Novartis jobs in Durham, NC

The Quality Assurance Engineer is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at Novartis Gene Therapies, Durham, N.C. About the Role Key Responsibilities: * Provides QE support for clinical and commercial gene therapy products. * Support of all internal and external audits in support of product manufacturing. * Ensures Quality and Compliance aspects of design and work in collaboration with Engineering, technical functions, Manufacturing Operations to ensure that the facility is: * Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing. * Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications. * Capable to meet intended design goals of output volume, turnaround time and operating and product costs. * Provides input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters). * Acts as Quality approver on project deliverables, as defined in the project plan. * Works with validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. * Authors and/or approves Standard Operating Procedures in support of project activity and deliverables. * Provides QA oversight of engineering, validation, and facilities activities related to maintaining a GMP facility in a validated state. * Acts as the Quality approver for change controls, deviations, and CAPAs required to maintain the manufacturing facility in a GMP state. * Works with supplier and Vendor Management colleagues to ensure that suppliers of goods and services for the new manufacturing facility are compliant and capable of fulfilling their contracted requirements. Essential Requirements: * B.S. degree in preferably engineering, chemistry or biochemistry. * 5 years' experience in Biotech/Pharmaceutical industry or 4 years' experience in Biotech/Pharmaceutical industry, with at least 2 years within Novartis Gene Therapies. * Experience with viral gene therapies, cell culture technologies and/or orphan disease indications is a plus. * Strong knowledge and application of the CFR's and cGMPs. * Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. * Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements. * Experience with deviations, CAPAs, and Change Controls. * Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations. * Excellent oral and written communication skills with strong technical writing experience required. * Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $85,400 and $158,600 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?

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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.

The Buyer Planner II plays a pivotal role in keeping operations running smoothly. This position oversees the entire journey of inventory materials - from the moment an order is placed to time of delivery, ensuring precision and timeliness every step of the way. Beyond tracking, this role drives innovation by sourcing new materials that power our manufacturing and lab activities, including identifying and partnering with the right suppliers to keep us ahead of the curve. Job Description Location: Durham, NC #LI-Onsite 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 Key Responsibilities: • Perform periodic review of supplier performance and work with his/her manager to alleviate any supplier issues. Periodic review may require setting reoccurring meetings with key suppliers. • Support the Process Science Team by attending weekly production meetings, forecasting material needs and coordinating with the warehouse to ensure materials are available for scheduled production. • Track all raw materials from time of purchase to time of receipt. • Maintain data within the ERP system. • Attend/host regular meetings with suppliers to review open orders/supplier performance. • Accountable for maintaining inventory at planned levels. • Works with manufacturing and lab teams to identify and source new raw materials. • Maintain and update the Item Master as requested. • Create and report key performance metrics related to purchasing and inventory management. • Identifies and sets-up new suppliers through the Supplier Quality Management process. • Work closely with Strategic Procurement to negotiate supply agreements, blanket orders and long-term purchase agreements. • Forecast/Plan material needs to support manufacturing. • Assist Warehouse team with any incoming receipt issues. • Other related duties as assigned. Essential Requirements: • B.S. degree in supply chain, engineering, science, business or related degree or an equivalent combination of education and related experience. • 2 years of supply chain or buyer/planner experience preferred. • Must be able to operate with limited supervision and exercise proper judgment. • Strong communication and organizational skills, detail oriented. • Proficient in MS Office suite of products. • Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies. • Approximately 5% travel. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $63,600 and $118,200 per 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. Company will not sponsor visas for this position. 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 $63,600.00 - $118,200.00 Skills Desired Computer Systems, Continual Improvement Process, General Hse Knowledge , Including Gdp, Knowledge Of Gmp, Manufacturing Production, Master Data, Operations, Order Fulfillment, Order Management, Product Distribution, Sap Erp, Supply Chain, Supply-Chain Management, Transportation, Warehouse Management

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

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

**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. 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.

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.

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.

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.

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

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?

#LI-Onsite Novartis is seeking an Associate Director of Engineering (Design & Construction) to oversee the execution of large-scale capital investment projects critical to the advancement of our technical operations and pharmaceutical manufacturing. This position will be responsible for managing projects throughout their entire lifecycle-from conceptualization to commissioning-ensuring that all deliverables meet established timelines, budgets, and quality benchmarks. The role involves coordinating multidisciplinary teams, implementing advanced engineering solutions, and supporting improvements in plant capacity, safety, and regulatory compliance. This opportunity offers the ability to contribute significantly to global pharmaceutical manufacturing by providing strategic leadership in engineering. Job Description Key Responsibilities: Lead execution of large-scale capital investment projects across assigned platforms and regions Develop and implement project strategies aligned with cost, schedule, and quality targets Prepare and manage project initiation documents including scope, cost, and risk assessments Oversee design coordination and ensure compliance with internal and legal standards Drive project procurement and vendor selection processes Monitor construction safety plans and conduct regular safety reviews Manage project reviews including technical quality and constructability assessments Execute commissioning plans and ensure successful project handover to operations Support audits and lead facility improvement initiatives for energy and compliance Mentor engineering teams and foster professional development across project functions Essential Requirements: Bachelor's degree in engineering or relevant discipline Minimum 10 years of professional experience, including at least 5 years in Capital Portfolio and Major Project Management and at least 5 years within the pharmaceutical industry. Proven leadership in managing external engineering resources and leading cross-functional teams Strong knowledge of project cost control, scheduling, and quality assurance Excellent communication and stakeholder alignment skills across technical and business domains Proven success delivering safe, effective, and compliant projects in the pharmaceutical industry Advanced understanding of HSE standards and GxP/QA compliance Ability to travel for the role. Approx. 10% Fluent in English Desirable Requirements: Experience leading capital projects >$20M Diverse pharmaceutical experience needed. Specifically, Small Molecule DS (Drug Substance) / Small Molecule DP/FP (Drug Product/Finished Product) is highly preferred. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $132,300 and $245,700 per 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 $132,300.00 - $245,700.00 Skills Desired Automation, Capital Expenditure, Change Management, Classification Systems, Critical Thinking, Efficiency, Flexibility, General Hse Knowledge , Including Gdp, Knowledge Of Gmp, Manufacturing Process (Production), Operations, Root Cause Analysis (RCA), Support Services

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Company Overview: At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. Position Brand Description: The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program. The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Objectives/Deliverables The Director/Senior Director, Global Process Owner for Sterility Assurance Level 2 Processes is responsible to: * Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally. * Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations. * Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset. * Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. * Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics. * Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance. * Monitor performance metrics, report and provide insights to inform decision making to drive further improvements. * Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools. * Actively collaborate with enterprise-wide teams on standardized global business processes. * As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed. * Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management. * Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique Basic Requirements: * 10+ years' experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing * 7+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment. * Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field. * Candidate will have previous experience implementing and leading global Sterility Assurance programs which can include Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management. * Strong technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, contamination control, Annex 1 interpretation) * Strong written and oral communication skills * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals * Approximately 25% travel Additional Preferences: * Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control. * Experience leading a major multi-site or global functions improvement initiative. * Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities. * Proficiency in addressing operational challenges through structured approaches and innovative solutions. * Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data. * Demonstrated change agility in anticipating and leading others through change and ambiguity. * Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats. * Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity. * Demonstrated influential leadership expertise and experience engaging with senior-level functional leads. * Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results. * Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks. * Demonstrated people management experience. * Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. * Experience leading a major multisite improvement initiative or driving multisite standardization. * Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training. * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance Education Requirements: BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.), preferably Microbiology. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $264,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Use Your Power for Purpose Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will: Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories. Support environmental monitoring and water collection in the QC Microbiology laboratory. Follow Environment Health and Safety requirements for site and QC laboratories. Write cleaning validation protocols and reports, and perform complex mathematical problems and data analysis. Support product transfers, new product development, regulatory queries, cost improvement projects, and Drug Product plant support for Cleaning Validation. Operate within established HR policies and basic colleague relations guidelines. Write Standard Operating Procedures (SOPs), technical reports, project plans, etc. Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience Demonstrated experience in manufacturing quality or engineering experience in the biotech or pharmaceutical industry Fundamental understanding of laboratory instrumentation function and analytical method troubleshooting Excellent oral, written, and interpersonal communication skills Knowledge of Microsoft Office applications, specifically Word and Excel Ability to perform complex mathematical problems and data analysis Bonus Points If You Have (Preferred Requirements) A deep understanding of Microbiology testing and experience in defending laboratory practices during regulatory audits Proficiency in both viable and non-viable environmental monitoring within pharmaceutical manufacturing Solid grasp of aseptic techniques Strong problem-solving skills Ability to work independently and as part of a team Ability to manage multiple tasks simultaneously Work Location Assignment: On Premise The annual base salary for this position ranges from $58,500.00 to $97,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Quality Assurance and Control

#LI-Onsite This position will be located at Durham, NC and will not have the ability to be located remotely. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. A Bioprocess Engineer Downstream/Fill-Finish plays a critical role in the manufacturing operations at a plant or site. This position is pivotal in ensuring the smooth execution of production processes, organizing and running operations effectively, and continuously improving the manufacturing workflow. Role Responsibilities: Performs commercial and clinical manufacturing operations on-site, including purification (downstream), fill-finish (drug product, visual inspection, packaging), media/buffer preparation, and any additional supporting activities. Troubleshoot equipment, collaborate with other business units to aid in manufacturing-led deviations, standardize equipment, and clean production areas. Assists in identifying root causes, implementing solutions, and verifying the effectiveness of those solutions. Contributes to the creation and ongoing maintenance of all pertinent equipment policies and procedures. Acquires and applies aseptic techniques relevant to cell culture, recovery, purification, aseptic fill/finish (upstream and downstream). Supports product requirements to ensure that all products are manufactured according to plan. Learns cGMP and cGDP protocols, ensures accurate completion of cGMP documentation, maintains current training, and adheres to all quality standards. Maintains quality standards to meet cGMP requirements, CFRs, and internal company policies directly related to the manufacturing process. Collaborates with the Quality department to ensure a compliant manufacturing environment Shift: This role is a 2-2-3 day shift position. 5:45am-6:15pm Role Requirements: **The level of the role will be determined by the years of relevant experience. For Bioprocess Engineer I - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field or 2 years equivalent experience; For Bioprocess Engineer II - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 2 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; OR four (4) years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree; For Bioprocess Engineer III - Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 4 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; OR six (6) years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree Excellent oral and written communication skills Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between: for Bioprocess Engineer I, $22.84 and $42.46; for Bioprocess Engineer II/III, $32.12 and $59.62, per hour. 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. Company will not sponsor visas for this position. 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 $66,800.00 - $124,000.00 Skills Desired Assembly Language, Cooperation, Efficiency, Electronic Components, Flexibility, General Hse Knowledge , Good Documentation Practice, Installations (Computer Programs), Iso (International Organization For Standardization), Job Description, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Nuclear Medicine, Physics, Product Distribution, Production Line, Scheduler

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.