Stability Specialist II BioPharma Manufacturing US Method & Tech Transfer

Job Description Specialist II - US Method and Tech Transfer Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com. Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Purpose & Scope The Specialist II Biopharma Manufacturing US Method and Tech Transfer will be responsible for support of the Quality Control stability program, organization of stability studies, document management and revision, contract test lab management, and as appropriate lead of laboratory investigations in support of pre-clinical, clinical, and commercial viral vector products in compliance with cGMP requirements. This role is hybrid, with the expectation to be onsite 3-days/week. Role and Responsibilities Initiate new stability study configuration documents; perform stability document revisions and document management; stability protocols and reports (interim/final) Assist with the stability schedule Interact with Analytical Development, CTLs, Site QC teams to ensure timely testing of samples according to protocol Provide feedback on design and workflow of stability modules in LIMs Serve as the single point of contact between Astellas and CTLs to review protocols and reports, routine testing data, and investigations Initiate works orders and purchase orders for contract lab testing, as needed Responsible for the management of the stability data: collect and review stability data and create/update stability tables using templates Assist with trending of stability data Lead or participate in CTL and stability deviations: invalid results, unexpected results, OOS/OOT, lab investigations, and contract lab discrepancies Author and manage change controls Statistical analysis support using JMP or other statistical software. Assist in the preparation and review of CMC regulatory submissions Ensure compliance with applicable cGMP regulations, ICH guidelines, and SOPs, and support regulatory audits Requirements Required Qualifications B.S. Degree in biological sciences, cell biology, chemistry, or related field with 5+ years of laboratory or stability experience in a GMP environment or a Masters in Biological Sciences, Cell Biology, Chemistry, or related field with 2+ years of laboratory experience. Experience with laboratory or stability deviations, investigations and/or discrepancies Experience with contract lab management Experience with Veeva or other EDMS Experience with statistical software (JMP) Good to excellent technical writing skills and verbal communication skills Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment. Highly self-motivated and goal oriented Preferred Qualifications Knowledge of Good Document Practices (GDP) Experience with LIMS Demonstrated proficiency in Microsoft Office suite Benefits Salary Range: $94,570-135,100 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down 401(k) match and annual company contribution Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions Long Term Incentive Plan for eligible positions Company fleet vehicle for eligible positions EEO Statement Our organization is committed to diversity, equal opportunity, and affirmative action. We are an equal opportunity employer. All applicants will be considered without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other protected characteristic. #J-18808-Ljbffr RadNet, Inc.