Takeda Pharmaceuticals U.S.A., Inc. jobs in Raleigh, NC

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary Member of a team that is collectively responsible for operating/monitoring a chemical manufacturing process that produces bulk organic chemicals. This position requires an individual who will abide by Company standards and operating procedures in order to maintain a safe operation while producing in-specification product. Standard tasks include: packaging product, taking process samples, changing filters, cleaning centrifuges, moving large hoppers, flushing lines, etc. He/she will also be responsible for accurately filling out operating reports and documentation. This position works on a 12hr rotating shift schedule. The schedule uses a four-week cycle: four night shifts, three days off, three day shifts, one day off, three night shifts, three days off, four day shifts, seven days off. Job Description ESSENTIAL FUNCTIONS: Operates in a regulated environment and complies with all PSM and OSHA regulations applicable to manufacturing responsibilities. This includes wearing appropriate personnel protection equipment (PPE), understanding and following all applicable standard operating procedures, work instructions, and standard work practices applicable to job responsibilities Operates and monitors reactors, decanters, filters, process columns, tanks, centrifuges, dryers, and other miscellaneous equipment through manual operations, panel boards, indicators, PLC displays, and DCS screens Packages, weighs, samples, and labels finished and intermediate products following applicable procedures and good manufacturing practices Maintains detailed operating reports and logs, including notes on problems, weights, volumes, measured temperatures, pH levels, pressures, and flow rates following applicable procedures and as directed by supervisor Delivers samples to laboratory and retrieves operating supplies from storeroom Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures. Operates hoists, and other material handling devices to physically move bulk raw materials, WIP, and packaged goods to and from pick-up points Requires a high level of safety awareness and ability to determine when equipment is not performing to standards or expectations. Responsible for proper operation of processing equipment to ensure optimum production of high quality products. Mistakes and errors normally result in unacceptable product and or mechanical equipment damage. Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed. Complete computer based training on time Other duties as assigned by Management MINIMUM REQUIREMENTS: Education: High School Diploma, GED, or equivalent required. Associate or Technical degree preferred. Experience: Previous PSM manufacturing experience preferred Skills/Competencies: Forklift Operation preferred. Other Skills: Must be able to read and follow detailed instructions and procedures, and effectively communicate in both verbal and written formats. Must be able to perform basic math. Possess sound decision making skills. Must work in a team environment to cover work stations during breaks and lunches Must be able to wear the required Personal Protective Equipment (PPE) required for the job or task. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Monitors environmental and safety devices (scrubbers, ruptured discs, etc.) to insure that the equipment is functioning properly. Performs Lock Out/Tag Out (LOTO) independently. Participate in various employee involvement teams and committees, such as Area/Site Safety Teams, kaizen events, Hazmat and/or Cost Savings Teams, to improve the workplace, increase efficiency, and improve productivity RELATIONSHIP WITH OTHERS/ SCOPE: Performs diversified duties following standard procedures and under the direction of a production supervisor or lead operator. No direct responsibility for the work of others; however, the team approach is emphasized in order to cover work stations during breaks and lunches. WORKING CONDITIONS: The plants open-air construction exposes operators to the normal year-round outside climate. However, all “homebase” workstations are indoors. Typical chemical plant environment. Wet floors are common, chemical staining of equipment makes environment appear “dirty”, and chemical fumes are occasionally present in the work areas. Must handle average to heavy weight materials (50lbs) by hand. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible but use of proper lifting and movement techniques is necessary to prevent injury. Must be able to physically climb stairs/ladders, roll drums, lift and pour bags of raw materials, drive forklifts and perform first aid. Large quantities of corrosive, flammable, and toxic materials are present in the plant. Layers of protection are in place to maintain a safe work environment, but the presence of these materials/chemicals is inherently hazardous. Must be able to work rotating 12 hours/day shift and overtime as needed. Mandatory overtime is necessary to keep plant staffed to safe levels. The mandatory overtime is handed out to the shift on “long-off” (7-Day Break). May be required to wear a full-face respirator contingent upon required job duties. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. The Role: The Global Study Associate is a member of the global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality. The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the Global Study Director (GSD), Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency. The GSA supports with administration & systems and with other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & best practices and AZ values & behaviours. Typical Accountabilities: Support GS(A) D and GSMs by completing delegated study work. May work across many different studies and delivery models concurrently. Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs. Provide oversight for non-complex, non-critical path vendors, ensuring compliance with study requirements and established processes. Interact/collaborate with internal staff and external stakeholders in collection of regulatory and other essential documents. Contribute to electronic applications/submissions in regulatory information management system by creating and managing clinical regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR. Initiate, maintain and/or support the creation of study documents, ensuring template and version compliance per study specific requirements. Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools and support team members in the usage of these tools. Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs. Support the GS(A) D with tracking, reconciliation and follow-up of the study budget/payments in relevant systems, including the creation and maintenance of purchase orders, running invoice and payment reports. Contribute to application, coordination, supply and tracking of study materials and equipment. Contribute to collection of study supplies, if required, at the study close-out. Coordinate and provide oversight of administrative tasks and logistical support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs. Lead the coordination and contribute to the preparation of internal and external meetings e.g., study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. Liaise with internal and external participants and/or vendors. Prepare, contribute and distribute presentation material for meetings, newsletters and websites. Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager. Other duties as assigned and within scope of role. Essential Experience: Bachelor level education, with at least 2 years' experience in in medical or biological sciences or discipline associated with clinical research preferred Proven study admin/assistant or relevant experience on a study level with experience in clinical study lifecycle Proven organizational and analytical skills Previous administrative training/experience Computer proficiency in day-to-day tasks Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines Excellent verbal and written communication in English Demonstrate ability to work independently, as well as in a team environment Ability to prepare presentation materials Demonstrate professionalism and mutual respect Willingness and ability to train others on study administration procedures Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high- volume environment with shifting priorities Are you interested in working at AZ, apply today! AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing *********************************. #LI-Hybrid Date Posted 15-Dec-2025 Closing Date 01-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.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: OH, WV, VA, NC, SC, KY, TN. Responsibilities: Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: Presenting disease state and Daiichi Sankyo product specific data to HCPs Responding to unsolicited requests for medical information Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards Gathering customer insights regarding DSI and competitor products to help inform medical and commercial decision-making Enhanced professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders Develops positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships Develops the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies Completes administrative duties, including monthly expense reporting and field activity reporting Represents the Medical Science Liaison function by participating in DSI meetings, functions, events Additional duties and responsibilities are based on position level/title, and may include but are not limited to: Provides innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives. Ability to anticipate trends and capitalize on opportunities Lead special projects/initiatives. Assist in the development of team members Represent FMA leadership at DSI meetings, functions and events Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): PharmD, MD, PhD, NP or PA in a health sciences-related field or an equivalent combination of education and experience preferred Experience Qualifications: MSL/Sr. MSL 1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Principal MSL/Associate Director MSL 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Additional Qualifications: Must have a valid driver's license with a driving record that meets company requirements Ability to travel up to 60% Compensation and seniority level/title based on experience and qualifications. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $150,800.00 - $226,200.00 Download Our Benefits Summary PDF

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. She/he will typically work on a rotating shift schedule. Job Description ESSENTIAL FUNCTIONS: Performs in process testing for internal customers. Performs finished goods, returned goods, and stability testing for external customers as needed. Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques. Performs specified analysis on all finished goods using approved written procedures and proper laboratory techniques as needed. Maintains accurate and precise records of all laboratory analysis using appropriate Mallinckrodt recordkeeping system. Troubleshoots and performs routine maintenance on laboratory instrumentation. Prepares all standards and reagents needed for proper execution of analytical methods and procedures. Prioritizes and plans workload to meet all internal and external customer needs for maximum efficiency and accuracy. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Assists in any non-routine analytical work needed to solve plant problems. Works on solving problems and implementing improvements in a teaming environment. Uses problem solving skills to help with failure investigations and testing problems. Aids in performing any non-routine quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment. Participates in a certified 5S Workplace System to ensure good housekeeping and organization. Assists with training others as needed. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: Associates of Science (AS) or Bachelor of Science (BS) or equivalent life science degree preferred. Appropriate experience may be a suitable replacement for degree. Experience: 1 - 3 years laboratory experience in a pharmaceutical manufacturing operation preferred. Working knowledge of cGMP is a plus. Expected Skills/Qualifications: Other Skills/Competencies: Must be able to perform basic mathematical calculations. Familiarity with basic laboratory procedures, equipment, and computer key punching. Sound and correct technical judgments are required during routine analysis. High degree of concentration is required. Ability to differentiate colors, as demonstrated by passing a test designed to identify color blindness (such as the Ishihara test). If testing criteria are not met with uncorrected vision, the use of color correcting glasses may be used as long as testing criteria are met while using them. Functional/Technical Skills, Priority Setting, Written Communication Customer Focus, Organizing RELATIONSHIP WITH OTHERS/ SCOPE: Laboratory technicians are responsible for communicating any uncompleted work to the next shift, as well as any immediate priorities. Majority of work is performed independently without direct supervision. Non-routine results, observations, or analytical requests are brought to the attention of the appropriate management personnel. Reports to Quality Testing and Release Manager. Frequent interact with operators, engineers, and Quality management for reporting routine analytical results. Communication may be though radio, telephone, email, or in person. Incorrect or inaccurate analyses can result in possible shipment of reject drug items to Mallinckrodt customers. Customer-requested specifications and Mallinckrodt methods of analysis are considered confidential for marketing purposes. Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks. Laboratory employees must be able to work effectively under these conditions. Completes all required Compliance trainings in a timely manner. WORKING CONDITIONS: Most work is performed in a well-equipped analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments. Boxes of solvents, compressed gas cylinders, old records, and reserve samples are stored in areas outside the laboratory and may require lifting and transporting to the laboratory area. Exposure to fugitive emissions of chemicals typical for chemical operations. Normal dexterity is required for routine handling of laboratory glassware and instruments. Colors must be well-visualized and slight differences in volumes of liquids in appropriate glassware distinguished. Must be able to wear the required personal protective equipment (PPE), such as hard-hat, steel-toe shoes, safety glasses, and other equipment as deemed necessary by EH&S, leadership team, corporate, or safety guidelines for the position. Must be able to work a rotating12 hour shift schedule of (7pm-7am / 7am-7pm) in addition to occasional overtime as needed. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary Summary 12 Hour Rotating Shift (7am - 7pm & 7pm -7am) SUMMARY OF POSITION: The Maintenance I/E Technician performs a variety of electrical and instrumentation duties involving the maintenance of plant facilities. S/he will be responsible for calibrating, installing, maintaining, repairing, and inspecting plant monitoring devices on a wide variety of complex digital, analog, programmable, and other auxiliary equipment. Job Description ESSENTIAL FUNCTIONS: Installs, troubleshoots, repairs, and calibrates low voltage AC/DC electrical and instrumentation controls as well as 3-phase 480-volt power circuits. Interfaces with OEM's and vendors as necessary. Requisitions equipment as needed. Accurately completes all work performed according to standard operating procedures (SOPs) and work instructions, including proper documentation. Completes work orders using CMMS (Maximo) system. Performs repairs and modifications as directed by maintenance supervisor, or other plant management. Supports and participates in training programs. Keeps the maintenance supervisor abreast of job status. Supports site safety programs. Supports/leads failure analysis process by discussing the causes of equipment failure with the maintenance supervisor, or the maintenance engineer. Accurately completes all required paperwork, including but not limited to timesheets, “found as-left” forms, calibration reports (ICIR), and PM checklists. Responsible for good housekeeping in the shop and at the job site. Must be able to wear the required Personal Protective Equipment (PPE), full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel -toe shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate, or safety guidelines for each job task. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodations. Supports the PM/PdM program and calibration program by ensuring a high quality of workmanship. Accurately enters all required information on work orders. Assists the maintenance supervisor and maintenance engineers, or others as needed with equipment installation, maintenance, repair techniques, and with identifying opportunities for improving equipment reliability. Shows emphasis on the design, installation, commissioning, maintenance, and use of mechanical equipment throughout the facility. Recognizes problem independently and troubleshoots malfunctioning equipment without direct supervision. MINIMUM REQUIREMENTS: Education: High School diploma, GED, or equivalent. Associate or Technical degree in a mechanical field preferred. Experience: 1 - 3 years I/E experience in a pharmaceutical manufacturing operation. Preferred Skills/Qualifications: Skills/Competencies: Other Skills: Work as an industrial I/E mechanic, PLC skills. Must have a working knowledge of the tools and test equipment used for testing, calibrating, repairing, and maintain production instruments and controls. Must be able to read and comprehend blueprints, electrical schematics, and engineering specifications. Must be able to perform shop math. Must be able to understand electricity, respect, and follow safety guidelines. Must be able to read and follow written instruction. Should be familiar with National Electrical Code, NFPA 70E, calibration standards, and cGMP. Experience working with voltages up to 480. Experience with CMMS, such as MP2 or Maximo. Learning on the Fly, Problem Solving, Interpersonal Savvy RELATIONSHIP WITH OTHERS/ SCOPE: Reports to Maintenance Supervisor. Utilizes a variety of test instruments, hand tools, supplies, and other shop equipment on a daily basis. On occasion, it may be required to take tools to the work area in the plant. No direct responsibility exists for the works of others, although adherence to the team concept requires mutual assistance in some jobs. Indirectly responsible for amount and quality of product through the maintenance and repair of production equipment. A thorough understanding of cGMP is critical. Significant responsibility for the safety of others, improperly repaired equipment could possibly result in safety hazards to plant personnel. Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed. WORKING CONDITIONS: I/E Technicians are required to work in all areas of the plant site, both inside and outside. There may be exposure to warm areas, dirt, oil, grease, chemicals/chemical fumes, and noise. Injuries could result from spills or leaks or corrosive, flammable, and toxic material, all which are normally handled in the plant. Dangers, such as sharp edges, pinch points, chemical and temperature burns, lifting, and electricity are often present. Personal protective equipment required to be worn often. Routinely lifts and carries objects of 50 pounds or less in weight. Must be able to go up and down several flights of steps on occasion. May be required to exert effort to pull control valves, loosen bolts, or move controls and instrumentations. May be required to wear a full-face respirator contingent upon required job duties. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Job Title: Director, Technology Alliance Management (Alliance Lead) Introduction to the role: Be part of a dedicated Research & Development team. Fueled by our commitment to help more patients, strengthen our pipeline and grow our area. This is the place to go beyond discovery - we think holistically about patients and are always learning from those living with diseases. The Alliance Management (AM) group sits within BioPharma Clinical Operations and is accountable for setting the sourcing strategy across R&D and managing adherence to it. They ensure our suppliers deliver to the needs of the organizations and develop strong, beneficial partnerships with key suppliers. About the role: The role of the Alliance Management Director is to act as the Alliance Lead for one or more supplier(s). They will be responsible for ensuring the supplier(s) are meeting the operational needs of the customers; ensuring alliance effectiveness, appropriate communications, ensuring that selected partners deliver to contract; and that strong relationships with the external suppliers are created and maintained. This role will support and lead Patient Recruitment and Retention. Accountabilities: Supplier / Model Governance Accountable for the alliance management of one or more supplier(s) within or across service line(s) Proactively identifies and manages risks at the supplier/model/service line level Serves as point of contact for issue escalation to AM for their assigned supplier (s), and key in ensuring solutions are identified in collaboration with the business stakeholders. Facilitates resolution of any operational issues that impact delivery Leads operational governance of the supplier(s)/ service line(s) In collaboration with the AM Group Lead, contributes to executive level governance meetings; and contributes to or leads model level governance and supplier council forums, as required Acts as audit Sponsor and/or audit co-ordinator for AZ led supplier audits as applicable Supplier / Model Quality and Performance With the AM Group Lead ensures definition of appropriate Metrics and SLAs for the supplier within the MSA Monitors quality and performance of service deliverables in alignment with the MSA Ensures that selected suppliers deliver to contract and that strong relationships with the external suppliers and internal customers are created and maintained Ensures effective visibility of supplier performance to relevant stakeholders Ensures ongoing assessment and integration of Lessons Learned for suppliers / models/service lines Seeks opportunities to drive efficiencies and continuous improvement within supplier and model/service lines Study Team Support Ensures understanding of roles and responsibilities across delivery teams for assigned delivery model(s) / service line(s) Works with AM Process Integration Lead, internal subject matter experts and counterparts in supplier organizations to ensure the effective use and maintenance of interface processes / ways of working (e.g. Alliance Handbooks) Alliance Management Development May have responsibility for line management or coaching of junior members of the team Serves as a delegate for the AM Group Lead for specific tasks or activities, as necessary May support or lead key critical initiatives within AM and contribute to initiatives outside of AM Essential Requirements University degree in related field, or equivalent (Phd/MSc preferred, BSc required with 10+ yrs of experience within the pharmaceutical industry or clinical research organization Strong experience from within the pharmaceutical industry or clinical research organization Detailed knowledge of clinical and pharmaceutical drug development process at various phases of development Experience of working successfully with external partners / managing relationships Experience of directing alliance governance frameworks and processes (incl performance metrics) Strong leadership and influencing skills, especially without authority Strong collaboration skills across global and functional boundaries Excellent conflict resolution, mediation and negotiation skills Ability to work with agility to solve problems that involve many decision makers, and develop multiple options/recommendations Familiar with ICH GCP and related guidelines and practices Why AstraZeneca? At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. Make a more meaningful impact to patients' lives around the globe! Apply today! Date Posted 15-Dec-2025 Closing Date 06-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.

We have an open position within in our Pharmaceutical Technology and Development (PT&D) department. PT&D is the bridge, which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations, and devices required to support new medicines - from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. Make a positive impact, in a team where it means more. In Operations, we have a big ambition. to deliver more medicines to patients, quicker and more affordable. Backed by investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking. Summary: We are currently recruiting for Director of Formulation and Process Design. This position will be accountable for the performance and results within formulation and process design oral/inhaled team - oral solid dosage form experience is required for this position. Key Responsibilities: * Leads a team of formulation scientists, setting clear goals, technical direction, and development priorities to align with organizational and portfolio objectives. Responsible for planning and executing formulation development strategies, optimizing drug product processes, and ensuring robust, scalable, and regulatory-compliant solutions across all stages of development from early-phase through commercial readiness. * Acts as a key interface with other GPD functions to accelerate project timelines and reduce development risk. Drives continuous improvement, talent development, and innovation within the team to support the company's scientific leadership in oral and inhaled delivery platforms Specific Responsibilities: * Leads a team of up to 10 scientists across local and global sites to drive inhaled and oral drug product portfolio * Coaches and develops direct reports to drive high performance, team engagement, and individual growth. * Drives local implementation of PT&D strategy and associated change initiatives, championing transformation and innovation. * Embeds new ways of working that enhance agility, flexibility, efficiency, and delivery, serving as a role model for lean leadership. * Shapes and delivers forward-thinking, digital-enabled approaches to product design and development, leveraging data science, predictive modeling, AI, and strategic workforce planning to meet evolving portfolio needs. * Builds and sustains a high-performing, innovative team culture focused on scientific excellence, new modalities, and continuous improvement. * Ensures full compliance with SHE and cGMP standards, aligning with AZ and external regulatory requirements. * Operates confidently within a global matrix organization, fostering integration and readiness for future challenges. Ensures capability building to support the diverse and emerging portfolio of modalities. * Collaborates with the Project Leadership Group to define and execute portfolio delivery strategies within the unit's remit. * Solves complex scientific and organizational challenges through strategic insight, conceptual thinking, and informed judgment. * Influences internal and external stakeholders, shaping the reputation and impact of the FPD department. * Demonstrates strong communication and leadership skills to set clear direction, inspire teams, and foster alignment across functions. Education, Qualifications, Skills and Experience Essential * BSc/PhD level education in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering), or in Pharmaceutical Sciences with related experience in the device and biopharmaceutical industry is essential. * Minimum 5 years relevant experience * Significant experience in the design and development of inhaled and oral products * Proven experiences in leading and managing direct reports * Leadership experience promoting, motivating and empowering diverse and inclusive culture to support accomplishment of individual, team and organisational objectives * Significant understanding of the overall drug development and commercialisation process from development and launch, through life cycle management * Strong Networking skills across complex, multi-national PT&D organization * LEAN leadership mindset Desirable * Ability to lead cross functional working groups and teams * Expert reputation within the business and industry * Extensive knowledge of the latest technical and regulatory developments * Excellent knowledge of AstraZeneca policies, procedures and guidelines 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. Why AstraZeneca: Be part of shaping the future of Operations here at AstraZeneca. Be part of shaping the next phase of Operations' journey towards the 2025 strategy. Build on our foundations of high performance through agility, responsiveness, reliability, and efficiency to deliver our new modalities and complex pipeline to market at speed. Backed by a supportive team, be part of accelerating our operational excellence with innovations in cutting-edge science, Lean ways of working, and fast-changing digital technologies. The annual base pay for this position ranges from $175,572 to $263,358 Annual USD. 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 salary (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. Date Posted 13-Nov-2025 Closing Date 30-Dec-2025 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 Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Job Description Summary We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards. Strategic Leadership: Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio. Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives. Innovation & Execution Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine. Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices. Risk Management & Problem Solving Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges. Thought Leadership & External Engagement Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices. Team Leadership & Development Manage and mentor a diverse team of data scientists and people managers across geographies. Foster career growth through open dialogue, performance management, and strategic development planning. Operational Excellence Ensure GxP compliance in data science programming for clinical trials. Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency. Executive Communication Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence. Qualifications Ph.D. in Biostatistics, Bioinformatics, or related computational sciences. Deep expertise in statistical methods and their application in clinical trials. Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics. Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine). Proven experience presenting at external forums and influencing regulatory authorities. Strong people leadership experience in a Data Science setting. Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred. Eisai Salary Transparency Language: The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Are you ready to play a pivotal role in transforming demand forecasting within BioPharma ClinOps? As an Associate Principal, Business Analyst, you'll be at the forefront of developing, testing, and implementing FTE demand algorithms using PLANIT, our enterprise project management tool. Collaborate closely with stakeholders across BioPharma ClinOps to ensure alignment with organizational productivity initiatives and drive impactful changes in ways of working. Accountabilities: In this dynamic role, you'll deliver value by managing the BAU process for ongoing review and refinement of functional FTE demand algorithms. You'll develop and manage a roadmap of planned deliveries, ensuring alignment with scorecard objectives and functional needs. Your expertise will ensure that FTE BioPharma ClinOps demand in PLANIT (PLANISWARE Enterprise project management tool), aligns with the current organizational structure and is driven by reliable forecast algorithms. You'll also ensure the impact of productivity initiatives is realized in our demand forecasting, while delivering documentation, communication, and training to support ongoing changes. Essential Skills/Experience: * University degree at Bachelor level, in a scientific or business discipline * 5-10 years of project/portfolio/resource management, in a Clinical Development environment * Broad drug development experience in a matrix environment * Minimum 5 years of working experience and understanding of business planning and capacity management process * Ability to look for and champion more efficient and effective methods/processes * Goal oriented and ability to drive performance * Experience in converting organizational needs into demand algorithms * Experience in developing demand algorithms for Clinical Development * Strong data modelling skills and the ability to transform data into forms easily understood by others * The ability to balance tact, patience and persistence with the need to move improvements at speed * Strong organizational skills to move multiple functions through the improvement processes at different speeds based upon their level of understanding and complexity of their business * Expert knowledge of PLANIT (PLANISWARE Enterprise project management tool), and demand algorithms Desirable Skills/Experience: * Advanced degree * Business relationship management skills * Accredited/Certified in Project Management tools/systems * Proven ability with enterprise project management systems 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. At AstraZeneca, you'll be part of a team that tackles complex challenges head-on, empowered to innovate and experiment. With access to extensive capabilities and a comprehensive pipeline, you'll engage in diverse projects across the drug development process. Our supportive yet challenging environment fosters continuous learning and improvement, driving us towards groundbreaking solutions that make a tangible difference in patients' lives. Ready to take on this exciting challenge? Apply now and be part of our journey to transform healthcare! Date Posted 26-Nov-2025 Closing Date 01-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.

The Director, Scientific Communications shapes and leads the long-term communications strategy for BioPharma Clinical Operations, elevating the visibility, reputation, and impact of BioPharma ClinOps across R&D and the enterprise. This strategic role partners directly with the Head of Clinical Operations and senior leadership to craft a compelling, science anchored narrative of how Clinical Operations accelerates innovative, patient centric development. The Director will steward integrated internal and external communications, thought leadership, leader visibility, and enterprise storytelling grounded in a deep understanding of clinical development, operational excellence, data/digital transformation, and compliance. Role purpose * Build and execute a multiyear communications strategy for BioPharma Clinical Operations that aligns to R&D and enterprise strategy, advances change adoption, and measurably improves awareness, engagement, and influence. * Serve as a principal advisor and communications lead to the Head of Clinical Operations, providing counsel, executive messaging, and issues management. * Translate complex scientific and operational topics (trials portfolio, digital/data innovation, risk-based quality, patient engagement, sustainability) into clear, compelling narratives for diverse audiences. * Strengthen Clinical Operations' voice and presence inside R&D and across AstraZeneca, and externally with industry partners. Key responsibilities Strategy and leadership * Set the long-term BioPharma Clinical Operations communications vision, priorities, and annual operating plan, with clear KPIs tied to business outcomes (e.g. cycle time, quality culture, talent brand, innovation adoption). * Establish the strategic narrative and messaging architecture for ClinOps 2030, mission, proof points, and signature stories, ensuring consistency across channels and markets. * Advise and coach the Head of Clinical Operations and LT on executive communications, change leadership, and stakeholder engagement. Act as communication lead for LT meetings, town halls, and enterprise forums. * Partner with other Communications team members as an experienced peer, offering guidance, coaching, mentoring, and thought partnership while collaborating on priority initiatives without direct line management. * Partner with R&D, Corporate Affairs, SEN and HR to integrate ClinOps narratives into broader enterprise communications and employer brand. Integrated communications and channels * Own the BioPharma ClinOps editorial calendar, content roadmap, and multichannel strategy (Workvivo posts, video, newsletters, podcasts, town halls, playbooks). * Lead development of high impact content: executive speeches, narratives, video series, infographics, thought leadership articles, and campaign toolkits. * Ensure compliance with regulatory, legal, IP, and data privacy requirements. * Map and manage critical stakeholder groups (ClinOps LT, functions, regions, sites, study teams via appropriate channels), tailor messaging to their needs and maturity. * Drive leader visibility and "leaders as communicators" programs, develop leader communication playbooks and coaching to cascade strategy and reinforce cultural behaviors. * Sponsor key events and flagship moments (ClinOps 2030 milestones, ClinOps Awards, innovation showcases) with measurable engagement and follow through. * Define success metrics across awareness, engagement, behavior change, and business impact. * Conduct audience insights, message testing, and channel analytics to continuously refine strategy, socialize learnings and scale proven practices. Qualifications Essential * Degree in Communications or Journalism. * 5+ years' experience in strategic communications within complex, global organizations, including executive advisory and enterprise change communications. * Pharma R&D experience with direct clinical operations preferred * Proven track record building multiyear communications strategies with measurable business impact. * Experience navigating regulated environments and partnering with Medical/Legal/Regulatory for external content. * Executive presence, stakeholder influence, and the ability to simplify complexity for global audiences. * Strong command of digital channels and analytics; proficiency with content management, enterprise social, Adobe Creative Cloud, and video/podcast production workflows. Desirable * Familiarity with AI assisted content, data storytelling, and measurement platforms. When we put unexpected teams in the same room, we unleash ambitious 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. If you're ready to make a significant impact on patients' lives by joining a team that follows the science with curiosity and courage, apply today! Date Posted 11-Dec-2025 Closing Date 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.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary We are seeking a skilled and safety-focused welder to join our team. The ideal candidate will have proven experience in pipe and plate welding along with metal fabrication. S/he has ability to interpret blueprints, project plans, and isometric drawings to complete pipe fitting and welding tasks. S/he must be able to accurately pre-fab and install pipe replacements and upgrades. This role requires strong technical knowledge, attention to detail, and the ability to collaborate with construction and maintenance teams to ensure safe, high-quality project execution. Job Description Blueprint and Drawing creation and interpretation Create, read, and interpret project plans, blueprints, piping diagrams, and isometric drawings. Translate written instructions and diagrams into precise fabrication and installation tasks. Fabrication and Installation Measure, cut, thread, groove, bend, and weld pipes according to specifications. Prefabricate piping systems and confirm alignment, tolerances, and fit prior to installation. Assemble pipes, fittings, and valves using appropriate tools, equipment, and joining techniques. Understanding and experience with carbon steel, stainless steel (304L & 316L), aluminum, and alloy 20 metals, among others. Ensure accurate pipe fit-up and compatibility with structural components. Repair equipment in the field, as needed, including within confined spaces. Testing and Quality Control Inspect and test completed piping systems for leaks, durability, and compliance with industry standards. Identify issues, perform adjustments, and report malfunctions or defects to supervisors. Ensure adherence to project specifications, codes, and safety regulations. Collaboration and Teamwork Work closely with welders, fabricators, and construction crews to ensure seamless project integration. Participate in failure analysis and troubleshooting to address causes of equipment or system failures. Communicate effectively with supervisors, engineers, and team members. Safety and Compliance Support and follow all site safety programs, policies, and guidelines. Wear and maintain all required Personal Protective Equipment (PPE), including full-face respirators, hard hats, safety glasses, gloves, steel-toe boots, and chemical-resistant gear when necessary. Contribute to a safe work environment by practicing proper housekeeping in the shop and on job sites. Equipment and Maintenance Operate and maintain pipefitting machinery and tools (cutting torches, threading machines, grinders, calipers, etc.). Ensure equipment is used safely and kept in good working condition. Report any equipment malfunctions promptly. Requirements Minimum of 2 years' proven experience as a Pipe Fitter. Strong ability to read and work from blueprints, isometric drawings, and piping diagrams. Skilled in pipe fabrication, alignment, and installation processes. Familiarity with welding processes and ability to collaborate with welders during fit-up and installation. Proficiency in using tools and equipment such as cutters, threading machines, torches, squares, and calipers. Ability to pass fit-up or pipefitting assessments as required. Strong attention to detail with a results-driven and safety-focused approach. Physical ability to stand, bend, squat, and lift heavy materials regularly. Must be able to work in varying environmental conditions (indoor/outdoor, hot/cold, confined spaces). Commitment to workplace safety and compliance with all PPE requirements. Preferred Qualifications Experience working on industrial, commercial, or construction piping systems. Knowledge of relevant codes and standards (ASME, ANSI, OSHA, etc.). Ability to weld pipe and plate using GTAW and SMAW methods when required. Demonstrated teamwork and communication skills in a construction or industrial setting. Ability to perform basic NDE techniques, such as visual examination and liquid dye penetrant examination. Work Environment This position involves work in both shop and field settings. Candidates must be able to adapt to changing work environments, including exposure to noise, dust, extreme temperatures, and confined spaces. Pipe Fitters must also be able to work at heights and in physically demanding conditions while maintaining strict adherence to safety standards. Shop and industrial manufacturing areas without climate control. Must be able to go up and down several flights of steps on occasion. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Boehringer Ingelheim is currently seeking a talented and innovative Pharmaceutical Sales Intern to join our diabetes sales team in one of our nine national regions. You will work with a team of experienced sales professionals who will guide you through a real world, hands-on experience in selling pharmaceuticals. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Duties & Responsibilities Participate and successfully complete training and selling skills development. In partnership with a mentor/coach, engage with customers and participate in clinical discussions (including virtual engagements). Attend weekly conference calls with regional field sales team to capture learnings and gain valuable insights. Schedule appointments for sales colleagues and participate in in-service programs. Requirements Must be a current undergraduate student in good academic standing; December 2026 and May 2027 graduates only. Must be enrolled at a college or university for the duration of the internship. Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred Must have completed at least 12 credit hours at current college or university. Must have reliable transportation and valid driver's license. Must be able to work the full duration of the internship (May 18, 2026 - August 14, 2026). Desired Experience, Skills & Abilities: Strong interpersonal skills Digital proficiency Ability to analyze qualitative and quantitative information Demonstrated ability to work in a team environment Ability to execute and follow through on priorities Eligibility Requirements: Must be legally authorized to work in the United States without restriction Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older

The Manager, Technical Compliance, is responsible for all aspects of the Gene Therapies North Carolina Site Data Integrity Program, including creation, implementation, defining, monitoring and reporting KPIs, creating solutions for KPI improvement and continuous improvement of the program. In addition, the Manager is responsible for the maintenance and monitoring of that quality risk management program, Quality Engineering, QA IT, and CMC Facilitation. The manager will also be responsible for being the Data Integrity Lead for the GTxNC site. About the Role Location: This position will be located in Durham, NC and will be able to work on Hybrid schedule Key Responsibilities * Manages a team that oversees quality engineering, QA IT and CMC Facilitation. * Manages the team to ensure on time delivery of compliance activities related to QA IT and Quality Engineering. * Manages the staff responsible for the regulatory CMC related launches and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements * Maintenance and Monitoring of the Quality Risk Management Program * Proactively drives establishment of Data Integrity culture through implementation and monitoring of the Data Integrity program. * Serves as the site subject matter expert for all DI-related inquiries/trainings and DI assessment tools. * Identifies and maintains a network of functional Data Integrity (DI) Subject Matter Experts (SME)/ DI Champions within appropriate GxP functional areas (e.g. Manufacturing, Maintenance, MS&T, engineering, QA Ops, QC, etc.). * Determines strategy and collaborates with functional DI SMEs/DI Champions to drive behavioral change management activities to strengthen DI culture. * Drives continuous/sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks, etc. * Manages/Leads DI topics at site in investigations, rapid alerts, reviews and audits related to Data Integrity for both internal Novartis and external parties. * Facilitates the identification of high-risk data processes and systems (via risk assessment, gap assessment, data mapping, etc.). * Identify and champion opportunities for mid and long-term actions and strategies to reduce DI risk. * Implementation of DI tools, training materials and guidance (e.g. DI Key cards, Data mapping optimization, audit trail review) at the site according to defined strategy. * Responsible for supporting QA approval of quality management records for the QA quality systems team. Essential Requirements: * BSc in Chemistry, Biology, Pharmacy, business, or related experience. * Advanced Degree in Quality / Regulatory, Business, Healthcare, Pharmacy, or Scientific discipline preferred. * Manages a team of 4+ employees. * 10 years' experience in Quality Systems, Quality / Regulatory Compliance, Operational GxP area(s) (Manufacturing / Development), Quality Control, Quality Assurance, Supplier Quality and / or Post Market Quality within the pharmaceutical, diagnostic and / or medical device industries. Experience in advanced therapies (CGT, RLT, etc) is preferred. * 5 years' of industry Data Integrity related experience. Prior experience with aseptic manufacturing is preferred. * Cross-functional experience in a GxP regulated pharmaceutical industry (e.g Quality Assurance), clinical operations, PV, preclinical operations, manufacturing/engineering operations, Quality Management Departments or equivalent external consultant positions with experience in quality risk management through application of ALCOA+ principles and 21CFR Part 11 requirements. Strong operational background preferred. * Knowledge of applicable cGMP regulations, for example, FDA Regulations (e.g., 21 CFR 4, 7, 11, 211, 212, 314, 803, 806, 820), ICH Guidelines, * EU Pharmaceutical Regulations and Directives, ISO Standards, etc. Strong experience in supporting DI programs, risk analysis, project management, budget, communication and presentation skills. * Prior experience successfully leading Health Authority Audits / Inspections, including, front room / back room, readiness, strategy and response to findings / observations. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $132,300 and $245,700 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Hybrid Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** SUMMARY OF POSITION: The Maintenance I/E Technician performs a variety of electrical and instrumentation duties involving the maintenance of plant facilities. S/he will be responsible for calibrating, installing, maintaining, repairing, and inspecting plant monitoring devices on a wide variety of complex digital, analog, programmable, and other auxiliary equipment. **** Job Description **ESSENTIAL FUNCTIONS** **:** + Installs, troubleshoots, repairs, and calibrates low voltage AC/DC electrical and instrumentation controls as well as 3-phase 480-volt power circuits. + Interfaces with OEM's and vendors as necessary. Requisitions equipment as needed. + Accurately completes all work performed according to standard operating procedures (SOPs) and work instructions, including proper documentation. Completes work orders using CMMS (Maximo) system. + Performs repairs and modifications as directed by maintenance supervisor, or other plant management. + Supports and participates in training programs. + Keeps the maintenance supervisor abreast of job status. + Supports site safety programs. + Supports/leads failure analysis process by discussing the causes of equipment failure with the maintenance supervisor, or the maintenance engineer. + Accurately completes all required paperwork, including but not limited to timesheets, "found as-left" forms, calibration reports (ICIR), and PM checklists. + Responsible for good housekeeping in the shop and at the job site. + Must be able to wear the required Personal Protective Equipment (PPE), full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel -toe shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate, or safety guidelines for each job task. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** Other duties as assigned with or without accommodations. + Supports the PM/PdM program and calibration program by ensuring a high quality of workmanship. + Accurately enters all required information on work orders. + Assists the maintenance supervisor and maintenance engineers, or others as needed with equipment installation, maintenance, repair techniques, and with identifying opportunities for improving equipment reliability. Shows emphasis on the design, installation, commissioning, maintenance, and use of mechanical equipment throughout the facility. + Recognizes problem independently and troubleshoots malfunctioning equipment without direct supervision. **MINIMUM REQUIREMENTS** **:** _Education:_ High School diploma, GED, or equivalent. Associate or Technical degree in a mechanical field preferred. _Experience:_ 1 - 3 years I/E experience in a pharmaceutical manufacturing operation. _Preferred Skills/Qualifications:_ _Skills/Competencies:_ _Other Skills:_ Work as an industrial I/E mechanic, PLC skills. Must have a working knowledge of the tools and test equipment used for testing, calibrating, repairing, and maintain production instruments and controls. Must be able to read and comprehend blueprints, electrical schematics, and engineering specifications. Must be able to perform shop math. Must be able to understand electricity, respect, and follow safety guidelines. Must be able to read and follow written instruction. Should be familiar with National Electrical Code, NFPA 70E, calibration standards, and cGMP. Experience working with voltages up to 480. Experience with CMMS, such as MP2 or Maximo. Learning on the Fly, Problem Solving, Interpersonal Savvy **RELATIONSHIP WITH OTHERS/ SCOPE:** + Reports to Maintenance Supervisor. + Utilizes a variety of test instruments, hand tools, supplies, and other shop equipment on a daily basis. On occasion, it may be required to take tools to the work area in the plant. + No direct responsibility exists for the works of others, although adherence to the team concept requires mutual assistance in some jobs. + Indirectly responsible for amount and quality of product through the maintenance and repair of production equipment. A thorough understanding of cGMP is critical. + Significant responsibility for the safety of others, improperly repaired equipment could possibly result in safety hazards to plant personnel. + Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed.WORKING CONDITIONS:I/E Technicians are required to work in all areas of the plant site, both inside and outside. There may be exposure to warm areas, dirt, oil, grease, chemicals/chemical fumes, and noise. + Injuries could result from spills or leaks or corrosive, flammable, and toxic material, all which are normally handled in the plant. + Dangers, such as sharp edges, pinch points, chemical and temperature burns, lifting, and electricity are often present. Personal protective equipment required to be worn often. + Routinely lifts and carries objects of 50 pounds or less in weight. Must be able to go up and down several flights of steps on occasion. May be required to exert effort to pull control valves, loosen bolts, or move controls and instrumentations. **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading, managing, strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This role involves providing hands-on operational support for submission activities while ensuring strategic alignment and process optimization across different regions. It also includes resource planning, budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads of Submissions Management for the EU and Japan as needed and utilize "Follow-the-sun" processes to ensure submission timelines are met regardless of the region. The Associate Director, Global Submission Management (GSM, is responsible for the effective operation of Global Submission projects, ensuring the consistent application of global procedures and standards, and proactively assessing process performance for necessary optimizations. The Associate Director serves as the primary liaison between R&D functions, acting as the submission lead for designated global applications (e.g., INDs, NDAs, MAAs, supplements, amendments, and variations), to facilitate cross-functional logistics and communication that support submission planning. This role provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in accordance with agreed-upon submission timelines. Additionally, the AD oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final deliverables, ensuring compliance with applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, HC, PMDA, Emerging Markets, ICH, CDISC) within defined timelines. Essential Functions: Leadership and Strategy * Provides leadership for the Global Submissions Team ensuring projects are appropriately resourced, partnering with other regional Submission Heads for additional support for resources when needed. * Provides the Regulatory Submission Management for a lead compound or submission project that has been identified as critical to Eisai's business success. * Provides management oversight for the Global Submission Management department, supporting the generation, and when necessary, the re-engineering of Eisai "Best Practices" related to global submission management and dossier development in pursuit of optimal processing performance while maintaining full compliance with Health Authority requirements and guideline. Global Collaboration * Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement "follow-the-sun" workflows for timely submissions across all regions. * Foster strong cross-regional communication and collaboration to support global objectives. * Promotes a culture of performance and teamwork, with a focus on staff development in technical skills, interpersonal skills, education, and training, enhancing competency and professionalism. * Maintains visibility within the organization by regularly presenting on various GSM-related topics. This includes showcasing the achievements, ongoing projects, and developments of the GSM organization, as well as emerging trends in eCTD regulatory submissions. Additionally, cultivate positive and constructive relationships with other members of the Global Regulatory Operations (GRO) team and regulatory colleagues. * Actively participates in agency/industry events regularly, staying abreast of current developments, trends, and technologies, fostering constructive business relations with other industry peers, Health Authority representatives, and critical business partners/vendors. * Analyzes trends and evaluates the impact of changes in Health Authority requirements for e-submissions, communicating these changes to the relevant areas within Eisai and driving the necessary changes to processes and procedures. * Ensure the timely completion of all administrative tasks for this position, including but not limited to monthly reports, performance objective setting, performance reviews, and training, for self and staff. Hands-On Submission Support * Actively participates in submission planning and execution, including document compilation, publishing, and quality checks. * Provide technical oversight and troubleshooting for eCTD submissions and related systems. Operational Excellence * Ensure consistent application of GSM global procedures and standards. * Proactively monitors and assess process performance, identifying opportunities for continuous improvement. Requirements * Bachelor's degree in scientific or information technology field; advanced degree preferred * 8+ years of pharmaceutical industry regulatory experience * 5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required * Proficient with U.S. and EU submission requirements including but not limited to Emerging Markets * Advance experience with the drug development process and eCTD regulatory submission standards * Expert understanding of Project Management concepts and techniques * Ability to apply SOPs regulations pertaining to electronic submissions * Ability to lead cross-functional team, establish effective relationships with team members and work well in a cross functional team environment * Advance experience creating timelines for the development and submission of drug filings to regulatory health authorities * Excellent organizational skills to support multi-task and manage submission timelines in a fast-paced environment with changing priorities * Well-organized with the ability to multi-task and work with minimal supervision * Ability to manage change to support organization's effectiveness by implementing change * Effectively communicates written and verbal communication skills * Demonstrates strong analytical, problem solving and critical thinking skills with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution. * Certification is a plus (such as Regulatory Affairs Professional Society (RAPS) Technical Skills Required * Advance working knowledge of global regulatory submission standards, publishing software, software validation concepts, and regulatory publishing best practices * Proficiency in eCTD publishing tools (e.g., Lorenz docu Bridge, Extedo eCTDmanager, or equivalent). * Strong understanding of ICH guidelines, regional regulatory requirements, and data standards (e.g., CDISC). * Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (e.g., Veeva Vault, SharePoint, Documentum) * PowerPoint, SharePoint, XML, Adobe Acrobat, ISI Toolbox and eData transfer systems * Ability to troubleshoot technical issues related to electronic submissions and publishing. We are open to remote-based, but the preference for this role is a hybrid work arrangement in Nutley, NJ with 3 days a week in office every week (Tuesday, Wednesday. Thursday). Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Global Submission Management is from :$159,000-$208,700 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Are you an analytical scientist with extensive experience in routine analytical testing supporting development of new products? AstraZeneca's Global Product Development (GPD) team is seeking a Scientist to expand analytical development capabilities especially with testing complex combination products within inhaled portfolio. At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person. Within Global Product Development, we are seeking an experienced and motivated Scientist with a strong background and hands on experience with testing complex inhalation products, to drive AZ's critical projects through development to commercialization. In this laboratory based and impactful role, you will support routine clinical lot releases, investigation work along with exposure to method development / optimization. You'll work collaboratively across different functions to support key license to operate testing as well as complaint investigation. The role will be in Durham, North Carolina, USA, but is part of AZ's Global Product Development organization with additional sites in Gothenburg, Sweden and Macclesfield, UK. GPD's vision is to work in seamless ways that bring the best of our collective scientific capabilities to develop and deliver innovative and sustainable medicines, making a meaningful impact on patients' quality of life. Within the role, your expert analytical support will range from early phase development work to late-stage cGMP testing. Experience with digital tools and AI is required to support overall vision for GPD. The ideal candidate will be energetic and focused, with a can-do attitude and strong problem-solving and data analytics skills. You will join a highly collaborative international team supporting various projects across different development lifecycles. What you will do: Manages own work to ensure that agreed targets are met in a timely manner and to agreed quality standards and communicating progress appropriately. Performs relevant experiments and interprets results based on a standard methodology in collaboration with formulation and/or device teams. Able to identify aberrant data and effectively communicate with project teams. Play a key role in supporting development work for automation to manual methods for inhalation products such as Delivered Dose Uniformity (DDU), aerodynamic particle size. Support technical and scientific review of data generated by peers. Identify and lead continuous improvement efforts to streamline laboratory operations and eliminate waste, ensuring compliance with GMP/GxP expectations. Champion laboratory automation technologies to improve efficiency and reliability in sample preparation, method execution, and data analysis. Demonstrate an active interest in leveraging AI /ML and other data science tools to enhance analytical results interpretation and workflow performance. Minimum Qualifications: Bachelor's degree with 3+ years experience, or Master's with 0 or more years experience, in Chemistry, Pharmaceutical Sciences, or closely related field. Strong background in analytical methodologies for inhalation dosage forms Hands on experience working with HPLC/UPLC, moisture analyzer, and mass spectrometry is required. Proficiency with analytical software such as Empower, Tiamo, ELN is required. Hands-on proficiency with workflow optimization. Experience with statistical tools such as JMP is preferable. Excellent organizational, problem-solving, and collaborative communication skills. Experience working in a GMP/GxP regulated environment. Strong people, organizational, and communication skills (both written and oral) Preferred Qualifications: Exposure to analytical methodologies for portfolios that vary across modalities and/or dosage formats, including but not limited to oral solid and inhaled products. Familiarity or interest in utilizing data science tools, including AI / ML, to advance analytical interpretation and data flow. Experience collaborating in cross-functional global teams. Why AstraZeneca At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference in medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development. So What's Next Are you already imagining yourself joining our team? Good, because we can't wait to hear from you! Find out more on Social Media: LinkedIn ************************************** Facebook ******************************************** Instagram ******************************************** About Operations ******************************************* Date Posted 11-Dec-2025 Closing Date 16-Dec-2025 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.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The IS Supervisor position is responsible for the Information Technology (IT) functions at a large manufacturing plant, including management, support, problem resolution, and technology implementation as well as management and implementation of all IT projects at that site. The position reports to the Director, Infrastructure and Operations. Job Description ESSENTIAL FUNCTIONS: Understand business goals & proposed technology solutions. Assess the requirements of technology solutions including estimates of time, staffing & costs to implement & support. Develop or contribute to the development of capital project requests to fund the implementation of technology solutions. Manage a team of IT professionals / specialists in the implementation of new technology and on-hour / off-hour support of in-place technologies. Oversees infrastructure and application support for local applications and systems ensuring all routine maintenance, backups & restores, including disaster recovery planning and testing are performed. Manages procedures for implementations & ongoing support. This includes keeping technologies current & supported, following and enforcing change control procedures, installation instructions, support request instructions, etc. Understand business goals & proposed technology solutions. Assess the requirements of technology solutions including estimates of time, staffing & costs to implement & support. Develop or contribute to the development of capital project requests to fund the implementation of technology solutions. Manage or supervise the implementation of IT projects. Works as liaison between users and corporate / outsourced support personnel, coordinating support activity to drive issues to root cause and correct issues affecting users at site. Develop procedures for implementation & ongoing support. This includes keeping technologies current & supported; change control procedures, installation instructions, support request instructions, etc. Assures site is complaint with all relevant regulatory controls and procedures and corporate standards and ensures security policies for supported systems are maintained. Develop and maintain plans to ensure the continuity of critical business functions and minimize information loss in the event of a disaster for local site. Establish and monitor metrics for system quality. Perform analysis on resolution time, root cause, proper communication with intention to prevent recurrences. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Participate in staff meetings and team meetings as required. Develop understanding of general industry usage of supported technologies. Develop deep understanding of business processes and business dependencies on supported technologies. Develop relationships within IT and with vendors to improve collaboration and teamwork necessary to accomplish organizational objectives. Participate in a development planning process where employee career goals are defined & understood, and development activities are incorporated into the employee objectives. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: Bachelor degree in Information Technology or related business field. Experience: 10+ Years Information Technology Experience with at least 2 years of people management experience. Preferred Skills/Qualifications: Strategy - Looks beyond daily activities to see trends in team performance / issues & addresses these trends with appropriate actions; contributes to the development of strategy in a functional area by researching industry trends and proactively proposing solutions to issues faced by the functional area supported. Project Development - Develops or contributes to the development of CER's to fund IT investments, key contributor to time, resource & cost estimates. Project Management - May manage large projects directly or establish mechanisms to monitor status of multiple projects being executed concurrently, mentors personnel in project management techniques. Operational Support - Manages the day-to-day operation of an IT team responsible for multiple technologies. This includes monitoring of up-time, service-level metrics. Includes business alignment responsibilities including cross functional meetings to review progress and discuss priorities of IT tasks. Financial Accountability - Responsible for managing IT budget for the site, and collaboration with corporate infrastructure team and local finance team to set priorities and track spending. Communication Skills - Solid communication skills, both written and oral, with very strong customer service orientation and win-win negotiation skills. Leadership - Leads by example; provides context & motivation to team members. Administration - Performs administrative functions as required to manage the daily activities of the functional area. ORGANIZATIONAL RELATIONSHIPS/SCOPE: Managers Information Services personnel at site. WORKING CONDITIONS: Manufacturing Plant and Office environment. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsibilities: Oversees URS, protocols, reports & support records to ensure compliance, timely resolution of documentation, compliance, and quality system issues. Identify, coordinate, execute and provide oversight of validation activities related to the start-up, commissioning, qualification, validation of a cGMP manufacturing facility (including manufacturing equipment, QC lab equipment, utilities). Performs environmental mapping and other miscellaneous validation activities. Evaluates and analyzes validation data for accuracy and adequacy. Supports the development of validation execution strategy and timeline for sustained operation within validated GMP environment. Collaboratively conducts Risk Assessments and Impact assessments and establish system boundaries. Owns validation Lifecycle documents including Validation Plans, Impact Assessments, and Validation Reports. Reviews and supports Computer Systems Validation efforts for global systems. Manages workload to ensure timely approval of validation testing and documentation. Assists Quality Assurance, Production, Quality Control and other departments during inspections or audits. Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required to control financial and execution related aspects of project. Other related duties as assigned. Requirements: BS/MS degree in Chemical, Industrial, Mechanical, or related engineering discipline; or Science with 5 years of relevant experience in the pharmaceutical or Biopharmaceutical industry (validation or engineering experience preferred).. Experience with Biosafety cabinet smoke studies. Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities. Experience supporting FDA approved, commercial products. Experience in cGMP environment (IQ, OQ, PQ) is essential. Familiar with current industry best practices, including ASTM e2500 to plan efficient/risk-based validation projects. Experience with validation tools and processes, including environmental mapping and use of Kaye Validator. Familiar with GAMP 5 applications and practices. Excellent technical writing and verbal communication skills. Proficient in Microsoft Word, Excel, PowerPoint, and Project. Experience providing technical support for problems of moderate scope where analysis requires a review of a variety of factors and able to drive toward issue resolution. Skills: Business Continuity. Change Control. Flexibility. General Hse Knowledge. Hvac (Heating Ventilation And Air Conditioning). Including Gdp. Installations (Computer Programs). Knowledge Of Capa. Knowledge Of Gmp. Manufacturing (Production). Project Commissioning. Project Engineering. Project Execution. Risk Management. Root Cause Analysis (Rca). Languages: English Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $89,600 and $166,400/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $89,600.00 - $166,400.00 Skills Desired Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems , Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** Summary SUMMARY OF POSITION: The Production Engineer will function as a part of the APAP Operations Team. The Production Engineer will apply technical skills to manage day-to-day production, optimize plant operation, resolve operational issues, and investigate process deviations. The Production Engineer will provide technical assistance to the APAP manufacturing employees to ensure that production targets are met while complying with all applicable Safety and Quality rules and regulations **Job Description** **ESSENTIAL FUNCTIONS** **:** + Studies process and equipment to identify problems and opportunities. Provides technical guidance and instruction to APAP Operations Team regarding troubleshooting and debottlenecking efforts. + Ensures that all processes operate within defined and validated limits. + Conducts training for APAP Operations Team on new equipment and process changes. + Represents the APAP Operations Team in developing and implementing capital projects. Activities include project scoping, operating requirements, process controls, process tolerances, alarm rationalization, and validation. + Prepares periodic reports that summarize production rate, yield, rework status, quality condition and that summarize any special projects or problems that have been encountered. + Identifies and implements changes to reduce product cost by increasing production rate, improving yield, reducing downtime, improving equipment efficiency, etc. + Participates in periodic process audits with management personnel with respect to safety, environmental, quality, production, and cost. + Generates, reviews, and updates documentation for managing the process, including operating reports, batch records, P&IDs, etc. Reviews operating reports and batch records for accuracy and improvements. + Participates in customer and regulatory audits. + Investigates process deviations, inquiries, complaints and equipment loss incidents and identifies corrective and preventative actions where needed. Coordinates implementation of corrective measures. + Actively supports site continuous improvement process and serves on teams as needed to improve the workplace and increase efficiency and productivity. + Other duties as assigned with or without accommodation. **MINIMUM REQUIREMENTS** : _Education:_ Must have a B.S. in Chemical or Mechanical Engineering _Experience:_ Must possess knowledge of chemical and chemical engineering principles in order to solve production, quality and throughput problems. 1-5 years of experience in chemical or bulk pharmaceutical (API) manufacturing operations _Preferred Skills/Qualifications:_ _Other Skills:_ _Competencies:_ Understanding of GMPs (ICH Q7) and process validation Understanding of Six Sigma and Lean Manufacturing tools and concepts Experience in root cause analysis Experience with change control / management of change Demonstrated technical and leadership skills including oral/written communications, conflict resolution, decision making and sufficient financial acumen to interpret cost analyses and other reports Ability to plan and execute tasks on multiple projects simultaneously Must strive for continuous improvements in all work activities Self-motivated, Action-oriented, Technical Skills, Problem Solving, Informing, Organizing **RELATIONSHIP WITH OTHERS/ SCOPE:** + The Production Engineer will report to the APAP Focus Factory Manager + The Production Engineer will work closely with the other APAP Sr. Production Engineers, Supervisors and Sr. Day Operator to coordinate tasks + Frequent interactions with the following functions will be required: + APAP production operators + QA and QC + Maintenance and Engineering + EHS + Periodic interaction/communication with all site departments and corporate groups + May work with outside engineering design firms, manufacturer's representatives, vendors, and construction contractors **WORKING CONDITIONS:** + Works in an office environment, but will spend significant time in a multi-story bulk pharmaceutical (API) manufacturing plant that is partly outdoors + May be exposed to fugitive emissions of chemicals typical of chemical operations + Must be able to climb stairs and ladders for equipment installation review, monitoring and troubleshooting. + Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses, earplugs, fire-resistant clothing and any other devices or equipment that may be required + Position is required to be periodically available for on-call nights/weekends **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.