Technical BioPharma Manufacturing MSAT Engineer MA-TC

Technical BioPharma Manufacturing MSAT Engineer MA-TC Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our . Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a Technical BioPharma Manufacturing MSAT Engineer MA-TC opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The Senior Process Engineer will be responsible for MSAT activities and deliverables and for providing technical leadership and support to expanding manufacturing process platforms and pipeline in cell / gene therapies. The position will support operations including upstream and downstream drug substance manufacturing and drug product filling. The role is also responsible for effective collaboration with several stakeholders including but not limited to: Manufacturing, Process Development, Quality Assurance, R&D, Regulatory, CMC teams, Facilities, Validation, Supply Chain, Quality Control, and various vendors. Essential Job Responsibilities: Deliver a tech transfer and product lifecycle management program that incorporates phase appropriate requirements and expectations, improves tech transfer efficiency, and drives process optimization and cost of goods reduction. Lead tech transfer discussions between sending unit (Research, Process Development, and Pilot Plant) and receiving unit (Manufacturing, QA, QC, Supply Chain, Automation, Process Engineering, and Validation) Author process descriptions, engineering protocols, and technical reports. Create feasibility/gap assessments and facility fit analysis for new products and processes. Drive risk assessments for new processes, process changes, and process comparability Author process comparability protocols for drug substance and drug product Own new product introduction and product phase progression change controls. Manage manufacturing process sample plans (site dependent-Sanford). Support audits and inspections from internal and health authority organizations. Support regulatory interactions and submissions. Collect, organize, analyze, and present process data to enhance process understanding and identify improvements. Author engineering and campaign summary reports. Support process deviation investigations, root cause analysis, and CAPAs Represent MSAT and the site in various CMC meetings with Regulatory and Program Leads Qualifications: Required: MS in Life Sciences with 2 years of relevant experience or BS with 4 years of relevant experience Experience in biologics GMP manufacturing tech transfer Knowledgeable in process and analytical development, phase appropriate technology transfer, process comparability and qualification, CMC regulatory guidelines, process monitoring and analytics, manufacturing operations support, and GMPs, ICH, ISPE, and BPE guidelines. Familiar with QC methods for testing cell/gene therapy Critical Quality Attributes for drug substance and drug product including purity, potency, safety, identity, and physiochemical properties. Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers. Ability to work in a fast-paced team environment with fluctuating priorities and collaborate effectively with others. Excellent organizational and time management skills with ability to set own priorities and strong attention to detail. High degree of flexibility, adaptability, and independence; able to work as needed to meet tight deadlines. Ability to think critically and demonstrated troubleshooting and problem-solving skills. Experience working in cross-functional organization with ability to multitask, prioritize and be an effective and influential decision maker. Demonstrate data integrity standards to ensure data of highest quality. Mentor/train junior staff may manage contractors. Keep current with advances in technologies, evaluate and recommend new technologies that will be useful in expanding and enhancing platform processes; coordinate and champion deployment in manufacturing as appropriate and develop and execute engineering studies. As assigned, this position may be required to work during non-traditional work hours to support critical business operations. Preferred: Deep knowledge and experience with various human cell culture platforms, especially in human pluripotent stem cell culture and differentiation processes towards products for regenerative medicine Experience in cell/gene therapy GMP manufacturing, scale-up/scale-down, and tech transfer Proficiency in using Microsoft Office software (Excel, PowerPoint, Word), common lab & biostatistical analysis software Understanding of industry expectations with respect to phase appropriate requirements while advancing products from clinical to commercial state Preferred: This position require on-site work This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. This is an on-site role. Working inside the cGMP regulated manufacturing facility is site dependent. On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%) Benefits: Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks 401(k) match and annual company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions Long Term Incentive Plan for eligible positions Referral bonus program #LI-LK Category Massachusetts TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Created: 2024-10-30