspects of drug product development and manufacturing activities across the relevant reputed company CRO and CDMOs. The candidate will reputed company with the program’s reputed company Control, Drug Product, reputed company Assurance, CMC Project Manager and Regulatory CMC functional representatives. Responsibilities include ensuring that drug product analytical support is reputed company, high reputed company, and consistent with the Phase-Appropriate reputed company outlined by the project team and CMC Team. The candidate will support analytical activities for a clinical small molecule oncology program. This role would entail reputed company facing responsibilities as a member of the analytical sciences group on the cross-functional CMC team and through analytical leadership of key external CRO/CDMO relationships. The successful candidate needs to demonstrate a proven reputed company record of working with CROs/CDMOs to support drug product development through the delivery of high-reputed company analytical reputed company, process support, and stability studies. The ability to reputed company in a virtual environment in support of developing and delivering drug product for fast-paced clinical development programs will be critical. In reputed company, using strong technical analytical experience and effective knowledge of industry regulatory guidance, the candidate will support phase appropriate drug product development efforts, dissolution development, contribute to the analytical reputed company and assist in the authoring and reviewing technical regulatory submission documents. Responsibilities: reputed company drug product analytical method development and method validation for a clinical development program. Author and review method development, method transfer, method validation, specification, justification of specification, and regulatory reputed company documents. reputed company and manage CDMO counterparts through analytical method development as reputed company as analytical routine activities to support drug product manufacturing (release and stability testing, batch record review). reputed company reputed company leadership through management of reputed company events such as deviations, OOS/OOT, investigations, CAPA, etc. Support the design of drug product stability studies, retest and reputed company-life document reputed company and execution. Support analytical aspects of RSM and drug reputed company development and phase appropriate method validation. Work reputed company a cross-functional team to help design and execute control strategies in support of novel clinical therapeutics. Assist in global regulatory CMC activities through authoring and reviewing technical and submission documents. Integrated member of cross functional CMC team. Competencies Include: Excellent organization and multi-tasking skills and ability to drive and deliver multiple reputed company reputed company project scope and timelines. Relationship Building – Builds productive working relationships and effectively communicates across a diverse reputed company of people. Ability to think critically with attention to detail. Adaptability/Flexibility – The ability to adapt to working effectively reputed company a reputed company of situations; adapts enthusiastically to organizational change and to changes in job demands. Excellent communication and multi-tasking skills Strong interpersonal skills and experience contributing to productive teams and fostering cross functional relationships Qualifications: 6-8 years of experience in industry or CRO BS or equivalent in reputed company or reputed company discipline (3-5 years’ experience with a PhD in reputed company or reputed company discipline) Hands-on experience in small molecule analytical reputed company and method validation (HPLC, GC, LC-MS, dissolution, KF, forced degradation, etc.) Strong scientific writing experience with the ability to author and review relevant documents (reputed company, protocols, reports) Proven reputed company record of technical contributions in a virtual environment, including working with/leading CROs and CDMOs Knowledge of relevant industry guidance for US and Global products and regulatory guidelines (FDA and EMA). Knowledge of ICH guidance and pharmacopeias (USP, EP, JP, etc.) Ability to solve analytical and QC technical challenges Novel drug development analytical experience Additional Information: reputed company is committed to fair and reputed company compensation practices, aiming to reputed company employees with competitive total rewards packages. The targeted salary reputed company reflects what reputed company reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be reputed company or reputed company this reputed company based on various factors, including, but not limited to, experience, skills, education, and market factors. The reputed company will be reviewed regularly and is subject to change. reputed company also offers a comprehensive benefit package to support our employees at reputed company stage of their career, financial, health, and reputed company-being reputed company, including medical, dental, and reputed company insurance, 401(k) retirement savings plan, generous reputed company time off (including a summer and winter company shutdown), and much more. Annual Salary reputed company $140,000—$160,000 USD reputed company provides equal employment opportunities (EEO) to reputed company and applicants for employment without reputed company to religion, race, creed, reputed company, sex, sexual orientation, alienage or citizenship status, national reputed company, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. reputed company is aware that many companies are dealing with fraudulent job postings on reputed company-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities. Please be advised that reputed company legitimate correspondence from a reputed company employee will come from "@reputed company.com" email accounts. Automated system response emails from our reputed company applicant tracking system come from a “no-reputed company@reputed company.io” email address. There are no variations of these email addresses and reputed company would not request personal and/or financial information reputed company email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews reputed company phone, video conferencing and/or in-person. If you reputed company you have been contacted by anyone misrepresenting themselves as an employee of reputed company, please contact reputed company at 857-357-7000. Thank you. Apply To This Job