Details
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients. This is what you will do: The Process Engineer III will support drug substance technology transfers as a technical subject matter expert (SME) within the biologics therapeutic pipeline for Alexion, Rare Disease Business Unit of Astra Zeneca. Transfer activities will be in support of CMC development of early phase, late phase and commercialization of biologics therapeutics. Primary responsibilities include technical and GMP document generation and review, coordinating manufacturing sample plans, manufacturing process monitoring and trending, and technical support for equipment and material evaluations and troubleshooting in support of GMP manufacturing. The ability to work independentally as well as work collaboratively in a team is essential. The Process Engineer II will routeinly work in collaboration with Process Development (PD), non-GMP internal Pilot network, Alexion Operations, Quality (QA), Regulatory (RA) and internal and external Manufacturing sites. The Process Engineer III will also support continuous improvement for efficiency of technology transfer plans and work processes. You will be responsible for: + Author or review of batch records, process validation protocols, change controls, and deviations to support drug substance GMP manufacturing throughout lifecycle of biologics pipeline in partnering with QA and Alexion Operations as applicable. + Assists in sample coordination and planning for manufacturing campaigns + Support evaluation of equipment, scale, and raw materials on manufacturing process. + Monitor and trend process performance, and provide manufacturing floor technical support, and contribute to investigations and deviations during manufacturing campaigns. + Actively participate in department and project team meetings, including assuming ownership and delivering on assigned action items. + Support the compilation of data for regulatory source documents + Initiate and lead continuous improvement projects for efficiency of technology transfer plans and work processes + This role includes domestic and international travel to manufacturing sites (~ 25%). You will need to have: + A B.S degree in a related Scientific discpline (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Biochemical, Mechanical) with at least 4 years of revelant experience or a MS degree in a related Scientific discpline with at least 2 years relevant experience.. + Experience in any area of biologics process development (purification and/or cell culture) or GMP manufacturing is required. + Ability to independently solve routine technical problems and to effectively lead or contribute to technical discussions with collaborators related to assigned technical tasks. + Demonstrated ability to prioritize multiple assigned tasks and/or projects and ensure assigned tasks are completed on time. + Excellent oral and written communication skills and strong attention to detail. + Familiarity with cGMP requirements for clinical and/or commercial biopharmaceutical manufacturing. + Proficiency with various MS Office programs, including Word, Excel, Outlook, and PowerPoint. + This role is primarily office based. Passport and ability to travel domestically and Internationally up to two weeks at a time for manufacturing site support. + During travel for manufacturing support, this role requires physical capabilities to gown and degown PPE in GMP cleanroom environment and be present during manufacturing operations in a technical support role. Physical elements include standing, climbing stairs, ladders, visual capability to read manufacturing control screens, use a computer, engage in communications via phone, video, and electronic messaging. Intellectual capabilities include engaging in problem solving and non-linear thought, analysis, and dialogue, collaboration with other peer functional representatives. We would prefer for you to have: + Knowledge and use of basic statistical analysis methods. + Certification or training in Lean Six Sigma Process Improvement, or equivalent. #LI-JR1 Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com . Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact ...@Alexion.com. Alexion participates in E-Verify. As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more. AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here ( .