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Prime Staffing is seeking a travel Mammography Technologist for a travel job in Hackensack, New Jersey. Job Description & Requirements • Specialty: Mammography Technologist, • Discipline: Allied Health Professional, • Start Date: 05/11/2026, • Duration: 33 weeks, • 40 hours per week, • Shift: 8 hours, • Employment Type: Travel ID: 62981654 Shift: 8:30 AM - 5:00 PM. 8:30 AM - 5:00 PM. 5x8 hours. 13 Weeks. Every other weekend. No Holidays. No on c Description: Job Summary:The Mammography Technologist is responsible for performing mammography examinations following ACR requirements.-This position assists with breast ultrasound, stereotactic biopsy, breast localization and other radiologic guided procedures performed within the Breast Center.-Performs diagnostic and screening mammographic examinations on adult, adolescent, and geriatric patients in an expedient and professional manner.-Performs mammographic imaging for breast needle localization procedures and stereotactic procedures inclusive of set up and clean up.-Assists in procedures using ultrasound guidance.-Provides immobilization devices, select proper technical factors based on individual patient needs and selects and operates equipment for specific procedures.-Identifies patient s films with the correct name, x-ray number, and correctly marks film as to side of the patient and initials all films.-Develops exposed x-ray film by using processing methods.-Completes patient requisitions with technologist s initials, date number, and size of films.-Assists with quality control procedures and documenting of: phantom image, darkroom fog test, screen-film contact test, repeat analysis, fixer retention analysis, screen cleanliness, compression test, visual machine checks, processor quality control, view box and reviewing conditions and darkroom cleanliness, as delegated by Chief Mammography Technologist.-Assists in BSE instruction and other patient education to include pre and post procedure instructions.-Prepares cases to be imaged including chart and films.-Assists with compiling statistics for: patient follow-ups, tracking of breast localizations, patient needing biopsies, and ultrasound examinations, follow-up on positive biopsy reports.-Documents procedures regarding quality control and quality assurance for mammography in compliance with ACR, MQSA, NJ State and FDA.-Documents in the Breast Center chart any pertinent information regarding patients.-Identifies the needs of the patient population served and modifies and delivers care that is specific to those needs (i.e., age, culture, language, hearing and/or visually impaired, etc.).-This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).-Other duties and/or projects as assigned.-Adheres to HMH Organizational competencies and standards of behavior. null Schedule Notes:8:30 AM - 5:00 PM. 5x8 hours. 13 Weeks. Every other weekend. No Holidays. No on call. Must have 2 years of experience. Will be working at the breast center institute.Weekends: Rotating every couple monthSkills: Required Skills & Experience:-Minimum 2 years prior experience as a Licensed Mammography Technologist.Preferred Skills & Experience:-N/A 8:30 AM - 5:00 PM. 5x8 hours. 13 Weeks. Every other weekend. No Holidays. No on call. Must have 2 years of experience. Will be working at the breast center institute.Weekends: Rotating every couple month RequiredMAMMO TECHAdditionalEducation: Required Education:-High school diploma or equivalent.Graduate of an AMA approved School of Radiologic Technology.Preferred Education:-N/ARequired Certifications & Licensure:-Must have ARRT.-Must obtain mammography certification within the first three months of employment.-Must have active Diagnostic Radiography License.Preferred Certifications & Licensure:-N/A null;Languages: English Read Write Speak English(Speak, Read, Write)Job Category: Clinical-Allied Guaranteed Hours: 40.00 Contract Weeks:234 Prime Staffing Job ID #36604712. Pay package is based on 8 hour shifts and 40.0 hours per week (subject to confirmation) with tax-free stipend amount to be determined. Posted job title: Allied / Tech:Mammo Tech,09:00:00-17:00:00 About Prime Staffing At Prime Staffing, we understand the importance of finding the perfect fit for both our clients and candidates. Prime Staffing utilizes a unique matchmaking approach, providing the most qualified contingent staffing to our clients, and the most competitive contracts to our workforce. Our experienced team takes the time to get to know both our clients and candidates, their needs, and preferences, to ensure that each placement is a success. We offer a wide range of staffing services including temporary, temp-to-perm, and direct hire placements. Our extensive network of qualified candidates includes nurses, allied healthcare professionals, corporate support professionals and executives.

Onsite Meeting and Event Operations Coordinator 5 Days - Onsite (East Hanover, NJ) Long Term Contract Pay Rate: $65K - $68K Purpose of the Role The Onsite Meeting and Event Operations Coordinator supports the planning and execution of onsite internal meetings, leadership sessions, special events, and high-visibility engagements by delivering a seamless client experience and strong operational coordination. This role serves as a key point of contact for clients and internal stakeholders, ensuring all meeting and event details are managed accurately, communicated clearly, and executed with a high level of professionalism. This position combines client-facing coordination with day-to-day event operations, partnering closely with IME Technical and Special Event Producers and cross-functional support teams including AV, Remote Team, Room Booking, Catering, Facilities, Security, and external vendors. The role requires strong communication skills, excellent attention to detail, sound judgment, and the ability to work confidently with senior leaders and multiple service teams in a fast-paced environment. Key Responsibilities Client and Meeting Coordination • Serve as a primary point of contact for clients for onsite meetings and events, ensuring a responsive, polished, and high-quality experience from planning through completion., • Communicate clearly and consistently with clients, internal stakeholders, senior leaders, and support teams to confirm event goals, requirements, timelines, and expectations., • Support high-visibility and regulated engagements such as FDA audits, drug launch training sessions, Launch Readiness Review meetings, and executive or leadership events., • Provide day-to-day coordination, troubleshooting, and follow-up to ensure meetings and events are executed as planned., • Support end users responsible for self-service meetings by providing guidance on process, logistics, and available services. Event Operations and Logistics • Coordinate all operational aspects of onsite meetings and events, including room bookings, catering, facilities support, security, campus travel, transportation, AV, webcast, virtual support, and production needs including managing crew schedule assignments., • Manage multiple event components and sub-services to ensure all services are delivered according to client requirements and timelines., • Oversee IME-supported activities in designated campus event spaces, including shared meeting and lobby spaces., • Support recurring onsite leadership and training programs, including standard and expanded service models, while coordinating with global support teams when applicable., • Prepare event materials and support logistics including supplies, equipment, printing, assembly, and shipment of materials., • Track project milestones, timelines, and priorities for meetings and events with time-sensitive deliverables. Production Team and Process Oversight • Support the Statement of Work (SOW) process by ensuring required SOWs are created, reviewed, approved, completed, posted, and stored accurately and on time., • Partner with IME Technical and Special Event Producers to review production details and confirm meeting requirements are properly documented., • Participate in production review meetings and global coordination calls to ensure accurate communication, readiness, and alignment across teams., • Maintain event records, project documentation, and planning materials in ServiceNow, Outlook, and SharePoint., • Support post-event review processes by gathering feedback, documenting outcomes, and identifying opportunities for continuous improvement., • Help maintain operational guides, support documents, and tools used to improve consistency and service delivery. Cross-Functional Coordination • Act as a liaison between clients and key support teams including IT, AV, Real Estate and Facilities, Security, Catering, janitorial services, transportation providers, and external vendors., • Submit, enter, and track event details in the appropriate systems, request forms, and internal trackers according to process requirements., • Coordinate vendor and service partner activities related to setup, execution, breakdown, staffing, and event support needs., • Work with service partners and vendors to help identify practical and cost-effective solutions that align with client needs and budget parameters., • Support crew requests, facilities requests, billing coordination, and technology-related event needs. Reporting, Documentation, and Administrative Support • Ensure all event details, schedules, updates, approvals, and records are accurately entered and maintained in ServiceNow, Outlook, and SharePoint., • Manage multiple Outlook calendars and mailboxes in support of meeting and event operations., • Prepare and maintain monthly reports, KPI and CSTT reporting, room utilization reports, attendance reports, incident reports, AV request counts, and other operational reporting as needed., • Support preparation of chargeback and event activity reports, including reporting related to executive committee meetings and campus meeting activity., • Track invoices, rental equipment, receipts, expenses, estimates, and service-related documentation to support reconciliation and financial tracking., • Maintain event timelines, project trackers, SOPs, presentation materials, and strategic project information., • Provide backup support for Room Booking team coverage and related coordination when needed., • Help ensure departmental OKRs and KPIs remain on track through accurate reporting and follow-up. Qualifications • Strong communication and organizational skills with a high level of professionalism and client service., • Excellent attention to detail and ability to manage multiple priorities with accuracy and consistency., • Comfortable communicating and coordinating with senior leaders and executive-level stakeholders., • Experience supporting onsite meetings, events, hospitality operations, workplace services, or similar corporate event environments., • Strong knowledge of Outlook, SharePoint, and ServiceNow., • Experience managing multiple Outlook calendars and shared mailboxes., • Ability to coordinate across multiple departments, support teams, and vendors., • Strong problem-solving skills with the ability to troubleshoot and adapt quickly in a fast-paced environment., • Experience maintaining documentation, trackers, and reporting with a strong focus on follow-through., • Ability to support budgets, estimates, invoices, and expense reconciliation., • Experience developing or maintaining SOPs and process documentation is a plus.

Quality Control Supervisor Position Summary The Quality Control Supervisor is responsible for ensuring the effectiveness of the Quality Management System (QMS) and supporting continuous improvement initiatives across the facility. This role oversees daily quality control operations to ensure products consistently meet customer expectations, internal specifications, and applicable regulatory requirements. The Quality Control Supervisor leads inspection and testing activities, manages quality documentation and calibration programs, supports audits and corrective actions, and supervises Quality Control Inspectors. This position reports directly to the Quality Assurance Manager. Key Responsibilities • Lead day-to-day quality control operations to ensure in-process and finished products meet specifications, customer requirements, and regulatory standards., • Develop, implement, and maintain inspection, sampling, and testing procedures for raw materials, in-process products, and finished goods., • Ensure all required quality records, logs, and documentation are accurately completed, maintained, and retained., • Supervise, schedule, train, and mentor Quality Control Inspectors while supporting cross-training and coverage needs., • Manage internal nonconformance and hold processes, including issue documentation, product disposition coordination, cost tracking, and file maintenance., • Collect, analyze, and maintain quality data within company systems and prepare routine and project-specific quality reports., • Administer the calibration program for inspection, measurement, and testing equipment, including coordination of internal checks and external calibration services., • Maintain calibration records and ensure expired or non-compliant equipment is removed from service., • Coordinate and maintain the Integrated Pest Management (IPM) program, including vendor scheduling, audit support, and license/certificate tracking., • Participate in internal audits, corrective actions, and continuous improvement initiatives to strengthen quality system effectiveness., • Support compliance with ISO 14001 and ISO 50001 management systems through documentation, audits, corrective actions, and improvement activities., • Review and approve incoming raw materials and colorants; maintain retains, sample libraries, receiving records, and required certificates., • Coordinate external product and material testing and maintain all associated records and documentation., • Support hygiene and product safety programs, including environmental monitoring and swabbing activities as required., • Ensure current quality procedures and work instructions are properly posted and available throughout the facility., • Support new product launches and projects by establishing inspection plans and communicating quality requirements to production teams., • Order and maintain quality-related supplies and equipment through established purchasing procedures., • Assist with translation and communication support for employees with limited English proficiency as needed., • Promote and uphold company safety, environmental, and compliance standards., • Perform additional duties and special projects as assigned. Qualifications & Requirements • Minimum 5 years of quality experience within a manufacturing environment., • Previous supervisory or team leadership experience preferred., • Bilingual in English and Spanish required., • Strong understanding of quality systems, inspections, testing procedures, and manufacturing processes., • Experience working within regulated environments and formal quality systems such as ISO, GMP, or FDA standards preferred., • Strong analytical, organizational, problem-solving, and communication skills., • Proficient computer skills, including Microsoft Office applications, spreadsheets, word processing, and quality data systems., • Ability to manage multiple priorities in a fast-paced manufacturing environment., • Quality certifications or industry-related certifications are a plus. Preferred Skills • Experience with continuous improvement methodologies., • Knowledge of calibration systems and environmental monitoring programs., • Familiarity with corrective and preventive action (CAPA) processes., • Strong documentation and reporting capabilities., • Ability to train, coach, and develop team members effectively. Work Environment • Manufacturing plant environment with exposure to production operations., • May require standing, walking, lifting, and use of inspection/testing equipment., • Must follow all safety, quality, and environmental procedures and regulations.

Director, GMP QA (CMC/Development) – Permanent – New York Proclinical is seeking a Quality Systems Director for an emerging biotech company based in New York. Primary Responsibilities: In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities. The position is based onsite in New York. Skills & Requirements: • B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional., • Experience in small molecule development, batch release, and SOP drafting., • Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections., • Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products., • Proven ability to build or scale quality systems in a dynamic environment., • Prior experience managing CDMOs and external quality oversight strongly preferred., • Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred. The Director, GMP QA (CMC/Development) will: • Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards., • Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies., • Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations., • Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management)., • Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams., • Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs)., • Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

Clinical Science Liaison 📍 New York / East Coast USA | Full-time, Permanent 🚀 Start: As soon as possible About Us Pentixapharm AG, together with its U.S. subsidiary Pentixapharm Inc., is a research-driven radiopharmaceutical and precision oncology company focused on the development and manufacturing of innovative theranostic agents. Our lead drug candidate pair, PentixaFor/PentixaTher, along with an antibody-based pipeline, targets the CXCR4 receptor, highly expressed in hematologic and solid cancers, as well as cardiovascular and endocrine disorders. The Role As our Clinical Science Liaison for the East Coast, you will serve as the operational and scientific bridge between our clinical development program and investigator sites. You'll support study execution, enable site success, and build a strong network of clinical thought leaders. You'll also provide strategic input to leadership on clinical landscape trends and emerging indications. What You'll Do • Support clinical trial site initiation, activation, and ongoing study conduct across the East Coast, • Identify and evaluate potential new investigator sites and facilitate feasibility assessments, • Organize meetings with clinical subject matter experts and key opinion leaders, • Serve as the primary scientific contact for investigators and site staff, • Provide strategic scientific intelligence to leadership on clinical trends and emerging opportunities, • Represent Pentixapharm at key scientific congresses, • Support regulatory interactions and submissions to the FDA What You Bring • Advanced degree (MS/PhD) in life sciences (e.g., oncology, pharmacology, nuclear medicine), • Substantial experience in a CSL, clinical scientist, CRA, or field-based clinical role, • Solid understanding of clinical trial operations, GCP, and ICH guidelines, • Proven ability to engage scientifically with investigators and translate complex protocols into practical guidance, • Willingness to travel approximately 50–60% What We Offer • Meaningful mission: Develop innovative radiopharmaceuticals that improve patients' lives, • Impactful work: High responsibility in a dynamic, science-driven environment, • Flexibility: Flexible hours, hybrid work in New York City

Territory Sales Representative – Entry Level / Full Time SOUTH MANHATTAN Break Into Pharmaceutical Sales with Pivya® at ImpactBio supporting Alembic Therapeutics Looking to launch a career in pharmaceutical sales? This is your opportunity. Alembic Therapeutics, in partnership with ImpactBio, is launching Pivya®, an FDA-approved oral antibiotic for uncomplicated urinary tract infections (uUTIs). Proven for over 40 years in Denmark as a first-line therapy, Pivya® is now entering the U.S. market—and we’re building a team of driven, ambitious sales professionals to support this high-profile launch. As a Territory Sales Representative, you don’t need prior pharmaceutical sales experience—we’re looking for motivated, coachable individuals who are eager to learn, follow a proven sales model, and build a long-term career in the industry. You’ll receive the training, tools, and mentorship needed to succeed while gaining real-world experience calling on healthcare providers. This full-time role is with ImpactBio, a premier commercial partner in Life Sciences, with the potential to transition to Alembic Therapeutics based on strong performance. View Openings & Apply Here Job Openings - ImpactBio Why This Role Matters This is more than a sales job—it’s a career entry point into pharmaceutical sales. You’ll be part of a national product launch, gaining experience in a highly competitive industry while developing the skills and discipline needed to grow your career. We’re looking for individuals who are: • Hungry to succeed, • Open to coaching and feedback, • Willing to follow a structured plan, • Ready to put in the work to build something meaningful If that sounds like you, we’ll teach you the rest. Key Responsibilities • Promote Pivya® to healthcare providers within your assigned territory, • Learn and execute a structured sales process and messaging strategy, • Build relationships with physicians, nurses, and office staff, • Consistently apply training and coaching in the field, • Develop and execute territory plans to achieve sales goals, • Provide timely updates, insights, and field feedback to leadership, • Maintain full compliance with all company and industry regulations What We’re Looking For • Bachelor’s degree required, • 1–3 years of sales or customer-facing experience (B2B, retail, service, or related), • A strong desire to break into pharmaceutical or healthcare sales, • Proven work ethic and a track record of meeting or exceeding goals, • Coachability—someone who takes direction well and applies feedback quickly, • High level of motivation, resilience, and accountability, • Strong communication and interpersonal skills, • Ability to work independently while following a defined sales plan, • Willingness to travel extensively within territory, • Valid driver’s license with a clean driving record Pharmaceutical experience is not required—drive, attitude, and willingness to learn are. What We Offer • Competitive base salary with a generous performance-based incentive plan, • Comprehensive Medical, Dental & Vision coverage, • Car allowance & mileage reimbursement, • 401K plan with company match, • Paid time off and holidays, • Structured training program designed to help you break into and succeed in pharmaceutical sales, • Ongoing mentorship and field coaching, • A clear path for career growth and advancement, • The chance to be part of a major U.S. product launch About Alembic Therapeutics Alembic Therapeutics LLC, a U.S. subsidiary of Alembic Pharmaceuticals Inc., is committed to delivering high-quality, patient-focused branded pharmaceuticals. Our mission is to bring innovative, reliable medicines to the U.S. market while upholding the highest standards of safety, efficacy, and quality. About ImpactBio At ImpactBio, we build and launch commercial teams with a focus on performance, development, and long-term success. We’re known for investing in our people and creating opportunities for driven individuals to grow into high-performing professionals in the life sciences industry. The annual base salary for this position is $65,000. Compensation is aligned with the position’s scope and internal pay structure. Apply Now View Openings & Apply Here Job Openings - ImpactBio ImpactBio is an affirmative action/equal opportunity employer (Minorities/Females/Veterans/Disabled) We appreciate your interest in our company, however; only candidates meeting qualifications will be considered.

📍 Now Hiring: Clinical/Compounding Pharmacist – Brooklyn, NY Immediate Start | Full-Time | Entry-Level Welcome We are seeking a licensed Pharmacist (PharmD) to join our dynamic and growing team in New York. This is a unique opportunity to contribute to our state-of-the-art compounding pharmacy, delivering top-tier medications and improving patient care across the region. 💼 Key Responsibilities: • Compound production and prescription verification, • Provide clinical consultations with patients and prescribers, • Maintain protocols to ensure product safety andeffectiveness, • Ensure quality assurance and compliance with FDA and state regulations, • Contribute to training programs, R&D formulation development, and process improvements 🧠 Qualifications: • PharmD and valid NYS pharmacist license required, • New grads welcome (0–1 year experience), • In-depth knowledge of USP 795/797, compounding best practices, and pharmacy software (PrimeRx a plus), • Strong communication, leadership, and patient-care skills ⭐ Bonus if you have: • Experience in non-sterile compounding, • Familiarity with ICD-9/10, CPT codes, and medical terminology 📌 Why You’ll Love It Here: • Work in a modern, innovative lab environment, • Join a passionate, supportive team, • Be part of something bigger—help improve patient lives daily Compensation pay range - $50-60 p/h

Job Description Summary #LI-Hybrid This position will be located at either the East Hanover, NJ or Cambridge, MA site and will not have the ability to be located remotely. This position will require travel as defined by the business (domestic and/ or international). Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. The Associate Director, US Market Access Strategy is responsible for supporting the optimization of the market access strategy for launch and inline brands in Neuroscience through the delivery of the tactics designed to achieve the market access strategy. This role will work across the US Market Access organization to ensure that different subgroups are involved and/or informed in tactical execution as appropriate (i.e., Strategic Pricing & Contracting, Commercial Access Integration, Patient & Support Services, Finance). Additionally, this individual will ensure that market access tactics are executed against across the broader affected organization (i.e., the Product, Integrated Marketing, and Customer Engagement Organizations). The overarching objective is to ensure that each of our products is positioned for optimal payer coverage, affordability for appropriate patients, and durable value for Novartis over time and as the product matures and/or extends into new indications. There are three openings for this position. Job Description Key Responsibilities: • Supporting Market Access Strategy Director as point of contact for US product teams across Immunology and Neuroscience brands, • Assisting in the development of annual and launch Market Access product-specific tactical plans and partnering with brand and other Market Access teams to ensure that annual budgets are secured, • Engaging with the Integrated Marketing and Customer Engagement Organizations to ensure that we are working efficiently and market access strategies are seamlessly executed upon across the organization, • Developing market access promotional materials for Market Access, Marketing, Patient Support, and Customer Engagement organizations, • Supporting annual forecast activities and LCM forecast activities. Supporting development of critical market research including development of qualitative and quantitative areas of study, and determining fundamental go-to-market principles to achieve optimal product commercialization, • Supporting the socialization of US market access product strategies as appropriate with US Product Leads, • Managing vendor RFP process and ensuring contracting compliance, • Responsible for managing multiple budgets and deliverables, including organizing interim project read-outs to ensure cross-functional alignment and ensuring deliverables do not exceed allocated budget, • Working closely and engaging with Legal, Compliance, Brand and Marketing teams to ensure tactics are aligned and implemented in an expeditious and compliant manner, • Mastering the NVS Material Approval Process, including FUSE platform, compliance with pharma/FDA marketing policies, and vendor payment systems Essential Requirements: • Education: Bachelor's degree required; MBA, Healthy Policy or equivalent preferred, • Minimum of 5 years of pharmaceutical experience in Marketing/Sales, Market Access, Patient Services, Managed Care Finance, or a related field, • Awareness and understanding, and experience with US healthcare dynamics and the drivers of pharmaceutical value, • Success in the areas of commercial pharmaceuticals and a track record of execution and results, • Ability to recognize complex relationships and market dynamics and to synthesize simplified, direct and effective communications, • Strong interpersonal, communication and analytical skills combined with an ability to successfully collaborate across a matrix organization, • Ability to consistently meet deadlines and manage multiple projects with potential interdependent findings and deadlines, • Ability to adapt to changes within the internal and external environment Novartis Compensation Summary: The salary for this position is expected to range between $160,300 and $297,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +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 $160,300.00 - $297,700.00 Skills Desired Access And Reimbursement Strategy, Agility, Analytical Skill, Analytical Thinking, Cross-Functional Collaboration, Customer-Centric Mindset, Employee Development, Finance, Go-To-Market Strategy, Healthcare Sector Understanding, Health Economics, Health Policy, Health Technology Assessment (HTA), Innovation, Inspirational Leadership, Market Access Strategy, Negotiation Skills, People Management, Process Management, Project Management, Public Affairs, Real World Evidence (RWE), Regulatory Compliance, Risk Management, Value Propositions

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Regulatory Affairs Program Manager leads crossfunctional regulatory projects from strategy through execution, ensuring that all products meet global regulatory requirements and are launched on schedule. This role partners closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission timelines, and drive successful product approvals worldwide. Essential Functions • Design, plan, and manage cross-functional and ongoing regulatory programs, defining schedules, milestones, deliverables, resources, and risk-mitigation strategies., • Act as a Regulatory Affairs point of contact for internal teams, translating regulatory requirements into clear and actionable objectives., • Coordinate crossfunctional project teams, ensuring alignment with regulatory objectives and strategy. Track and report program status to senior leadership and external partners., • Conduct regulatory intelligence to anticipate changes in laws, guidance, and standards. Assess impact on products/processes and communicate findings., • Identify risks early, develop mitigation plans, and resolve issues that could impact timelines or approvals., • Foster a culture of continuous improvement and regulatory excellence., • Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates., • Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in sciences, business, project management or a related field with 5+ years of relevant progressive experience is required., • 4+years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred., • 3+years managing complex, multiregional regulatory programs is preferred. Knowledge, Skills, & Abilities • Understanding and knowledge of FDA and other major healthauthority requirements, a plus., • Proven ability to work with crossfunctional teams, manage budgets, and deliver on schedule., • Excellent written and oral communication skills., • Strong analytical and problemsolving abilities., • Proficiency with MS Office suites and project management tools. Working Environment / Physical Environment • This position works on-site, • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer., • Lift and carry materials weighing up to 30 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $141,300 (entry-level qualifications) to $157,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

The Quality Engineer supports a chemical mixing / medical device manufacturing operation, ensuring compliance with applicable quality system regulations while providing direct shop-floor quality support. This role is responsible for complaints management, CAPA, change control, and supplier quality management, and works cross-functionally with Manufacturing, Engineering, Supply Chain, and Regulatory Affairs to drive product quality, process robustness, and continuous improvement. In This Position, You Will Have the Opportunity To: Shop Floor Quality • Provide day-to-day quality support for operations, • Perform batch record review, deviations, nonconforming material investigations, and process troubleshooting, • Develop and implement test methods and procedures for inspecting, testing and evaluating product and processes Complaints & Post-Market Surveillance • Lead and/or participate in complaint investigations in accordance with FDA QSR, ISO 13485, and customer requirements, • Perform root cause analysis and ensure appropriate corrective and preventive actions, • Conduct trend analysis, escalation, and regulatory reporting (e.g., MDR support as applicable), • Interface with customers regarding complaint investigations and responses when required Corrective and Preventive Action (CAPA) • Own and manage CAPA records, from initiation through effectiveness verification, • Apply structured problem-solving tools (e.g., 5-Why, Fishbone, FMEA), • Monitor CAPA metrics, timeliness, and effectiveness to ensure sustained improvement, • Address CAPAs identified during internal and external audits Change Control • Participate in change control activities related to materials, suppliers, processes, equipment, and documentation, • Assess quality and regulatory impact of proposed changes, including risk evaluations, • Ensure changes are implemented in compliance with customer requirements and applicable regulations, • Assist with validation and verification activities as required Supplier Quality Management • Execute Supplier Quality initiatives and programs with activities such as supplier qualification, auditing, SCAR management, and PPAP, • Perform supplier qualification, monitoring, and performance management, • Review and approve supplier documentation (COAs, specifications, quality agreements), • Participate in supplier audits, issue supplier corrective actions, and track resolution, • Maintain incoming inspection strategies and supplier risk assessments Quality System & Compliance • Ensure compliance with applicable regulations (FDA’s QMSR, ISO 13485, EUMDR, ISO 14971), • Participate in internal, customer, and regulatory audits, including preparation and response activities, • Perform data analysis and reporting of quality metrics (scrap, rework, complaints, CAPA)

Position Summary The Senior Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements. Essential Functions • Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization., • Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements, • Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products., • Assist with developing and evaluating regulatory strategy, • Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on products., • Author and review departmental SOPs, as well as other SOPs that may impact Regulatory Affairs., • Performs other special projects and duties as requested. Education & Experience • Bachelor’s Degree in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development required; or, • Master’s Degree in life sciences required with 5+ years of relevant regulatory compliance experience in pharmaceutical drug development required., • Knowledge and experience with organizing responses to Regulatory Authority requests required, • Experience with US and International Health Authority regulatory submissions preferred Knowledge, Skills, & Abilities • Knowledge of FDA, ICH and other guidance documents and requirements, • Knowledge of organizing responses to Regulatory Authority requests, • Strong knowledge of Health Authority regulatory requirements/guidelines, • Strong project management and computer skills (including Microsoft office), • Strong document management experience (hard and e-copy), • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written/oral communication skills and attention to detail, • Ability to manage conflicting priorities and respond in a timely, effective manner

Location: NYC Contract-about 20 hours a week Join my client’s growing clinical research network and play a pivotal role in advancing Phase II–III clinical trials that improve patient outcomes. This is an opportunity to lead meaningful studies, work alongside experienced investigators, and help shape the future of clinical research in a fast-paced, collaborative environment. Why You Should Apply • Lead impactful Phase II–III clinical trials across multiple therapeutic areas, • Join an innovative research network focused on high-quality site operations, • Work independently while collaborating with sponsors, CROs, and investigators, • Hands-on role with patient interaction, study management, and advanced clinical procedures, • Bilingual English/Spanish skills highly valued in a patient-centered environment What You’ll Be Doing • Manage clinical trials from site initiation through close-out in compliance with GCP/ICH and FDA regulations, • Coordinate recruitment, informed consent, scheduling, EDC entry, query resolution, and protocol implementation, • Perform clinical procedures including phlebotomy, ECGs, specimen processing, and drug administration, • Prepare for monitoring visits, audits, and inspections while resolving protocol issues, • Track adverse events, protocol deviations, and regulatory documentation About You • Bachelor’s degree required; RN, LPN, MA, or Master’s degree preferred, • CCRC or CCRP preferred, • Expertise in ICH/GCP, FDA regulations, and human subject research compliance, • Experience with EDC systems and eSource platforms, preferably CRIO, • Bilingual in English and Spanish required, • Phlebotomy experience desired How To Apply We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to tori@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume. Please include Job#19886.

Responsible for receipt and documentation of Safety information for Marketed and Investigational Products. Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events with company products. Provides product information to health care professionals, consumers, and sales representatives. Codes and enters information into the global safety database. Verifies the accuracy, completeness and validity of information for each adverse event report for which he/she is responsible. Assures consistency of case records and documentation. Creates and ensures distribution of regulatory reports for FDA and other regulatory health authorities. Accurate and timely data entry of both domestic and foreign adverse event and serious adverse event information into the PSSS (Product Safety Surveillance System) consistent with the ARISg coding manual, SOPs/WIDs, process flows and established time frames within the ARISg workflow. Full understanding of the products’ company Core Data sheet, PI, and/or IB for accurate labeling and listedness. Perform appropriate and timely follow-up per department guidelines, including accurate and thorough communication documentation within the case. Maintain proficiency in the utilization of the PSSS, including MedDRA coding. This may include participating in the validation process for the PSSS. Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes. Utilize ARISg for all reporting and confirmation of successful distribution and acknowledgement. Maintain sufficient knowledge of all company products to ensure professional and knowledgeable discussions with consumers and healthcare providers and dissemination of accurate product information in response to queries. Provide high level customer service to consumers, health care professionals and internal customers. Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental SOP’s, SWP’s and WID’s. Ensure timeliness in regulatory compliance Gather sufficient information to assess the medical significance of an adverse event report, while at the same time assuring the information provided adequately addresses the concerns of the health care provider and/or consumer. Required Qualification & Skills: Bachelor’s degree in Medical field with RN or RPh licensure, or PharmD/MD degree required. Minimum 2 to 4 years in industry application of clinical medicine/pharmacy with a minimum of 1 year in pharmaceutical drug safety Experience in verbally interviewing and/or providing medical information to health care professionals and consumers Application of clinical medicine to patient care Medical terminology and standards of patient care Computer proficiency

Evermark is a newly formed beauty and personal care company bringing together a portfolio of iconic, everyday brands with enormous reach and untapped potential: Suave, ChapStick, Q-tips, Caress, St. Ives, TIGI Bed Head, Noxzema, Pond’s, Lever 2000. These are brands people know, trust, and use daily - and we are building their next chapter. Backed by a growth-oriented YellowWood Partners, we operate with speed, focus, and accountability. Our goal is simple: modernize these brands, accelerate growth, and build a company that consistently outperforms expectations. That means sharpening strategy, raising the bar on execution, and making smart, decisive moves across the enterprise - from how we plan and operate to how we go to market. This is a company in motion. We are scaling quickly, building new capabilities, and creating the operating model as we go. For the right people, that means rare access, real influence, and the opportunity to help shape not just a role, but a company. Position Summary The TIGI Head of R&D is responsible for leading end-to-end product development and technical execution across a highly externalized R&D model. This role serves as the single point of accountability for delivering innovation from concept through commercialization by effectively managing external labs, suppliers, and contract manufacturers. The TIGI Head of R&D combines strong technical expertise with hands-on project leadership to ensure products meet performance, claims, regulatory, cost, and timing expectations. This individual will also lead claims development and clinical/consumer testing programs while managing the TIGI Packaging Lead to ensure seamless integration of formula, packaging, and manufacturing. Primary Responsibilities · Partner with Marketing and Packaging on developing new product innovations and work with external suppliers on the briefing and prototyping stages of the project. · Ensure seamless product technical transfer from site-to-site and partner closely with personnel in the external manufacturing space to enable speed-to-market targets set by the needs of the categories we play in. · Develop and execute the end-to-end product development operations via external global suppliers and manufacturers to ensure high quality, reproducibility, and reliability for all categories withing the TIGI portfolio. · Collaborate with Procurement in establishing raw material supplier strategic partnerships across different categories (i.e. critical raw materials, fragrances, etc.) to co-develop/tap into innovation based on supplier’s expertise. · Partner with Procurement, Operations, and Quality in supplier selection, qualification, and onboarding processes to ensure the availability of high-quality, cost-effective packaging materials and services. · Unlock value and drive agility partnering with external labs and manufacturers to establish the Evermark innovation process to fit the needs of the various categories we play in. · Establish product and process development processes, procedures, and best practices with Quality to drive agility and efficiency and to better anticipate failures. · Ensure that formulation intent makes it all the way to shelf meeting all regulatory requirements and right-first-time, including the e-commerce channel. · Establish and maintain strong relationships with suppliers globally, ensuring strategic partnerships, regular performance evaluations, and continuous improvement programs. · In partnership with Quality, drive supplier performance metrics, conduct regular supplier assessments, and implement corrective actions as necessary to maintain high standards of quality, delivery, and cost efficiency. · Partner with procurement to secure project cost targets with raw material suppliers and external manufacturers. · Act as the lead for the specification management, encompassing the transition, creation and maintenance of technical data across the portfolio. Required Qualifications · BS in Chemistry, Chemical Engineering, or related field. · 10+ years of proven experience in formulation / product development for a global portfolio of cosmetic products. · Experience in end-to-end development from ideation to commercialization of surfactant, hot-pour, and aerosol products. · Understanding of GxPs and FDA Compliance requirements. · Strong technical and leadership skills. · Ability to partner effectively across a diverse set of business partners and customers to deliver key results in a timely manner. · Entrepreneurial; Business owner mentality, willing to be hands-on and contribute as one team. · Critical thinking and comprehensive business acumen. · Excellent communication skills, including spoken and written English. · Ability to travel both internationally and domestically up to 40%. · Strong PC skills: MS Office, PowerPoint, CAD software is a plus. People Who Thrive Here We look for people who take ownership, move with urgency, and care deeply about results. Across every level and function, success here comes from thinking like an operator; not waiting to be told what to do but seeing what needs to happen and driving it forward. The individual must be comfortable working across teams, influencing without hierarchy, and making progress even when the path isn’t perfectly defined. This is a fast-moving environment with high standards and real accountability. In return, you’ll have meaningful responsibility, autonomy to lead your work, and the opportunity to grow alongside brands, and a company, that are being actively shaped. Compensation: The base salary range for this position is $170,000 - $190,000 USD per year. In addition, this role is eligible for an annual discretionary bonus based on individual and company performance. Actual compensation may vary based on experience, skills, and geographic location.

Director of Clinical Operations ABOUT THE ROLE We are partnering with a growing clinical research site in the Bronx to recruit a Senior Director of Clinical Operations — the operational beast who will own site performance end-to-end. This is the go-to person who runs the site. Trial activation timelines, enrollment performance, study quality, regulatory compliance, financial operations, and the coordinator and research nursing teams all roll up to this seat. The right candidate has lived this work at a research site or site network before — they already know what good looks like, what breaks, and how to fix it without a 90-day diagnostic. This is an onsite role in the Bronx. Five days a week, in the building with the team, the patients, the PIs, and the studies. The site needs presence and operational leadership in the room. WHAT YOU'LL OWN • End-to-end site performance: trial activation timelines, enrollment to target, retention, data quality, regulatory compliance, and financial outcomes per study, • Direct leadership of clinical operations staff, including CRCs, research nurses, regulatory and data coordinators, and operations support, • Operational accountability across the full study lifecycle: feasibility input, site activation, enrollment ramp, conduct, monitoring response, database lock, and close-out, • Sponsor and CRO relationships at the operational level — site qualification visits, monitoring visits, audit response, and corrective action planning, • Standardization of SOPs, training programs, quality systems, and operational metrics across the site, • Budget management at the study level: per-protocol P&L oversight, invoicing accuracy, and study-level margin discipline, • Hiring, onboarding, performance management, and retention of clinical operations staff, • Direct partnership with site leadership and PIs on prioritization, capacity planning, and study mix decisions WHAT WE'RE LOOKING FOR Required • 10+ years of clinical research operations experience, with at least 5 years in a senior operational role at a clinical research site, multi-site network, SMO, or IRO, • Demonstrated track record of owning site performance metrics — enrollment, retention, activation timelines, quality, and study-level financials, • Direct experience managing CRC, research RN, regulatory, and data coordination teams, • Deep working knowledge of GCP, FDA regulations, sponsor and CRO operational expectations, and audit readiness, • Strong financial acumen at the study level — feasibility budgeting, invoicing, monitoring of study P&L, • Experience standing up or scaling SOPs, training programs, and operational quality systems at a site, • Bachelor's degree required; advanced degree, RN/BSN, or relevant certification (CCRC, CCRP, ACRP-CP) preferred Strongly Preferred • VP or Director-level experience at a comparable research site network or SMO, • Track record running multi-therapeutic-area sites with diverse sponsor and CRO portfolios, • Prior experience in fast-growing or PE-backed clinical research environments, • Hands-on experience with CTMS, eRegulatory, EDC, and patient recruitment platforms Non-Negotiables • Onsite five days a week in the Bronx. This is not a hybrid or remote role., • Site-side or site-network operational experience. Pure CRO operations, pharma operations, or academic medical center operations backgrounds will not fit this role., • A demonstrated bias toward operational ownership and execution — this is a doer's seat, not a strategist's seat.

Medical Writer – Clinical Content & Health Economics and Outcomes Research (HEOR), Clinical Content Creation Group Location: Remote Duration: 6 month contract with the potential for extension, based on performance Culture and Values Our people are our strength—combining collaboration, speed, and quality while fostering a positive team culture and strong standardization to enable confident, compliant decision‑making. Purpose / Role Summary The Medical Writer – Clinical & HEOR is responsible for developing high‑quality, scientifically rigorous, compliant, and engaging content across clinical, medical, and HEOR domains. This role plays a critical role in shaping scientific and value‑based narratives that support engagement with diverse stakeholders, including HCPs, payers, IDNs, and health systems. The position requires strong scientific and HEOR literacy, excellent writing skills, and the ability to translate complex clinical, economic, and outcomes data into clear, audience‑appropriate materials aligned with therapeutic area and brand objectives. Key Responsibilities Scientific & Medical Content Development • Author and support complex scientific deliverables including abstracts, posters, manuscripts, oral presentations, publication extenders, response documents, and white papers across therapeutic areas., • Develop Medical Information content such as standard response letters, FAQs, and customer‑facing materials., • Draft, edit, and review HEOR‑related outputs including value dossiers, slide decks, economic evidence materials, and submissions. HEOR & Data Interpretation • Conduct comprehensive literature searches and systematic or targeted reviews to support clinical and HEOR narratives., • Partner with health economists, TA researchers, analysts, and statisticians to accurately interpret and translate data from clinical studies, real‑world evidence, cost‑effectiveness analyses, and budget impact models. Publications & Congress Support • Support preparation and submission of content for peer‑reviewed journals and scientific congresses., • Ensure adherence to publication standards and best practices (e.g., GPP, ICMJE, ISMPP) throughout the content lifecycle. Compliance, Quality & Standards • Ensure all materials comply with client policies and external regulatory and ethical guidelines (e.g., FDA/EMA, AMA style)., • Maintain high standards for accuracy, consistency, and scientific integrity across all deliverables. Collaboration & Project Management • Collaborate cross‑functionally with internal creative, editorial, medical, and strategic partners., • Manage multiple concurrent projects while meeting timelines, quality expectations, and stakeholder needs., • Provide flexible writing support across group initiatives as priorities evolve. Qualifications Required • PharmD or advanced scientific degree OR Bachelor’s degree in life sciences, pharmacy, public health, health economics, or related field with relevant experience., • 1–3+ years of experience in medical writing, medical communications, pharma, consultancy, or related environment; HEOR experience preferred., • Strong scientific literacy with the ability to interpret and synthesize clinical, medical, and economic data., • Excellent writing and editing skills tailored to both scientific and non‑scientific audiences., • Knowledge of clinical research processes, publication practices, and regulatory standards., • Strong attention to detail, organization, and ability to work independently within cross‑functional teams., • Proficiency with standard authoring and reference tools (e.g., Microsoft Office, EndNote, Adobe Acrobat). Preferred / Nice to Have • Experience with HEOR methodologies (e.g., real‑world evidence, cost‑effectiveness analyses, budget impact models)., • Familiarity with publication and approval platforms (e.g., Veeva Vault, Pubstrat, iEnvision/Datavision, Nubela)., • Knowledge of AMA style and global publication guidelines., • Professional certification (e.g., CMPP)., • Background working within a pharmaceutical company or healthcare consultancy.

Position R&D Regulatory Compliance (Entry level) Department R&D Classification Non-Exempt Reports to Director of R&D and Technical Sales Job type Full-time (on-site) Job Summary This role combines regulatory compliance and hands-on product development within a fast-paced food manufacturing environment. You will support food labeling compliance while also assisting in the creation of innovative seasoning blends alongside the R&D team. Responsibilities include reviewing and preparing product labels and documentation to ensure compliance with FDA, USDA, and international regulations, as well as maintaining accurate records and supporting audits. This is a hands-on, non-routine role ideal for a detail-oriented and motivated individual eager to gain real-world experience in both regulatory compliance and food product development. You’ll collaborate with cross-functional teams and play a key role in bringing new food products from concept to market. Key Responsibilities: • • Assist in creating and reviewing product labels and specifications, • • Ensure compliance with food regulations and customer requirements, • • Support documentation for domestic and international products, • • Research regulations and help resolve labeling questions, • • Work with cross-functional teams (marketing, operations, etc.), • • Maintain accurate records and support audits or compliance checks, • • Help improve internal processes and compliance procedures What We’re Looking For • • Basic knowledge of food labeling regulations (FDA, USDA, and international), • • Strong research and problem-solving skills, • • Detail-oriented with good organization and time management, • • Able to handle multiple tasks and adapt in a fast-paced environment, • • Good communication and teamwork skills, • • Proficient in Microsoft Office (Excel, Word, PowerPoint), • • Bachelor’s degree in Nutrition, Food Science, or related field, • • Some experience or internship in food labeling or regulatory work preferred Why This Role Stands Out This is a rare opportunity to break into the food industry in a meaningful way. You won’t just observe—you’ll actively contribute, learn rapidly, and gain hands-on experience that can accelerate your career. We are looking for individuals who are ready to work hard, stay curious, and grow. Work Location: 1835 Burnet Ave, Union NJ 07083 Compensation/ Benefits • • Competitive base and bonus, • • 401k, • • Medical, Dental, Vision, • • Life Insurance and AD&D, • • 12 Holidays, • • 7 Flexible days, • • 10 Vacation Days and more This is an excellent opportunity to kick-start your career in the field of culin ry research and development. If you are enthusiastic, reliable, and excited about contributing to the creation of unique and flavorful seasoning blends, we encourage you to apply for the Seasoning Blending Lab Technician position." Our Motto: One Team – One Goal The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Furthermore, they do not imply or establish a contract for employment and are subject to change at the discretion of the employer. EEO Statement: Kalustyan Corporation and its subsidiaries is an equal opportunity employer which does not discriminate on the basis of race, color, sex, sexual or affectional preference, gender, sexual orientation, gender identity or expression, religion, creed, ancestry or national origin, age, disability, marital or domestic status, veteran status, genetic information, atypical hereditary cellular or blood trait, or any other protected class. This policy applies to all employment actions including but not limited to, recruitment, selection, training, promotion, transfer, layoff, termination, and job-related social or recreational programs. If you need a reasonable accommodation for any part of the employment process, please contact us by email at hr@kalustyan.com and let us know the nature of your request and your contact inormation Requests for accommodations will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

The Senior Director will represent Company in key stakeholder and strategy meetings on regulatory matters related to medical product development and commercialization, including meetings with executive leadership, meetings with the Food and Drug Administration (FDA) and other regulators. Ability to

Job Description Experience Candidates should possess the following skills: • 3+ years experience driving a forklift and Electric Pallet Jack single pallet., • Bilingual (English/Spanish / Chinese) preferred., • Strong knowledge of working in a Warehouse environment Dry and Cold., • Highly organized, with the ability to manage multiple task., • Forklift Operator is responsible for operating an electric powered industrial forklift to move, locate, relocate, stack, push, pull, tier, and count product and materials. The operator is accountable for the safe and efficient operations of the vehicle in a manner that meets UBL standards for quality, productivity, and accuracy., • Regarding the electric pallet jacks, they are a single-pallet model. Duties and Responsibilities • Receive all inbound raw materials and packaging, • Checks delivered items against the delivery invoice/ P.O.s, • Inspect all received materials for defects, damage, and overall quality, • Ensure compliance with all shipping SOPS, communicating to Warehouse Manager any deviations, • Ensure all shipping paperwork is completed and processed in line with Standard Operating Procedures, • Transfer all raw materials and frozen goods to and from racks and freezer to correct locations, • Assist in periodic inventory counts and adjustments, • Use manual and powered pallet jacks, • Multiple types of powered forklifts are safely operated., • Follow quality, safety and good manufacturing processes (GMPs) are followed, • Comply with FDA, USDA, and HACCP standards, • Communicate with (or to) individuals or groups verbally and/or in writing, • Pull requisitions for Production., • Receive and unload trucks., • Stack and down stack pallets neatly and evenly to ensure safe transport. Equal Opportunity Employer: ATC Healthcare Services is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, age, sex, sexual orientation, gender identity, national origin, veteran or disability status or any other category protected by Federal, State or local law. M/F/D/V EOE

Software Engineer, Infrastructure.AcuityMD is a software and data platform that accelerates access to medical technologies.We help MedTech companies understand how their products are used, why customers vary, and identify opportunities for physicians to better serve their patients.Each year, the FDA

FDA-cleared brain-computer interface technology with personalized telehealth services.Our IpsiHand® device is durable medical equipment that enables chronic stroke survivors to regain upper extremity function with daily home use.Combining this advanced technology with the support of expert clinicia

ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve. WHY JOIN OUR FAST-GROWING TEAM At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team! ABOUT THIS POSITION The Sleep Support Specialist role is for a highly-trained specialist dedicated to optimizing Inspire Upper Airway Stimulation (UAS) therapy outcomes once the system has been implanted. This position provides expertise and leadership in the areas of clinical sleep medicine, specifically polysomnography, PAP therapy and patient care management and is responsible for performing tasks that will ensure the success of Inspire therapy. Through empiric learning and customer interactions, this position will furthermore aid research and development of Inspire UAS therapy. This position must be based in the Kansas City area and this role covers Kansas City, Topeka and Wichita. OPPORTUNITIES YOU WILL HAVE IN THIS ROLE • Assist with customer training for new Inspire UAS commercial & clinical sites., • Train new customers to use the Inspire Programmer System., • Train new customers to use the current Inspire UAS titration algorithm and how to perform Inspire UAS device programming., • Assist with future development and improvements to the UAS titration algorithm., • Develop and research new methods to improve training materials to ensure adequate and efficient training of new commercial and clinical sites., • Provide direct on-site support for Inspire UAS titration sleep studies at night, support daytime education of providers and sleep lab staff and partner with the field team members in driving company initiatives, • Provide remote (via internet or phone) support for Inspire UAS titration sleep studies at night and other troubleshooting appointments., • Assist with coverage of a therapy support phone line as part of an “on-call” coverage team fielding questions from both allied healthcare professionals and patients., • Develop long term relationships with customers to provide high quality and reliable therapy support services., • Work within a changing weekly schedule, which is dependent upon numerous factors including upcoming sleep studies and weekly customer support needs. WHAT YOU CAN BRING TO OUR GREAT TEAM Required: • High school degree or equivalent, • Meet one of the following experience requirements:, • 1+ year of experience in a sleep laboratory as either a sleep technologist or an allied health care professional, with the primary responsibility of sleep apnea care and management, along with a Registered Polysomnographic Technologist certification (RPSGT), Registered Sleep Technologist (RST) certification, and/or a clinical sleep educator certification, • 5+ years of experience in the field of sleep medicine, including having worked a majority of time in a sleep clinic, sleep laboratory or durable medical equipment (DME) company., • Experience manually scoring and/or interpreting sleep studies, • Demonstrated knowledge of at least one polysomnography (PSG) software suite., • Strong understanding and working knowledge of computer programs related to OSA therapy management (electronic medical record (EMR) system, patient tracking system, polysomnography recording software etc.)., • Demonstrated creative and effective problem-solving skills which will be needed to troubleshoot, and support Inspire UAS titration sleep studies., • Ability to travel up to 75+%., • Ability to work varying hours including overnight sleep studies., • Ability to meet any future credentialing requirements. Preferred: • Associates degree, • In depth knowledge of PSG preparation and setup., • In depth knowledge of Continuous Positive Airway Pressure (CPAP) titration as defined by the American Academy of Sleep Medicine (AASM)., • In depth knowledge of Obstructive Sleep Apnea Syndrome (OSA) pathophysiology, diagnosis, treatment and long-term care management. Knowledge of the most current AASM guidelines: The AASM Manual for the Scoring of and Associated Events., • Registered polysomnographic technologist certification (RPSGT), Registered Sleep Technologist (RST) certification, or clinical sleep educator certification. #LI-Remote The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level. Salary $85,000 - $90,000 USD BENEFITS AND OTHER COMPENSATION Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered): • Multiple health insurance plan options., • Employer contributions to Health Savings Account., • Dental, Vision, Life and Disability benefits., • 401k plan + employer match., • Identity Protection., • Flexible time off., • Tuition Reimbursement., • Employee Assistance program., • All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program. Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis. Inspire Medical Systems is an _ employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com Inspire Medical Systems participates in E-Verify.

AcuityMD is a software and data platform that accelerates access to medical technologies. We help MedTech companies understand how their products are used, why customers vary, and identify opportunities for physicians to better serve their patients. Each year, the FDA approves ~6,000 new medical devices. Our solution helps MedTech companies get these products to physicians more effectively so they can improve patient care with the latest technology. We're backed by Benchmark, Redpoint, ICONIQ Growth, and Ajax Health. We’re a high-growth SaaS company scaling rapidly. We are looking for a strongly technical and empathetic engineering leader to lead our Adoption and Value Realization team, focused on driving meaningful user engagement with our existing product functionality and ensuring customers realize clear, demonstrable value from AcuityMD. As the founding manager of this new team, you will be instrumental in guiding the team’s technical investments, achieving product success, growing the team, and mentoring engineers. You will join the engineering leadership team to help shape the culture, processes, and technical investments across engineering. We are looking for a world-class technical and systems thinker and a world-class leader for this highly impactful role. We believe the important aspects of software are deep in the details and lead-from-the-front managers who have an in-depth understanding of their team’s mission, product, and software and its connection to our overall company strategy truly thrive in our environment. The Adoption and Value Realization Team is responsible for driving meaningful engagement across our existing customer base. Our mission is to ensure that each AcuityMD user experiences the value and improved commercial outcomes of AcuityMD weekly or more — broadening consistent usage across our paid subscriber base and deepening usage of our most impactful workflows. This team owns the systems and experiences that connect product value to user behavior — including notifications across email, push notifications, and sms, as well as marketing enablement tooling, value storytelling, and our engagement dashboard. We build the feedback loops, activation surfaces, and insight tools that turn product capability into realized customer outcomes. • Partner with teams throughout the org and directly deliver product experiences that drive measurable increases in engagement and value realization, in close cross-functional partnership, • Partner closely with Product to define, instrument, and improve engagement funnels and feedback loops, • Build systems that enable intelligent notifications, get high-impact insights to our users, and help managers enable their team on the platform, • Lead experimentation and iteration cycles (A/B testing, behavioral insights, activation flows) to continuously improve our user’s AcuityMD engagement and sales outcomes, • Be a strong voice for technical excellence, a passionate advocate for thoughtful software design, and a mentor and coach who inspires engineers to grow, • Drive initiatives across our engineering team to build and reinforce our culture of expansive ownership, individual autonomy, and constant learning through curiosity, • Contribute meaningfully to the growth of each engineer individually and to the team’s overall operating capability, • Facilitate collaboration with other teams to deliver the best solution for the customer regardless of internal lines of ownership, • Take a leadership role throughout the engineering organization, including in our hiring and onboarding processes, • 5+ years of experience as a professional software engineer, • 3+ years of experience as a deeply-technical engineering manager, • Experience leading complex technical projects, • Proven track record of architecting, building, and delivering software, • Strong leadership, collaboration, and communication skills, • Experience working on growth, adoption, activation, or engagement-focused product teams, • Comfort operating in metrics-driven environments with clear ownership over behavioral and usage outcomes, • Strong product instincts and ability to translate ambiguous engagement and value measurement challenges into concrete engineering strategy You must have an eligible work permit in the USA to be considered for this position. AcuityMD is committed to providing highly competitive cash compensation, equity, and benefits. The compensation offered for this role will be based on multiple factors such as location, the role’s scope and complexity, and the candidate’s experience and expertise, market data and may vary from the range provided. Base salary range: $220,000 to $265,000 • Ground floor opportunity: Join a high-growth startup, backed by world-class investors across Enterprise SaaS and Medical Devices (Benchmark, Redpoint Ventures, and Ajax Health)., • Learning Budget: Reimbursements for relevant learning and up-skilling opportunities., • Remote work: AcuityMD is committed to supporting full-remote flexibility for employees in the US. We provide a work-from-home stipend for all employees., • Flexible PTO: Generous time off and flexible hours give you the freedom to do your best work., • Paid Health, Dental, and Vision Plans: We offer 100% paid health, dental, and vision plans for all employees and 75% paid for our employees' dependents., • Home Office Stipend: $1,000 to invest in remote office equipment and WiFi reimbursement., • Optional Team Retreats: We meet in-person multiple times per year for co-working and social gatherings., • Parental Leave: 8-16 weeks of fully-paid, flexible parental leave. The Company: We are builders, who are inspired by our mission to expand patient access to cutting-edge medical technologies. We value working collaboratively to solve hard problems for our customers with simple, innovative solutions. We push ourselves to learn with empathy. We foster an active culture of mentorship and inclusion, and we welcome new team members that share our values. We're backed by Benchmark, Redpoint Ventures, Ajax Health, and several other leading software and medical device investors. Since Acuity launched in 2020, we've brought on customers ranging from publicly traded Fortune 500 companies to innovative growth-stage companies and regional medical device distributors. The Product: AcuityMD uses data and software to help teams collaborate around the complex relationships they have with the users of medical technologies: doctors. Our platform empowers medical technology companies to see how their products are used, understand why outcomes vary, and identify opportunities where physicians or sites of care can better serve their patients. AcuityMD is an Equal Opportunity Employer AcuityMD is seeking to create a diverse work environment because all teams are stronger with different perspectives and life experiences. We strongly encourage people of all backgrounds to apply. We do not discriminate on the basis of race, gender, religion, color, national origin, sexual orientation, age, marital status, veteran status, or disability status. All employees and contractors of AcuityMD are responsible for maintaining a work culture free from discrimination and harassment by treating others with kindness and respect.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Manager, Lifecycle Maintenance will advance the maintenance global clinical regulatory compliance for investigational and marketed products and manage the maintenance of study files in eCTD format. This position will contribute to the organization in the design and conduct of clinical trials in conformance with Health Authority requirements and the management of clinical trial documentation to support clinical submissions. Essential Functions • Lead Lifecycle Maintenance staff by delegating projects, establishing and meeting timelines, and ensuring high quality work products, • Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance., • Provide input to the design and reporting of clinical studies performed by IBRX or by CROs, • Manage the review, cataloguing, and submission of documents including investigator brochures, protocols, informed consent forms, clinical study reports, annual reports, DSURs, PSURs, PAERs, and clinicaltrials.gov entries in the US and abroad, • Manage all protocol supportive documentation including the cataloguing and submission of essential investigator qualification documents, • Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan, • Create and maintain project plans for regulatory lifecycle maintenance operations, • Monitor FDA and other healthauthority guidance, prepare supplemental dossiers, and manage the lifecycle documentation for postapproval changes., • Lead datadriven strategic initiatives to maintain comprehensive regulatory documentation, ensuring compliance and supporting organizational objectives., • Oversee configuration, maintenance, and user support for internal platforms used for file storage., • Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Manage the internal review of the relevant clinical sections of written summaries for regulatory submissions including INDs, NDAs, and BLAs, • Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 7+ years relevant progressive experience required; or, • Master's degree in life sciences or technical discipline with 5+ years relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 3+ years relevant progressive experience required, • Experience managing staff preferred, • Experience in the management and preparation of the submission of clinical modules in eCTD format required, • Experience with organizing responses to Health Authority information requests required, • Familiarity with global regulatory submissions (US and ex-US) strongly preferred Knowledge, Skills, & Abilities • Strong knowledge of Health Authority guidance documents and requirements, • Strong leadership skills with the ability to direct and develop professional staff, • Strong knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval, • This position may need to sit for long periods of time and use various computer programs, • This desk-based role involves the close study of scientific and regulatory documents, • This position will work closely with scientific colleagues throughout the day, often on a project-team basis This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $165,000 (entry-level qualifications) to $181,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

We’re partnering with a design-led consumer hardware company that develops and ships products across DTC, retail, and global distribution channels. They’re hiring a Senior Product Quality Engineer to own product quality across the full product lifecycle and serve as a key partner to engineering, operations, and global manufacturing teams. This is a highly cross-functional, hands-on role where you’ll be responsible for how product quality is defined, measured, and improved in-market. You’ll analyze product performance, returns, and failure trends, drive root cause investigations, and work directly with overseas manufacturers to resolve issues and implement long-term improvements. This is a full-time, permanent position onsite Monday-Thursday in Brooklyn, NY (Dumbo), with Fridays remote. If you are not local, relocation assistance may be available. Responsibilities: • Own product quality across the lifecycle, including in-market performance, returns, failure analysis, and corrective actions, • Analyze product performance data, customer feedback, and field issues to identify trends and drive improvements, • Partner cross-functionally with engineering, operations, and manufacturing teams to resolve product issues and improve reliability, • Work directly with overseas manufacturers and suppliers to drive supplier quality improvements and corrective actions, • Lead supplier quality initiatives including audits, performance tracking, issue resolution, and continuous improvement, • Drive root cause analysis, failure investigations, and hands-on product teardowns, • Support reliability, validation, and lifecycle testing programs, • Own and improve quality systems, reporting, and processes that help drive better product and manufacturing decisions, • Participate in risk management activities including FMEA and related quality documentation, • Support regulatory/compliance conversations and documentation as needed in partnership with internal teams Must-Have Skills: • Bachelor’s degree in Mechanical Engineering or related engineering discipline, • 8+ years of experience working in new product development with Asian suppliers and contract manufacturers with a focus on high-volume electronic consumer products • 4+ years of experience working in quality engineering or quality systems management, • Strong experience owning in-market product quality, including returns, field failures, defect trends, and corrective actions, • Hands-on experience working directly with Asia-based manufacturers / contract manufacturers in high-volume production environments, • Experience with injection molded components and consumer product manufacturing processes, • Strong background in root cause analysis, failure analysis, and supplier quality management, • Experience with electromechanical consumer products, • Familiarity with regulatory/compliance processes (UL, CE, ISO, FDA, etc.) through partnership or support, not necessarily direct ownership, • Strong data orientation with ability to analyze quality trends and translate insights into action, • Comfortable communicating quality risks and recommendations cross-functionally Nice to Have Skills: • Experience with PCBA, motors, or electromechanical systems, • Experience with IPX-rated or moisture-sensitive products, • SolidWorks or CAD familiarity, • Startup or smaller-company experience Benefits: • Competitive medical benefit package, • Commuter benefits for parking & transit, • Competitive paid parental leave policy for qualifying employees, • Year round early “summer Fridays”, • Open vacation policy, • Dog friendly office space, • 401k Tax Benefits, • Competitive compensation package, • Fully stocked kitchen with snacks

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

Territory Sales Representative – Entry Level / Full Time LOWER MANHATTAN Break Into Pharmaceutical Sales with Pivya® at ImpactBio supporting Alembic Therapeutics Looking to launch a career in pharmaceutical sales? This is your opportunity. Alembic Therapeutics, in partnership with ImpactBio, is launching Pivya®, an FDA-approved oral antibiotic for uncomplicated urinary tract infections (uUTIs). Proven for over 40 years in Denmark as a first-line therapy, Pivya® is now entering the U.S. market—and we’re building a team of driven, ambitious sales professionals to support this high-profile launch. As a Territory Sales Representative, you don’t need prior pharmaceutical sales experience—we’re looking for motivated, coachable individuals who are eager to learn, follow a proven sales model, and build a long-term career in the industry. You’ll receive the training, tools, and mentorship needed to succeed while gaining real-world experience calling on healthcare providers. This full-time role is with ImpactBio, a premier commercial partner in Life Sciences, with the potential to transition to Alembic Therapeutics based on strong performance. View Openings & Apply Here _ Why This Role Matters This is more than a sales job—it’s a career entry point into pharmaceutical sales. You’ll be part of a national product launch, gaining experience in a highly competitive industry while developing the skills and discipline needed to grow your career. We’re looking for individuals who are: • Hungry to succeed, • Open to coaching and feedback, • Willing to follow a structured plan, • Ready to put in the work to build something meaningful If that sounds like you, we’ll teach you the rest. Key Responsibilities • Promote Pivya® to healthcare providers within your assigned territory, • Learn and execute a structured sales process and messaging strategy, • Build relationships with physicians, nurses, and office staff, • Consistently apply training and coaching in the field, • Develop and execute territory plans to achieve sales goals, • Provide timely updates, insights, and field feedback to leadership, • Maintain full compliance with all company and industry regulations What We’re Looking For • Bachelor’s degree required, • 1–3 years of sales or customer-facing experience (B2B, retail, service, or related), • A strong desire to break into pharmaceutical or healthcare sales, • Proven work ethic and a track record of meeting or exceeding goals, • Coachability—someone who takes direction well and applies feedback quickly, • High level of motivation, resilience, and accountability, • Strong communication and interpersonal skills, • Ability to work independently while following a defined sales plan, • Willingness to travel extensively within territory, • Valid driver’s license with a clean driving record Pharmaceutical experience is not required—drive, attitude, and willingness to learn are. What We Offer • Competitive base salary with a generous performance-based incentive plan, • Comprehensive Medical, Dental & Vision coverage, • Car allowance & mileage reimbursement, • 401K plan with company match, • Paid time off and holidays, • Structured training program designed to help you break into and succeed in pharmaceutical sales, • Ongoing mentorship and field coaching, • A clear path for career growth and advancement, • The chance to be part of a major U.S. product launch About Alembic Therapeutics Alembic Therapeutics LLC, a U.S. subsidiary of Alembic Pharmaceuticals Inc., is committed to delivering high-quality, patient-focused branded pharmaceuticals. Our mission is to bring innovative, reliable medicines to the U.S. market while upholding the highest standards of safety, efficacy, and quality. About ImpactBio At ImpactBio, we build and launch commercial teams with a focus on performance, development, and long-term success. We’re known for investing in our people and creating opportunities for driven individuals to grow into high-performing professionals in the life sciences industry. The annual base salary for this position is $65,000. Compensation is aligned with the position’s scope and internal pay structure. Apply Now View Openings & Apply Here _ ImpactBio is an affirmative action/equal opportunity employer (Minorities/Females/Veterans/Disabled) We appreciate your interest in our company, however; only candidates meeting qualifications will be considered.

About the Company Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world. About the Role This position reports to the Vice President, Quality Assurance and will manage or support: cGMP compliance assessment of contract manufacturers, the company SOP and Training systems, QA/QC Testing /Audit program, and Quality/Compliance decisions related to the Company’s ANDA products, as well as its products subject to OTC Monographs and FDA or other industry-accepted standards for Dietary Supplements, Medical Foods or Foods for special dietary use. Responsibilities • Perform, support and evaluate third party audits of current and proposed vendors for cGMP compliance, • Manage the SOP system, including writing/ revising and maintaining SOPs, SOP Tracking and SOP Training, • Support market distribution of batches, • Manage the review and resolve batch deviations / Out-of-Specification (OOS) reports and proposed Corrective and Preventative Actions (CAPAs) from manufacturers for Dietary Supplements and Medical Foods, • Manage product quality complaints, • Support FDA audits/inspections of the company or its manufacturing partners, as needed, • Product Quality Reviews, including review of manufacturers' reports of annual product reviews, • Manage change control review of Dietary Supplements and Medical Foods products, • Batch record reviews, as required Qualifications • Bachelor of Science required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology), • Minimum 10 years’ experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems (preferably at least 5 years in a QA-management role), • Ability to travel domestically 3-4 times per year to perform audits on facilities, potential international travel Required Skills • Strong knowledge of quality and compliance for drug production, • Strong knowledge of cGMP regulations (21 CFR 210 and 211 and 21 CFR 110 and 111), • Strong leadership skills, • Excellent attention to detail and organizational skills, • Effective communication and interpersonal skills Pay range and compensation package At Breckenridge Pharmaceutical Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location: • Flexible approach to how we work, • Health benefits and time-off programs, • Competitive compensation packages, • The anticipated annual salary for this role is $120,000 – 145,000 Equal Opportunity Statement Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Director, Clinical Quality Assurance – Biotech in New York About Us Join a cutting-edge biotech business driving the next generation of Cell & Gene Therapy therapies. As the Director of Clinical Quality Assurance, you will play a critical role in establishing the GCP Quality strategy and support multiple clinical studies, directly supporting the development of life-saving therapies. Why Join Us? • Strategic Leadership: Build and lead the Clinical QA function across global clinical programs, • High-Impact Role: Drive GCP compliance, inspection readiness, and quality strategy across early and late-phase studies, • Innovation & Growth: Shape quality frameworks within a cutting-edge cell & gene therapy environment Who We’re Looking For We’re seeking an experienced Clinical QA leader who thrives in global environments. You bring deep GCP expertise, a strategic mindset, and a proven ability to lead teams while influencing cross-functional stakeholders. Your Role & Impact As Director, Clinical Quality Assurance, you will: • Define and execute Clinical QA strategy across the full clinical development lifecycle, • Provide oversight of GCP compliance, • Lead inspection readiness activities and support Health Authority inspections, • Drive risk-based quality management and continuous improvement initiatives, • Act as a subject matter expert for GCP quality assurance across the organization Key Qualifications • Bachelor’s degree in Life Science or similar, • 10+ years of GCP expertise in Biotech / Pharma, • Knowledge of global GCP regulations (FDA, EMA, ICH) and GxP frameworks What We Offer Join a mission-driven biotech organization at the forefront of innovation in cell and gene therapy. You’ll have the opportunity to shape global quality strategy, lead high-impact initiatives, and work in a collaborative environment focused on delivering meaningful outcomes for patients. Get in Touch If this opportunity is of interest, please reach out to Guled Samatar at Meet Life Sciences • Call: 646-582-3675, • Email: guled.samatar@meetlifesciences.com

Territory: Manhattan N, NY – Key Residences: Westchester, Bronx Remote with 40-50% Travel LENZ Therapeutics is excited to be expanding its sales team! Looking to join LENZ as a Specialty Sales Representatives to lead the launch of a groundbreaking product in the ophthalmic presbyopia market? New specialty sales territory positions are now open across the U.S. LENZ Therapeutics is a pharmaceutical company focused on the commercialization of VIZZ® (aceclidine ophthalmologic solution) 1.44%, the first and only FDA-approved aceclidine based eye drop for treating presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. LENZ is commercializing VIZZ® in the United States and continues to establish licensing partnerships internationally to provide access to VIZZ globally. The company is headquartered in San Diego, California. We are committed to providing an engaging, rewarding work experience that reflects the passion our employees bring to our mission to improve and sustain vision. Our company fosters a diverse and inclusive culture where our employees are encouraged to learn, grow, and innovate, while making a meaningful difference for millions of people around the world. LENZ provides equal employment opportunities to all employees and applicants. Overall Purpose: We are hiring frontline sales professionals to launch a product in the ophthalmic presbyopia market. The Specialty Sales Representative will be responsible for territory disease state education along with the launch and ongoing growth of LENZ Therapeutics product portfolio. They will deliver high standards for the ongoing launch and will champion a culture of outstanding performance, compliance and full ownership of all activities and results. The Specialty Sales Representative will be experts in sales execution, resource utilization, account management, business ownership, and will build/foster relationships with key eye care customers. They will relentlessly pursue excellence to maximize sales in their territory while learning to adapt to changes and needs of the business. This critical sales role will be ideal for someone who thinks strategically, operates with tactical precision, and strives for excellence. Key Responsibilities of the Role: • Expert in selling skills and account development including building relationships with targeted physicians. Optometrists & Ophthalmologists., • Drive execution by exceeding sales performance goals and key productivity metrics across the territory., • Use analytical skills to guide highly productive activity, prioritize key customer engagements, drive reach and frequency to extend depth and breadth of product trial and utilization., • Understand all functions within ophthalmology/optometry practices and how their roles impact product prescribing and pull through., • Complete knowledge in eye care clinical information: Ocular anatomy, disease state, products, and office treatment patterns., • Ensure actionable business plans are set and align all selling activities to drive impact., • Personal accountability for driving the highest standards of ethics and compliance., • Maximize all key resources that lead to territory success., • Achieve success and be prepared to adapt in a selling environment partnering with many stakeholders: district managers, marketing, medical affairs, sales ops, inside sales, and training., • Share ongoing best practices among peers and leadership to elevate national performance., • Ensure PDMA compliance and adhere to all company and industry compliance guidelines., • Highly adaptable to change, able to quickly pivot, and respond to new market information in a fast-paced environment., • Strong communication and change management skills. Additional Dimensions: • This position will be field based (remote). Candidate must live within the assigned territory, • Travel will be required within the selling territory & beyond to sales meetings, customer conventions & to headquarters in San Diego, CA., • Up to 40-50% Travel Required in some larger territories, • This position reports directly to the District Manager. Travel within the selling geography, sales meetings, conferences, customer meetings, and our corporate headquarters in San Diego, CA will be required. Physical Demands and Work Environment Typically works in an office environment and at ophthalmic practitioner’s locations. May, on a continuous basis, sit at desk for a long period of time, intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. Must be flexible to work varying schedules and hours as needed. Frequent out-of-town travel will be required. The physical demands described above 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. Salary Range • $110,000 - $140,000 per year, based on successful sales experience in pharma, eye care pharma, & vision care At Lenz, we understand the importance of attracting and retaining top talent. In addition to a competitive base pay, we offer an incentive bonus, stock equity, and comprehensive benefits. Qualifications Education and Experience • Bachelor's degree in business, marketing, or a related field., • 2+ years of experience in pharmaceutical sales with a proven track record of success - required., • Proven track record of pharmaceutical launch experience strongly preferred., • Eye Care experience – strongly preferred

Company Description Lagniappe Foods is a dynamic and forward-thinking food production company dedicated to providing high-quality food products to meet the diverse needs of our customers. We pride ourselves on delivering excellence while adhering to the highest standards of safety and sustainability. As a growing organization, we value innovation, teamwork, and a commitment to continuous improvement in every aspect of our operations. Joining Lagniappe Foods means contributing to a brand that is passionate about quality and customer satisfaction. Role Description The Assistant Quality Assurance Manager will support the quality assurance team in ensuring food products meet regulatory and company standards. Key responsibilities include overseeing quality control processes, reviewing compliance with safety protocols, conducting inspections, preparing reports, and assisting in the development of quality improvement initiatives. This is a full-time, on-site role located in Orange, NJ, requiring hands-on involvement in daily operations. Qualifications • Quality Assurance and Control skills, including knowledge of quality management systems and ability to implement quality standards, • Experience with regulatory compliance and food safety standards, such as HACCP and FDA regulations, • Strong analytical skills for identifying issues, problem-solving, and implementing corrective actions, • Excellent communication and leadership skills for team collaboration and providing clear guidance, • Proficiency in creating reports and analyzing data to monitor processes and improve performance, • Attention to detail and the ability to work under pressure in a fast-paced environment, • Bachelor’s degree in Food Science, Biology, Chemistry, or a related field, • Prior experience in food production or quality assurance is highly desirable

Director, GMP Quality Assurance Location: Remote EmploymentType: Contract (9-12 months+) Hourly Rate - $100-125HR Scientific Search has partnered with an innovative biotechnology organization seeking an experienced Director, GMP Quality Assurance to provide strategic and operational QA leadership supporting biologics manufacturing, analytical testing, stability programs, and external partner oversight. This individual will play a key role in ensuring GMP compliance, supporting quality systems, and driving cross-functional collaboration across manufacturing, quality control, regulatory, and supply chain activities within a fast-paced clinical-stage environment. Responsibilities Manufacturing & Analytical QA Oversight • Provide GMP QA oversight for drug substance and drug product manufacturing activities conducted at external CMOs, including batch record review and approval, • Review and approve GMP analytical methods, test protocols, and associated documentation generated at external contract laboratories, • Provide quality partnership and oversight for biologics manufacturing, testing, and product disposition activities, including combination products Stability Program QA Oversight • Provide QA oversight of stability programs for drug substance and drug product activities, including review and approval of stability protocols, reports, and supporting data, • Partner with Clinical QC teams to ensure stability study design and execution align with ICH guidelines and applicable regulatory commitments Reference Standard QA Oversight • Oversee QA activities related to reference standard qualification, characterization, and requalification, • Review and approve reference standard protocols and reports while ensuring proper chain of custody, storage, and release documentation General QA & Cross-Functional Collaboration • Support compliance within Quality Management Systems and external CDMO manufacturing/testing operations in accordance with FDA and global GMP regulations, including 21 CFR Parts 4, 210, 211, 820 and EU GMP guidelines, • Collaborate cross-functionally with CMC, Manufacturing, Analytical Testing, Quality Control, Regulatory CMC, Clinical Operations, and Supply Chain teams, • Review and verify quality-related documents, records, protocols, reports, and data supporting biologics programs and products, • Identify, assess, and escalate quality risks while driving compliant resolutions and continuous quality improvement initiatives, • Contribute to the development and refinement of quality processes, procedures, and organizational quality culture Requirements • Bachelor’s degree in scientific discipline or related field required, • 10–15 years of progressive GMP Quality Assurance experience within biotech, pharmaceutical, or biologics environments, • Strong experience overseeing external CDMO/CTO manufacturing and testing operations, • Hands-on expertise supporting QA oversight of QC operations, manufacturing, analytical testing, and supply chain activities, • Strong working knowledge of FDA and global GMP regulations and quality systems, • Experience supporting biologics and/or combination products strongly preferred, • Excellent communication, collaboration, and problem-solving skills within matrixed organizations, • Ability to support occasional evening meetings based on business needs How To Apply We’d love to see your resume, but we don’t need it to have a conversation. Email tom@scientificsearch.com or message me directly to learn more. • REMOTE

Job DescriptionNow Hiring: Inventory Associates – Pharmaceutical Manufacturer Please read the entire post; application instructions are located at the very bottom. ¡Sí, hablamos español! Shifts Available:1st Shift: 7:00 AM – 3:15 PM 2nd Shift: 3:00 PM – 11:15 PM 3rd Shift: 11:00 PM – 7:15 AM Pay Rate: $20.00 per hour Locations: • East Hanover, NJ, • Whippany, NJ Job Responsibilities • Perform daily inventory counts and reconcile discrepancies in the warehouse management system (WMS)., • Receive, inspect, and verify inbound pharmaceutical materials against packing lists and purchase orders., • Store, organize, and label inventory according to lot numbers, expiration dates, temperature requirements, and GMP guidelines., • Pick, stage, and prepare materials for production and order fulfillment while maintaining full traceability., • Monitor product shelf life and identify soontoexpire or nonconforming inventory for quality review., • Maintain accuracy when using RF scanners and material handling equipment (training provided)., • Follow all cGMP, FDA, and company SOPs to ensure compliance and product integrity., • Keep work areas clean, organized, and compliant with pharmaceutical safety and sanitation standards., • Collaborate with warehouse, production, and quality teams to support efficient material flow.This role requires strong attention to detail, accuracy, and strict adherence to safety, quality, and regulatory standards. Requirements • Background check and drug test may be required., • Ability to work in a fastpaced, GMPregulated warehouse environment., • Noise levels may range from moderate to high. What to Bring When Applying • Valid forms of ID that authorize you to work in the United States. Ready to Get Started? Call us today: 9737509000 ️‍ Walkins Welcome! Office Location:159 Speedwell Avenue Morristown, NJ 07960 Hours:Monday – Friday, 8:00 AM – 12:00 PM (Hours may vary; please call ahead to confirm.) #ZIP

Summary We are seeking an experienced Manufacturing Process Engineer with experience in powder-based manufacturing, with a strong chemistry background to lead and optimize manufacturing operations. This role is responsible for the design, improvement, and oversight of production processes, ensuring efficiency, quality, safety, and regulatory compliance. The ideal candidate combines hands-on plant experience with technical leadership, customer interaction, and cross-functional collaboration to drive continuous improvement across operations. Key Responsibilities • Design, develop, test, and improve mechanical systems, equipment, and process applications., • Analyze and optimize chemical and manufacturing processes to increase throughput, improve efficiency, and reduce waste., • Schedule and manage production operations involving blending, milling, drying, and screening equipment for maximum efficiency., • Lead employees across production and technical operations., • Oversee preventive maintenance and downtime activities to ensure operational reliability., • Conduct client laboratory testing, including data intake, feasibility studies, process development, optimization, and final reporting; ensure high client satisfaction., • Perform root cause analysis on process failures and implement corrective and preventive actions., • Manage operational budgets and present performance metrics and financial results to leadership., • Collaborate with operations, R&D, quality, and regulatory teams to implement new or improved processes., • Develop, maintain, and manage technical documentation, including SOPs, certifications, regulatory filings, and compliance records., • Ensure full compliance with FDA, DEP, EPA, cGMP, SQF, and other applicable regulatory and safety standards. Qualifications • Bachelor’s degree in Chemical Engineering, Process Engineering, or a related field., • Minimum of 5+ years of process engineering experience, • Experience in powder-based manufacturing within pharmaceutical, nutraceutical, cosmetic, or chemical industries., • Hands-on experience with laboratory equipment, including particle size analyzers, microscopes, moisture balances, and scales., • Proven ability to work directly with customers and present technical findings., • Strong understanding of chemical engineering fundamentals, including fluid dynamics, thermodynamics, and heat transfer., • Knowledge of industrial electrical control panels and their integration with manufacturing equipment., • Strong regulatory background, with responsibility for maintaining FDA, DEP, EPA, cGMP, SQF, and related programs., • Proficiency with CAD and process simulation software is a plus., • Excellent analytical, problem-solving, and organizational skills.

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. 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 _.

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles. Empowering the world starts with living _ and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office. We are seeking a Senior Product Manager – Heart Health to join our growing Health Sensing organization. Reporting to the Director of Product Management, Health Risk Detection, this role will focus on advancing Oura’s cardiovascular health experiences, from proactive monitoring to long-term heart health insights. You’ll join an established, cross-functional team dedicated to Heart Health. You’ll collaborate with Science, Design, Engineering, and Regulatory partners to accelerate our roadmap, deepen member value, and bring science-backed heart health features to life. This is a high-impact opportunity to help shape how millions of people understand and care for their cardiovascular health through wearable technology. • Partner closely with Science and Engineering teams to define and deliver next-generation heart health sensing and signal analysis capabilities, • Translate scientific findings and physiological concepts into intuitive, meaningful product experiences that empower members to better understand their heart health, • Support discovery and development of new features spanning both wellness and regulated use cases, • Contribute to the prioritization and delivery of roadmap initiatives, balancing scientific feasibility, user impact, and business opportunity, • Partner with Design to create user experiences that communicate complex heart health data with simplicity and empathy, • Collaborate with Regulatory, Legal, and Quality teams on product strategies that align with applicable regulatory frameworks, • Communicate progress, insights, and tradeoffs effectively to leadership and cross-functional stakeholders, • Contribute to the broader Health Risk Detection strategy and align heart health workstreams with Oura’s mission to empower proactive health ownership This is a remote US role with a preference for east coast time zone. Openness to flexible hours to support cross-time-zone collaboration with teams in Europe and the U.S. REQUIREMENTS We would love to have you on our team if you have: • 5+ years of product management experience, ideally in connected health, digital biomarkers, or wearable sensing., • Experience delivering products or research-based features in cardiovascular health, fitness, or related physiological domains., • Strong understanding of key cardiovascular signals (e.g., HRV, ECG, PPG, blood pressure estimation) and their application in consumer or regulated products., • Proven success translating early-stage scientific research into member-facing experiences., • Familiarity with the nuances between wellness and medical-grade products; experience with FDA or other regulatory processes is a plus., • Excellent collaboration and communication skills with scientists, engineers, designers, and clinicians., • A passion for helping people live longer, healthier lives through actionable, science-backed insights. BENEFITS At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health. What we offer: • Competitive salary and equity packages, • Health, dental, vision insurance, and mental health resources, • An Oura Ring of your own plus employee discounts for friends & family, • 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off, • Paid sick leave and parental leave Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future. • Region 1: $172,550 - $203,000, • Region 2 $158,950 - $187,000, • Region 3 $147,900 - $174,000 A recruiter can determine your zones/tiers based on your US location. We are not considering candidates residing in the following states: Alaska (AK), Arkansas (AR), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), Rhode Island (RI), South Dakota (SD), Vermont (VT), West Virginia (WV), and Wisconsin (WI). Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics. We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Disclaimer: Beware of fake job offers! We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note: • Our jobs are listed only on the ŌURA Careers page and trusted job boards., • We will never ask for personal information like ID or payment for equipment upfront., • Official offers are sent through Docusign after a verbal offer, not via text or email. Stay cautious and protect your personal details. To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.

Job Locations US-NY-NEW HYDE PARK ID 2026-188133 Line of Business Amerita Position Type Full-Time Pay Min USD $25.00/Hr. Pay Max USD $30.00/Hr. Amerita Prepares technical and clerical tasks associated with the preparation, labeling and dispensing of pharmaceuticals. Plays an integral role in the inventory and quality assurance activities. Schedule: Monday - Friday 9:00am - 5:30pm with rotating Saturday • Competitive Pay, • Health, Dental, Vision & Life Insurance, • Company-Paid Short & Long-Term Disability, • Flexible Schedules & Paid Time Off, • Tuition Reimbursement, • Employee Discount Program & DailyPay, • 401k, • Pet Insurance Coordinates and facilitates new referrals and admissions through collaboration with nurses, customer service and distribution • Conducts and documents initial and ongoing assessment of specific patient, drug and disease information to identify real and potential drug-related problems or needs, • Escalates to a clinician as needed, • Answers inquiries from patients, families, physicians and other healthcare professionals. Escalates to a clinician as needed, • Maintains thorough and appropriate documentation in the customer/patient record of all clinical activities and communication with patients, physicians and other healthcare professionals, • Coordinates and schedules the preparation of IV therapies and home medical equipment orders with the assistance of the Pharmacist, • Helps coordinate patient care activities with Pharmacists, Nurses, other Technicians and Patient Care Coordinators, • Prepares labels, prescriptions and compounding/mixing worksheets and completes and maintains product lot numbers, expiration dates and batch records, • Generates delivery/pick slips under the supervision of the Pharmacist. Picks and pulls supplies and home medical equipment, • Obtains supply inventories from patients/clients and communicates information obtained to the Pharmacist as required and documents all communication in patient progress notes on the pharmacy computer system, • Participates in branch management, department and intra-departmental meetings and quality improvement activities, • Adheres to all accreditation, OSHA, FDA, state, local and federal regulations and standards relevant to infusion pharmacy and home medical equipment, • Other duties as assigned, • Supervisory Responsibility: No, • Successful completion of an approved/accredited pharmacy technician training program; IV certification preferred, • Registered Pharmacy Technician license in state of practice per state regulations, • National Pharmacy Technician Certification as required by the state board of pharmacy in state of practice, • One to three (1-3) years of related pharmacy experience in a home care setting, retail, or pharmacy setting, • General knowledge of drug terminology, pharmaceutical calculations, drug use and aseptic techniques, • Flexible schedule with the ability to work on-call evenings and weekends on an as-scheduled basis, • Effective mathematical and communication skills required, • Basic pharmacy knowledge of reading and interpreting prescriptions, • Ability to work independently, accurately, and efficiently To perform this role will require constant sitting and typing on a keyboard with fingers, and occasional standing, and walking. The physical requirements will be the ability to push/pull and lift/carry 10-30 lbs Amerita, an affiliate of BrightSpring Health Services, is a specialty infusion company focused on providing complex pharmaceutical products and clinical services to patients outside of the hospital. Committed to excellent service, our vision is to combine the administrative efficiencies of a large organization with the flexibility, responsiveness, and entrepreneurial spirit of a local provider. For more information, please visit www.ameritaiv.com. Follow us on Facebook, LinkedIn, and X. USD $25.00 - $30.00 / Hour

Senior Clinical Project Manager - Inflammation/ Phase 2b (Sponsor Dedicated - Remote; Preference for Hybrid Foster City, CA ) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Preference for Hybrid Foster City, CA-Based Candidates Are you a senior clinical operations professional who knows how to independently lead complex global clinical trials from start-up through closeout - while still staying deeply connected to the operational details that drive execution success? This is a highly visible opportunity supporting large-scale global Phase 2b inflammation programs within a sponsor-dedicated environment. The ideal candidate brings both strategic global trial leadership and a hands-on operational mindset - someone who can confidently lead international cross-functional teams, oversee global vendors and CROs, and still comfortably work "in the weeds" to proactively solve problems, remove roadblocks, and keep studies moving forward. This role is best suited for a Senior Clinical Project Manager who thrives in fast-paced, high-accountability environments where timelines move quickly, priorities shift often, and strong execution is critical. You will play a central role in driving operational excellence across complex global studies spanning multiple regions and stakeholders. While remote/home-based candidates may be considered, priority will be given to candidates located in or near Foster City, California, with the ability to work onsite 2-3 days per week. Opportunity to lead highly visible, large-scale global Phase 2b clinical programs with significant strategic and operational impact Exposure to complex international trial execution across North America, Europe, APAC, Japan, and China Significant ownership and autonomy with the expectation to independently drive studies from start-up through closeout Ability to influence operational strategy while remaining deeply involved in day-to-day execution Collaborative sponsor-dedicated environment with engaged leadership that values partnership, communication, and professional growth Work alongside experienced global clinical operations professionals in a highly supportive and team-oriented culture Fast-paced environment that values accountability, urgency, collaboration, and executional excellence Excellent opportunity for senior Clinical Project Managers seeking broader global responsibility, increased visibility, and continued advancement within clinical operations leadership Global Clinical Trial Leadership & Execution Independently lead complex global clinical trials from study start-up through database lock and closeout Drive operational execution across multiple international regions while maintaining alignment to global study strategy and timelines Maintain deep operational oversight across all aspects of study execution - this is not a "high-level only" oversight role Operate effectively both strategically and tactically, balancing big-picture program leadership with hands-on operational involvement Proactively identify global operational risks, regional challenges, and study execution issues while driving resolution plans forward Ensure study deliverables, milestones, and timelines remain on track within fast-paced development environments Lead global study execution efforts across cross-functional stakeholders, vendors, CROs, and regional teams Global Vendor & CRO Oversight Provide strong oversight and accountability management for global CROs and external vendors Lead vendor governance discussions, escalation management, and performance oversight activities Drive operational follow-through and execution accountability across external partners Contribute to vendor strategy, resourcing discussions, and operational planning activities Navigate complex global vendor relationships across multiple regions and time zones Cross-Functional Global Leadership Lead large, matrixed global cross-functional teams within highly collaborative clinical development environments Facilitate effective meetings with clear agendas, decision-making, accountability, and follow-up Build strong partnerships across Clinical Operations, Data Management, Regulatory, Safety, Medical, and external stakeholders Communicate confidently with senior leadership while effectively managing competing priorities and stakeholder expectations Mentor junior team members and contribute to a collaborative, solutions-oriented team culture Study Operations & Clinical Program Management Oversee development and review of key study documents including protocols, informed consents, monitoring plans, investigator brochures, and clinical study reports Support global study planning, forecasting, budget management, and resource coordination Review operational metrics, study data listings, enrollment trends, and study performance indicators Ensure alignment across regional operational requirements and global study objectives Contribute to process improvement initiatives, SOP development, and operational best practices Required Qualifications Significant Clinical Operations and global clinical trial management experience within CRO, biotech, or pharmaceutical environments Proven success independently leading complex global clinical trials from start-up through closeout Strong experience managing large-scale international studies across multiple global regions Demonstrated expertise leading global cross-functional teams and managing complex stakeholder environments Strong vendor oversight and CRO management experience with the ability to drive accountability and execution Ability to operate effectively at both strategic and tactical levels, including deep involvement in operational study details Excellent organizational, communication, risk management, and problem-solving skills Proven ability to manage competing priorities and maintain executional excellence in fast-paced clinical development environments Strong leadership presence with high emotional intelligence and the ability to build credibility across teams and leadership levels Experience navigating complex global operational challenges, timelines, and regional considerations Preferred Qualifications Phase 2b global study leadership experience strongly preferred Inflammation therapeutic area experience preferred Experience managing studies across APAC, Japan, and China regions Experience within sponsor-dedicated or embedded sponsor models Stable career progression demonstrating increasing ownership, operational leadership, and global study complexity Ability to thrive in highly collaborative, high-visibility, and high-accountability environments This team values collaboration, transparency, accountability, and execution. Leadership is highly engaged, approachable, and supportive, while also maintaining high expectations around ownership and operational excellence. The environment is fast-moving and highly interactive, making it an ideal fit for professionals who enjoy being actively involved in solving problems, driving execution, and partnering closely with teams across the globe. The strongest candidates for this role are individuals who naturally take initiative, communicate proactively, stay calm under pressure, and are comfortable leading highly complex studies while remaining deeply connected to operational execution details. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. _ Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

About Sequel Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel’s flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management. We are seeking a Salesforce System Engineer to serve as the technical lead and solution architect for our CRM platforms. This individual will own the system design, configuration standards, and technical implementation of Salesforce Health Cloud, Sales Cloud, and related solutions. As a key technical partner to the Salesforce Product Manager, you will translate business requirements into scalable, secure, and future-ready solutions. You’ll collaborate with cross-functional teams (Commercial, Clinical Ops, Customer Support, Data/Integration, and IT Security), ensure platform performance, guide platform enhancements, and lead the technical delivery of a HIPAA-compliant CRM that supports our rapid growth. This role blends architectural thinking, configuration expertise, integration design, and hands-on build. • Platform Architecture & Design Lead the system architecture and technical design of Salesforce Health Cloud and Sales Cloud solutions. Define data models, object relationships, sharing rules, and platform integration patterns. Ensure alignment between business goals, product roadmaps, and scalable system architecture., • Configuration & Technical Implementation Translate functional requirements into robust technical designs and declarative solutions. Implement and optimize Flows, Process Builder, Custom Objects, Page Layouts, Validation Rules, and Permissions. Review and guide Apex code and Lightning component development (via internal or external developers)., • Integration & Data Engineering Support Partner with data and integration teams on APIs, ETL pipelines, and external data connections (e.g., Snowflake, S3, MuleSoft). Design secure, scalable, and performant integration architectures between Salesforce and adjacent systems., • Release Management & Change Control Coordinate with the Product Manager to plan and execute platform releases, enhancements, and testing cycles. Support change control processes including sandbox management, deployment automation, and documentation. Identify and resolve deployment risks and cross-environment dependencies., • Compliance, Security & Governance Ensure the Salesforce environment adheres to HIPAA, FDA, and internal security and data retention requirements. Partner with IT Security and Compliance to implement appropriate encryption, access controls, and audit logging., • Documentation & Support Create technical documentation for configurations, data models, and integrations. Mentor admins or junior engineers, and support troubleshooting as a Tier 3 resource for Salesforce issues., • Bachelor’s degree (4-year) in Computer Science, Engineering, Information Systems, or related technical discipline preferred, or equivalent combination of education and experience., • 5+ years of experience as a Salesforce System Engineer, Technical Consultant, or Solution Architect., • 3+ years working directly with Salesforce Health Cloud and/or Sales Cloud in regulated environments., • Active Salesforce certifications (e.g., Platform App Builder, Advanced Administrator, Data Architect, or Integration Architect) are strongly preferred., • Deep understanding of Salesforce declarative tools (Flows, Permissions, Object Model, Profiles, Sharing Settings)., • Experience integrating Salesforce with external platforms using REST/SOAP APIs, middleware, or file-based data loads., • Knowledge of Apex, SOQL, Lightning Web Components (LWC), and deployment tools (Change Sets, VS Code, DevOps Center, or CI/CD pipelines)., • Familiarity with Salesforce Connect, External Objects, data sync strategies, and error handling., • Experience in designing and optimizing data models for both B2B and B2C use cases., • Strong working knowledge of HIPAA and data privacy standards., • Experience supporting technology in med-tech, healthcare, or other FDA-regulated domains preferred., • Strong systems thinking, documentation skills, and the ability to break down complex requirements., • Ability to collaborate effectively with business users, architects, and technical partners., • Comfortable in fast-paced environments where flexibility and initiative are key., • Proven track record managing cross-functional projects and facilitating workshops or requirement sessions., • Comfortable working in Agile environments and using tools like Jira or Aha! for backlog and roadmap management. $150,000 - $165,000 a yearSequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. At Sequel, we believe that when you thrive, we thrive. That’s why our benefits package is designed to support you from day one. You’ll be automatically enrolled in our 401k plan, featuring a 6% company match and 100% immediate vesting. We’re committed to your well-being and understand the unique needs of employees and families living with diabetes, so we offer capped out-of-pocket insulin costs and GLP-1 coverage across all plans. You’ll have access to a variety of Meritain health insurance plans to suit your needs and can also take advantage of Flexible Spending Accounts (FSAs) or Health Savings Account (HSA). Our comprehensive benefits package includes vision and dental coverage, plus voluntary options such as long-term disability, accident, critical illness, hospital indemnity, and even discounts for pet care. In addition, we provide employer-paid short-term disability and life insurance for extra peace of mind. We know the importance of taking time to rest and recharge. That’s why Sequel offers flexible PTO, generous paid holidays, and Flex Time options to help you balance work and life when you need it most. Our team enjoys a culture built on hard work, fun, and genuine support. At Sequel, you’re not just starting a job, you’re building a rewarding career and a brighter future. Join us, and let’s thrive together! 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 Physical requirements such as lifting specific weights Some travelling is expected

Are You Ready?CAI is a 100% employee-owned professional services company established in 1996 that has grown year over year to nearly 850 people worldwide. For mission critical and FDA-regulated industries that need to deliver high-stakes solutions, we provide commissioning, qualification, validation, start-up, project management, and consulting services focused on operational readiness and performance excellence. Our approach is simple because our Purpose informs everything we do:We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.At CAI, we are committed to living our Foundational Principles, both professionally and personally:- We act with integrity- We serve each other- We serve society- We work for our future As owners, our shared success drives our team-first approach. We put clients’ interests first, never stop until it's right, and do whatever it takes to get there. CAI agents work with cutting-edge technologies in advanced medicine and regulated facilities. You will have opportunities to engage with leading experts, participate in hands-on certifications, and make a direct impact by helping bring life-saving therapies to market. Our collaborative, values-driven culture ensures delivery of excellence across all services. Job Summary:The Associate Product Manager is an individual contributor role supporting the execution and operational management of CAI’s digital product portfolio. This role the digital product team and is responsible for driving roadmap execution, coordinating cross-functional deliverables, and ensuring alignment between regional stakeholders and the digital product team. The Associate Product Manager serves as a project lead for roadmap initiatives, manages product-related requests from CAI regions as internal “accounts,” and supports marketing, sales enablement, and delivery tracking activities. This role requires a highly motivated, self-directed professional capable of independently managing priorities while informally leading small project teams and working groups. Key Responsibilities:1. Roadmap Execution & Project Management- Manage tasks and activities associated with digital product roadmap initiatives. - Break down roadmap epics into actionable tasks, track timelines and dependencies, and manage delivery progress. - Coordinate cross-functional contributors including development, marketing, sales, and operations. - Identify risks, escalate issues appropriately, and drive resolution. - Ensure deliverables meet defined scope, timeline, and quality expectations. 1. Regional Account Management- Manage CAI regions as an internal account. - Manage intake, prioritization, and tracking of regional requirements, requests, and support needs. - Coordinate resources to deliver solutions, ensuring alignment with overall product strategy and roadmap priorities. - Maintain transparency with regional leaders regarding status, trade-offs, and timelines. - Stakeholder Engagement & Requirements Management - Participate in stakeholder meetings to gather requirements, define business needs, and document outcomes. - Facilitate requirements gathering sessions and contribute to solution design discussions. - Develop process maps, user workflows, and functional documentation as needed. - Manage meeting actions, decisions, and follow-ups to ensure accountability and execution., 2. Marketing and Sales Enablement Support- Manage execution of marketing deliverables associated with product launches and updates.- Develop and maintain marketing collateral, product one-pagers, pitch decks, and sales support content.- Support go-to-market activities in coordination with product and commercial leadership.- Assist in creating value messaging aligned with regional and market needs., 3. Training and Enablement- Support development and ongoing updates of user training materials and sales enablement resources for the digital portfolio.- Coordinate training sessions and ensure materials reflect current product capabilities.- Collect feedback from users and sales teams to continuously improve enablement materials.- Maintain Knowledge Management libraries as part of the Digital Community of Practice, 4. Commercial and Delivery Tracking- Track digital product opportunities, proposals, and active delivery projects.- Maintain reporting dashboards and summary metrics for leadership visibility.- Support pipeline management and ensure alignment between product availability and sales commitments. Qualifications:Required:- Bachelor’s degree in Business, Engineering, Life Sciences, Information Systems, or related field.- 3–5 years of experience in product operations, project management, account management, customer support or related discipline.- Demonstrated ability to independently manage multiple concurrent initiatives.- Experience coordinating cross-functional teams without formal authority.- Strong organizational and follow-through skills.- Excellent written and verbal communication skills.- Proficiency in Microsoft Office tools, Sharepoint, Teams Preferred:Project Management (Agile or Waterfall) #LI-MV1$85,000 - $105,000 a yearAverage base salary range - not including benefits and bonus. CAI Benefits:•Comprehensive Health Insurance coverage•24 days of Paid Time Off•ESOP/401K - 15% Company Contribution (US Only)•Company paid Life Insurance•Company paid Long Term DisabilityWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Are You Ready?CAI is a 100% employee-owned professional services company established in 1996 that has grown year over year to nearly 850 people worldwide. For mission critical and FDA-regulated industries that need to deliver high-stakes solutions, we provide commissioning, qualification, validation, start-up, project management, and consulting services focused on operational readiness and performance excellence. Our approach is simple because our Purpose informs everything we do:We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.At CAI, we are committed to living our Foundational Principles, both professionally and personally:- We act with integrity- We serve each other- We serve society- We work for our future As owners, our shared success drives our team-first approach. We put clients’ interests first, never stop until it's right, and do whatever it takes to get there. CAI agents work with cutting-edge technologies in advanced medicine and regulated facilities. You will have opportunities to engage with leading experts, participate in hands-on certifications, and make a direct impact by helping bring life-saving therapies to market. Our collaborative, values-driven culture ensures delivery of excellence across all services. Job Summary:We are seeking an experienced and execution-focused Product Manager to serve as the owner of CAI’s expanding toolkit of digital products and services. In this role, you will drive innovation, alignment, and delivery of configurable, scalable, and compliant digital solutions that support operational readiness and operational excellence in regulated industries. You will own the full product lifecycle, act as Product Owner within Agile teams, and ensure successful delivery from intake through launch and continuous improvement. Key Responsibilities:1. Project & Delivery LeadershipOwn and drive end-to-end execution of digital product initiatives from intake through launch, ensuring delivery aligns with business and customer outcomes.Lead planning, scheduling, and coordination across cross-functional teams, managing dependencies, milestones, and deliverables.Develop and maintain delivery artifacts including delivery plans, RAID logs, milestone tracking, and action registers.Proactively identify risks, escalate issues as needed, and drive mitigation strategies to protect delivery commitments.Serve as the central owner for execution, ensuring work progresses efficiently and priorities remain aligned. 1. Product Strategy & Portfolio ManagementDefine and evolve the vision, strategy, and roadmap for CAI’s digital toolkit in alignment with business objectives and customer needs.Prioritize and manage a product backlog spanning multiple digital products and service components.Own the full product lifecycle from concept through deployment and continuous improvement, ensuring delivery of measurable business value., 2. Agile Product Ownership & ExecutionAct as Scrum Product Owner across one or more Agile teams, maintaining delivery momentum and achieving sprint goals.Translate business needs into clear epics, features, and user stories with defined acceptance criteria.Lead backlog refinement, sprint planning, reviews, and retrospectives in partnership with Scrum teams.Make real-time trade-off decisions to balance scope, risk, schedule, and value.Monitor sprint progress and velocity, adjusting plans as capacity or priorities change., 3. Stakeholder Management & Cross-Functional CollaborationFacilitate alignment and decision-making across operations, subject matter experts, regulatory advisors, technology partners, customer success, and leadership.Coordinate internal and external contributors to ensure deliverables are reviewed, approved, and implemented on schedule.Partner with marketing, sales, and delivery teams to support messaging, training, onboarding, and rollout activities.Communicate status updates, risks, and key decisions with clarity and consistency., 4. Customer-Centric Requirements & Compliance DeliveryGather, refine, validate, and manage requirements from internal and external stakeholders.Drive customer feedback loops and iterative MVP delivery while maintaining scope and delivery discipline.Ensure solutions align with global regulatory expectations including 21 CFR Part 11, GAMP 5, GxP, and ISO 27001, with appropriate validation rigor and documentation., 5. Solution Development, Scalability & Performance OptimizationLead development and configuration of reusable templates, workflows, and components to accelerate client time-to-value.Drive standardization and harmonization across digital products to support scalable, multi-site and global deployments.Track delivery, adoption, and performance metrics (cycle time, ROI, usage, quality outcomes) and use insights to continuously improve solutions and execution. Qualifications:Required:5+ years of experience in product management, digital transformation, or software delivery within life sciences or highly regulated environments.2+ years of experience as a Scrum Product Owner or equivalent Agile delivery role.Experience with digital validation, quality systems, or operational technology platforms (e.g., Kneat Gx, Veeva, TrackWise).Strong understanding of GxP, data integrity, and CSV principles.Excellent stakeholder management, communication, and prioritization skills. Preferred:Certified Scrum Product Owner (CSPO), Scrum Master, or equivalent certification.Experience with configurable SaaS platforms, productized services, or reusable digital toolkits.Familiarity with validation-related business processes including commissioning, qualification, change control, and quality risk management. #LI-MV1$140,000 - $160,000 a yearAverage base salary range - not including benefits and bonus. CAI Benefits:•Comprehensive Health Insurance coverage•24 days of Paid Time Off•ESOP/401K - 15% Company Contribution (US Only)•Company paid Life Insurance•Company paid Long Term DisabilityWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Company Overview Circadia Health is a medical technology company that has developed the world's first FDA cleared completely contactless remote patient monitoring system. Powered by cutting-edge technology and AI, the system allows for the early detection of medical events such as Congestive Heart Failure, COPD Exacerbations, Pneumonia, Sepsis, UTIs, and Falls. We're monitoring over 20,000 lives daily and growing rapidly. As we scale our team, Circadia is looking for energetic, personable, and solutions-oriented individuals driven by creating the ultimate customer experience. Prior experience in healthcare is preferred, but not required. Our mission is to enhance patient outcomes and improve healthcare processes by providing cutting-edge solutions to healthcare providers and patients alike. Position Overview Within Customer Success at Circadia Health you will be responsible for driving customer satisfaction, retention, and success. By understanding our customers' needs and challenges, you will develop strong relationships and work collaboratively with cross-functional teams to ensure that our products and services are tailored to meet customer objectives, ultimately driving their success and satisfaction. You will play a pivotal role in managing the entire customer lifecycle post-sales. This includes oversight throughout the onboarding process, successful implementation of our technology, training customers in the field, and driving customer retention. You will enable customers with our cutting-edge predictive clinical analytics solutions to improve outcomes and ultimately save patient lives. Our ideal candidate loves traveling at least 50% of the time, thrives in a fast-paced environment, excels in building and maintaining strong customer relationships, and is driven by our mission. On a day to day basis, you will be responsible for the entire lifecycle of a Customer post-sales. We're looking for individuals who are passionate about connecting with people and committed to making a difference in saving lives. \n Key Responsibilities: • Customer Relationship Management: Develop and maintain strong relationships with key leadership teams by understanding their unique needs and objectives to ensure their success with Circadia Health's services., • Customer Onboarding & Implementation: Assist customers through a seamless onboarding process, ensuring a smooth and successful implementation of our products and services tailored to meet customer needs and timelines., • Training & Education: Conduct training sessions to help customers effectively use our technology and services, ensuring they are well-equipped to achieve their desired outcomes., • Customer Success Strategies: Develop and implement customer success strategies to drive user adoption, customer satisfaction, and overall account growth. Our Customer Success team is mission-driven to help customers achieve their desired outcomes by providing timely resources, resolutions, and services, all while leveraging our advanced technology., • Customer Support: Oversee a support team to address customer inquiries and concerns promptly, ensuring that issues are resolved to achieve high customer satisfaction rates. Maintain updated Customer information on all CRM / Company Software platforms., • Voice of the Customer: Gather feedback from customers to collect opinions and experiences, analyze data to identify common trends and areas of improvement from collected feedback, and communicate these insights back to the clinical, product, and engineering teams for continuous product and user-end enhancement., • Metrics and Reporting: Track key performance indicators (KPIs) and report metrics to identify areas for improvement and ensure customers are on track to achieve their goals., • Customer Advocacy: Promote customer advocacy by identifying satisfied customers willing to participate in case studies, testimonials, and other marketing initiatives., • Customer Success Culture: Instill a customer success mindset across the organization, ensuring that all teams prioritize customer satisfaction and success. Qualifications • Bachelor's degree in Business, Marketing, Healthcare, or a related field; advanced degree preferred., • Proven experience in clinical implementation, customer success, or account management teams, preferably in the technology, medical technology, or healthcare industry., • Strong communication, interpersonal, and relationship-building skills., • Ability to analyze data and draw actionable insights to improve customer success initiatives., • Results-driven with a track record of meeting or exceeding customer retention and growth targets., • Strategic thinker with the capacity to develop and execute successful customer success strategies., • Ability to work in fast-paced environments, • Passion for innovation and improving patient outcomes through technology., • Proficiency in Google Suite, Monday and other relevant software. Benefits: • Fully expensed travel, • Full Single Coverage Health Care Plan (Medical, Dental & Vision), • Retirement Plan Contribution (401k, IRA), • Hybrid Role - Ability to work from home when not onsite / office, • Paid Time Off ~_ days per month (Vacation, Sick & Public Holidays), • Family Leave (Maternity, Paternity), • Professional Training & Development, • Opportunity to collaborate with a diverse team of professionals, including engineers, physicians, nurses, and others from various backgrounds on a daily basis, • Annual Company Retreat \n$80,000 - $110,000 a year\n

Company Profile Founded in 1997 by Thierry Gillier, Zadig&Voltaire is a French contemporary designer brand known for redefining luxury with a bold, modern perspective offering fashion for both women and men. Rooted in freedom and creative audacity, the brand draws inspiration from contemporary art, rock & roll, a Parisian spirit, and self-empowerment, values that inform everything we do, from design to the way we collaborate, innovate, and grow our teams. The spirit of the brand is eternally youthful, encouraging its community to embrace individuality and self-expression while practicing self-love, taking bold steps, and living on their own terms. Zadig&Voltaire is dedicated to nurturing the talents of tomorrow and supporting the development of its employees' skills across all the countries where the brand is present. True to its founders’ vision, the company is guided by an artistic and entrepreneurial mindset where employees are encouraged to be agile and proactive within a fast-growing global brand. Zadig&Voltaire fully embraces the complex challenges of the 21st century by actively engaging in its global sustainability program VoltAIRe. As an evolving global brand, Zadig & Voltaire is looking for talented people to get involved. Zadig & Voltaire is an equal opportunity employer. Overview We are seeking a detail-oriented Import/Export & Customs Compliance Specialist to manage international shipments while ensuring full compliance with applicable customs regulations. This role partners closely with logistics providers, customs brokers, and internal teams to drive the efficient and compliant movement of goods into and out of North America. The ideal candidate brings strong operational execution along with hands-on expertise in U.S. customs compliance, classification, and cost optimization. Key Responsibilities Logistics Operations • Own day-to-day execution of international shipments (air, ocean, and ground) from factories to distribution center., • Coordinate with Paris headquarters, freight forwarders, carriers, and customs brokers to ensure on-time delivery., • Track shipments and proactively resolve delays, customs holds, discrepancies, and damage claims., • Optimize routing, transit times, and freight costs while enforcing routing guides and vendor compliance standards., • Develop and maintain shipment tracking tools to monitor time-to-market and logistics spend., • Issue export documentation and ensure completeness and accuracy of shipping paperwork., • Review and validate freight invoices and customs entries for accuracy, ensuring proper recording in internal systems., • Develop and maintain SOP for logistics and compliance processes, • Assist with operations activities as needed. Customs Compliance • Ensure compliance with all applicable import/export regulations, including requirements from U.S. Customs and Border Protection., • Classify products using HTS codes; determine country of origin and MID requirements in collaboration with Paris headquarters., • Manage pre-classification processes, and work with U.S. Customs Brokers to identify and resolve potential Quota, F&WL, or tariff issues., • Review and approve commercial invoices, packing lists, and other customs documentation., • Audit CBP Form 7501 for accuracy; manage duty payments (ACH/PMS) and post entry adjustments., • Maintain records for North America in accordance with regulatory requirements and support internal/external audits., • Support duty optimization programs (e.g., free trade agreements, duty drawback), • Support Headquarters with regulatory requirements for North and South America (e.g., FDA, CPSC, FTC, USDA). Reporting & Systems • Track and analyze KPIs (on-time delivery, clearance times, logistics cost)., • Maintain accurate data in M3 and Winddle., • Generate reporting and insight for leadership on shipment activity and compliance metrics. Required Experience and Skills • 3-5 years of experience in import/export and US Customs Compliance (fashion apparel/footwear, or retail supply chain preferred)., • Strong knowledge of international shipping processes, Incoterms, and customs procedures., • Hands-on experience with HTS classification and import/export documentation., • Knowledge of duty savings programs and trade agreements., • Experience working with freight forwarders and customs brokers, • Bachelor's degree or equivalent experience in related field., • Advanced Excel skills (Pivot Tables, VLOOKUP required)., • Strong analytical and problem-solving capabilities., • High attention to detail, accuracy and organization., • Effective communication across global teams., • Ability to manage multiple priorities in a fast-paced environment., • Proactive, solutions-oriented mindset with a focus on continuous improvement. Job Type: Full-time Benefits: • 401(k), • Dental insurance, • Health insurance, • Life insurance, • Vision insurance, • Unlimited Time Off Schedule: • Monday - Thursday HQ, • Friday Work from Hom

Paralegal Location: 505 Park Ave – Onsite (5 days per week) Industry: Medical Device / Life Sciences Position Summary We are seeking a highly organized and detail-oriented Paralegal to support the legal and compliance functions of a growing medical device company. This role provides hands-on support in contract management, regulatory documentation, corporate governance, and legal operations. The ideal candidate has experience drafting, reviewing, and negotiating commercial contracts, managing contract lifecycle processes (CLM), and supporting attorneys in a fast-paced, collaborative environment. This position works directly under the supervision of one or more Attorneys, in accordance with the American Bar Association (ABA) definition of a Paralegal. This is a high-demand role that requires flexibility. Overtime and weekend work are a regular and expected part of the position. Key Responsibilities Contract Management • Assist Attorneys with drafting, reviewing, and maintaining contract templates (NDAs, commercial agreements, rebate agreements, vendor agreements, clinical trial agreements, consulting agreements, etc.), • Track contract lifecycles, deadlines, renewals, and approvals, • Support development and implementation of document management systems (DMS) and contract lifecycle management (CLM) tools, • Coordinate contract negotiations with internal stakeholders and occasional external parties, • Maintain contract logs and ensure proper routing procedures, • Draft letters and other legal documents; proofread and ensure accuracy, • Perform contract comparisons and revisions, • Perform additional duties under Attorney supervision as assigned Regulatory & Compliance Support • Assist with regulatory filings and document management related to FDA submissions and product approvals, • Maintain records to ensure compliance with FDA, EU MDR, ISO 13485, and other applicable regulations, • Monitor and support implementation of compliance updates, including Sunshine Act and transparency requirements Corporate Governance • Support corporate filings and maintain minute books and corporate records, • Assist with preparation of board and committee materials and resolutions General Legal & Administrative Support • Conduct legal research related to medical devices, intellectual property, employment law, and related areas, • Maintain confidentiality and ensure data security across legal processes, • Support policy development and internal training initiatives, • Schedule appointments, meetings, and travel arrangements, • Provide general administrative support to the legal department Qualifications Education • Bachelor’s or Associate’s degree (or equivalent experience), • Paralegal Certificate from an ABA-approved program preferred Experience • Minimum of 2 years of experience in a legal environment, • Prior experience in life sciences, healthcare, or medical device industry preferred, • Experience drafting and negotiating commercial contracts, • Experience managing contract lifecycle processes (CLM), • Familiarity with regulatory documentation and corporate governance processes Skills & Competencies • Strong organizational and time-management skills, • Excellent attention to detail and proofreading ability, • Strong written and verbal communication skills, • Ability to manage shifting priorities in a demanding environment, • Professionalism, discretion, and ability to handle confidential information, • Strong problem-solving and critical-thinking skills, • Proficiency in Microsoft Office, • Experience with document management systems (DMS) Work Expectations & Requirements • Must be willing and able to commute onsite to 505 Park Ave, 5 days per week, • Overtime and weekend work are a regular and expected part of this role, • Prolonged periods of sitting and computer work (potentially exceeding 12 hours), • Ability to lift up to 15 pounds occasionally, • Occasional travel for team meetings or company events, • Ability to manage multiple deadlines in a fast-paced environment with a high level of accuracy and discretion

The Director, Medical Affairs (Nutrition) is responsible for leading and managing medical affairs for approved nutrition products and those in development. Areas of support include Product pre-launch and launch activities, Product Development, Product Lifecycle management, Business Development, and Post-Marketing medical affairs strategies. Collaborates cross-functionally and globally to ensure corporate goals and objectives are met at the highest levels. Directs the Region's medical needs for support of drugs and devices on the market, in development, and under evaluation. Responsible for cultivating and maintaining external relationships esp. with Health Care Providers (HCPs) and/or Health Care Decision Makers (HCDMs) to enable comprehensive scientific exchange around disease states and associated Company products. Must maintain scientific expertise in the application of treatment guidelines and clinical data as it pertains to disease states and associated Company products. Must be able to communicate complex medical and scientific concepts to a broad range of audiences. The Director, Medical Affairs, will also support execution of Medical Affairs strategy and activities where and as appropriate. The Director, Medical Affairs will lead the field clinical education team and ensure that the respective territory engagement plans are effectively executed per defined targets, following Fresenius Kabi compliance rules and code of conduct and that relevant medical and scientific insight is routinely shared to optimize the Medical Affairs strategy for the nutrition portfolio. *Priority will be given to candidates in the Chicagoland area who are able to regularly work at our Lake Zurich, IL site. *This position does not offer visa sponsorship either now or in the future. • Salary Range: $185,000-220,000., • Position is eligible to participate in an annual bonus plan with a target of 16% of the base salary., • Position is eligible to participate in our medium-term incentive plan., • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities., • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage., • Lead the strategic planning, launch, and lifecycle support of nutrition products including high-risk medications., • Lead the development and execution of medical affairs strategy to support successful product launch ensuring alignment with commercial, clinical development, regulatory teams and internal stakeholders., • Maintain the highest levels of professional integrity & performance standards by consistently providing high quality medical deliverables on time. Maintains a high standard for medical and scientific accuracy, representative of a comprehensive understanding of the medical concept at hand. Maintains a high level of professional expertise by staying abreast of current medical landscape with regard to key clinical conditions our products support., • Identify, engage, and build strong relationships with Key Opinion Leaders (KOLs), influencers in HCP community, scientific experts, and medical societies to support scientific exchange and advocacy., • Lead the nutrition team ensuring achievement of compliant and effective healthcare professional interaction for scientific exchange related to disease states and/or associated Company products per predefined engagement plans and targets., • Establish and maintain relationships with HCPs and HCDMs to provide scientific exchange related to disease states and/or associated Company products., • Represent the company at major medical and scientific conferences; manage planning and coordination of congress activities, including symposia, medical affairs booth presence, and thought leader engagements., • Oversee publication planning and execution, including abstracts, posters, manuscripts, and scientific communications, ensuring timely and compliant dissemination of clinical data., • Drive medical education initiatives for internal and external stakeholders, including training programs, advisory boards, and peer-to-peer education aligned with the product's scientific platform., • Provide scientific leadership and oversight for Investigator-Initiated Trials (IITs), including review, approval, and ongoing collaboration with investigators., • Collaborate cross-functionally to design and implement company-sponsored clinical studies to support product differentiation, real-world evidence generation, cost-effectiveness analysis, HEOR studies and post-marketing commitments., • Lead and manage a team of medical affairs professionals; provide coaching, development, and performance management to ensure high team effectiveness., • Collaborate with Global Medical Affairs in the support of USA-based clinical trials, both internal and external., • Review, develop, and approve clinical summaries in support of NDA 505(b)(2), ANDA, NDA applications., • Serve as a medical expert for on market parenteral nutrition products, products in development, and potential acquisition targets providing medical affairs strategies and due diligence for on market products and business development opportunities., • Responsible for writing and/or review of relevant Standard Operating Procedures (SOPs) pertaining to the role as needed. Job Requirements: • Medical/clinical professional degree required, such as Licensed Registered Dietitian., • Clinical Nutrition knowledge is required., • 10+ years of experience in the pharmaceutical industry in a medical affairs or clinical development role required., • 3+ years of hands-on experience in patient care and in hospital and/or clinic and/or home infusion settings is required, with demonstrated expertise in clinical nutrition including experience in managing formula selection for oral nutritional supplement use and tube feeding regimens., • 5+ years of clinical experience preferred., • 5+ years of direct people management experience with demonstrated ability to develop and lead high-performing teams., • Ability to understand and interpret the regulatory requirements under which drugs and devices are developed, reviewed, and supported after approval., • Experience with the clinical drug development process and product launch experience is highly preferred., • Scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents., • Position will require travel (20-50%), including overnight stays. A valid US driver's license and clean driving record are required., • Ability to understand and interpret FDA 505(b)2, 505(b)1, 505 (j) submission requirements., • Knowledge of PC systems and Microsoft Office Suite (Word, Excel) is required. We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Program Lead, Digital Informatics QMS Strategy. This Program Lead is responsible for developing, maintaining, and communicating QuidelOrtho' s Quality Management System strategy for Digital Informatics, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Automation platforms as they pertain to in vitro diagnostic (IVD) products and associated services across all global markets. This role serves as the strategic quality authority for digitalenabled products, ensuring that regulatory, quality, and compliance expectations are proactively embedded into product lifecycle processes, digital delivery models, and organizational ways of working. This position will be onsite in Rochester, NY. Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/MLenabled systems, cloudbased platforms, and automated workflows. Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions. Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle. Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance. Lead riskbased approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring. Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, realworld data, automation, and digital transformation. Perform other work-related duties as assigned. Required: Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline. 8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions. Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations. Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems. Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products. Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation. Bias toward action, with a track record of driving execution aligned to organizational strategy. Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership. Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions. Willingness and ability to travel approximately 10-15%. Preferred: Advanced degree (MS, PhD, or PharmD) strongly preferred. Experience with AI/ML governance, algorithm change management, or real-world performance monitoring. Background in cloudbased systems, cybersecurity, data integrity, or regulated automation platforms. Experience supporting global regulatory inspections involving software or digital health products. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: Thrive Together - Collaborate intentionally, grow as a team Make It Happen - Focus on priorities, embrace continuous improvement Commit to Service - Cultivate a service mindset Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $202,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-SP1

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Senior Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements. Essential Functions • Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization., • Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements, • Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products., • Assist with developing and evaluating regulatory strategy, • Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on ImmunityBio products., • Author and review departmental SOPs, as well as other SOPs that may impact Regulatory Affairs., • Performs other special projects and duties as requested. Education & Experience • Bachelor's Degree in life sciences required with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development required; or, • Master's Degree in life sciences required with 5+ years of relevant regulatory compliance experience in pharmaceutical drug development required., • Knowledge and experience with organizing responses to Regulatory Authority requests required, • Experience with US and International Health Authority regulatory submissions preferred Knowledge, Skills, & Abilities • Knowledge of FDA, ICH and other guidance documents and requirements, • Knowledge of organizing responses to Regulatory Authority requests, • Strong knowledge of Health Authority regulatory requirements/guidelines, • Strong project management and computer skills (including Microsoft office), • Strong document management experience (hard and e-copy), • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written/oral communication skills and attention to detail, • Ability to manage conflicting priorities and respond in a timely, effective manner Working Environment / Physical Environment • This is a full-time position (40 hours per week) Monday through Friday., • This role may need to sit for long periods of time and use various computer programs., • This desk-based role involves the close study of scientific and regulatory documents., • They will work closely with scientific colleagues throughout the day, often on a project team basis. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $135,000 (entry-level qualifications) to $150,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.