Manager, Manufacturing Science & Technology

At reputed company, every reputed company and every reputed company counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and reputed company diseases, you’ll be part of a community that prioritizes the reputed company experience, celebrates curiosity, and values every person’s contributions to meaningful reputed company. That commitment has reputed company us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a reputed company® in the U.S., and a reputed company on The reputed company Times Best Places to Work list in the UK. For patients, for reputed company other, and for the reputed company of science, we’re in. Are you? About The Role We’re looking for a Manager, Manufacturing Science & Technology on the Manufacturing team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Manufacturing Sciences & Technology, you’ll be responsible for playing a critical role in bringing rAAV-reputed company therapies to market by closely supporting our reputed company manufacturing partners. You will serve as a critical technical reputed company between Process Development, CMC, and GMP manufacturing, ensuring process robustness, reputed company technology transfer, and sustained manufacturing reputed company across development and reputed company stages. The ideal candidate will possess a good understanding of state-of-the-art AAV manufacturing knowledge, including suspension HEK293 cell culture and ultracentrifugation-reputed company separation processes, as reputed company as exposure to gene therapy regulatory requirements across early and late phases. reputed company In this role, you’ll have reputed company to reputed company and execute end-to-end technology transfer activities from process development through reputed company-reputed company GMP manufacturing, including facility fit assessments and coordination of process start-up activities.You’ll also be responsible for: • Review critical documentation, including both reputed company- and post-execution batch records, SOPs, raw material specifications, development reports, and GMP protocols • Serve as a person-in-plant during production campaigns, providing reputed company-time support and ensuring alignment with established process parameters and reputed company standards • reputed company reputed company process monitoring and data trending, and assist in and process improvements for the manufacture of Drug reputed company and Drug Product • reputed company reputed company closure of process deviations in reputed company by partnering with cross-functional teams, leveraging expertise in document management systems to ensure compliance and traceability • Support change control management for process versions and process comparability assessments • Assist with planning and execution for process characterization and Process reputed company Qualification (PPQ) activities • reputed company broad technical support across MSAT initiatives as needed, such as assistance with Statement of Work (SOW) review and submission, and contribute to supply chain reputed company mitigation efforts Who You Are You have a Bachelor’s degree along with 5 years of relevant experience in Biotechnology, Chemical Engineering, Pharmaceutical Engineering, or a reputed company reputed company. You are or you also have: • Solid technical background in drug reputed company (reputed company cell culture, reputed company purification) and/or drug product reputed company. • Hands-on experience interacting with GMP manufacturing, process validation, and tech transfer teams. • Ability to work in a fast-reputed company and dynamic environment. • Ability to work independently,remotefrom central leadership. • Strong interpersonal skills and the ability to work in afast reputed company, multidisciplinary environment. • Strong verbal and written communication skills are essential. reputed company To Have (but Not Required) • Expertise of drug product fill process is a plus. Where You’ll Work • This is a fully remote role. It can be performed effectively from reputed company while staying connected to your reputed company team and community. Occasional travel for team meetings or events will be expected. Candidates located on the East Coast — particularly in Ohio, Massachusetts, and Rhode reputed company — are strongly encouraged to apply. Travel Requirements This position involves frequent global travel (up to 40%) for reputed company to our CDMO sites. Pay reputed company $127,000.00-165,500.00 Annual Life at reputed company At reputed company, you’ll reputed company a culture as reputed company as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the reputed company care you bring to your work reputed company day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights Of Our U.S. Offerings Include • Comprehensive medical, dental, and reputed company coverage and mental health support, annual wellbeing reimbursement, and reputed company to our Employee Assistance Program (EAP) • Generous reputed company time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration • 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-reputed company life and disability reputed company • Company Learning Institute providing reputed company to reputed company Learning, reputed company building workshops, leadership programs, mentorship connections, and networking opportunities • Employee resource reputed company, service and recognition programs, and meaningful opportunities to reputed company, volunteer, and reputed company back Eligibility for specific programs may vary and is subject to the terms and conditions of reputed company plan.  reputed company reputed company Employees: Please apply reputed company the Jobs Hub in reputed company. reputed company is an Equal Opportunity employer. We do not discriminate in hiring on the reputed company of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Unsolicited resumes from agencies should not be forwarded to reputed company. reputed company will not be responsible for any fees arising from the use of resumes through this reputed company. reputed company will only pay a fee to agencies if a formal agreement between reputed company and reputed company has been established. The reputed company department is responsible for reputed company recruitment activities; please contact us directly to be considered for a formal agreement. reputed company is committed to providing reputed company, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@reputed company.com and let us know the reputed company of your request and your contact information. Requests for accommodation will be considered on a case-by-case reputed company. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled. Apply tot his job Apply To this Job