This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Senior Manager, Packaging Engineering will report to the Associate Director, Biologics Product Development and will be responsible for packaging engineering, development, and qualification. The ideal candidate must be an outstanding leader with a proven track record of execution in biologics combination product packaging, having supported packaging development and management of lifecycle changes of commercial packaged goods. This role requires experience with shipping validation, including transport qualification of Vera’s temperature-controlled supply chain, and global label/artwork management. Responsibilities - Develop and optimize packaging solutions for drug/device combination products, considering factors such as product integrity, stability, regulatory compliance, and patient usability and safety. - Conduct packaging material selection and testing to ensure compatibility, protection, and adherence to regulatory standards. - Optimize packaging design for efficient manufacturing, labeling, storage, and transportation within the pharmaceutical industry. - Manage the shipping validation and transport qualification of temperature-controlled shipment of goods across the end-to-end supply chain. - Direct day-to-day project oversight, including projection of material requirements, budgets, and timelines. - Collaborate with cross-functional teams to address any vendor-related issues, including non-conformances, quality concerns, or supply disruptions. - Conduct risk assessments and develop contingency plans to mitigate potential packaging issues or regulatory challenges. - Manage technical oversight and guidance to CMOs for packaging development, optimization, process validation, and cGMP packaging of biologics drug product in support of clinical and commercial supply. - Manage the development of printed components artwork partnering with CMC, Regulatory, Marketing, Legal, CMOs and third-party printer/converters. - Execute plans in accordance with industry standards, cGMP, ICH, and FDA regulations. - Write, update and review relevant sections for regulatory submissions. - Prepare, review, or edit cGMP protocols, reports, CMC regulatory and quality documents. Qualifications - MS/M. Eng. in relevant life sciences or engineering discipline with a minimum of 5 years of Pharmaceutical/Biotechnology industry experience in cGMP of biologics, or a related field. - BS in relevant life sciences or engineering discipline with a minimum of 8 years of Pharmaceutical/Biotechnology industry experience in cGMP of biologics. - Biologic/Device combination product development and packaging experience is highly desirable. - Experience in managing US/international CDMOs/CTLs. - Experience validating and overseeing temperature controlled global transportation lanes. - Familiarity with shipping validation including packaging standards (ASTM, ISTA, ISO), container closure integrity (CCI), product quality testing. - Working knowledge of FDA and international cGMP regulatory guidelines and submissions. - Proven leadership and cross-functional management of CMC-related programs. - Critical thinking and problem-solving skills with ability to drive risk-based decision making. - Excellent communication and interpersonal skills in working across the organization. Requirements - Track record of successfully driving and managing programs, overcoming challenges, and managing risks. Benefits - Vera Therapeutics is committed to fair and equitable compensation practices and strives to provide employees with total compensation packages that are market competitive. - The anticipated base pay range for this role is $125,000 - $170,000 USD.

Role Description Sev1Tech is seeking an Asset Manager with significant DPAS experience to provide fielded property accountability support to Project Manager Tactical Radios (PM TR) at the O-6 level. - Leverage the Enterprise Logistics Management System (ELMS) to execute data entry, coordinate equipment movements, and maintain accurate records of asset location and condition. - Execute all fielding activities utilizing ELMS in strict accordance with AR 700-142 (Material Release, Fielding, and Transfer) and AR 710-2. - Develop and execute a standardized inventory management framework to maintain Total Asset Visibility (TAV) within the Readiness Management Division (RMD), managing Tobyhanna Army Depot (TYAD) stock and optimizing fielding equipment oversight. - Manage, track, and archive all tactical radio and equipment configurations, including installation kits for various US Army tactical vehicles. Qualifications - Must be a US Citizen and possess an active DoD Clearance with eligibility and access at the secret level. - Minimum seven (7) years' relevant experience and understanding in the field of acquisition logistics and sustainment support. - Bachelor's degree in business or related field; an additional four (4) years of direct relevant technical experience may be substituted for education. - Experience and training on Army Property Book Management and Army Regulation 770-2. - Significant experience with US Army Accountable Property Systems of Record (APSR) specifically Defense Property Accountability System (DPAS), and familiarity with other APSR’s such as Logistics Management Plan (LMP), and Global Command Support System-Army (GCSS-A). - Experience with US Army Material fielding of C5ISR systems. - This position requires familiarity with US Army tactical formation in support of the US Army Campaign Plan. - Knowledge of maintaining inventories and experience forecasting high distribution of systems fielded to many different types of tactical unit formations and platforms. - Proficiency with computer applications such as Excel, Word, PowerPoint, and databases. - Excellent communication and coordination skills. - Travel may be required, up to 20% as needed to meet mission requirements. Company Description Welcome to Sev1Tech! Founded in 2010, we are proud to be a leading provider of IT modernization, engineering, and program management solutions. Our commitment is to deliver exceptional program and IT support services that empower critical missions for both Federal and Commercial clients. - Our mission is clear: Build better companies. Enable better government. Protect our nation. Build better humans across the country. - We believe that through innovation and dedication, we can make a significant impact on the communities we serve. - Join the Sev1Tech family, where your potential for greatness is limitless! - Explore opportunities with us and become part of a team that values your contributions and growth. Ready to take the next step? Apply directly through our website: Sev1Tech Careers and use the hashtag #joinSev1Tech to connect with us on social media! For any additional questions or to submit referrals, feel free to reach out to recruiting@sev1tech.com .

• Reporting to the Franchise Head, Haematology UK and Ireland, responsible for maximising the performance of BeOne’s products across the UK and Ireland • Implement marketing strategies for existing and upcoming launches in the haematology market • Achieve national commercial goals and defined performance parameters • Build an image/brand and awareness for BeOne and its products in the haematology market • Establish strong relationships and future-oriented collaborations with key opinion leaders (KOLs) and key accounts • Prepare the commercial market for the approval of BeOne’s future products in haematology • Cross-functional collaboration across the matrix team • Supervise and monitor development and implementation of key account plans • Provide exceptional leadership, fostering an environment to drive high performance, engagement, accountability, empowerment, and behaviours fully consistent with BeOne’s values and culture

• act as the face of Kyowa Kirin and the single point of contact for HCPs • develop and implement local account strategies • provide scientific and clinical knowledge to stakeholders • project manage initiatives to improve patient outcomes • conduct medical education programs and update healthcare professionals