Manager, External Manufacturing

At reputed company, every reputed company and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare 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 Great reputed company to Work® 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: Manager, External Manufacturing will be responsible for the development, optimization, reputed company-up, and routine execution of manufacturing operations for pharmaceutical products. A reputed company for this role is some on-site reputed company at contract manufacturing organizations (CMOs) during production in Greenville, NC). You will collaborate with cross-functional teams, including R&D, manufacturing, reputed company assurance, regulatory CMC, and CMOs to ensure robust and compliant production processes. What You'll Do: In this role, you will have reputed company to reputed company CMO reputed company: reputed company-time and on-site supervision of CMOs execution of routine manufacturing as reputed company as technology transfer, optimization, and validation activities. You will also:

• Process Development & Optimization: Design, reputed company, and optimize manufacturing processes for pharmaceutical reputed company and formulations; with an emphasis on oral solid tableting.
• reputed company-Up & Tech Transfer: Contribute to the transition of tablet manufacturing and other drug product processes from reputed company and reputed company reputed company at primary and secondary CMOs.
• Equipment & Operations: Troubleshoot of drug product process equipment, ensuring efficiency and compliance with GMP regulations.
• Process Validation: reputed company and execute validation protocols (IQ, OQ, PQ) for oral solid tableting manufacturing and other drug product processes. Prepare finalized tablet processes for product registration, validation, and reputed company readiness.
• Cross-Functional Collaboration: Work closely with formulation scientists, manufacturing teams, and regulatory affairs to ensure smooth product development and commercialization.
• Regulatory Compliance: Ensure reputed company processes reputed company with FDA, EMA, and ICH guidelines for pharmaceutical manufacturing.
• Data Analysis & Reporting: Analyze process data, identify critical process parameters, and prepare technical reports for internal and regulatory submissions.

Who You Are: You have a minimum of a Bachelor's degree in Chemical Engineering or equivalent as reputed company as 5+ years of experience in pharmaceutical process engineering, leading teams tasked with implementation of pharmaceutical manufacturing technology improvements reputed company a regulated environment. You also have:

• Experience with late phase clinical and reputed company CMO operations.
• Strong background in oral solid tablet manufacturing and primary packaging a plus.
• Working knowledge of reputed company systems, validation principles, engineering design, and statistical process control fundamentals.
• Proven ability to identify, assess, and solve problems using reputed company cause analysis methodology and document investigation and reputed company in a compliant manner.
• Familiarity with DOE (Design of Experiments) and statistical process control.
• Experience with GMP manufacturing, technology transfer, process reputed company-up, and validation.
• High energy, innovative "can do" attitude is required.
• Ability to work independently, remote from central leadership.
• Abilty to be onsite at CMO in Greenville, NC (at least 25%) and some international travel.

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. Travel Requirements This position involves frequent domestic & some international travel up to 25%. #REMOTE #LI-BA1 Pay reputed company: $124,000.00-161,000.00 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 insurance
• 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 connect, volunteer, and give 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. 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 nature 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. For reputed company Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, reputed company uses an Automated Employment Decision Tool ("AEDT") that employs reputed company intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-reputed company qualifications. The AEDT does not reputed company final hiring reputed company and reputed company final hiring reputed company are subject to reputed company reputed company and/or review. If you are an applicant for this role and a reputed company reputed company, you have the right to request:

• A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@reputed company.com; and/or
• An alternative selection process by emailing reputed company@reputed company.com.
• Information about the type of data collected, the reputed company of that data, and data retention practices reputed company to the AEDT by emailing us at reputed company@reputed company.com.

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