Supply Chain Manager jobs at Vertex Pharmaceuticals - 133 jobs

Job Title: Supply Chain Manager Department: SG&A Status: Full Time - Exempt Reporting To: Global Operations Support Leader (CEO Interim) The Supply Chain Manager is responsible for overseeing and managing the entire supply chain of the organization, including international sites. This role involves planning, coordinating, and optimizing the flow of goods, services, information, and finances from the point of origin to the point of consumption. Additionally, they will anticipate disruptions and establish effective plans to address challenges in the supply chain. Key Responsibilities: Team Leadership Lead and develop the supply chain team, including training, performance management and more Foster a collaborative and efficient working environment Set performance goals and conduct regular reviews with team members Operations Oversee all aspects of supply chain operations, including procurement, inventory management, and logistics Challenge the status quo to Identify, implement and document process improvements to enhance efficiency and reduce costs Supply Chain Strategy Develop and implement supply chain strategies for planning, sourcing, manufacturing, delivery, disposal, etc. and align it with business goals and the S&OP process Monitor market trends and performance metrics to adjust strategies as needed Shipping and Receiving Oversee all inbound and outbound shipping activities Ensure that shipments are accurately documented, tracked, and delivered on time Manage receiving processes to verify the quantity and quality of materials received Risk Management Address supply chain disruptions promptly and ensure team manages to completion Mitigate risks related to sourcing, transportation and production Vendor Relations Collaborate with suppliers to ensure timely delivery of materials Negotiate contracts, develop and manage relationships with suppliers Present and monitor supplier scorecards on a recurring basis, present corrective actions as needed Data Analysis Analyze supply chain data to identify areas for improvement Implement cost-effective solutions and process enhancements based on data Prepare and present regular reports on supply chain performance to senior management Quality Control Ensure compliance with quality and safety standards Monitor product quality throughout supply chain Inventory Management Maintain optimal inventory levels to prevent shortages or excess stock Coordinate storage and distribution efficiently Education, Qualifications and Experience: Bachelor's degree in Supply Chain Management, Business Administration, or a related field. Minimum of 5 years of experience in supply chain management Strong leadership and team management skills Strong knowledge of procurement, logistics, inventory management, and distribution Excellent negotiation, communication and interpersonal skills Detail oriented with a focus on accuracy and efficiency Excellent communication and interpersonal skills Experience with supply chain management software and tools Strong analytical and problem-solving abilities Ability to work in a fast-paced environment and manage multiple priorities Preferred Qualifications: Certification in supply chain management (e.g., APICS, CSCMP). Experience in medical manufacturing industry Working Condition and Health & Safety: Heated and air-conditioned office environment Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space Harland Medical System's commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System's internal procedures, where deemed appropriate per assigned job functions. Physical Demands: While performing the duties of this job, the employee is regularly required to stand and walk on level surfaces for a prolonged period of time. The employee is frequently required to talk and hear; use hands to finger, handle or feel; and reach with hands and arms above shoulder height and below the waist. This position may occasionally be exposed to areas that require the use of personal protective equipment such as safety glasses with side shields and mandatory hearing protection.

GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. STAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com A DAY IN THE LIFE: Sr Supply Chain Specialist are responsible for the procurement and planning of components and finished goods assemblies as well as supplier management of contract manufacturers and component suppliers. This role coordinates purchasing activities with manufacturing, planning, and engineering departments to acquire inventory in a cost effective and timely manner and is responsible for procurement business system data input and integrity. Sr Supply Chain Specialists at Tandem Diabetes Care also: Manage Procurement activities using thorough forecasting and proper planning techniques to ensure suppliers receive forecasts & purchase orders to meet production demand and maintain inventory levels at targets. Ensure compliance with international labeling and packaging regulations by managing updates to user guides, product labels, and packaging materials across global markets. Collaborate with cross-functional teams to implement regulatory changes efficiently, minimizing supply chain disruptions. Monitor inventory levels and develop raw material forecasts using data-driven models to ensure optimal supply chain efficiency Perform Change Order Supply Chain activities: BOM change review, purchased part number set up and maintenance. Maintain and improve MRP data integrity on part numbers and BOMs as designated Utilize thorough forecasting and proper planning techniques to ensure that Contract Manufacturers maintain optimal inventory levels of commodities to meet production demand and ramp up requirements, while mitigating excess inventory claims Work in collaboration with Supply Chain Management to ensure the appropriate supplier strategy is being utilized in time for new product releases and production purchasing Minimize material lead times and ensure on time delivery of material to support NPI project schedules. Tracks and updates orders, delivery commitments, and inventory receipts both inside and outside of MRP Work with the manufacturing engineering group to assist suppliers in developing efficient fabrication processes; identify preliminary critical parts, long-lead parts, and inspection requirements. Evaluate supplier reliability and assist Engineering and Supply Chain Management to develop new supply sources as needed Perform analysis on EOL components and offer last time buy recommendations to management based on forecasts and product life cycles Participate in the continuous improvement of current systems and processes (I.E. Warranty repair replacement tracking, MRB, Internal replenishment of CM PM materials) Identify potential supplier capacity issues; work with Suppliers to resolve these issues and to ensure no impact on production schedules Quickly and proactively resolve and/or escalate issues related to delivery, supplier performance, quality or cost Responsible for overall Supplier Management; including organizing and conducting Quarterly Business Reviews (QBRs), regular cost analysis, reviews of Term & Conditions, Supply Agreement negotiations, Quality & Delivery KPIs and any other general activities to ensure peak performance from the Supply Base Maintain accuracy of all applicable reports, purchase orders, component item master information, etc. Work with engineering and Contract Manufacturers to ensure BOMs are accurate and will function in a production environment Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements WHEN & WHERE YOU'LL WORK: This role will be a mix of in-office work at manufacturing site in San Diego and remote work with an anticipated 3 days a week in office after onboarding. WHAT YOU'LL NEED: BA/BS with or equivalent combination of education and applicable job experience 6 plus years of experience in material procurement and planning Change order experience in a purchasing/procurement environment required Experience partnering with international suppliers is preferred. Ability to work effectively in a fast-paced environment of constant change Excellent verbal and written communication skills with the ability to communicate at both high (strategic) and detailed (tactical) levels using discernment Detail oriented with demonstrated ability to proactively follow-up on areas of responsibility in a timely manner Ability to read and have a basic understanding of engineering drawings Proficient in MS Office (MS Outlook, PowerPoint, Word, Excel) and ERP Information Systems, preferably AX Familiar with project management techniques Positive attitude, willingness to continuously improve and help others Drive and commitment to go the extra mile and find a better way; a team player with the ability to work cross-functionally Resolves a wide range of issues in creative ways, demonstrating good judgment in selecting methods and techniques for obtaining solutions Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors Ability to work autonomously COMPENSATION & BENEFITS: The starting base pay range for this position is $89,000 to $112,250 annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate's location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package. Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts. You'll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan. Learn more about Tandem's benefits here! YOU SHOULD KNOW: Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information. Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders. SPONSORSHIP: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. WHY YOU'LL LOVE WORKING HERE: At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at *************************************** BE YOU, WITH US! We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don't meet 100% of a job description's criteria - maybe you're feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone. REFERRALS: We love a good referral! If you know someone who would be a great fit for this position, please share! APPLICATION DEADLINE: The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications. Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow. #LI-Hybrid #LI-BC1

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Enterprise Management Job Sub Function: Supply Chain Management Job Category: Professional All Job Posting Locations: Irvine, California, United States of America Job Description: Johnson & Johnson MedTech Electrophysiology is recruiting for a Vice President, Global Supply Chain Planning located in Irvine, CA. The Vice President, Electrophysiology Plan is responsible for developing and leading the end-to-end strategic direction of the Electrophysiology Supply Chain Plan organization to drive best-in-class supply chain processes. This role covers 3 main areas of responsibility: drive transformational change (e.g., advancing digital capabilities), orchestrate E2E planning across functions and franchise platforms while demonstrating strong business acumen, and lead the operational/transactional day-to-day foundational planning activities. This includes functional responsibility for demand planning (consolidation regional demand planning at global level), supply planning, global sales and operations planning processes, capacity planning, inventory management and systems integration across the Franchise. This leader will also serve as an active member of the Electrophysiology Franchise Leadership Team where they will be a key contributor of optimizing the Supply Chain from a service and working capital perspective while contributing to the J&J strategies for the function. DUTIES & RESPONSIBILITIES Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Ensure a powerful and inspiring vision and strategy aligned to the Electrophysiology and Supply Chain needs * Develop, communicate, and reinforce an inspiring vision and strategy to deliver best in class e2e planning capabilities to support the Electrophysiology business. * The vision and strategy must deliver customer connectivity and seamless integration - with speed and agility - through a deep understanding of global customer needs through regular connection and assessment. * Strategies need to ensure growth priorities are anticipated and planned for, by an organization that has deep product and business understanding. * External perspectives are critical to embed the latest technology, systems, automation and digital capacities into the ongoing operating model to deliver the vision and strategies in an efficient and effective manner. Deliver significantly improved performance in supply reliability, and cash optimization * Ensure strong partnership and collaboration with key stakeholders across the Supply Chain and Commercial teams to translate customer needs to product requirements, Make, Source, External Operations, Quality, Deliver, New Product Development teams: Launch management and Scenario planning, the MD SC Planning team and the Johnson & Johnson Supply Chain * Planning of product needs to meet customer demand in an efficient and effective global operation with strong emphasis on continuous improvement in performance. * Deliver outstanding Reliable Supply (Service) with appropriate metrics e.g., OTIF@D/S/A. * Ensure rapid response to events and issues, with analysis to assess root cause * Ensure optimal cash management of Inventory ($ and DOS), minimize E&O, SLOB * Drive continuous improvement in forecast accuracy (MAPE / Bias) linked to Sales and Financial forecasts * Implement strong focus on agility with appropriate metrics to show flexibility and responsiveness, particularly on strategic products. * Partner with enterprise plan leaders to share and leverage resource, benchmarks, and best practices * Ensure planning integration for acquisitions to align Electrophysiology /MD/J&J operating model rapidly (and provide appropriate support in reverse for divestitures). * Ensure data accuracy and visibility, through robust MDM processes. Build and deploy "best in class" processes * Translate customer needs flawlessly - with speed - to supply points, inclusive of patients, HCP's, hospitals, distributors commercial leadership and sales force. * Drive process standardization based on best practices and emphasis on the SCOR model. * Ensure platform focused Service and Inventory management processes to drive e2e accountability with the E2E platform leaders on short-, medium- and long-term performance measures * Ensure clear communication and updates on event management. Be responsible for communicating business related issues or opportunities to all stake holders from sales force to senior management level as needed * Enable "best in class" S&OP processes supporting local needs through to executive engagement and alignment. * Enable PMR (portfolio management review) and LCM (life cycle management) processes to ensure an optimal product portfolio, with insights to drive GP improvement. * Ensure strong strategic forecasting, integrated to the LRFP's and updated at least twice annually, is in place for all platforms, built on strong partnership with commercial * Ensure strategic capacity planning to provide appropriate visibility to long term growth to enable sufficient production capacity to fulfill the market requirements over the LRFP * Plan and deliver the annual BP and subsequent quarterly updates to meet and exceed business requirements * Partner closely with Deliver on Customer Order Management and effective, efficient demand fulfillments. * Partner with the franchise SC functions, Deliver and Commercial to ensure a clear roadmap for inventory management and strong integration with the plan processes. * Partner with commercial on long term demand planning, strategic forecasts to ensure strategic capacity planning is in place * Provide strong and timely demand signals to External Operations and Suppliers. * Ensure robust New Product Launch planning to meet reliability needs and provide flexibility whilst minimizing inventory, in collaboration with the product management team and other functions (Make, Source, Ext Ops,). * Performs proper inventory and replenishment management in order to balance the level of inventory and reduce obsolete stock, while optimizing service, balanced against uncertainties in the supply chain * Provide Data and Analytics capability to generate insights on performance and improvement opportunities. * Collaborate with the SI&D team to ensure BCP, SC resiliency and Network optimization * Ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. * Take responsivity for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Advance and leverage the latest technology * Ensure the latest understanding of technology and how it can be implemented to drive improved customer performance. * CSS business owner for translation of planning capability needs, working with the Digital Transformation team to ensure a clear strategy and roadmap for ERP systems (transcend), advanced planning systems (Blue Yonder, Signify), and other support systems and digital capabilities. * Build a strategic vision and roadmap for digital solutions to accelerate capability partnering with the MDSC strategy and customer solutions teams. * Drive automation of processes, where possible, using the latest digital technologies * Partner with commercial to drive innovation in business models and customer connectivity. * Ensure strong external focus and benchmarking to bring new perspectives and insights - working with J&J SC to leverage wherever possible. * Define key planning functionality requirements and manage the interface with the IT organization to ensure correct priority is given for key IT developments within the planning area. * Advance technology to improve visibility and asset performance end to end where applicable Ensure a holistic, impactful, operating model that delivers value * Enable an outstanding customer centric, performance driven, plan capability * Seek organization leverage and operating model efficiency - with a standardized approach bringing alignment across the planning Electrophysiology franchise team and the Regions to deliver best practices * Ensure the highest levels of E2E teamwork and collaboration with the customer at the center * Develop and optimize local capabilities to support growth (e.g. China) or scale back and leverage as needed. * Drive cross country, region and sector sharing of best practices. Recruit and develop outstanding talent * Ensure the recruitment and development of outstanding talent * Ensure robust succession planning process and build strong talent pipelines, with clarity and relentless focus on development plans to accelerate talent capabilities * Accelerate diverse talent representation, especially female and African American leadership, with a stronger pipeline to represent the populations we serve * Put emphasis health and wellbeing and support with ongoing education to deliver work life harmony, to maximize energy levels across the team * Ensure strong training and education processes for all e2e planning, management and support capabilities * Enable talent leverage across the enterprise Build a customer focused winning culture * Build a credo focused culture, with the customer at the center - based on clear purpose supporting J&J, Electrophysiology and Medical Devices * Ensure a culture of inclusivity to enable all talent to bring their whole self to work and engage fully with their best energy * Ensure teamwork that emphasizes the value of diversity in building the best capability * Instill a winning spirit to serve customers and grow products and solutions that improve the health of humanity. * Value servant leadership and instill those principles across the organization * Build open, transparent and objective communications direct to the sales force and commercial leaders to enable e2e effectiveness and customer trust * Build caring interdependent teamwork, with resilience and renewal to provide strong support - particularly for those individuals under consistent pressure EXPERIENCE AND EDUCATION * Master's Degree or equivalent highly preferred * Minimum 12 years' experience in a complex Supply Chain environment, including in multiple of the following functional areas production, planning, supply chain, quality, procurement, new products, supply chain strategy * Advanced understanding of end-to-end supply chain, preferably in Medical Device Industry with advanced financial understanding * Strong international experience * Understanding of statutory and regulatory requirements (e.g., GMP, GDP practices) * Track record of influencing the external environment based on knowledge of social, political, regulatory, and economic issues affecting businesses domestically and globally * Articulating a vision, engaging, and mobilizing employees around that vision, and delivering superior value * Driving long-term, profitable, and sustainable growth in multiple functions, businesses, sectors and markets * Leading people through organizational uncertainty or key change initiative such as merger, acquisition, divesture, or restructuring * Identifying new partnership opportunities, determining optimal relationship conditions/model (licensing, co-promotion, acquisition), and executing these relationships * Creating and sustaining a culture of quality and compliance that encourages open communication, reporting noncompliant actions, taking corrective action and holding self/others accountable KNOWLEDGE & SKILLS * Lead large transformation efforts within the segment supply chain organization aligned with the global supply chain strategy. * Implement global standards while maintaining a strong regional execution and connection with the business. * Create, support, and reinforce an externally focused culture that instills best practices through benchmarking and understanding customer needs; Instill greater rigor in measures of productivity, customer intimacy, and innovation * Ensure full understanding of customer needs and requirements; increase time spent with customers * Align with internal business partners to execute deliverables and anticipate future customer needs * High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others. * Financial, moral, personal integrity and the values that inspire trust in the organization. * Energy, enthusiasm, commitment, courage and entrepreneurial excitement. Must be able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas. * Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally. Makes the customer central to all thinking. * Ability to fit in well culturally in a complex organization. * ERP system (SAP/JDE/Blue Yonder, Signify) knowledge and practical application would be an asset About Cardiovascular Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $199,000.00 - $366,850.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. For additional general information on Company benefits, please go to: - *********************************************

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

The Manager, Clinical Supply and Logistics will be the liaison between the Clinical Research Operations team and the Technical Operations team to facilitate cross functional collaboration for proactive problem solving and alignment of end-to-end clinical supply chain management to support clinical trial execution. This position will be responsible for supporting the strategic planning and execution of new clinical trial supply chains on time and within budget and is tasked with supporting an integrated operating model with close collaboration with cross functional stakeholders. Responsibilities • Oversees clinical supply labeling, packaging, release, distribution, return and destruction at contract manufacturing organizations. • Manages inventory globally at depots and sites including order management and proof of delivery confirmation, return or destruction and distribution logistics. • Acts as a key interface between the Technical Operations and Clinical Research Operations teams to operationalize supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans. • Interprets protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time. • Manages clinical supply activities for clinical trials including clinical supply needs identification, determination of appropriate presentation to clinical site and participants and IP expiry date management. • Collaborates with project team members including Technical Operations, Regulatory and Quality to design and implement drug labelling, packaging and supply strategies that not only meet the requirements of the study design, the clinical study sites, project timeline and the relevant regulatory authorities, but also maximizes efficiency of supply. • Leads the logistics of the forecasting, planning, and distribution of ancillary supplies for all clinical trials in conjunction with senior team members. • Coordinates supply strategies with internal Supply Chain/Technical Operations team and external packaging suppliers in conjunction with senior team members. • Manages external clinical vendors including IRT vendors, as assigned, in conjunction with senior team members. • Proactively identifies, prevents, and mitigates cross functional program risks related to clinical supply logistics. • Work with the cross functional project team to ensure consistent communication of clinical trial material supply chain status. • Collaborates with cross-functional study team members to ensure compliance of department/study activities with ICH guidelines, GxP, FDA and other applicable country regulations. • Other tasks as requested by managers. Qualifications • Bachelor's degree (B.A./B.S.) or equivalent, preferably in life sciences or related discipline. • 5+ years of related experience supporting clinical trial teams. • Experience managing clinical trial vendors. • A high level of proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is also required • Competencies: Teamwork & Collaboration, Attention to Detail, Analytical skills, Organizational skills, Written and Verbal Communications, Adaptability, Time Management skills • Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management's discretion. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-HYBRID As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $95,000-180,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Manager, Clinical Supply and Logistics will be the liaison between the Clinical Research Operations team and the Technical Operations team to facilitate cross functional collaboration for proactive problem solving and alignment of end-to-end clinical supply chain management to support clinical trial execution. This position will be responsible for supporting the strategic planning and execution of new clinical trial supply chains on time and within budget and is tasked with supporting an integrated operating model with close collaboration with cross functional stakeholders. **Responsibilities** - Oversees clinical supply labeling, packaging, release, distribution, return and destruction at contract manufacturing organizations. - Manages inventory globally at depots and sites including order management and proof of delivery confirmation, return or destruction and distribution logistics. - Acts as a key interface between the Technical Operations and Clinical Research Operations teams to operationalize supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans. - Interprets protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time. - Manages clinical supply activities for clinical trials including clinical supply needs identification, determination of appropriate presentation to clinical site and participants and IP expiry date management. - Collaborates with project team members including Technical Operations, Regulatory and Quality to design and implement drug labelling, packaging and supply strategies that not only meet the requirements of the study design, the clinical study sites, project timeline and the relevant regulatory authorities, but also maximizes efficiency of supply. - Leads the logistics of the forecasting, planning, and distribution of ancillary supplies for all clinical trials in conjunction with senior team members. - Coordinates supply strategies with internal Supply Chain/Technical Operations team and external packaging suppliers in conjunction with senior team members. - Manages external clinical vendors including IRT vendors, as assigned, in conjunction with senior team members. - Proactively identifies, prevents, and mitigates cross functional program risks related to clinical supply logistics. - Work with the cross functional project team to ensure consistent communication of clinical trial material supply chain status. - Collaborates with cross-functional study team members to ensure compliance of department/study activities with ICH guidelines, GxP, FDA and other applicable country regulations. - Other tasks as requested by managers. **Qualifications** - Bachelor's degree (B.A./B.S.) or equivalent, preferably in life sciences or related discipline. - 5+ years of related experience supporting clinical trial teams. - Experience managing clinical trial vendors. - A high level of proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is also required -Competencies: Teamwork & Collaboration, Attention to Detail, Analytical skills, Organizational skills, Written and Verbal Communications, Adaptability, Time Management skills -Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid position based in Xeris' Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management's discretion. _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-HYBRID _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $95,000-180,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US-IL-Chicago_ **Title** _Manager, Clinical Supply & Logistics_ **ID** _2025-2272_ **Category** _Clinical Development_ **Type** _Full-Time_

Director of Supply Chain Reporting to the COO, the Director of Supply Chain position is responsible for procurement and purchasing of systems for harvest, and parts to fulfill orders and build appropriate inventory level to support sales. The role oversees the purchase of materials and services in support of the company's business requirements, in accordance with company policy and compliance. The position supports the procurement activities for all departments within the sales, services, product development, distribution, and administration to obtain and analyze competitive bids, negotiate terms and resolve fulfillment needs. The identification of Essential Job Function does not display an exhaustive list of all duties that may be assigned to this position, nor does it restrict the related work that may be assigned to this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Essential Job Functions & Responsibilities Manages a team of buyers to procure and purchase equipment and parts needed to fulfill sales orders and stocking requirements for Ultrasound and Diagnostic Imaging equipment Works with sales and operations departments to forecast and procure parts and equipment needed to support future sales based on forecasting and market knowledge Provides input to and/or leads aspects of the Sales, Inventory and Operations Planning process, such as review and adjustment of stocking levels, review of assets under contract and impact on stocking strategy, changes in sourcing strategy for specific items, and preparation for and leading cross-functional meetings Pro-actively identifies, highlights and works cross-functionally to resolve gaps in the supply chain Identifies opportunities to procure items at favorable pricing that could drive future sales and repairs; procurement sites include, but not limited to hospitals, medical device auctions, etc. Ensures appropriate timing of procurement to enhance sales flow and avoids delays in the sales order process due to sourcing Ensures that wholesale and dealers' relationships with Avante Health Solutions receive quality and cost-effective procurement opportunities Identifies and builds new sources of supply for systems and equipment Identifies change in processes and offers applications and solutions to promote optimal efficiency as Avante continues to grow Takes strong initiative to meet goals, thinks and performs strategically to enhance the company's overall platform; serves as team member with sales, marketing, purchasing & inventory Works professionally and efficiently with all level within the organization Demonstrates professionalism in all internal and external communication and demeanor Collaborates with all departments as internal customers, prioritizing tasks as needed for efficiency and compliance Adheres to all company employment policies, including Quality and safe practices Performs other duties as assigned Experience/Training/Education 5+ years' acquisition and purchasing experience in medical equipment Ultrasound and Diagnostic Imaging device purchasing and procurement experience highly preferred. Exposure to best practices as well as experience in an entrepreneurial company with a roll-up-the-sleeves, hands on culture. Knowledge/Skills/Abilities General: Strong ability strategize, implement and retain current and new business relationships. Exceptional ability to speak and write effectively in a business environment. Ability to maintain an elevated level of accuracy in preparing and entering data. Superb time management and organizational skills with the ability to meet regular and frequent deadlines. Attention to detail required. Ability to work well as a team member. Must demonstrate sound work ethic, flexibility, respectfulness, honesty and trustworthiness. Must also be punctual and dependable. Must possess cultural awareness and sensitivity. Technical: Ability to effectively use accounting software and Enterprise Resource Planning systems, email, search engine, Internet; ability to effectively use Microsoft Products: Outlook, Word, Excel and to use or learn specific software needed to improve productivity. Communication: Strong oral and written communication skills. Ability to read and interpret documents such as financial journals, operating and accounting instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with customers or employees of the organization. Ability to read through reporting and compliance requirements. Math & Reasoning: Ability to calculate figures and amounts such as discounts, interest, and percentages. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to carry out instructions furnished in written, oral, or diagram form. Ability to manage multiple projects simultaneously and willingness to adapt to change and take the initiative. Physical and Environmental Elements Physical Demands: Ability to sit continuously for over 3/4 of normal work shift, and stand, walk, and reach with hands and arms for at least 1/4 of the normal work shift. Ability to climb stairs. Ability to talk or hear continuously. Ability to see clearly to do all work-related tasks (clear or corrected vision at 20 inches or less). Finger dexterity is required frequently for over 3/4 of the normal work shift. Work Environment: Position is typically performed in the office environment with standard equipment and moderate noise levels (examples: computers, printers, fax, copiers, light traffic, and phone); however will often interact with the production/warehouse environment. Thus, the employee works in a normal office setting and will travel to an open warehouse area where temperatures are subject to outdoor conditions in terms of cold and heat. There is exposure to various tools and equipment as well as forklift operations and corresponding noise levels. Company Culture Avante Health Solutions is committed to a respectful and purposeful work environment; this includes each team member taking responsibility for the greater good of the company and its goal to provide exceptional products and services and to create a sustainable future for the company and its employee. Each team member is expected to strive for excellence in all aspects of their work, as well as actively engage in productive work. Additionally, Avante Health Solutions is an Equal Opportunity Employer; we proudly promote a diverse workforce and do not discriminate. We encourage all employees and applicants who meet the position requirements to apply for advancement within the organization regardless of race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Harassment or inappropriate behavior of any kind is not tolerated and could be grounds for termination. If assistance or accommodation due to a disability is needed, please discuss it with the hiring manager.

Position Title Clinical Supply Chain Operations Manager, Operating Room Outpatient Pavilion Job Description Purpose & Scope: The Clinical Supply Chain Operations Manager provides leadership, direction, and mentorship to the Clinical Supply Chain team, fostering a high-performance culture grounded in operational excellence, accountability, and continuous learning. This role oversees the operational and strategic management of supply chain functions. The manager ensures the seamless flow of materials, compliance with regulatory standards, and alignment with organizational goals to support clinical excellence and patient care. Education: Bachelor's degree in supply chain, Finance, Business, or a related field. Experience: Three (3) years of experience in Supply Chain Management is required. Certification/Licensure: Certified Materials & Resource Professional (CMRP) preferred. Other Qualifications Advanced proficiency in MS Excel and data analytics. Working knowledge of Workday and experience with EPIC Cogito, including Reporting Workbench and SlicerDicer. Proficient in PowerPoint, Word, and Graphic Design. Familiar with Lean Six Sigma principles and continuous improvement methodologies. The ability to learn and adapt quickly to healthcare-specific challenges, with a solid understanding of medical terminology. Strong analytical and problem-solving skills; independently analyzes data, provides actionable insights, and collaborates with leadership and cross-functional teams. Proven success in leading mid- to large-scale projects and process improvement initiatives across cross-functional teams. Exceptional communication, organizational, and coaching skills. Skilled in presenting complex information to all levels of leadership. Knowledge of surgical supplies, instruments, and procedures. Strong organizational, analytical, and problem-solving skills. Familiarity with ERP or inventory systems (e.g., Workday, Lawson, Cerner, Pyxis). Ability to work in a fast-paced environment with attention to detail. Excellent communication and teamwork skills.

Job Description Qualifications Purpose & Scope: The Clinical Supply Chain Operations Manager provides leadership, direction, and mentorship to the Clinical Supply Chain team, fostering a high-performance culture grounded in operational excellence, accountability, and continuous learning. This role oversees the operational and strategic management of supply chain functions. The manager ensures the seamless flow of materials, compliance with regulatory standards, and alignment with organizational goals to support clinical excellence and patient care. Education: Bachelor's degree in supply chain, Finance, Business, or a related field. Experience: Three (3) years of experience in Supply Chain Management is required. Certification/Licensure: Certified Materials & Resource Professional (CMRP) preferred. Other Qualifications Advanced proficiency in MS Excel and data analytics. Working knowledge of Workday and experience with EPIC Cogito, including Reporting Workbench and SlicerDicer. Proficient in PowerPoint, Word, and Graphic Design. Familiar with Lean Six Sigma principles and continuous improvement methodologies. The ability to learn and adapt quickly to healthcare-specific challenges, with a solid understanding of medical terminology. Strong analytical and problem-solving skills; independently analyzes data, provides actionable insights, and collaborates with leadership and cross-functional teams. Proven success in leading mid- to large-scale projects and process improvement initiatives across cross-functional teams. Exceptional communication, organizational, and coaching skills. Skilled in presenting complex information to all levels of leadership. Knowledge of surgical supplies, instruments, and procedures. Strong organizational, analytical, and problem-solving skills. Familiarity with ERP or inventory systems (e.g., Workday, Lawson, Cerner, Pyxis). Ability to work in a fast-paced environment with attention to detail. Excellent communication and teamwork skills.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Are you ready to lead and shape the future of life-saving cell therapies? We are seeking a visionary and results-oriented Director of Cell Therapy Manufacturing to oversee and scale GMP manufacturing operations across our Santa Monica and Tarzana sites. This role offers a unique opportunity to make a direct impact on patients' lives by delivering high-quality autologous and allogeneic cell therapy products globally. As a key member of the Site Leadership Team, you will combine strategic vision with hands-on leadership to build and sustain world-class operations. You will drive site readiness, operational excellence, and cross-functional collaboration to ensure safe, efficient, and compliant manufacturing of innovative therapies. What You'll Do Lead end-to-end GMP manufacturing at both sites, delivering on clinical and commercial production goals. Drive a culture of accountability, safety, compliance, and quality, fostering ownership and excellence across teams. Translate enterprise manufacturing strategy into site-level execution, including new product introductions (NPIs), scale-up, and capacity expansions. Design and evolve site governance, organizational structures, and operational interfaces to support multi-product operations and a growing commercial pipeline. Contribute to global capacity planning, resource forecasting, and scenario-based planning. Lead operating model implementation across sites, including change management and effective communication. Partner across functions-MS&T, Quality, Supply Chain, Engineering, and Regulatory Affairs-to ensure seamless tech transfers, scale-up, and process robustness. Champion Lean principles and continuous improvement, driving efficiency, throughput, and cost competitiveness. Ensure inspection readiness and support health authority interactions. Mentor and develop a high-performing team of manufacturing leaders, building succession readiness and a culture of engagement. Apply lessons learned across sites to support network standardization and continuous improvement initiatives. What We're Looking For Education: Bachelor's degree in Life Sciences, Engineering, or related field; Master's or MBA preferred. Experience: 10-15 years of progressive leadership in Cell/ Gene therapy manufacturing or GMP biologics, including multi-site or network exposure. Proven track record in clinical and commercial operations, tech transfer, scale-up, or launch readiness. Skills & Competencies Strategic thinker with a hands-on approach to execution. Deep expertise in GMP compliance, batch execution, capacity planning, and change management. Strong financial acumen and experience managing budgets and cost optimization. Experience leading operations through site build-outs, expansions, or digital transformation. Familiarity with MES, LIMS, and ERP systems in regulated manufacturing environments. Successful in matrixed, global organizations with cross-site responsibility. Why Join Us Make a tangible impact on patients' lives worldwide. Lead and develop a dynamic, high-performing team. Drive innovative cell therapy manufacturing at the forefront of the industry. Collaborate across a cutting-edge, multi-site operation and influence the future of cell therapy production. If you're ready to bring your leadership, vision, and expertise to a role that truly makes a difference, we want to hear from you. The annual base pay for this position ranges from $162,682.40 - $244,023.60. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #celltherapy #LI-Onsite Date Posted 11-Jan-2026 Closing Date 29-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients. **Exec Director, Global Supply Chain Strategic Sourcing and Supplier Management** **FOSTER CITY, CA** **Key Responsibilities:** Reporting to the SVP of Global Supply Chain, and part of the larger Pharmaceutical Development and Manufacturing organization (PDM), the ED Strategic Sourcing and Supplier management will lead a team of Supply chain professionals sourcing and leading our outsourced CMO network. This role is accountable for the strategic business relationships with external suppliers of both Development and Commercial services and/or materials. This includes ownership of the strategy, selection, and performance management of all suppliers providing API, SDD, OSD, BDS, sterile DP, and secondary packaging services as well as all suppliers of direct materials including medical devices, primary packaging, excipients, and manufacturing consumables. This role collaborates closely with all PDM functional groups including RA, Tech Dev, Mfg. Ops, QA, Product & Portfolio Strategy, and Global Supply Chain and is accountable for continuous improvement and ongoing collaboration with our suppliers through product lifecycle. **Responsibilities:** **Development and Commercial Programs:** Own the strategic business relationship with suppliers of manufacturing services and direct materials including but not exhaustive: + Accountable for sourcing of strategic partners, contract negotiation and ongoing business relationship with the suppliers. (MSAs, SOWs, Supply Agreements, Pricing, etc.) + Lead strategic business discussions, long range supply and/capacity planning, and business development, through the product lifecycle and ensure financial discipline, win win and savings opportunities. + Participate and contribute into CD & OP and S & OP. + Management of supplier performance (monthly/annually) Key KPI: i.e., OTD, Batch Release First Time %). Deviation on time Closure (%), Batch Rejection Rate (%), Deviations per batch + The escalation points for Mfg. Ops team members for recurrent or chronic performance issues from suppliers + Lead quarterly / annual business review meetings (BRMs) with strategic/high suppliers + Lead the assessment and mitigation of supplier risks through regular supplier risk management processes + BCP plans with suppliers articulated and desk top exercises completed to ensure robustness + Responsible for preparation and tracking of RFPs/RFQs for new business with external suppliers and in consultation with functional stakeholders (Mfg. Ops, Tech. Dev. QA, etc.) + In collaboration with Product and Portfolio Strategy team members, identify and manage strategic suppliers of manufacturing services in alignment with network supply chain strategies + Own the development and execution of supplier strategies for direct material suppliers + Identify and manage strategic suppliers of direct materials in alignment with approved CMT strategies + Establish quality and technical execution expectations with vendors + Segment our supplier and have a strategy for strategic and tiered suppliers. + Articulate digital roadmap and integration with key suppliers, plan and execute against it + Sustainability and resilience strategy articulated with key suppliers **Development/Clinical Programs:** Support PDM Development sub team, in the selection of external service and/or material suppliers to provide required services and/or supplies throughout Development and up to Commercialization by: + Providing intel, options, and solutions; staying informed and knowledgeable of relevant Development CDMO and material supplier capabilities, offerings, capacities, etc. as they relate to potential or known Gilead pipeline needs + Leading site assessment teams (SATs) and/or category management teams (CMTs) for the assessment and selection of new service or material suppliers to meet Development program needs + Ensuring the full scope of supplier selections made during Development align with Commercial manufacturing and/or network strategies, as necessary. + Establish quality and technical execution expectations with vendors + Prepare and/or review agreements covering confidentiality, supply terms & conditions, and quality **Commercial Programs:** Support PDM Product teams through the selection, onboarding, and/or offboarding of external services, material suppliers and/or supplies throughout the product lifecycle by: + Providing intel, options, or solutions; staying informed and knowledgeable of relevant Commercial CMO and material supplier capabilities, offerings, capacities, etc. as they relate to Gilead Commercial supply needs + Leading site assessment teams (SATs) and/or category management teams (CMTs) for the assessment and selection of service or material suppliers to meet commercial Program needs **Qualifications:** + Primary degree in Business, Science or Engineering discipline. Master's degree and/or professional qualifications in supply chain management desired. + 15+ years of biopharmaceutical industry experience with at least 5 years of experience focused on management and leadership roles with contract manufacturers in a supply chain capacity. + Experience developing, implementing, and executing strategic plans and objectives for organizations and departments. + Solid understanding of current industry trends. + Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence, coaching, goal setting and performance management. + Strong business acumen. Capability to navigate and lead in a highly matrixed environment. + Influencing skills. + Demonstrated ability to understand complex and complicated situations and to strip out complications. + Effective communication skills, both written and verbal. Can make convincing arguments, inspire action, and bridge diverse cultures. Capable to communicate the world of PDM to people outside of PDM, and to communicate about the world outside of PDM to those inside. + Negotiation and conflict resolution skills. + A proven capability to contribute to your team's success through servant leadership. + A proven capability to contribute to the success of PDM and Gilead as a senior leader. **Gilead Core Values** + Integrity (Doing What's Right) + Inclusion (Encouraging Diversity) + Teamwork (Working Together) + Excellence (Being Your Best) + Accountability (Taking Personal Responsibility) The salary range for this position is: $281,010.00 - $363,660.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (********************************************************* YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.