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Territory: Queens, NY - Psychiatry Target area for territory is Queens - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: all of Queens, NY as well the Great Neck portion of Nassau County, NY. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university., • 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience., • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually., • Self-starter, with a strong work ethic and outstanding communication skills., • Must be computer literate with proficiency in Microsoft Office software., • Must live within 40 miles of territory boundaries., • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Previous experience within a specialty product sales force., • Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder., • Documented successful sales performance., • Ownership and accountability for the development and execution of fully integrated account plans., • Strong analytical background, and experience using sales data reporting tools to identify trends., • Experience in product launches., • Previous experience working with alliance partners (i.e., co-promotions)., • Strong leadership through participation in committees, job rotations, panels and related activities. TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is specifically for those potential hires who will work or reside in the state of New York, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $125,000 - $147,000 and eligibility for a sales incentive target of $40,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Territory: Manhattan South, NY - Neurology Target area for territory is Manhattan - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: 60th street and South. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. It’s a very exciting time to join our team as we lead the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager, you lead the promotion of our infusion product, driving demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local market and partnering to deploy approved services necessary to meet the needs of each account/customer. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory effectiveness in competitive markets. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Engage with multi-disciplinary customers using a total office call approach to communicate value proposition of a new delivery method. Customer Development - Entrepreneurial mindset to gain access, build and maintain productive internal and external relationships through effective communication and collaboration based on customer needs and organizational goals. Payer Access - Ability to grasp sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and communicates impact on product portfolio to key internal and external partners and effectively addresses payer access issues (Medicare, Medicaid, Commercial) using Lundbeck resources. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Demonstrates a clear and detailed understanding of the disease state and its impact on customers and patients including the full range of treatment options available. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA, and PDMA guidelines. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university., • 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience., • Ownership and accountability for the development and execution of a fully integrated account plans., • Self-starter, with a strong work ethic and outstanding communication skills., • Proven track record of consistent sales performance., • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually., • Must be computer literate with proficiency in Microsoft Office Software., • Must live within 40 miles of territory boundaries., • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Previous experience within a specialty product sales force., • Infusion/rare disease sales experience in both the Outpatient Infusion setting and Specialty Pharmacy channel with a strong understanding of pricing and reimbursement., • Neurology experience specific to migraine., • Experience in both the medical or specialty pharmacy benefit market., • Experience working with high influence customers in physician clinics, integrated health systems, infusion centers and alternative sites of care., • Product launch or expansion experience, particularly in a new therapeutic class., • Strong analytical background, and experience using sales data reporting tools to identify trends., • Strong leadership through participation in committees, job rotations, panels and related activities. TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to a regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $155,000 - $172,000 and eligibility for a sales incentive target of $41,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our _. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Job Description | Quality Manager, Partners Title | Quality Manager, Partners Location | Hybrid (Totowa, NJ) Department | Quality/Regulatory/EH&S Reports To | Director, Quality Management, Partners & Training Compensation: $90-100k Overview SOFIE is committed to all aspects of Quality and Compliance in the production of the Radiopharmaceutical products they manufacture. This role supports the Director, Quality Assurance, Partners & Training, and provides Quality leadership to the Radiopharmaceutical Contract Manufacturing (RCM) division throughout the SOFIE network. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products. This person will play an active and integral part of the Quality team supporting compliance, improvement, and implementation with all RCM products at all SOFIE facilities. Essential Duties and Responsibilities Provide quality assurance support to the Radiopharmaceutical Contract Manufacturing (RCM) group within the SOFIE Network. This includes making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products. Be a quality liaison, develop solid relationships, and establish open communication with SOFIE partners and sponsors. Assist in the roll-out of new products at SOFIE network sites. Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Part 211 and 212 requirements, and continuing to establish an effective and efficient quality management system at one SOFIE facility, at minimum, and companywide. Provide Quality Leadership to develop, maintain, and continually improve the Quality Management System (QMS). Assist Director, RCM, Directors, Quality Management, Directors, QA and Regional Managers, QA with quality initiatives, decisions, and training, etc. Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA when necessary. Closely track and follow-up on these activities for timely closure. Ensure that scientifically sound investigations are conducted, and root causes are identified. Initiate and implement CAPA plans. Evaluate effectiveness of the CAPA plans through reporting and trending. Author and review cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents. Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions. Assist with the ongoing training program and present training presentations on applicable job-related procedures and topics. Identify non-compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site and corporate level and resolve quality related issues. Initiate action plans to prevent cGMP non-compliance and product quality problems proactively. Ensure continuous and sustained improvements. Liaise with corporate QA for audits, customer audits, partner audits, and regulatory agency audits. Perform readiness assessment and take corrective actions as needed prior to the audits. Summarize and report auditing progresses daily during each audit. Prepare complete responses to the audit outcomes on time. Ensure corrective actions being implemented according to the committed timelines. Review partner customer/patient complaints to determine the possible root causes. Work with the partners and customers to ensure their concerns are addressed, quality standards are met, and issues are resolved promptly and effectively. Maintain knowledge of current regulations and quality policies. Attend quality related meetings and conference calls. Interface with corporate QA on quality related issues. Provide quality status updates as required by corporate QA. Be a Subject Matter Expert resource for the entire network for the key area: Radiopharmaceutical Contract Manufacturing (RCM). \ Author or review certain sections of regulatory submissions, including responses to regulatory inquiries as needed. Perform other tasks as required. Qualifications Bachelor of Science Degree (B.Sc.) in an appropriate scientific subject, e.g., Chemistry, Microbiology, Quality and Regulatory Affairs, Regulatory Science, etc. preferred but will entertain applicants with relevant education and work experience. 2+ years of work experience in Quality Assurance or Regulatory Affairs in a cGMP pharmaceutical and/or biological manufacturing regulated environment preferred. 1+ years’ supervisory experience within a Quality Assurance or Quality Control function preferred. Experience with FDA regulatory submissions (establishment registration, safety reports, annual reports, amendments, etc.) preferred. Familiarity with radiopharmaceutical manufacturing processes and related QC release testing preferred. Working knowledge of US and ICH cGMP regulations and guidelines, risk management standards, quality attributes, and Quality Assurance best practices in the pharmaceutical industry required. Experience leading internal audits preferred. Knowledge of current FDA enforcement issues preferred. Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision required. Ability to effectively communicate (written and verbal) with site personnel, corporate QA, customers, and regulatory agencies required. Ability to prepare and present written and verbal reports to upper management required. Ability to project manage and have excellent organization and prioritization skills. Travel: up to 50% domestically.

Position Title: Associate Expert Microbiology Work Location: East Hanover, NJ 07936 Assignment Duration: 12 Months Work Schedule: Work in shifts covering daytime hours from 12 PM to 8 PM and work one or both weekend days at least once per month. Shifts will be fixed based on business needs. Work Arrangement: Onsite Position Summary: Under general direction, perform microbiology/EM testing and other activities in functions supporting the Quality Control department. Key Responsibilities: • Perform micro/EM testing in support of clinical release strategies. • Perform all testing and activities compliantly following appropriate SOPs and procedures. • Maintain controls and reference standards to support testing. • Executes and follows SOPs, WPs, and quality policies. • Peer review and archive analytical data in lab documentation systems. • Support monthly/quarterly laboratory cleaning. • Appropriate use of laboratory logbooks and monthly laboratory cleaning. • Manage reagent/consumable inventory and equipment cleaning for assigned areas of responsibilities. • Ensures cleanliness of laboratory working areas. • Support and author OOS/OOE/OOT and deviation investigations. • Participate in CAPA implementation in a timely manner. • Follows GxP quality policies and procedures. • Ensures all assigned training is completed within required time frame. • Support 5S and Lean projects. • Identify process improvements. • Knowledge of LabWare, LIMS and/or other QC data systems. • Knowledge of appropriate GMP/GLP quality systems (e.g., ESOPs, Trackwise, 1QEM, BMRAM, etc.). • Support execution method qualification/optimization of methods. • Interface with regulatory agencies during audits as required. • In addition to these primary duties, provide coverage for all appropriate areas. • Contributes to assigned projects by following predefined tasks and executing as instructed. • Perform other job duties as assigned. • Collects and generates data for trend reporting. • Verify the accuracy of data generated. • Contributes to the gowning qualification program by taking samples and analyzes and generates data. Qualification & Experience: • BA/BS or MS or advanced degree in microbiology, biology, biochemistry, or other related science or equivalent work experience. • Fluent in English. • 1 - 3 years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry. • Knowledge of cGMP and an understanding of the concepts of GDP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.). • Thorough knowledge of microbiological and environmental monitoring, test methods. • Microbiology/Environmental Monitoring knowledge to facilitate investigations. • Knowledge of LIMS systems. • Ability to communicate clearly with a variety of individuals in various aspects of our organization operations. • Detail-oriented with expertise in problem solving and solid decision-making abilities. • Strong interpersonal skills which include a professional demeanor when interacting with our organization personnel. • Strong written and verbal communication skills are essential. Connecting media strategy with loyalty strategy Conduct business strategy reviews to assess progress of strategy achievement Spanning growth strategy and continuous development Developing business and operational strategy around technology Leverage strategy and analytics partners Ensure ongoing alignment with strategy Develop the content strategy including website content Providing content, strategy and design recommendations Providing analytical and strategic support to the pricing strategy lead Provide analytical support to the strategy development process Develop new and ongoing efforts for business strategy Spearheading and leading innovative sourcing strategy projects Identifying the correct strategy for tool Guiding the development and launch of digital marketing strategy across channels Conduct projects to drive Level 3's market evolution, product strategy, and/or overall business strategy Translate market opportunities into concrete product strategy and tactical roadmaps Develop a proactive workforce strategy and plan Reviewing the process and strategy of investment portfolio implementation Organize strategy material and transaction documentation Implement strategy for innovative solutions and superior services

Job Description: QC Chemist II, Radiopharmaceutical Contract Manufacturing, NJ5 Title QC Chemist II Location NJ5-Totowa, New Jersey Department Radiopharmaceutical Contract Manufacturing Training Curriculum ID TCU.004 Overview: The QC Chemist II will perform analysis of diagnostic and therapeutic radiopharmaceuticals for SOFIE within the Radiopharmaceutical Contract Manufacturing Division. Following SOFIE's QA program and cGMP guidelines, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and EudraLex Volume 4). Essential Duties and Responsibilities • Conduct required Quality Control analytical tests for regular production of radiopharmaceuticals for preclinical, clinical, or commercial use according to cGMP standards. • Prepare standards, samples, and mobile phase solutions for analytical methods. • Ability to perform precise production visual inspection or laboratory appearance testing of finished product requiring 20/20 vision and accurate color differentiation (with or without reasonable accommodation) to assess product quality by evaluating color, clarity and absence of visible particulates for the drug product solution and evaluating attributes of the container closure system (e.g., cracks or chips in glass vials, creases in crimps, presence of stoppers, color of flip tops, etc.) in compliance with FDA, EudraLex and Rest of World guidance. • Initiate deviation and OOS reports, lead root cause investigations • Assist in the development, implementation, and validation of Quality Control analytical methods • Follow protocols for the analysis of clinical-grade radiopharmaceuticals, validate these methodologies against quality requirements, and implement them for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. • Validate existing analytical methods on existing or new equipment. Follow method transfer protocols for clinical and commercial-grade radiopharmaceuticals. • Write clear Standard Operating Protocols (SOPs) for QC protocols. • Review existing SOPs and suggest logical modifications based on either scientific rationales and/or regulatory requirements. • Install, qualify, and maintain laboratory equipment on site. • Collaborate with production radiochemists as required to ensure successful protocol development and radiopharmaceutical production. • Perform release testing, according to SOPs, on other materials (e.g., raw materials for radiopharmaceutical production). • Conduct environmental monitoring of environment and facilities. • Maintain all qualification and validation requirements for entering ISO classified areas. • Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations. • Maintain accurate radiopharmaceutical test and validation results. • Liaise with our contract partners as needed (e.g., biotech and pharma). • Other duties as assigned. Qualifications • Bachelor's degree in Chemistry or natural science required with 2+ years of experience in analytical chemistry and instrumentation (qualification, troubleshooting and maintenance) required; a Master's degree preferred. • Experience in a GMP manufacturing environment is highly preferred. • Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.). • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. • Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification required. • Efficient in the use of MS Office Suite required.Ability to be detail-oriented, accountable, patient, organized, and work in a team environment with minimum supervision required. • Strong technical writing skills required. • Excellent organizational skills required. • 20/20 natural or corrected vision and normal color vision, only for performance of visual inspection or appearance testing. • Ability to work various shifts and weekends required.

SUMMARY We are seeking a dynamic Marketing Product Manager to oversee a portfolio of products and ensure strategic alignment with company objectives. Reporting to the Marketing Director, this role is responsible for product launches, market planning, brand messaging, and sales strategy development. The Product Manager will play a key role in developing marketing campaigns, collaborating with key opinion leaders (KOLs), managing advisory boards, and supporting the salesforce through training and analytical insights. This position requires close collaboration with internal and external stakeholders to drive product performance and market success. RESPONSIBILITIES • Develop and execute healthcare professional marketing strategies., • Lead new product planning and launch initiatives., • Conduct market analysis to support strategic decision-making and actionable recommendations., • Design and implement promotional and non-promotional marketing materials., • Act as the primary liaison for marketing agencies., • Plan and manage industry conferences and events., • Cultivate and maintain relationships with key opinion leaders (KOLs)., • Organize and execute speaker programs and advisory boards., • Oversee salesforce training to ensure effective product positioning., • Collaborate cross-functionally with sales, market access, medical affairs, regulatory, and commercial operations teams., • Conduct competitive intelligence gathering and customer insight analysis to refine marketing strategies. QUALIFICATIONS • Strong expertise in product marketing within pharma or medical devices., • Deep understanding of market dynamics, data analytics, and competitive intelligence., • Demonstrated success in strategic and operational marketing initiatives., • Excellent problem-solving skills and project management experience., • Ability to manage timelines, prioritize tasks, and meet deadlines., • Effective collaborator with outstanding interpersonal and stakeholder engagement skills., • Strong capabilities in developing presentations, data analysis, and storytelling., • Advanced negotiation and influencing skills., • Exceptional written and verbal communication abilities., • Entrepreneurial mindset with a proactive approach to challenges., • High proficiency in Excel and PowerPoint preferred., • Bachelor’s degree required (MBA or advanced degree preferred)., • 5+ years of marketing experience with at least 2 years in wound care, therapeutic skincare, medical devices, surgical products, or pharmaceuticals., • In-depth knowledge of FDA regulations and PhRMA guidelines., • Proven experience in product launches.

My client is a leading commercial-stage biopharmaceutical company focused on non-opioid pain management and regenerative health solutions, with a robust pipeline of small molecules, biologics, and gene therapies. Position: The Senior Director, Regulatory Clinical Strategy, will lead the development and execution of global regulatory strategies supporting multiple development programs across clinical and non-clinical. This individual will serve as a strategic regulatory leader, partnering closely with cross-functional teams and senior leadership to support global development objectives and interactions with health authorities. Responsibilities: • Lead global regulatory strategy development for multiple and complex development programs spanning early development through post-marketing activities., • Provide strategic regulatory guidance for INDs, CTAs, NDAs, BLAs, and interactions with global health authorities., • Develop regulatory submission strategies, briefing materials, and communications with health authorities., • Assess regulatory risks and provide strategic recommendations to advance the program., • Support regulatory planning across clinical and non-clinical development activities., • Guide cross-functional teams on regulatory pathways, development strategy, and submission planning., • Remain current on evolving regulatory guidance, competitive intelligence, and industry trends that may impact development strategy., • Partner closely with Clinical Development, Non-Clinical, CMC, Medical Affairs, Legal, and Commercial teams., • Lead regulatory discussions with internal stakeholders and external regulatory agencies., • Support project planning, prioritization, and execution to ensure key milestones are achieved., • Influence strategic decision-making through effective communication and regulatory leadership. Qualifications: • Bachelor’s degree in Life Sciences or related field required; advanced degree preferred., • 10+ years of progressive Regulatory Affairs, Clinical, and Non-Clinical experience within the pharmaceutical or biotechnology industry., • Strong experience supporting global regulatory strategy across clinical and non-clinical development., • Experience supporting regulatory submissions and interactions with FDA and other global health authorities., • Demonstrated expertise in regulatory pathways, drug development strategy, and regulatory risk assessment., • Strong understanding of non-clinical, clinical, and pharmaceutical development requirements., • Ability to lead cross-functional initiatives within a matrixed environment., • Excellent communication, presentation, and leadership skills., • Strong analytical, strategic thinking, and problem-solving capabilities., • Experience supporting complex development programs, including biologics, specialty pharmaceuticals, or innovative therapeutic platforms, is highly desirable.

Job Description Summary #LI-Hybrid The Content Compliance Manager role sits at the center of how trusted, compliant content comes to life-where strategy, execution, and partnership intersect. As a Content Compliance Manager, you'll own the end-to-end stewardship of commercial content, working closely with Brand, Medical, Legal, Regulatory, and agency partners to enable confident decisions, reduce risk, and bring predictability to the content lifecycle. If you're motivated by ownership, impact, and building disciplined, modern ways of working that truly matter, this is a role where your influence will be seen and felt. This position will be located in East Hanover, NJ and will not have the ability to be located remotely. Relocation may be possible and requires necessary approvals. Job Description Key Responsibilities: • Own endtoend MAP execution from intake through approval, distribution, maintenance, and withdrawal., • Lead MAP submissions across brands and functions, including Urgent PR, Market Access, Training, Communications, and Patient Services., • Validate submission readiness, metadata accuracy, and reviewer routing aligned to MAP governance and triage standards., • Anticipate and manage risks, delays, and dependencies through forecasting, communication, and crossfunctional collaboration., • Ensure inmarket compliance by managing asset expiration, withdrawal, and documentation in DAM and downstream systems., • Partner with Content Owners to ensure timely asset removal aligned to expiration, withdrawal, or label changes., • Contribute to MAP forecasting and capacity planning to improve demand visibility and reduce unplanned work., • Govern consistent use of MAP and DAM tools, troubleshooting issues and enabling standardized ways of working., • Serve as a trusted crossfunctional partner, clearly communicating status, risks, options, and recommendations. Essential Requirements: • Bachelor's degree required; major in Business, Marketing, Communications, or related discipline preferred, • 3+ years of experience in pharmaceutical advertising, marketing operations, content, or communications, • Working knowledge of FDA and pharmaceutical promotional regulations and compliance principles, • Familiarity with pharmaceutical review and approval processes (MAP or equivalent), • Strong project and workflow management skills, • Ability to use data, systems, and structured methodologies to manage work and inform decisions, • Proficiency with Microsoft 365 and content review / DAM systems (e.g., Aprimo or similar preferred, PowerPoint, and Excel), • Clear communicator with strong organizational skills and attention to detail Novartis Compensation Summary: The salary for this position is expected to range between $108,500 and $201,500 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 +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $108,500.00 - $201,500.00 Skills Desired Agility, Analytical Thinking, Brand Awareness, Business Analytics, Cross-Functional Collaboration, Digital Marketing, Marketing Strategy, Media Campaigns, Project Management, Project Planning, Sales, Stakeholder Engagement, Stakeholder Management, Strategic Marketing, Waterfall Model

Job Description Summary Location: East Hanover, United States Novartis will not sponsor visas for this position. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. This role is required to be in our East Hanover, NJ office 5x/week Role Purpose: This is a hands-on lead role responsible for the execution of maintenance, calibration and commissioning activities for equipment and instrumentation projects at site level. Performs a wide range of maintenance, calibration, repair, and requalification activities on cell processing/production systems, equipment, and laboratory instrumentation. Ensures efficient, timely GMP, HSE and regulatory compliant maintenance and calibration of systems and equipment to include troubleshooting instrument failures with the ability to diagnose and perform effective repair. Ensures good workmanship with minimum delay to support the safe, effective and compliant operation of the CGT East Hanover laboratory facility equipment. Job Description Major accountabilities: • Leads and performs metrology and maintenance shop-floor activities such as equipment and facility calibration, preventive maintenance, and repairs, • Execute work orders for maintenance & calibration as per method statement/ procedure and completes equipment work orders thoroughly and accurately document them in the Computerized Maintenance Management System., • Executes and leads maintenance / calibration work on laboratory systems and equipment and performs documented troubleshooting studies on equipment to outline opportunities for improvements., • Executes Biological safety cabinet and facility HEPA filter certification activities, as well as calibration and testing of production facility systems to include differential pressure controls and facility safety monitoring devices such as O2 & CO2 alarms., • Support and/or perform investigations / deviations from an engineering / maintenance perspective and help with data for timely closure of deviations and CAPAs., • Manages tools, spare parts etc. for maintenance I calibration, as required to include the goods receipt, incoming inspection, inventory control, and storage of spare parts to ensure adequate stock for quick repairs and improvements., • Adhere to all applicable procedures, cGMP, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)., • Plans and schedules third-party vendors for routine and non-routine maintenance and qualification and provides 3rd party service provider oversight as local process Subject Matter Expert (SME)., • Continuously develops personal and professional skills. Key performance indicators: Highest safety standard implemented during projects and operations No critical findings in HSE or regulatory/internal audits Completes PM's and Calibrations on time as scheduled GMP/HSE compliance Adherence to Site KPls Minimum Requirements: Execution of equipment and instrument calibrations, preventive maintenance and repairs in pharmaceutical or like regulatory industry. Operations management of technicians and maintenance personnel in GxP regulated environment. Education: University degree (BSc) or equivalent. Experience: 5+ years GMP equipment and instrument maintenance and calibration experience in a regulatory pharmaceutical facility, Cell and Gene Production facility & Laboratory systems facility experience preferred. Language: English Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $93,800 and $174,200 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. 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 +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $93,800.00 - $174,200.00 Skills Desired

Job Description Summary Are you ready to shape sterility assurance strategy with a strong U.S. regulatory focus while influencing manufacturing quality across the Novartis network? As Global Senior Director, Sterility Assurance, you will set sterility assurance and aseptic processing standards with primary accountability for aligning U.S. manufacturing operations to FDA expectations. Partnering closely with senior leaders across Quality, Manufacturing, Engineering, and Technical Operations, you will drive inspection readiness, strengthen aseptic capabilities, and guide complex, cross-platform initiatives. This role blends deep technical expertise with enterprise leadership-protecting product quality, safeguarding patient supply in the U.S., and enabling consistent sterility assurance excellence globally. #LI-Remote Other Locations: Morris Plains, New Jersey, United States Job Description Key Responsibilities • Lead sterility assurance strategy with primary focus on U.S. manufacturing and FDA regulatory expectations., • Drive U.S. inspection readiness and remediation programs, partnering with sites to prevent repeat observations., • Serve as Global Process Owner for Sterile Operations, governing and harmonizing aseptic processes across platforms and sites., • Provide proactive sterility assurance leadership during the design and qualification of new production facilities and microbiology laboratories, ensuring that layouts, processes, and controls meet all relevant regulatory, aseptic, and quality compliance requirements., • Serve as subject matter expert in microbiological topics, leading resolution of sterility and contamination escalations., • Lead complex, cross-functional and cross-site projects delivering U.S. sterility assurance priorities and global quality initiatives., • Monitor sterility assurance performance indicators and deliver clear, executive-level insights to enable timely, compliant decision-making., • Represent Novartis externally as a recognized sterility assurance expert, supporting U.S. industry engagement and global alignment. Essential Requirements • Bachelor's degree in pharmacy, chemistry, microbiology, or a related scientific discipline; advanced degree preferred., • Minimum of 10 years of experience in global, cross-disciplinary project management and leadership roles within the pharmaceutical industry, preferably in strategic Site or global QA Operations and/or Compliance roles. Pharmaceutical production experience is indispensable., • Extensive experience delivering sterility assurance leadership within U.S. pharmaceutical manufacturing and FDA-regulated environments., • Deep technical expertise in microbiology, aseptic processing, and sterile manufacturing operations., • Demonstrated success leading enterprise-level quality initiatives across multiple sites and manufacturing platforms., • Proven ability to influence senior stakeholders, lead cross-functional teams, and drive complex, high-impact programs., • Travel up to 25% The salary for this position is expected to range between $168,000 and $ 312,000 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. To learn more about the culture, rewards and benefits we offer our people click _. 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 +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $168,000.00 - $312,000.00 Skills Desired Business Partnering, Business Strategy, Collaboration, Communication Skills, Continuous Improvement mindset, Data Integrity, Decision Making, Digital saviness, Finance Acumen, Leadership, Smart Risk Taking, Stakeholder Management, Storytelling, Strategic Planning, Strategic Thinking

Job Description Summary #LI-Remote This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 30% travel. Looking to turn breakthrough science into transformative treatments? Join our team as a SSO Field Monitoring Area Head, where you will play a critical leadership role in advancing clinical trial execution across your geographic Area. In this highly visible role, you will drive field strategy, optimize site engagement, and lead high-performing teams to deliver trials with quality, speed, and impact-helping bring innovative medicines to patients worldwide. Job Description Key Responsibilities • Lead and Develop Field Teams: Provide leadership for CRAs, CRA Managers, and FSP partners, ensuring strong functional management, coaching, and performance excellence., • Drive Trial Execution Excellence: Ensure trials are delivered against enrollment targets, timelines, and budgets, using data-driven insights and KPIs to guide decision-making and performance optimization, • Strategic Field Planning & Execution: Design and implement field strategies that enhance site engagement, patient recruitment, and overall trial quality in alignment with global SSO objectives., • Optimize Resource Allocation: Collaborate with the CRA Managers and FSP Vendor Line Managers to strategically allocate field monitoring resources and ensure alignment with portfolio priorities., • Strengthen Monitoring Quality & Compliance: Ensure adherence to ICH/GCP, regulatory requirements, SOPs, and data standards while proactively addressing risks and compliance challenges., • Advance Monitoring Excellence: Oversight of team's Field Monitor Accompanied Visit Plan, assessing monitoring quality and driving continuous improvement through targeted development and issue resolution., • Collaborate Cross-Functionally: Partner with global and regional stakeholders to support end-to-end trial delivery and contribute to broader clinical operations initiatives., • Lead Change and Innovation: Champion innovation, digital enablement, and future-ready capabilities to evolve field monitoring strategies and trial delivery models. Essential Requirements • Bachelor's degree in a scientific or health-related discipline, • Fluent in written and spoken English, • 10+ years' experience in clinical study management, including progressive leadership responsibility, • 5+ years' experience managing direct reports, • Proven experience in Vendor and FSP management; leading internal and external clinical teams; Site monitoring and clinical quality compliance; Clinical trial budgeting and financial, • Deep understanding of clinical drug development, with strong expertise in monitoring and trial execution, • Demonstrated ability to lead teams, solve complex problems, and navigate compliance challenges with accountability, • Strong knowledge of global clinical standards (ICH/GCP), regulatory authorities (FDA, EMA), and applicable local regulations Desirable Requirements • Advanced degree (e.g., MSc, PhD, or equivalent) The salary for this position is expected to range between $176,400 and $327,600 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 +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $176,400.00 - $327,600.00 Skills Desired Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Resource Management (Organizational), Risk Management

Job Description Summary #LI-Hybrid Location: East Hanover, United States Relocation Support: This role is based in East Hanover, United States. Novartis is unable to offer relocation support: please only apply if accessible. Ready to lead at the forefront of patient safety and pharmacovigilance? As Head of US PS PV Case Management, you will shape how critical safety information is captured, processed, and delivered ensuring patients remain at the center of everything we do. This is a high-impact leadership role where you will drive end-to-end case management excellence, champion digital and artificial intelligence-enabled transformation, and build high-performing teams that deliver quality, compliance, and innovation at scale. You'll play a pivotal role in safeguarding patients while transforming the future of pharmacovigilance operations in a dynamic, globally connected environment. Job Description Key Responsibilities: Strategic & Operational Leadership Lead end-to-end case management operations, including case intake, triage, processing, followup, quality control, case corrections and submission ensuring timely, accurate, and compliant safety reporting. Serve as the primary operational escalation point for complex, sensitive, or highrisk case processing issues and caserelated risks and operational challenges. Ensure compliance with FDA regulations, ICH standards, and internal requirements. Vendor Oversight & Quality Assurance Oversee vendor performance, governance, and capacity models to optimize delivery and resource mix. Maintain robust workload forecasting and capacity models; optimize inhouse vs. vendor mix, responsible for resourcing. Drive quality, compliance, and performance through key performance indicators, audits, and inspection readiness initiatives. Digitalization, AI & Process Excellence Champion digital, automation, and artificial intelligence solutions to enhance efficiency and data quality Identify and drive continuous process improvement initiatives, applying Lean and datadriven methodologies to simplify, standardize, and harmonize case handling processes. People Leadership & Capability Development Build, coach, and develop high-performing teams, fostering a culture of continuous improvement and accountability. Foster a culture of quality, compliance, accountability, continuous improvement, inspection readiness and learning. Global Coordination & CrossFunctional Engagement Serve as a key partner across internal and external stakeholders on adverse event reporting and case management, proactively identifying and mitigating issues to ensure aligned, effective, and compliant processes. Coordinate with Global Countries and Regions for simplified/harmonized practices and case exchange and collaborate with Regulatory Affairs, Quality, Legal/Data Privacy, Risk Management, and Medical Safety to support submissions, inspections, signal detection, RMPs, REMS, labeling updates, and periodic reports. Essential Requirements: Bachelor's degree in a relevant life sciences or healthcare-related field. An advanced degree is preferred (Pharm. D., M.D., Ph.D.). 10+ years pharmacovigilance experience with 7+ years leading case management teams and vendors in mediumtolarge pharma/biotech, including regulatory submissions. Strong knowledge of FDA PV regulations and ICH E2A/E2D/E2B(R3); deep understanding of MedDRA coding and case medical evaluation. Handson strong expertise with safety databases (Argus, Veeva Vault Safety, or similar), E2B(R3) case exchange, Electronic Data Capture (EDC) systems, call center telephony systems, and quality systems. Experience with drug, biologics, medical devices and combination products. Experience with project management and process excellence methodologies (e.g., Lean, Six Sigma). Strong leadership capability, with a track record of developing high-performing teams and driving operational excellence. Demonstrated capability to influence, provide strategic direction, negotiate, and resolve complex regulatory and operational challenges. Demonstrated experience leading inspections, audits, and ensuring inspection readiness. Proven people leadership experience, including coaching and developing managers and teams. Excellent planning, communication, interpersonal, and organizational skills, with a demonstrated ability to think innovatively and strategically at an enterprise level. Ability to lead cross-functional teams and deliver complex transformation initiatives, including digital automation and artificial intelligence solutions. Experience with patient support program data flows and third-party oversight. Expertise in workflow design, resourcing, budgeting, and performance monitoring. The salary for this position is expected to range between $204,000 and $379,000 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. To learn more about the culture, rewards and benefits we offer our people_. 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?_ Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally. _ 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 & 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_or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 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 +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $204,400.00 - $379,600.00 Skills Desired Clinical Research, Clinical Trials, Regulatory Compliance, Safety Science, Team Management

Job Description Summary Location: #LI-Hybrid This role sits at the intersection of AI/ML, real-world data, digital health, and commercial pharma strategy within the Strategy, Platforms & Transformation Personalized & Precision Medicine (PPM) team. The Director will architect, develop, deploy, and scale patient identification models, HCP prioritization algorithms, and site-of-care analytics across Novartis's US portfolio. This is a multidisciplinary role requiring deep technical expertise in machine learning, hands-on implementation experience in healthcare/clinical settings, and the strategic acumen to manage external partnerships with health systems, AI/CDS vendors, real-world data aggregators, and digital health developers. The successful candidate thrives in ambiguity, operates with a high degree of independence, and brings a builder mindset to an evolving precision medicine function. This position will be located at East Hanover, NJ site and will not have the ability to be located remotely. This position will require 10% travel as defined by the business (domestic and/ or international) Job Description Key Responsibilities: • Lead end-to-end development and deployment of patient identification, HCP targeting AI/ML, ensuring clinical validity and commercial impact across therapeutic areas., • Design clinical decision support (CDS) algorithms to improve patient outcomes via accelerating time to diagnosis, and treatment leveraging real-world data sources including claims, EHR, lab, genomic, patient generated health data, and registry data. Own and advance external partnership strategies with health systems, AI/CDS vendors to integrate these algorithms into clinical workflows leading to measurable impact on clinical outcomes., • Architect scalable model lifecycle frameworks - from ideation through development, validation, deployment, monitoring, optimization, and sunsetting - ensuring governance, fairness, and reproducibility., • Navigate regulatory and compliance requirements related to AI/ML in healthcare, including FDA CDS guidance frameworks, HIPAA, and anti-kickback safe harbor considerations., • Collaborate cross-functionally with Brand/Marketing, Medical Affairs, HEOR, Legal/Compliance, Field Teams, and Patient Support to translate clinical and commercial needs into actionable AI/ML solutions., • Drive integration of advanced AI technologies including large language models (LLMs), generative AI, deep learning, and foundation models into precision medicine workflows where applicable., • Develop go-to-market frameworks and field activation resources that enable model-adjacent materials for commercial teams to act on model outputs., • Champion a culture of experimentation, continuous improvement, and scientific rigor - contributing to peer-reviewed publications, conference presentations, and open-source model externalization where appropriate., • Operate with a high level of autonomy and self-direction, proactively identifying opportunities, managing ambiguity, and driving initiatives forward without close supervision., • Serve as a thought leader within Strategy, Platforms & Transformation and across the Novartis US organization on the convergence of AI, real-world data, and precision medicine in commercial pharma. Essential Requirements: • Master's degree required; PhD or doctoral degree preferred. Relevant fields: Data Science, Computer Science, Bioinformatics, Health Informatics, Computational Biology, Statistics, Epidemiology, or related quantitative/health sciences discipline. Clinical or health-focused education or research background is a plus., • Minimum 10+ years of experience in data science, AI/ML, or digital health, with at least 5 years in pharmaceutical, medical device, health-tech, or digital health settings., • Demonstrated hands-on expertise building and deploying machine learning models (classification, NLP, deep learning, recommendation systems) using Python, Spark, TensorFlow, PyTorch, or equivalent., • Experience designing and executing model validation frameworks - ensuring accuracy, reliability, clinical validity, and reproducibility of AI/ML algorithms prior to clinical or commercial deployment, • Proven experience with cloud-based ML infrastructure (AWS, Azure, GCP) for scalable model deployment., • Deep working knowledge of healthcare data: EHR (structured and unstructured), medical/pharmacy claims, lab results, genomic data, and patient registries., • Working knowledge of clinical terminologies and coding systems (e.g., ICD-10, SNOMED CT, LOINC, RxNorm, CPT) used in model feature engineering and clinical data interpretation, • Proven ability to communicate complex AI/ML concepts and strategies to senior executive leadership and non-technical audiences, translating technical outputs into business value narratives., • Experience implementing or partnering on AI/ML solutions in clinical or healthcare delivery settings, including clinical decision support integration into EHR workflows., • Track record managing external partnerships with health systems, AI/CDS vendors, EHR platforms, data aggregators, or digital health companies., • Working knowledge of regulatory and compliance landscape for AI in healthcare: FDA CDS frameworks, HIPAA, anti-kickback statutes., • Experience working in complex, matrixed organizational environments with demonstrated ability to influence without authority across commercial, medical, legal, and technical stakeholders., • Knowledge of large language models (LLMs) such as GPT, BERT, Cohere, and their practical applications in healthcare and commercial pharma. Desirable Requirements: • External thought leadership (publications, conference presentations, industry working groups) is a plus. Novartis Compensation Summary: The salary for this position is expected to range between $194,600.00 and $361,400.00 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 +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $194,600.00 - $361,400.00 Skills Desired Agile (Programming Methodology), Artificial Intelligence (AI), Business Value Creation, Change Management, Curious Mindset, Data Governance, Data Literacy, Data Quality, Data Science, Data Strategy, Data Visualization, Deep Learning, Learning Agility, Machine Learning (ML), Machine Learning Algorithms, Mentorship, Nlp (Neuro-Linguistic Programming) And Genai, Organization Awareness, Stakeholder Engagement, Statistical Analysis, Time Series Analysis, Vision, Visualization

Job DescriptionSUMAMRYThe Packer is responsible for accuracy of bag weights, sealing and labeling of bags, coding of bags, checking to be sure the correct bags are being packed, and ensuring volume of output. They are also responsible for keeping the work area neat and clean. Packers may be assigned other duties as needed by the Manager/Supervisor.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Operate the pack line in an efficient manner to meet operating targets for efficiency, downtime, and minimal rework, • Repair pallets of finished product as they occur (broken bags, missing labels etc.), • Operate Forklift, • Pull pallets of flour from packing line and place them accurately in designated storage areas with proper scanning using Scanwork, • Operate tote packer; fill totes with farina, whole wheat, flour, etc., • Understand and use Scanworx inventory system in regards to warehouse packing supplies and finished product movements, • Understand policies and procedures set forth by BSM, USDA & other applicable food production entitiesQUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • Must have operational knowledge of packing equipment, including a Packer, Check-Weigher, Stacker/Bundler, Palletizer, and Stretch Hooder, • Must be capable of trouble-shooting common issues and communicating problems to maintenance/management, • Must be Forklift Certified, • Must be able to communicate in English, both verbal and written, • Must be able to perform basic math functions, with or without the aid of a calculator, • Must be capable of learning computer entry, • Must be an independent worker with self-initiative to carry out job functions, • Must be willing to rotate shifts and cover absences if requiredPHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • Must be able to work in an environment, which has extremes in temperature, • Must be able to climb ladders, • Must have physical dexterity to perform basic repair functions, • Must be able to stand for extended periods of time, • Must be able to bend, stoop, kneel, crouch, twist and crawl frequently, • Must be able to frequently lift and/or move 50 pound bags, • Vision requirements are close vision, distance vision, color vision and depth perceptionWORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly exposed to moving mechanical parts, and fumes or airborne particles. The employee is exposed to vibrations. The employee is occasionally exposed to high precarious places. The employee will be exposed to extremes in temperature, both hot and cold. The work environment is noisy, at times in excess of 100 decibels.FOOD SAFETY / SECURITY AND QUALITY REQUIREMENTSThe Company is committed to producing and delivering defect free products that are in compliance with all applicable legal and regulatory requirements and are of the highest levels of food safety, quality and productivity. To ensure this, all employees are required to be trained on and adhere to the FDA Current Good Manufacturing Policies as set forth by the Company as they pertain to personnel practices, equipment and facilities. It is also vital that all employees be aware of their work environment and prevent any accidental or intentional adulteration of the products produced at the facility.FULL-TIME/PART-TIME: Full timeSALARY: $25.49AVAILABILITY: Open AvailabilityPOSITION: Packing OperatorNUMBER OF OPENINGS: 2LOCATION” Strike Force Staffing- Clifton, NJ

Placement Type: Temp to Perm Salary: $85,000-90,000 Salary Start Date: Jun 29, 2026 Aquent Studios at our Pharmaceutical client is a custom-built agency partnership that provides scalability with world class talent to Novartis' in-house Materials Approval Process team. This collaboration creates exciting opportunities to work with Aquent Studios at one of the most admired pharmaceutical companies in the world. Focus on planning to drive operational excellence in the Material Approval Process (MAP) executing on E2E critical tasks to compliantly advance the in and above brand commercial assets from submission to compliant withdrawal from the Digital Asset Management system (DAM) and the Market. Major Activities Lead MAP for Urgent PR, Market Access, Training, Communications, and NPS Submissions: Review assets for readiness, ensure the MAP metadata is accurate, and triage to appropriate reviewers in accordance with Tiered Review process, published guidance documents, and WPDs. Understand, articulate, and execute specific deliverables critical to MAP capacity and resource planning with agility to pivot based on business dynamics. Own projects by navigating obstacles, seeking stakeholder input, and presenting options with recommendations. Inventory Management: Collaborate with Content Owners (CO), and lead system workflows to ensure all commercial materials are proactively expired as required and ensure compliance by validating that assets are removed from Market no later than expiration/withdrawal from the DAM. Project Management: Collaborate cross-functionally to drive creation and maintenance of MAP Forecasts to ensure appropriate planning and progress of all brand deliverables for Launches, Label Updates, CORE triggers, Campaigns, Congresses, and Events. Ensure MAP workflows are followed to drive efficient review process while aligned with compliance standards. Active participant in weekly agency status and MAP meetings, to ensure all projects are on track. Process and System: Troubleshoot system challenges for internal and external partners. As technologies evolve, provide solutions, guidance, and best practices to all users. Identify optimization opportunities based on observations, system user experience, and agency technology advancements. Ideal Background Minimum requirements: Education (minimum/desirable): • 4-Year degree. Focus in Business, Marketing, or Communications preferred. Experience/Professional Requirements: • 2+ years' experience in pharmaceutical advertising, marketing, communications, digital/content strategy, • Functional experience in pharmaceutical marketing operations, preferred, • Working knowledge of FDA and Pharmaceutical regulatory and compliance guidelines for advertising and promotion, • Understanding of pharmaceutical review and approval process preferred, • Project Management skills, • Proficiency in computer applications, including Microsoft 365, Adobe Acrobat, and Content Review software (Aprimo Marketing Studio a plus) with excellent meeting hygiene, data organization, and clear accountability #LI-JH5

AML/BSA program evaluation) - Provide structured feedback on AI accuracy in areas such as regulatory standards (FINRA, OCC, FFIEC, FDA, SEC, GDPR, HIPAA), risk frameworks (COSO, ISO 31000), and industry-specific compliance terminology - Collaborate asynchronously with research teams to refine evalua

Have strong experience with one or more of: AML/BSA, OFAC sanctions screening, FCPA/anti-corruption, healthcare regulatory (HIPAA, Stark Law, Anti-Kickback Statute, Medicare/Medicaid), FDA submissions, privacy (GDPR/CCPA/PIA/DPIA), environmental permitting, export control, or administrative hearings

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Responsible for internal, domestic and international compliance activities. Prepare comprehensive regulatory strategies for new devices and post market changes. Clearly communicates strategies to RA management., project teams and business unit leadership. Preparing regulatory filings for new products, as well as post market changes. As necessary, reviews complex regulatory issues with RA management. Job Responsibilities and Essential Duties • Professionally negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management., • Prepares Regulatory strategy/plans and requirements., • Prepares documentation and coordinates activities related to EuMDR, PMA amendments, PMA supplements, PMA annual reports, Q-subs, 510(k)s and IEDs., • Prepares worldwide regulatory submissions/registrations including collecting information and documentation for submissions to regulatory agencies., • Update/maintain basic information provided to various departments regarding submission requirements and standards to facilitate efficient processing by agency., • Participates in the review and disposition of labeling, promotional material and product modifications., • Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations, the MDD, EuMDR, CMDR, and other international regulations., • Complies and logs submissions that need review to ensure they meet regulatory submission standard policies, and operating procedure requirement and tracks timeline through review process to ensure timely submission., • Participates in cross-functional departmental team projects and products development activities/meetings., • Support with Field Correction and Recall activities, • Responsible for FDA/ISO/MDD/MDR/CMDR compliance documentation, • Participates in and support internal and third-party audits, • Assists in special projects as needed, • Contributes to team effort by accomplishing related duties as requested Minimum Requirements • Bachelor's Degree and a minimum four years of directly related experience in Regulatory Affairs in a medical device environment, or a minimum ten years of directly related experience in Regulatory Affairs in a medical device environment., • Experience wit the preparation, submissions and approval for medical devices is required including 410(k) or PMA., • Understands the requirements of FDA 21CFR Part 820, EU MDD, EU MDR, MDSAP, CMDR and ISO 13485., • Proficient computer skills, including MS office applications (Word/Excel) are required. Required Knowledge, Skills and Abilities • Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment., • Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills., • Demonstrated proficiency in regulatory planning and strategy submissions along with strong negotiation skills., • Ability to represent Regulatory Affairs to other departments., • Working knowledge of principle compliance focused ISO Standards (13485, 14971, 62366) and the use of ISO Standards as special controls. Supervision/Management Of Others: None Internal and External Contacts/Relationships • Maintains effective relationships with internal customers., • Build relationships and participates as a member of a cross-functional product development team., • Professionally negotiate/communicate directly with regulatory entities (e.g., governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. Environmental/Safety/Physical Work Conditions • Ensures environmental consciousness and safe practices are exhibited in decisions, • Use of computer and telephone equipment and other related office accessories/devices to complete assignments, • May work extended hours during peak business cycles About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview • This position provides technical leadership in the development, optimization and sustaining of manufacturing processes for medical devices in accordance with Getinge's Quality system and regulatory requirements (ISO 13485 and FDA 21 CRF Part 820)., • This individual is a key resource during Design for Manufacturability (DFM), collaborating closely with cross-functional teams to ensure current and new products are scalable, robust, cost-effective, and production-ready., • Leadership cross-functional initiatives, drive strategic improvements, oversee process validations, implement continuous improvement strategies, and support commercial-scale operations. Job Responsibilities and Essential Duties Design for Manufacturability (DFM), Design For Six Sigma (DFSS) & Product Development • Establish and standardize DFM and DFSS best practices, templates, and guidelines across engineering teams., • Lead early design phases to influence product architecture, material selection to ensure scalability, robust manufacturability, and cost-optimized solutions, • Drive Design for Six Sigma methodologies (DMADV/IDOV) during product development to ensure critical-to-quality (CTQ) requirements are met., • Integrate Design for Cost (DFC) principles into product and process development, ensuring costeffective material choices, processes, and tooling strategies., • Provide technical leadership in DFM reviews, tolerance analyses, design risk assessments, and capability studies., • Translate product requirements into manufacturing specifications, tooling designs, and process control strategies., • Support prototype builds and pilot manufacturing, documenting design/assembly issues and implementing corrective actions. Process Development & Validation • Develop and optimize manufacturing processes including molding, machining, laser processing, automated assembly, packaging, and/or sterilization workflows., • Lead large scale process validations (IQ/OQ/PQ), process characterization efforts, and statistical justification aligned with regulatory expectations., • Establish longterm process capability targets, implement control strategies, and ensure audit readiness., • Apply DFSS tools such as DOE, and tolerance stackups to guide process optimization. Manufacturing Support & Continuous Improvement • Serve as the technical escalation point for complex manufacturing challenges, driving root-cause investigations and high-impact CAPAs to closure., • Lead yield improvement initiatives, cost-reduction programs, and process harmonization across multiple product families., • Partner with Operations and Quality to enhance throughput, reduce scrap, optimize workflow, and expand manufacturing capacity., • Lead Lean/Six Sigma initiatives targeting waste reduction, workflow optimization, and standardization. Cross-Functional Collaboration • Act as the primary technical interface in a cross-functional team as a Core Team member, • Lead technical discussions with suppliers on component manufacturability, material selection, tooling design, and qualification of new technologies., • Apply Design for Cost and Lean principles to reduce waste, optimize workflow, and lower overall cost of goods., • Partner with Operations and Quality to enhance throughput, reduce scrap, and expand manufacturing capacity. Minimum Requirements • Master's (Preferred) or Bachelor's degree in Industrial, Mechanical, Manufacturing Systems, Biomedical Engineering, Biomedical Engineering, or related technical field with 6+ years of experience., • Certification in Six Sigma Black Belt (Preferred) or Green Belt Required Knowledge, Skills and Abilities • Demonstrated expertise in Design for Manufacturability (DFM) principles and tools., • Hands-on experience with process validation (IQ/OQ/PQ), risk management (FMEA), and statistical analysis., • Proficiency with CAD tools (SolidWorks, Creo), GD&T, and tolerancing methods., • Strong problem-solving skills with familiarity in DOE, SPC, and root-cause methodologies., • Experience with automated assembly systems, robotics, or high-volume manufacturing., • Knowledge of polymer processing, metal fabrication, laser welding or additive manufacturing., • Experience in Audit Readiness and Internal/External Audits with the various Regulatory bodies (FDA, TGA, PMDA, etc.), • Ability to communicate within the discipline and with others who are not technically trained, • Ability to prioritize tasks in a fast-paced environment. The salary range for this position is between $120k - $135k per year depending on experience and location. #LI-MV1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Senior Compliance Engineer is responsible for ensuring that Cardiac Assist electromechanical medical devices meet all applicable global regulatory, quality, and safety requirements throughout their lifecycle. This role provides technical leadership across product safety, electrical safety, design control compliance, labeling and safety markings, environmental/material compliance (RoHS/REACH), and global marketaccess requirements, ensuring products remain aligned with stateoftheart expectations. The Senior Compliance Engineer serves as a critical interface between Engineering, Quality, Regulatory Affairs, Supplier Quality, and Manufacturing, ensuring that product designs, sustaining engineering activities, and change initiatives remain auditdefensible, traceable, riskbased, and compliant across international markets. Job Responsibilities and Essential Duties • Lead compliance evaluations for new designs, design changes, sustaining engineering, and remediation activities., • Interpret and apply global standards including IEC 606011 series (electrical safety), IEC 6060118, IEC 60601112, EN 1789, GB 9706 series, UL/CSA, and other applicable international product and safety requirements., • Support development and verification of labeling, product safety markings, regional electrical requirements, and marketspecific compliance deliverables (EU MDR, FDA, China, LATAM)., • Conduct compliance impact assessments during design reviews, ensuring requirements, risks, verifications, and mitigations are aligned with global expectations., • Ensure compliance documentation is complete, consistent, and auditready (DHF/Technical File), including traceability, risk management, verification and validation records, and certification artifacts., • Provide guidance on environmental and material compliance (RoHS, REACH, China RoHS) and ensure supplier documentation meets regulatory expectations., • Support CAPA investigations that require compliance input, including evidence review, standards interpretation, and riskbased justification., • Maintain awareness of emerging regulatory changes and stateoftheart updates; drive integration into engineering processes and technical documentation, and identifying required retesting with recognized third party test labs., • Support global regulatory submissions (510(k), EU MDR Technical Documentation, and regional registrations) with compliance rationale and evidence., • Collaborate with Supplier Quality and Procurement to evaluate compliance of purchased components, including safetycritical and regulated materials., • Support internal and external audits, inspections, and technical inquiries, ensuring timely, accurate, and welldocumented responses., • Guide engineering teams in applying compliance principles early in product development to reduce downstream redesign and accelerate global approvals. Minimum Requirements • BS in Systems, Biomedical, Electrical, or Software Engineering with 5+ years of related experience, • MS or PhD in Systems, Biomedical, Electrical, or Software Engineering with 3-4+ years of related experience, • Demonstrated experience working with relevant medical device regulatory and productsafety standards (e.g., IEC 606011, ISO 14971, IEC/ISO environmental testing, labeling requirements, or international certification processes). Required Knowledge, Skills, and Abilities • Proven experience supporting compliance evaluation, maintenance, or certification of electromechanical medical devices., • Strong understanding of medical electrical safety (IEC 606011 series), product safety principles, risk management (ISO 14971), and global marketaccess requirements., • Working knowledge of FDA QMSR, ISO 13485, ISO 14971, EU MDR and related regulatory frameworks., • Ability to interpret technical compliance reports (e.g., electrical safety, environmental compliance, risk controls, labeling/marking evaluations), identify gaps, and guide engineering teams toward compliant solutions., • Strong analytical and problemsolving skills with ability to apply riskbased decision making., • Excellent verbal and written communication skills, including preparation of auditready technical documentation., • Ability to work crossfunctionally and communicate effectively with engineers, quality, regulatory, suppliers, and certification bodies., • Strong organizational skills with the ability to manage multiple priorities in a regulated environment., • Ability to participate in and lead technical meetings, design reviews, and compliancefocused assessments. Salary range: $120k - 135k #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Principal Product Manager & Team Lead is a senior strategic leader within the Cardiovascular Surgery (CVS) business, responsible for high-level ownership of a broad and complex product portfolio. This role drives portfolio strategy, lifecycle performance, upstream marketing, voice of the customer interface, and cross-functional execution while ensuring alignment with business growth objectives and financial commitments. In addition to portfolio leadership, this position serves as the Team Lead for the Wayne Cardiovascular Surgery Product Management team and may directly manage Product Managers. The role provides mentorship, establishes operational rigor, and ensures excellence in product management execution within a highly regulated medical device environment. The individual must possess extensive medical device product management experience in highly regulated environments and demonstrated clinical marketing expertise. Job Responsibilities and Essential Duties • Hold high-level responsibility for a broad and strategically significant Cardiovascular Surgery product portfolio., • May directly manage a defined portfolio and/or individual Product Managers., • Drive full product lifecycle management from concept through commercialization and post-launch optimization., • Ensure portfolio alignment with strategic priorities and financial targets., • Optimize portfolio mix based on growth, profitability, clinical relevance, and competitive dynamics., • Serve as Leader for the Wayne Cardiovascular Surgery Product Management and PA Marketing/Training team., • Provide mentorship and coaching locally and across ACT product management teams., • Establish performance expectations and foster accountability., • May directly supervise and manage Product Managers., • Contribute to business strategy development and translate strategic objectives into actionable portfolio roadmaps., • Lead multi-year product planning aligned with innovation pipelines and commercial growth objectives., • Identify new market opportunities and unmet clinical needs., • Support Annual Operating Plan (AOP) and Long-Range Plan (LRP) development., • Provide oversight of major product management initiatives., • Lead governance for complex, high-impact programs including launches and lifecycle initiatives., • Manage risks, dependencies, and milestone adherence., • Develop and support robust business cases for capital investments (CAPEX)., • Track product and portfolio performance relative to approved CAPEX requests post-launch., • Monitor revenue, margin, ROI, and forecast performance., • Implement corrective strategies when performance deviates from projections., • Direct customer interface to understand customer experience and key requirements; resulting in strong messaging and customer strategy., • Lead market analytics initiatives across the portfolio., • Establish frameworks for competitive intelligence, pricing strategy, and market share analysis., • Leverage clinical marketing expertise to translate clinical evidence into compelling value propositions that drive the product management funnel activities., • Drive data-informed decision-making that enhances customer centricity., • Own creation and updates of all local product management procedures and support ACT standards., • Establish best practices for lifecycle management and launch excellence., • Ensure compliance with global regulatory and quality system requirements. Minimum Requirements • Bachelor's degree in Business, Engineering, Life Sciences, or related field required., • MBA or advanced degree preferred. Required Knowledge, Skills and Abilities • 10+ years of progressive medical device product management experience, • Extensive experience in highly regulated environments (FDA, EU MDR, global regulatory frameworks)., • Clinical marketing experience required, including surgeon engagement and clinical data translation., • Demonstrated success managing complex medical device portfolios., • Prior people leadership or team lead experience preferred. #LI-JF1 #LI-Hybrid Targeted salary range: $210,000- $245,000, depending upon experience and location +30% bonus target About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview As a Sr. Quality Engineer specializing in Quality Operations, you will be responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices. Job Responsibilities and Essential Duties • Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards., • Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement., • Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements., • Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability., • Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans., • Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations., • Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA)., • Track and monitor CAPA effectiveness to ensure issues are resolved and prevented., • Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee., • Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues., • Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy., • Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively., • Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity., • Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction., • Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards., • Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes., • Provide mentorship and guidance to new Engineers/Interns within the organization. Minimum Requirements • Bachelor's degree in engineering, Science, or other related field is required. ASQ, CQE, Six Sigma Green Belt or other applicable certifications are a plus., • A minimum of 7 years' experience in Quality or Engineering., • Experience in a medical device or pharmaceutical industry., • Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred., • Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred. Required Knowledge, Skills, and Abilities • Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans., • Project management and leadership experience is desirable., • Strong analytical and problem-solving skills., • Excellent communication and interpersonal skills., • Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R)., • Ability to work effectively in a cross-functional team environment., • Ability to review and understand technical standards and their requirements for products., • Proficiency in Microsoft Office Products such as Word, Excel, or equivalent software applications. Salary range: $115k - $120k plus 10% annual bonus #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Principal Systems Engineer is a senior technical leader responsible for defining, architecting, and integrating complex medical device systems across hardware, software, firmware, and clinical use environments. This role provides technical direction across product development lifecycle phases, ensuring system-level requirements, risk management, verification, and validation activities meet regulatory and business objectives. The position partners closely with cross-functional teams to deliver safe, compliant, and high-quality products to market. The role also ensures alignment with usability engineering, reliability, and post-market surveillance expectations for medical devices as outlined by FDA and global regulatory bodies. As a subject-matter expert, the Principal Systems Engineer mentors engineers and influences technical strategy across programs. This role also assumes systemlevel product ownership for safety, performance, and compliance across the full lifecycle, including development, installed base, and postmarket use. The Principal Systems Engineer collaborates with Product Care, PostMarket Surveillance, and Field Action teams to ensure product issues are identified, assessed, and mitigated in alignment with regulatory expectations. Job Responsibilities and Essential Duties: System Architecture & Requirements Leadership (40%) Define and maintain system architectures, system-level requirements, and interface definitions across hardware, software, mechanical, usability, and clinical domains. Ensure traceability throughout the product lifecycle. Collaborate with Product Care teams to ensure system requirements remain aligned with field performance, complaint trends, and postmarket insights. Technical Integration & Risk Management (25%) Lead system integration activities, hazard analyses, and risk management in accordance with ISO 14971. Identify and resolve cross-domain technical issues and ensure alignment with regulatory expectations. Review and contribute to NCRs (NonConformance Reports), assessing systemlevel risk, technical impact, and the need for design or manufacturing actions. Provide system-level approval or input for NCRs requiring deviation or production impact decisions. Participate in investigations of product safety, performance, and compliance issues and support risk evaluations triggered by complaints, NCRs, or production trends. Verification, Validation & Regulatory Support (20%) Provide systems engineering leadership for verification and validation strategies, ensuring compliance with FDA, IEC, ISO, and global regulatory standards. Support design reviews, submissions, and audits. Support HF validation per IEC 623661 and FDA human factors guidance. Contribute to regulatory submissions (e.g., 510(k), PMA, technical files) by providing system-level documentation, architecture descriptions, risk traces, and verification summaries. Support Field Actions, Quality Holds, and CAPA processes when system-level issues require technical coordination. Coordinate crossfunctional data collection for complaints, investigations, PSUR inputs, and system-level risk analyses to ensure accurate evaluation and timely resolution of product issues. Technical Mentorship & Strategic Influence (15%) Mentor engineers, establish systems engineering best practices, and contribute to longterm technical roadmaps and platform strategies. Serve as a subject matter expert for Design Controls and systems engineering processes, guiding teams during audits and regulatory inspections. Act as a technical SME during audits related to postmarket surveillance, field actions, risk management, engineering change processes, NCRs, and product safety evaluations. Minimum Requirements • Bachelor's degree in engineering (Systems, Biomedical, Electrical, Mechanical, Software, or related field) required with 10+ years of related experience., • MS or PhD in Systems, Mechanical, Biomedical, Electrical, or Software Engineering with 8+ years of related experience, • 5+ years in medical devices or similarly regulated industries preferred., • Experience supporting postmarket investigations (complaints, NCRs, product concerns) and coordinating cross-functional data collection for safety and performance evaluations is strongly preferred. Certifications (Preferred) INCOSE Systems Engineering Certification (ASEP/CSEP) Project Management or Risk Management certifications a plus Training or certification in PostMarket Surveillance, CAPA, NCR processes, or Regulatory Compliance is desirable. Required Knowledge, Skills, and Abilities Deep knowledge of systems engineering methodologies, requirements management, and system architecture development Strong understanding of FDA Design Controls, ISO 13485, IEC 62304, IEC 60601, ISO 14971, and usability engineering principles Proven ability to lead cross-functional technical teams and resolve complex integration challenges Experience with requirements management and modeling tools (e.g., SOLIDWORKS, Polarion, Jama, SysML tools) Excellent analytical, documentation, and communication skills Ability to influence without direct authority and operate effectively in a matrixed organization Strong judgment, accountability, and attention to detail in safety-critical environments Knowledge of postmarket surveillance processes, field action coordination, complaint trend analysis, and systemlevel safety assessments. Familiarity with ECO/Change Control processes and ability to provide system-level technical assessments for design updates and NCR/Deviation evaluations. Salary Range:$150k - $180k #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Principal Quality Auditor plays a vital role in leading and participating in internal and external audits within the medical device industry. This position ensures compliance with medical device regulations including, but not limited to ISO 13485, ISO 14971, 21 CFR Part 820. The auditor brings expert knowledge from prior roles leading audits and driving compliance improvements, risk management, and regulatory adherence. The position requires strong leadership in audit planning, execution, reporting, and follow-up, as well as mentoring audit teams and liaising with regulatory agencies. Job Responsibilities and Essential Duties • Lead and execute comprehensive audits of quality systems and processes to ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR, etc., • Participate in and lead FDA and Notified Body audits, including audit planning, execution, reporting, and corrective action follow-up., • Evaluate Quality Management Systems (QMS) for effectiveness, regulatory compliance, and risk management integration., • Assess and verify compliance with risk management standards (ISO 14971) and reporting requirements (21 CFR Part 803 Medical Device Reporting)., • Conduct audits on various QMS elements such as design controls, complaint handling, CAPA systems, supplier controls, and production processes., • Review and approve audit reports, findings, and CAPA plans to ensure timely and effective resolution of nonconformities., • Provide training and mentorship to internal audit teams to build auditor competency and ensure consistency., • Collaborate with cross-functional teams (Regulatory Affairs, QA, R&D, Manufacturing) to drive audit readiness and regulatory compliance., • Serve as a subject matter expert representing the company during regulatory inspections and notified body assessments., • Maintain up-to-date knowledge of regulatory changes and communicate their impact on quality systems and audit processes., • Facilitate internal audits and risk assessments to support continuous improvement and regulatory compliance readiness., • Support management review activities by providing audit findings and quality metrics relevant to compliance status. Minimum Requirements • Bachelor's degree in Engineering, Science, or equivalent; advanced degree preferred., • Minimum of 7 years of quality auditing experience in the medical device industry, including direct audit leadership at FDA or Notified Bodies preferred., • Deep expertise in ISO 13485, ISO 14971, and 21 CFR Part 820 regulations., • Certified Quality Auditor (CQA) or equivalent ISO 13485 Lead Auditor Certification preferred., • Proven experience in planning, conducting, and leading regulatory audits and inspections., • Strong knowledge of risk management principles and medical device regulatory reporting requirements., • Excellent ability to analyze complex quality systems and processes and identify compliance gaps., • Strong communication skills to effectively present audit results and influence corrective action implementation., • Proficiency with quality management software tools and Microsoft Office. Salary range: $155k - $165k #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Responsibilities: Inspect cylinders and perform safety checks; Fill cylinders by pressure and weight while ensuring compliance; Operate forklift and warehouse equipment; Maintain records to regulatory standards (DOT, FDA, OSHA); Label cylinders accurately.

Job DescriptionPosition Description: Dr. Praegers was founded in 1992 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management:, • Documentation control (master batch record, specification and method), • Batch record review and product disposition, • Investigations, complaints, deviations, CAPAs, APRs, • Production and Pharmaceutical Development support, • APRs, GMP training and SOP review, • Validation / qualification documentation review and approval, • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site, • Develop, maintain, and enhance training programs and systems, • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives., • Must be able to move about the facility, • Experience with FDA Audit, • Extensive knowledge of US and EU current Good Manufacturing Practices, • Experience with a CDMO would be preferable, • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals Company DescriptionWe are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..

Job DescriptionThis is a temporary 6-month contracted W2 position. The pay range for this position is $70-$85/hr (depending on prior experience) Job Functions: • Applies expertise as an emerging authority in the mechanical engineering discipline., • Conceives and develops solutions to difficult analytical and pneumatic/mechanical/electrical design problems., • Participates in establishing system or component design objectives and writes portions of complex specifications and engineering reports., • Reviews and helps to develop product specifications, • Conducts conceptual design studies using MCAD and other applicable design tools. Collaborates with other engineering functions, • Develops prototype hardware using internal manufacturing resources and outside vendors, • Tests product to verify that designs meet specification requirements such as environmental, regulatory and safety requirements, • Generates documentation supporting the design, • Provides training, technical advice and guidance to junior engineers. Guidance may be technical or project related as Project Leader or Lead Engineer of small to medium projects. Required Knowledge, Skills and Abilities: • Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software., • Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable., • Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable., • Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data., • Experience with electronic document control systems in medical device and/or medical equipment design and development., • Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis., • Ability to create and meet scheduled timelines (manage and coordinate tasks as required)., • Ability to work in a team environment., • Strong communication skills., • Familiarity with dimensioning and tolerance, thermal and structural analysis, and vibration testing/analysis, • Intermediate knowledge of FDA, IEC and UL standards relating to medical electronic equipment, • Strong technical and analytical ability, verbal and written communication skills, ingenuity and creativity, interpersonal and project management skills, • Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM’s and oscilloscopes, • Familiarity and the ability to operate basic shop equipment such as a drill press, lathe, milling machine, brake and shear Minimum Requirements: • BSME or MSME and a minimum of 10 years of related experience in design/product development of electro pneumatic assemblies including technical supervision of sub-projects, • Formal training in basic and advanced topics in Solid Works is strongly preferred, • Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat, • Advanced proficiency with SolidWorks, MCAD/CAE software and database management software preferred, • Advanced proficiency with Microsoft Visio and Microsoft Project preferred Important Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com. Powered by JazzHR YICfO1XHEv

Job DescriptionPosition Description: Dr. Praegers was founded in 1994 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job DescriptionTitle: Stability Coordinator Reports to: Manager, Quality Systems/Validations Department: Quality Assurance Organizational Relationships: Batching & Filling/Assembly areas, Customer Reps, Customers, Approved Testing Labs and Warehouse/Shipping personnel. Responsibility Summary: The Stability Coordinator is responsible for managing all aspects of stability sample preparation, submission, and documentation in compliance with approved protocols and cGMP standards. Key duties include coordinating with testing laboratories, maintaining accurate logs, monitoring stability chambers, and preparing detailed reports for quality review. The role ensures timely tracking of test results, supports regulatory requirements, and promptly reports any out-of-specification findings to the Quality team. Responsibilities: The Stability Coordinator is responsible for supporting the company's business events through a variety of tasks, including: • Reviews batch and finished product stability samples using approved stability protocol, current product specifications and sample submission forms., • Prepares stability samples and submission documents., • Co-ordinates with testing labs as required., • Facilitates maintenance of awareness and compliance with cGMP and safety regulations in production, manufacturing and related areas., • Maintain current logs (with sent dates, result due dates, result receipt dates, etc) for all stability samples to support approved protocols., • Daily / Periodic monitoring and documentation of (a) Walk-in; (b) Reach-in; and (c) Freeze/Thaw chambers and their parameters such as temperature and humidity, PM, calibration, Water supply, etc., • Must be familiar and current with Englewood SOP 1-050 (Operating, Maintaining and Monitoring of Stability Chambers); SOP 1-033 (Stability Testing for Drug Products) and Englewood Lab Quality Form, EQF 206, 207, 022 and EQF 121., • Prepares stability sample submission documents to cover long term, accelerated, freeze-thaw, intermediate (if applicable), preservative challenge test (PET)., • Maintains stability reports including compatibility, analytical method validation, and PET., • Assemble on-going, in-progress, and completed reports for review by QC Manager or designee., • Maintain tracking logs and correspondence to support stability sample submission to approved labs and for customer evaluation., • Immediately notify Quality personnel if out-of-specification (OOS) is observed in stability test results., • Periodically review stability logs for completeness., • Ensure that only most current versions of product specifications are used for product testing by the approved labs., • Ensure on-time submission of samples and receipt of results/customer approvals., • Maintains awareness and compliance with US FDA, ICH Stability, GMP and safety regulations in performing job duties., • All other functions and duties as may be assigned by immediate supervisor. Qualifications: • Associate’s degree (2-year college degree) required., • Experience in cosmetic, device, food or pharmaceutical inspection process preferred., • Good math skills., • Ability to read and interpret internal and external sampling plans and effectively report results., • Effective communication skills with internal and external customers., • Ability to lift and carry up to 10-15 pounds. This position is Full-Time, Onsite in Totowa, New Jersey, five days per week in the office (9:00AM - 6:00PM) Compensation & Benefits: The approximate pay range for this position is $50,000 - $60,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. The benefit package includes: • Medical, Dental, Vision, Life, • PTO, • Special Paid Leave for employees’ personal events, • Company Paid Holidays, • 401(k) employer match, • Year-End Gift Powered by JazzHR CsigK53ac5

Job Description Job description Granulation Technology, Inc. is a leading pharmaceutical manufacturer specializing in high-quality OTC (over-the-counter) products. As a fast-growing, Indian-owned and majority women-owned company, we are committed to excellence, innovation, and customer satisfaction. Role Overview: We are seeking a results-driven Pharmaceutical OTC Sales Representative to expand our market presence, secure new accounts, and maintain strong relationships with key customers. This is an exciting opportunity for a sales professional with experience in the pharmaceutical OTC industry. Responsibilities: ✅ Identify and develop new sales opportunities within the OTC pharmaceutical market. ✅ Build and maintain relationships with distributors, retailers, and healthcare providers. ✅ Present and promote our OTC products to potential clients. ✅ Negotiate contracts, pricing, and supply agreements. ✅ Stay updated on industry trends, competitor activity, and market demands. ✅ Collaborate with internal teams (marketing, regulatory, and logistics) to ensure customer satisfaction. ✅ Meet or exceed sales targets and KPIs. Qualifications: Experience: 10+ years in OTC pharmaceutical sales. Skills: Strong negotiation, relationship-building, and communication skills. Knowledge: Familiarity with the OTC market, retail distribution, and pharmacy channels. Self-Motivated: Ability to work independently and drive results. Travel: Willingness to travel as needed for client meetings and industry events. Why Join Us? ✨ Opportunity to work with a growing pharmaceutical company. ✨ Competitive salary with uncapped commission potential. ✨ Flexible work environment with career growth opportunities. ✨ Be part of a dynamic, diverse, and innovative team. Company DescriptionGranulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.Granulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.