Material Manager jobs at Johnson & Johnson - 271 jobs

Manufacturing Test Engineering Manager (or Senior/Lead Test Engineer) Red Oak Technologies is partnering with our client, a leader in LiDAR sensor technology, to identify a highly skilled Manufacturing Test Engineering Manager. We are open to considering strong Senior or Lead-level Test Engineers who are ready to take on team leadership responsibilities while continuing to code daily. This role is fully onsite in San Francisco, CA. Position Overview The Manufacturing Test Engineering Manager will be a hands-on technical leader responsible for developing and maintaining production test software for high-volume LiDAR sensor manufacturing. The ideal candidate will have strong Python development skills, proven experience in test engineering for electro-mechanical assemblies, and the ability to mentor and guide a team while contributing individually on a daily basis. The role requires close collaboration with cross-functional teams to improve test coverage, reduce test time, and ensure production readiness as new products move from development into manufacturing. Key Responsibilities Develop, maintain, and improve production test software using Python for LiDAR sensor and sub-assembly manufacturing. Serve as a working manager, providing technical leadership while contributing hands-on daily. Mentor and train Test Engineers on both technical and soft skills. Establish team priorities, KPIs, and work goals aligned with product development schedules and company objectives. Collaborate with cross-functional teams on software development, verification, and validation for new product introductions. Drive continuous improvement initiatives, including test time reduction, data quality enhancements, and production process optimization. Apply software engineering best practices, including coding standards, code reviews, source control management, CI/CD pipelines, and test automation. Communicate project updates, risks, and recommendations to management and stakeholders. Ensure timely completion of team deliverables and proactively address constraints or delays. Support contract manufacturing facilities with occasional travel (less than 10%). Work full-time onsite in San Francisco, CA. Qualifications and Skills Strong proficiency in Python development (minimum 5 years). Experience with CI/CD infrastructure, GitLab, Jenkins, and SQL database design. Strong skills in debugging, programming, data collection, and data analysis. Experience using project tracking tools such as Jira, Confluence, or equivalents. Proven ability to deliver results in a fast-paced engineering environment. Excellent organizational skills with the ability to manage multiple concurrent projects. Demonstrated people management or technical leadership experience (3+ years preferred). Experience working with high-precision electro-mechanical assemblies. Preferred: Experience developing test software for high-volume production and test equipment. Education BS in Computer Science, Mechatronics, Mechanical Engineering, or a related technical field required. MS degree preferred. Additional Information Background screening is conducted by the client. The Manufacturing group has zero tolerance for misdemeanor or felony theft or robbery offenses. This position is within an electrical component manufacturing environment (not medical devices). About Red Oak Technologies Since 1995, Red Oak Technologies has been a trusted partner in the technology industry, specializing in identifying and placing highly skilled contract, permanent, and project-based professionals. We value diversity and welcome applicants from all backgrounds and experiences. Red Oak Core Values: Relationships First | Exceptional Quality and Service | Unwavering Integrity and Trust | Be Easy To Do Business With | Respect Everyone

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.

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_

The Director of Financial Planning and Analysis, Biopharmaceutical Sciences and Manufacturing Operations (BSMO) is a key member of Vertex's Financial Planning & Analysis team. This role will partner closely with Commercial Manufacturing and Tech Ops (CMTO), Commercial Finance and Disease Strategy Team (DST) Finance in support of our Cell and Gene Therapies portfolio, with a specific focus on CASGEVY, the first-ever approved CRISPR-based gene-editing therapy used to treat Sickle Cell Disease and Transfusion-Dependent Thalassemia. This role will have the opportunity to work across the organization by providing analysis and insights that will drive key decisions around manufacturing strategy and resource allocation in order to optimize the profitability of CASGEVY. In addition, this position will be an integral part of the BSMO Finance team and play a key role in support of P&L, Capital and Inventory budgeting, forecasting, long range planning, and month-end close processes. This position is based in our Boston, MA location (Seaport area) and requires a hybrid work schedule with 3 days in office /2 days remote on a weekly basis. Key Duties & Responsibilities: Partners with the External Manufacturing, Supply Chain, and Commercial functions to influence CASGEVY business operations and optimize decisions as part of the Sales and Operations Planning (S&OP) process. Identifies ROI/trade-off opportunities to drive profitability and support key decisions around CASGEVY manufacturing and supply chain strategy. Oversees the monthly/quarterly accounting close for expenses and accruals related to CASGEVY Operating Expense and COGS, including flux analysis and compliance with SOX control requirements. Supports analytics and transparent reporting to drive forecast accuracy and inform on key drivers of any variances to plan, with full transparency on any judgments about risks and opportunities for both operating expenses, capital expenses and COGS. Supports the financial planning process (annual budget, forecasts, long range plan, etc.) by providing forward-looking observations and developing key scenarios. Develops and coaches team members to encourage growth and new opportunities and contributes to an atmosphere of inclusivity across the team Works closely with other members of the CFO organization including Commercial Finance, DST Finance, Strategic Sourcing and Accounting to maintain a continuous improvement mindset and promote strong communication, sharing of best practices and efficient processes. Basic Requirements Bachelor's degree in Finance or Accounting required. MBA and/or other advanced degree preferred. 10+ years of relevant experience in finance managerial role, demonstrating strong technical and analytical skills and a track record of success working in a team-based environment or the equivalent combination of education and experience. Experience in business partnering with Manufacturing/Supply Chain executive teams Proven ability to proactively manage efficient processes across Operating Expenses, Inventory and COGS, driving high-quality inputs from the business in support of creating and managing complex budgets, forecasts, and analyses in a dynamic, fast-paced environment. Deep understanding of Biotech/Pharma manufacturing finance to address a broad range of challenges and business issues across all functions with the ability to make and facilitate quick decisions Expert analytical and financial modeling skills to evaluate a broad range of financial questions. Excellent communication and presentation skills, with a proven ability to present complex financial insights to senior stakeholders. Knowledge and Skills: Strategic thinking and problem-solving. Critically, this role requires an expert ability to influence without authority at the highest level and collaborate effectively in support of shared goals. Strong business acumen and judgment, and knowledge of the company's markets/products and industry trends. Expertise with Excel and PowerPoint; Working knowledge of Hyperion or similar enterprise planning tools. Exceptional interpersonal, written, and verbal communication skills Ability to lead and drive change in an evolving business environment, coordinating processes involving large numbers of people, complex systems, and tight deadlines to deliver innovative solutions. Demonstrated ability to lead and collaborate cross-functionally, sharing insights and translating learnings into actionable business initiatives whilst partnering to ensure timely execution of project plans Proactive, organized, and comfortable managing shifting priorities in a rapidly changing environment. Leads with a continuous improvement mindset, with flexibility and ability to adapt to change. #LI-DB1 #LI-HYBRID Pay Range: $182,400 - $273,600 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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_

Job Title: Director, Manufacturing Platform Technology - Global Tech OpsLocation: Gaithersburg, MD Hybrid working ~ 3 days per week in the office location Introduction to role Are you ready to lead the charge in transforming AstraZeneca's manufacturing capabilities for 2030 and beyond? As the Director of Manufacturing Platform Technology, you'll be at the forefront of change, driving platform establishment across the enterprise! The GTO Platform Lead represents a strategic cross-functional leadership role within Biologics Operations and Global Technical Operations. This position encompasses the leadership and development of a diverse, cross-functional team whilst maintaining primary accountability for strategic planning, coordination of technical leadership initiatives, and the provision of comprehensive operational support to our global technical network and key customer partnerships. Join us in shaping the future of manufacturing technology and equipment platforms across biologics and new modalities! Key Accountabilities: Lead a matrixed, cross-functional team to shape and scale AstraZeneca's manufacturing technology/equipment platforms across biologics and new modalities. Partner closely with Development, Operations, Quality, Regulatory, and external manufacturers to deliver robust, flexible, and inspection-ready platforms. Enterprise impact: Set the platform vision, standards, and roadmap; accelerate continuous manufacturing adoption; harmonize ways of working across internal sites and CMOs to improve speed, reliability, and cost to serve. Platform strategy and standards: Technology/Equipment Operating envelopes: Define highs/lows, critical process parameters, and control strategies for each unit operation. Templates and playbooks: Publish platform process descriptions, tech transfer playbooks, and manufacturing technology standards that teams can use globally. Change agility: Build comparability and “switch” strategies into equipment platforms to manage lifecycle changes with minimal disruption. Modalities in scope: Core: Fed-batch, intensified, microbial fermentation, and continuous mammalian bioprocessing Emerging: Nucleic acid therapies, Antibody drug conjugates, radioconjugates, viral and gene therapies, enzyme-produced biologics, protozoan fermentation Continuous manufacturing leadership: Vision and adoption: Set enterprise standards and the adoption plan for end-to-end continuous processing. Design and control: Define PAT/APC, residence-time distribution, steady-state verification, and start-up/shutdown strategies that meet global regulatory expectations. Scale-up and launch: Guide piloting through commercial implementation; quantify business value and embed learnings across the network. Collaboration and matrix leadership: Co-create with partners: Work hand-in-hand with CMC, Clinical, Regulatory, QA, and site leaders to align on risk, control, and lifecycle strategies. Network integration: Harmonize processes and capabilities across internal sites, CMOs, and acquisitions; establish clear governance, roles, and accountability. Transparent communication: Maintain timely updates, risk escalation, and portfolio alignment across Global Tech Ops and Biologics leadership. Technology and site enablement: Site readiness: Working closely with tech transfer leads, Stand up technology transfers to site, define ways of working, and embed digital tools for monitoring and decision-making. Technology Readiness: Acting along with current site leads, or in lieu of local MS&T for new sites, Regulatory partnership: Authoring and strategy: Co-author technical content for design control strategies that enable post-approval flexibility. Engagement and inspection: Prepare teams and sites for regulatory interactions and inspections. Data-driven improvement: Data and Process Standardization: Collaborating across the enterprise, establish standards for process data and information needed to support autonomous decision making. Performance management: Define metrics and scorecards; use feedback loops to track adoption and impact. What Success Looks Like in This Role Standardisation and Speed You will establish reusable platform standards that dramatically reduce development and technology transfer timelines, enabling faster delivery of life-changing medicines to patients. Your work will create scalable frameworks that eliminate redundancy and accelerate innovation across our manufacturing operations. Continuous Adoption Leadership Drive the scaled implementation of continuous manufacturing processes, delivering measurable improvements in operational robustness, cost efficiency, and sustainability performance. You will champion pioneering manufacturing technologies that position AstraZeneca at the forefront of pharmaceutical innovation. Network Alignment Excellence Establish consistent ways of working across all manufacturing sites and Contract Manufacturing Organisations (CMOs), implementing clear governance structures that ensure seamless collaboration and operational excellence throughout our global network. Operational Impact Delivery Your initiatives will directly contribute to higher yields, reduced variability, and accelerated time to clinical and commercial supply, ultimately ensuring patients receive high-quality medicines more quickly and reliably. Essential Skills/Experience Experience: 12 years in biologics manufacturing (or 10+ with an advanced degree); 5+ years in process engineering/development; late-stage and commercial exposure. Continuous manufacturing: Recent, hands-on leadership implementing continuous bioprocessing in a manufacturing setting. Regulatory: Proven authoring of technical sections or leading technical regulatory strategy. Collaboration: Strong record of leading matrix teams and influencing across internal customers and external partners/CMOs. Desirable Skills/Experience Preferred: Site engineering background; validation experience for new modalities/formulations; late-phase nucleic acid manufacturing or analytics; proficiency with Power BI, Power Automate, and Microsoft Office. The annual base salary for this position ranges from $175,572.00 to $263,358.00. However, 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). When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca offers an environment where you can make a positive impact while building a long-term career filled with global opportunities. Our commitment to delivering accelerated growth pushes us to innovate continuously. With a focus on Lean processes, cutting-edge science, digitalization, and sustainable practices, we are dedicated to making people's lives better. Our inclusive community supports each other on our journeys, fostering curiosity and problem-solving. Embrace the chance to broaden your knowledge and skills in a place where your dedication is rewarded. Ready to take on this exciting challenge? Apply now to join us in shaping the future of manufacturing technology at AstraZeneca! Date Posted 18-Dec-2025 Closing Date 30-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.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Job Responsibilities: Administer and lead a team to support manufacturing operations following manufacturing Standards for Operational Excellence. Lead and organize the work priorities and objectives, aligned with the business vision and mission. Act as a leader, integrator, and have accountability for the objectives, ensuring safety, quality, and compliance performance by the application of operational excellence principles. Supervise staff and ensure there is an adequate number of qualified personnel to support the operation. Manage the budget and provide input to the Strategic and Business Planning processes. Ability to lead and integrate cross-functional teams in both production and material management environments. Experience managing warehouse operations, including inventory control and dispensing processes. Ability to lead and integrate cross-functional teams in both production and material management environments. Experience managing warehouse operations, including inventory control and dispensing processes. Education Requirements: Bachelor's or master's degree in engineering, science or business administration Experience Requirements: At least (5) years of experience in related area. Experience leading group of work. Bilingual (English and Spanish) Experience in project management and change management Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $108,000 - $173,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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.

Step into the role of Global Supply Chain Customs & Trade Manager and lead the charge in ensuring compliant, efficient cross-border operations across the U.S. and Canada. You'll play a critical part in mitigating risk, optimizing costs, and aligning regional activities with global customs strategies-keeping trade flowing seamlessly and securely. Your Key Responsibilities: * Lead implementation of customs compliance programs in the U.S. and Canada, aligned with global policies * Serve as internal consultant on customs and regulatory matters for North American business units and corporate functions * Oversee customs audits and focused assessments, ensuring organizational readiness and alignment * Maintain and update the North America Customs Manual and ensure compliance with security programs * Drive improvements in customs-related master data in SAP and advise on tariff classification, country of origin, and labeling requirements * Identify and implement duty savings and trade optimization programs and manage the Duty Drawback program and related third-party engagements We Bring: * A dynamic, global environment with exposure to cutting-edge manufacturing and supply chain technologies * A space to grow by encouraging and supporting curiosity and an open mindset * Barrier-free communities within our organization where every employee is equally valued and respected - regardless of their background, beliefs, or identity * An eagerness to be one team and learn from each other to bring progress to life and create a better future * A vibrant, creative atmosphere where innovation is celebrated * Empowerment to make meaningful contributions while upholding ethical standards You Bring: * Minimum of 5 years of experience managing U.S. and Canadian import/export compliance in a multinational environment * Experience managing U.S. Customs Reconciliation Programs, including oversight of post-entry adjustments, compliance reviews, and coordination with customs brokers and internal stakeholders * Familiarity with C-TPAT and other security programs * Basic understanding of chemistry and product composition * Experience with Harmonized Tariff Schedule and classification of products * Bachelor's degree in business, International Trade, or related field required The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Salary $128,000-$150,000. In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements. About dsm-firmenich At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. The application process Interested in this position? Please apply online by uploading your resume in English via our career portal by November 21, 2025. Inclusion, belonging and equal opportunity statement At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency statement We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.

Our Director, Manufacturing Operations plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include overseeing the support of site and company-wide objectives through the reporting of department Key Performance Indicators (KPI). Meeting quality, safety, delivery, and productivity objectives. Ensures people and processes comply with current Good Manufacturing Practices and company procedures. The Director, Manufacturing Operations, is also responsible for: * The support of site and company-wide objectives through the reporting of department Key Performance Indicators * Ensuring people and processes comply with current Good Manufacturing Practices and company procedures * Modifies department standard operating procedures and executes change controls to support business and quality objectives * Establishes and maintains cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Pharmacy Services, Research & Development, and Supply Chain to meet site and corporate objectives What the Director, Manufacturing Operations Does Each Day: * Direct and plan the overall company's pharmaceutical production operations * Runs operation to meet or exceed delivery performance and customer service objectives * Establish and ensure that cGMP compliant policies, processes, procedures and best practices are developed and consistently executed across the manufacturing operations and provide support and guidance on policy related matters * Counsels and develops colleagues for efficient performance; provides constructive feedback; creates an atmosphere of team effort and open communication * Ensure that all production areas have the processes, equipment, and adequately trained staff to support the continuing growth goals of the company and meet customer demand * Troubleshoots and resolves issues impending deliverables; proactively demonstrates the ownership to achieve * Maintain and report key performance indictors and escalate any identified risks to permit timeliness to remain contiguous * Maintain a contemporaneous working knowledge in cGMP requirements * Other duties that may reasonably be assigned from time to time by the company * This is a security-sensitive position as the incumbent works with controlled substances and therefore will be subject to periodic drug screen per company policy * Consistently promote and support best practices involving work methods (lean methodology), technology, and operational systems in order to remain innovative and to maintain and/or increase quality of production methods and final product quality * Provide leadership and direction to team to assure consistently high levels of performance in pharmaceutical operations * Lead employees to meet the organization's expectations for safety, quality and productivity goals * Manage the overall operational, budgetary, and financial responsibilities and activities of the manufacturing operations departments * Provide input towards the selection, hiring and placement of personnel within the departments as needed * Actively participate in performance evaluations * Other duties as assigned Our Most Successful Director, Manufacturing Operations: * Has outstanding written, oral communication skills * Can organize large volumes of data * Is experienced in pharmaceutical manufacturing especially sterile injectable * Manages multiple, parallel projects * Is an expert in Pharmaceutical manufacturing Minimum Requirements for this Role: * BA/BS Degree in Business, Science or related field or significant experience * 5 years' experience in managing a cGMP manufacturing plant operation required * 7-10 years of related experience in cGMP/FDA regulated industry (CFR 201 & 211 emphasis on FDA guidance for industry aseptic processing preferred) * Demonstrated experience and leadership in cGMP compliance audits and inspections required * Demonstrated knowledge of lean manufacturing and metric concepts preferred * Demonstrated ability to increase others knowledge of cGMP regulations and guidance preferred * Proficient in computer skills. (e.g. Microsoft Office suite: Visio, ERP systems, MS Project) Benefits of Working at Quva: * Comprehensive health and wellness benefits including medical, dental and vision * 401k retirement program with company match * A minimum of 25 paid days off plus 8 paid holidays per year * National, industry-leading high growth company with future career advancement opportunities * The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions * Range: $163,764 - $225,175 Annually * This role is also eligible for an annual incentive bonus, subject to program terms and guidelines About Quva: Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will." California Consumer Privacy Act (CCPA) Notice for Applicants and Employees

Job SummaryThe Director, Manufacturing Operations oversees management of all areas of Manufacturing operations to produce products and direct activities so that approved products are manufactured on-schedule within the quality standards and cost objectives. This position reports directly to the Plant Manager. Directly manages approximately 7 Production Manager(s) and/or Senior Manager(s) for the formulation, filling, and component preparation departments that support the terminal sterilization lines including terminal sterilizers and aseptic fill lines including lyophilizers. Indirectly manages approximately 400 Direct Labor Production Employees and Manufacturing Engineers. *This position requires working onsite at our Melrose Park, IL site. *This position does not offer visa sponsorship either now or in the future. • Salary Range: $190,000-225,000. • Position is eligible to participate in an annual bonus plan with a target of 16% of the base salary. • Position is eligible to participate in our medium-term incentive plan. • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.Responsibilities Establish and control the processes and procedures for compounding, aseptic and terminal sterilization filling, component preparation, capping, and lyophilization. Assist company officers and senior staff members in the development and formulation of long and short-range planning, policies, programs, and objectives. Develop the manufacturing plan and establish procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards. Achieve optimum employee levels with the least amount of overhead and raw material costs to meet annual budget. Formulate and recommend manufacturing policies and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation. Direct and monitor department managers and supervisors to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures. Act as a liaison between department management/subordinate levels, as well as executive/Supervisor levels to inform personnel of communications, decisions, policies, and all matters that affect their performance and results. Hire, train, develop, and evaluate staff. Take corrective action as necessary on a timely basis and in accordance with company policy. Ensure compliance with current federal and local regulations. Consult with Human Resources Department as appropriate. Identify, recommend, and implement changes to improve productivity, reduce defects and reduce cost and scrap, monitor scrap and rework data. Direct the establishment, implementation and maintenance of production standards. Direct and coordinate efforts to improve Right First-Time execution, reduce deviations and manage the prioritization of the deviation writers to close deviations needed for on time batch release. Direct and coordinate various programs essential to manufacturing procedures (e.g., training, safety, housekeeping, cost reduction, worker involvement, security, etc.) Initiate and coordinate major projects (e.g., plant layout changes, installation of capital equipment, major repairs, etc.) Work effectively and relate well with others. Exhibiting a professional manner in dealing with others while working to maintain constructive working relationships Keep current on information and technology affecting functional areas to increase innovation and ensure compliance Participate in the preparation and presentation of site related business metrics and performance metrics, such as Line OEE achievement and production output, to upper level management. Support regulatory inspections and company audits as the Subject Matter Expert for the assigned departments under your control and engage direct reports as needed for support. Job Requirements: Bachelor's of Science degree in related field or equivalent education and experience. 10+ years of experience in pharmaceutical manufacturing in a cGMP environment required with 5+ years of progressive levels of managerial experience and broad span of organizational control. Terminal sterilization and lyophilization experience preferred. Excellent analytical and technical skills. Excellent written and verbal communication skills. Must be able to communicate and interact with all levels of the organization and manage in a dynamic environment to meet plant and company objectives. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Inventory Control Manager - Direct Hire | Superior Skilled Trades 💰 Pay Range: $35-$40/hour 🕒 Schedule: Monday-Friday, 7:00 AM-4:00 PM 🎯 Benefits: Full benefits package Superior Skilled Trades is seeking an experienced Inventory Control Manager for a full-time, direct-hire opportunity in Hartland, WI. This role is responsible for overseeing material planning, purchasing, and inventory control activities to support production schedules and customer demand. The ideal candidate will have strong ERP experience and hands-on purchasing experience with metals and structural materials, including aluminum, stainless steel, carbon steel, coated sheet, weld nuts, PEMS, and similar components. Key Responsibilities Plan and place purchase orders to support production schedules; proactively manage and expedite orders as needed Monitor planned material requirements and inventory levels on a daily basis Perform cycle counts, investigate variances, and resolve discrepancies within the ERP system (M1) Own the cycle count program, including variance analysis, corrective actions, and inventory accuracy reporting Manage open purchase orders to ensure on-time delivery and proper closure Support receiving activities, material documentation, and management of material certifications Build and maintain strong vendor relationships to improve cost, reliability, and inventory levels Adjust orders based on schedule changes, BOM updates, obsolescence, and new product introductions Resolve invoice, purchase order, and return discrepancies with suppliers and Accounts Payable Collaborate cross-functionally with Production, Engineering, Sales, and Accounting teams Support Sales with small quotes, customer orders, and account management as needed Monitor and report supplier performance metrics, including on-time delivery and quality Assist with inter-facility material transfers Support continuous improvement initiatives within procurement and inventory processes QualificationsEducation & Experience Bachelor's degree in Supply Chain, Business, or a related field preferred Minimum of 5 years of purchasing or materials management experience in a manufacturing environment Required: Experience purchasing metals and structural materials (aluminum, stainless steel, carbon steel, coated sheet, weld nuts, PEMS, etc.) Equivalent combinations of education and experience will be considered Technical & Professional Skills Strong knowledge of inventory control, material planning, and supply chain workflows ERP experience, including purchase orders, inventory transactions, and material planning (M1 preferred) Proven ability to analyze demand, forecast material requirements, and manage supplier relationships Strong organizational, communication, and problem-solving skills INDH