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Job Title: Supervisor Location: SBC Corporation Department Name: Lab NBI Req #: 0000234024 Status: Salaried Shift: Day Pay Range: $93,150.00 - $113,850.00 per year Pay Transparency: The above reflects the anticipated annual salary range for this position if hired to work in New Jersey. The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience. Step into a fast-paced, deeply rewarding role where the work you do truly matters. As the Laboratory Supervisor of the Blood Bank at Newark Beth Israel, you will be a key member of the patient care team and collaborate with physicians and other clinical professionals to contribute to safe and effective care. The Lab Supervisor may be the perfect role for you if you have strong leadership skills, knowledge of specialized principles and techniques in Blood Banking, and want to make a difference in the lives of our patients. If you are passionate about healthcare, eager to advance your skills, and motivated to make a tangible difference during every shift, this position provides the experience, challenge, and purpose you are seeking. As the Laboratory Supervisor of the Blood Bank at Newark Beth Israel, below are your key responsibilities: • Day-to-day operational oversight of the Blood Bank / Transfusion Services, • Ensure safe, accurate, and timely provision of blood and blood components, • This role provides technical leadership, staff supervision, regulatory compliance oversight, and quality assurance in accordance with AABB, CAP, CLIA, FDA, and hospital policies, • Perform or supervise complex immunohematology testing (ABO/Rh, antibody identification, crossmatching) and component modification (irradiation), • Review records of blood testing, processing, and transfusion reactions; manage Occurrence Report Forms for process improvement, • Supervises duties related to record documentation, consults with Medical Director and Administrative Director on regulatory compliance updates, • Participates in the administrative and budgetary operations of the section The Laboratory Supervisor role might be for you if you: • Have previous experience in Laboratory leadership at a high-volume healthcare facility, • Have previous experience working in a Blood Bank, • Excellent customer service, • Outstanding communication skills including verbal and written To be considered for this opportunity, you must have a Bachelor of Science or Medical Technology degree and Minimum of 3 years experience as a medical technologist. ASCP or NCA certification preferred. Benefits and Perks: At RWJBarnabas Health, our market-competitive Total Rewards package provides comprehensive benefits and resources to support our employees’ physical, emotional, social, and financial health. • Paid Time Off (PTO), • Medical and Prescription Drug Insurance, • Dental and Vision Insurance, • Retirement Plans, • Short & Long Term Disability, • Life & Accidental Death Insurance, • Tuition Reimbursement, • Health Care/Dependent Care Flexible Spending Accounts, • Wellness Programs, • Voluntary Benefits (e.g., Pet Insurance), • Discounts Through our Partners such as NJ Devils, NJ PAC, Verizon, and more! Choosing RWJBarnabas Health! RWJBarnabas Health is the premier health care destination providing patient-centered, high-quality academic medicine in a compassionate and equitable manner, while delivering a best-in-class work experience to every member of the team. We honor and appreciate the privilege of creating and sustaining healthier communities, one person and one community at a time. As the leading academic health system in New Jersey, we advance innovative strategies in high-quality patient care, education, and research to address both the clinical and social determinants of health. RWJBarnabas Health aims to truly make a unique impact in local communities throughout New Jersey. From vastly improving the health of local residents to creating educational and career opportunities, this combination greatly benefits the state. We understand the growing and evolving needs of residents in New Jersey—whether that be enhancing the coordination for treating complex health conditions or improving community health through local programs and education. Equal Opportunity Employer

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

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

Territory: Brooklyn South, NY - Neuroscience - Psychiatry Target city for territory is Brooklyn - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Prospect Heights, Coney Island, Bay Ridge and Flatbush. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! As a Neuroscience Account Manager, you lead the promotion of our psychiatry portfolio to Psychiatrist and Institutional Accounts such as community mental health centers and hospitals, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Neuroscience Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university, • 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience, • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually, • Self-starter, with a strong work ethic and outstanding communication skills, • Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network, • 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: • Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder, • Documented successful sales performance, • Ownership and accountability for the development and execution of fully integrated account plans, • Strong analytical background, and experience using sales data reporting tools to identify trends_, • Experience in calling on customers at a variety of call points, including offices, community mental health centers and hospitals, • Sales experience with buy & bill/injectable products, • Experience in product launches, • Previous experience working with alliance partners (i.e., co-promotions), • Strong leadership through participation in committees, job rotations, panels and related activities TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is specifically for those potential hires who will work or reside in NYC, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $135,000 - $165,000 and eligibility for a sales incentive target of $40,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our _. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

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

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

HCLTech is looking for a highly talented and self- motivated SAP Life Sciences Portfolio Lead to join it in advancing the technological world through innovation and creativity. Job Title: SAP Life Sciences Portfolio Lead Job ID: 39100 Position Type: Full-time Location: Remote w/travel Overview We are seeking an experienced SAP Life Sciences Portfolio Lead to drive strategic growth, delivery excellence, and client engagement across our SAP Life Sciences portfolio. This role combines business leadership, solution expertise, and delivery oversight to expand market presence and ensure successful execution of complex SAP transformation programs within the life sciences sector. Key Responsibilities Portfolio Leadership & Growth • Own and grow the SAP Life Sciences portfolio, including revenue, pipeline, and profitability, • Develop and execute go-to-market strategies aligned with industry trends (e.g., digital manufacturing, compliance, AI, and data platforms), • Identify and pursue new business opportunities, including large SAP S/4HANA, BTP, and RISE programs, • Build and maintain strong relationships with C-level stakeholders (CIO, CTO, CFO, Business Leaders) Client Engagement & Advisory • Serve as a trusted advisor to life sciences clients on digital transformation strategies, • Provide thought leadership on regulatory compliance (GxP), validation, and quality systems within SAP landscapes, • Lead executive discussions, proposals, and solution positioning for complex deals Delivery Oversight • Oversee end-to-end delivery of SAP programs across the portfolio, ensuring quality, timelines, and financial performance, • Ensure adherence to industry standards and regulatory requirements (FDA, EMA, GxP, CSV), • Manage risks, escalations, and governance across multiple engagements, • Drive adoption of best practices, accelerators, and delivery frameworks Practice & Capability Development • Build and scale high-performing teams across functional, technical, and industry domains, • Develop capabilities in SAP S/4HANA, BTP, AI/ML, data & analytics, and digital supply chain, • Mentor leaders and create succession pipelines within the practice Innovation & Thought Leadership • Lead initiatives around AI, automation, and advanced analytics in life sciences (e.g., clinical, manufacturing, supply chain), • Contribute to industry solutions, accelerators, and reusable assets, • Represent the organization at industry forums, conferences, and client events Required Qualifications • 15+ years of experience in SAP consulting/delivery, with significant focus on Life Sciences (pharma, biotech, medical devices), • Proven experience leading large SAP transformation programs (S/4HANA, ECC to S/4, RISE with SAP), • Strong understanding of GxP, CSV, regulatory compliance, and validation processes, • Experience managing P&L, portfolio delivery, and large teams, • Demonstrated success in business development, sales pursuits, and client relationship management, • Deep knowledge of SAP ecosystem (S/4HANA, BTP, supply chain, manufacturing, quality, finance) Preferred Qualifications • Experience with SAP Digital Manufacturing, ATTP, IBP, or Clinical solutions, • Exposure to AI/ML, data platforms (SAP Datasphere), and automation tools, • Background in global delivery models and multi-vendor environments, • MBA or relevant advanced degree Key Competencies • Strategic thinking and business acumen, • Executive presence and stakeholder management, • Delivery leadership and operational excellence, • Innovation mindset and continuous improvement Pay and Benefits Pay Range Minimum: $139,000 base per year Pay Range Maximum: $286,000 base per year HCLTech is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to secure@hcltech.com for investigation. A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year How You’ll Grow At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

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

Hudson Regional Health System (HRHS) seeks a results-driven and collaborative laboratory leader to oversee outpatient diagnostic and clinical laboratory operations the system. The Director is accountable for ensuring regulatory compliance, service quality, and operational efficiency across outpatient services, supporting HRHS’s mission of delivering exceptional, patient-centered care. Position Summary The Director of Outpatient Lab Services manages all outpatient laboratory functions for Hudson Regional Health, including technical operations, process improvement, strategic growth, compliance, and financial performance. This position is based in Hudson Regional Health - Bayonne University Hospital while ensuring consistency, quality, and innovation across all outpatient lab functions and working in close collaboration with the inpatient Director and other lab supervisors. This position reports directly to the HRH-Bayonne University Hospital Chief Hospital Executive. Key Responsibilities · Oversee daily operations of outpatient clinical laboratory services · Ensure full compliance with CLIA, CAP, Joint Commission, OSHA, FDA, and applicable state regulations. · Supervise outpatient laboratory teams, including supervisors, technical personnel, and phlebotomists. ·Maintain appropriate staffing, scheduling, and budgetary controls to ensure cost-effective performance. · Collaborate with hospital executives, medical directors, outpatient facilities, and clinical departments to support patient care initiatives. · Lead continuous quality improvement and performance optimization efforts. · Manage equipment procurement, service contracts, and laboratory supply chains necessary for successful outpatient lab functions. · Partner with IT and system teams to standardize data, reporting, and laboratory information systems. · Track and report KPIs, turnaround times, and quality metrics to system leadership. · Participate in HRHS system-level meetings and cross-facility standardization initiatives. Leadership & Collaboration · Serve as the administrative and operational leader for outpatient laboratory services. · Collaborate directly system executives to align goals and share best practices. · Work closely with other HRHS laboratory leaders to advance system standardization and integration. · Promote employee engagement, professional development, and a culture of continuous improvement. Qualifications · Bachelor’s degree in clinical laboratory science, Medical Technology, or related field required; Master’s degree preferred. · Current licensure and national certification (ASCP, NCA, or AMT) required. · Minimum 7 years of progressive experience in laboratory management, including multi-site leadership preferred. · Outpatient and Reference Lab experience required. · Deep understanding of regulatory requirements, budget management, and process improvement methodologies. · Exceptional interpersonal and leadership skills, with the ability to collaborate effectively across departments. Job Type: Full-time Work Location: In person Benefits: • 401(k), • Dental insurance, • Flexible schedule, • Health insurance, • Paid time off, • Tuition reimbursement, • Vision insurance

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 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 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.

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. At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager of Regulatory Affairs. This role will manage and support a team of managers and employees of different levels. You will be responsible for developing and implementing local strategy and leading the day-to-day regulatory affairs on base business operations and new product development projects within the Transfusion Medicine Business Unit. This position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. Interact with US FDA and/or EU Notified Body regulatory personnel (including Corporate International RA and/or country RA) to define submission content, expedite pending applications, and resolve regulatory matters. Responsible for the final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed. Make judgments about the operational impact of proposed actions, and identify, and interact with appropriate resources to successfully achieve company and regulatory strategy objectives. Reviews/ interprets product-specific regulatory issues that may have a material impact on the business, the corporation, or the customer; develop strategic and tactical responses to influence a reasonable and compliant regulatory environment. Represent QuidelOrtho to US and EU regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions. Identify and/ or lead process improvement projects to streamline current activities and increase department efficiencies. Development goals, such as webinars, reviewing FDA website and articles, reading journals, and attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs. Coach, mentor junior staff. Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes. Perform other work-related duties as assigned. Required: Bachelor's degree in a scientific or related discipline; or equivalent combination of education and experience. 10 years+ of experience in a regulated In Vitro Diagnostics and/ or Biologics Industry. 7+ years of experience developing and executing regulatory strategies for complex projects under product development or post-market changes requiring a US FDA submission (510(k), PMA and BLA or associated supplements and Annual Reports). Review and approval of product labeling and promotional and advertisement brochures and multimedia content. Coordinate and submit Pre-Sub meeting requests and associated regulatory strategic information and direct interaction with FDA product review branch(s). Previous people management experience. Excellent interpersonal, teamwork, and verbal/written communication skills. Good organizational skills and an ability to manage multiple tasks/projects/priorities. The ability to demonstrate model behavior and understand priorities and encourage others to drive for results will be needed. Ability to mentor and coach junior level staff as well as cross-train with peers. This position is not currently eligible for visa sponsorship. Preferred Direct experience with FDA CBER. Experience hosting or supporting Pre-Approval Inspections for either FDA, EU Notified Bodies or both. RAC (Regulatory Affairs Certification). Medical Device and/ or Pharmaceutical Industry experience is highly desirable. CE Mark under IVDD and current IVDR requirements, Canadian Licensing, and Rest of World (ROW) registrations is a plus. Use of Process Excellence (PEx) tools for process improvement initiatives. Internal Partners: Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality/Manufacturing Quality, Regulatory Affairs Managers/Directors, QO International and Regional Regulatory Affairs groups External Partners: Regulators in worldwide markets, for example TUV/BSI, FDA, Health Canada, etc. Third Party Contract Manufacturers and Suppliers. Use of a computer is required. Traditional office workspace or remote home office location. On occasion, may require up to 20% of domestic/international travel. The 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 the facts and circumstances of each case. The salary range for this position is $155,677.15 - $202,380.30 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 the 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-HF1

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 Regulatory Affairs Program Manager leads complex cross-functional regulatory initiatives from strategy through execution, ensuring products meet global regulatory requirements and are delivered in alignment with business objectives and launch timelines. This role partners closely with R&D, Clinical, CMC, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission activities and timelines, and support successful product approvals and lifecycle management worldwide. The position also serves as a key regulatory liaison, driving cross-functional alignment, proactive risk management, and regulatory excellence across the organization. Essential Functions • Lead the design, planning, and execution of complex, cross-functional regulatory programs and strategic initiatives, establishing integrated project plans, timelines, milestones, deliverables, resource allocation, and proactive risk-mitigation strategies to ensure successful outcomes., • Drive cross-functional collaboration across Regulatory Affairs, Quality, Clinical, R&D, Operations, Manufacturing, and Commercial teams to ensure alignment with global regulatory strategy, business priorities, and product development objectives., • Provide program leadership and governance oversight for regulatory initiatives, including tracking key milestones, managing dependencies, escalating critical issues, and delivering concise status updates and strategic recommendations to executive leadership and external partners., • Author, review, revise, and maintain Standard Operating Procedures (SOPs), work instructions, regulatory processes, and standardized templates to ensure consistency, inspection readiness, and adherence to applicable regulatory requirements., • Mentor and provide guidance to junior team members and cross-functional partners on regulatory processes, project execution, and compliance expectations to strengthen organizational capabilities., • Support regulatory inspections, audits, and health authority interactions by coordinating responses, preparing documentation, and ensuring timely follow-through on commitments and corrective actions., • Lead and contribute to special projects, business-critical initiatives, and cross-functional assignments that support organizational objectives, drive innovation, and provide leadership development opportunities. Education & Experience • Bachelor's degree in sciences, business, project management or a related field with 8+ years of relevant progressive experience required, • 5+ years in leadership preferred., • 6+years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred., • 5+years managing complex, multiregional regulatory programs is preferred. Knowledge, Skills, & Abilities • Working knowledge of FDA regulations and other applicable global health authority requirements; experience supporting regulatory submissions and compliance activities preferred., • Demonstrated ability to collaborate effectively with cross-functional teams, manage multiple priorities, and deliver projects within established timelines., • Strong written and verbal communication skills, with the ability to clearly communicate regulatory requirements and project updates to diverse stakeholders., • Strong analytical, organizational, and problem-solving skills with attention to detail and the ability to identify and mitigate potential risks., • Proficiency with Microsoft Office Suite and project management tools and platforms (e.g., Monday.com); including task tracking, workflow management, timeline coordination, and team collaboration. Experience with regulatory systems or document management platforms is a plus., • Ability to work independently in a fast-paced environment while maintaining a high level of accuracy, accountability, and professionalism., • Commitment to continuous improvement, process efficiency, and maintaining high standards of regulatory compliance. 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. $170,000 (entry-level qualifications) to $187,000 (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.

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.

Position: Manufacturing Associate, CAR-T, Manufacturing Operations Duration: 06 Months Location: Summit West, NJ, 07901 Manufacturing Associate Abecma (Quad 1: 5:00am-5:30pm, Alt Wednesday, Sunday - Tuesday) Training schedule: • The training period may range from 1 to 6 weeks, depending on business needs, as determined by the client., • The selected candidate is required to maintain full availability, with no planned leave during the entire training period., • Training will commence with a Monday to Friday, 9:00 AM - 5:00 PM schedule for the initial 1-2 weeks (subject to change based on business needs)., • Subsequently, the schedule will transition to the assigned Quad shift. Description: Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. • Required Competencies: Knowledge/ Skills, and Abilities:, • Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique, • Knowledge of cGMP/FDA regulated industry, • Basic mathematical skills - General understanding of cGMPs, • Technical writing capability, • Proficient in MS Office applications, • Background to include an understanding of biology, chemistry, medical or clinical practices Pre-requisites: Entry- Level, • Duties and Responsibilities:, • Production of blood component lots through cell culture, harvest, and cryopreservation., • Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum., • Weighs and measures in-process materials to ensure proper quantities are added/removed., • Adheres to the production schedule ensuring on-time, internal production logistics., • Records production data and information in a clear, concise, format according to proper GDPs., • Works in a team based, cross-functional environment to complete production tasks required by shift schedule., • Motivated, team consciousness individuals are needed to fulfill job requirements., • Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor., • No direct reports will be assigned to this job role., • Performs other tasks as assigned., • Education and Experience: Bachelor's degree or Associate/ Medical Technical degree and 2 years of Manufacturing or Operations experience or High School diploma/GED and 4 years of Manufacturing or Operations experience Important Notes about working in the clean room: This position takes place in a GMP clean room environment, which includes being gowned for up to 6 hours. During the processing time in the clean room, no breaks may be taken Working Conditions: • Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. - Physical dexterity sufficient to use computers and documentation., • Sufficient vision and hearing capability to work in job environment., • Ability to lift up to 25 pounds., • Must have the ability to work around laboratories and controlled, enclosed, restricted areas., • Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet., • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas., • Flexibility to don clean room garments and personal protective equipment (PPE)., • Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected., • Routine exposure to human blood components., • Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other jobrelated duties as requested by management.

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

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Summary of role As a key member of the Evergreen Manufacturing site senior leadership team, the Director, Internal Manufacturing provides technical and operational leadership across radiopharmaceutical manufacturing (e.g., RLT, PET and isotope products). This role is accountable for robust, compliant, and reliable manufacturing performance through the end-to-end product lifecycle-from process design and tech transfer through routine commercial execution and continuous improvement-while ensuring operations remain in full cGMP compliance and aligned with all applicable Federal, State, and local laws and regulations. This Technical Leader partners closely with Quality, Engineering, Employee Health and Safety, Radiation Safety, Supply Chain, Chemistry Manufacturing and Controls/Regulatory, and external partners to deliver safe, on-time product and to advance technical capability, capacity, and operational excellence. This position is based in New Jersey and requires a presence on-site 5 days per week, and open to applicants authorized to work for any employer within the United States. Responsibilities • Provide day-to-day technical leadership for Evergreen Manufacturing Operations and the MSAT team, ensuring safety, quality, service, cost, and people performance is measured, analyzed, and improved to meet business objectives. Scope includes production teams, facilities, RSO/EHS, and manufacturing process support. Establish and govern key metrics (e.g., right-first-time, batch release cycle time, deviation rate, OEE, EM performance) and use leading indicators to anticipate and mitigate risks to product supply., • Contribute to site and network strategy for radiopharmaceutical manufacturing, including capacity planning, capital investment, facility/utilities strategy, sourcing, make/buy decisions, partnering models, and development of technical capabilities required for just-in-time manufacturing and cold-chain distribution., • Develop and maintain deep technical expertise in radiopharmaceutical manufacturing (RLT, PET and isotope products), including radioactive material handling and controls, radiochemistry/radiosynthesis, automated synthesis platforms, aseptic processing, sterile filtration/fill-finish interfaces (as applicable), in-process controls, and analytical/quality attributes. Ensure technical knowledge is translated into robust procedures, training, and standardized ways of working., • Lead and/or sponsor capital projects and technical upgrades from concept through execution, including user requirements, design review, risk assessments, vendor management, commissioning/qualification/validation (CQV), and readiness for GMP use. Ensure changes are implemented through compliant change control and support rapid issue resolution during start-up., • Serve as a key manufacturing technical representative during regulatory interactions and inspections (e.g., FDA, EMA and other agencies). Ensure sustained inspection readiness, effective responses to information requests, and timely completion of CAPAs. Partner with CMC/Regulatory on dossier content (as applicable) related to manufacturing, process validation, control strategies, and comparability/changes., • Demonstrate visible, hands-on leadership and effective cross-functional influence. Implement and sustain tiered daily management, escalation pathways, and structured problem-solving to drive timely decisions and alignment. Ensure managers maintain active two-way communication and engagement programs to sustain commitment and performance., • Champion radiation, chemical safety, and environmental compliance. Ensure proper handling, storage, and disposition of radioactive and other hazardous materials; maintain effective radiation protection practices (dosimetry, contamination control, radiometric monitoring, ALARA). Ensure training, supervision, and emergency response readiness to protect employees and the environment; promptly report, investigate, and correct hazards., • Ensure a safe work environment for all employees, contractors, and visitors at the Evergreen site. Monitor the condition of the facilities and implement improvements where necessary to reduce safety risks. Champion behavior based safety and create a culture in which everyone's actions in the plant preserve and protect the safety of themselves and others., • Model company values and a culture of accountability, transparency, and continuous improvement, with an uncompromising focus on patient safety, product quality, and reliable supply., • Attract, retain, and develop technical talent and frontline leaders through coaching, training, and succession planning. Build and maintain technical competency in radiochemistry, aseptic/GMP behaviors, deviation writing, problem solving, and data-driven decision-making., • Own and drive robust Quality and issue management systems: lead/oversee deviations, investigations, OOS/OOT, root-cause analyses, CAPA development and effectiveness evaluation, ensuring timely closure, prevention of recurrence, and continuous improvement while protecting product supply and compliance., • Lead manufacturing technical activities for new product introductions and tech transfers, including process characterization, control strategy implementation, PPQ support, operator training, and readiness-to-execute for clinical and commercial supply., • Govern technical change control and validation lifecycle activities for manufacturing processes, equipment, facilities, utilities, and computerized systems, including continued process verification and periodic review of process performance and product quality., • Advance manufacturing automation, data systems, and data integrity practices (e.g., MES/EBR, equipment integration, trending/analytics) to improve right-first-time performance, compliance, and throughput in a time-critical radiopharmaceutical environment., • Partner with Supply Chain, QC, and external suppliers/CMOs to ensure materials and services meet technical and quality requirements (e.g., isotopes/targets, precursors, sterile components). Support supplier qualification, performance management, and resolution of quality events impacting supply. Basic Qualifications • Bachelor's degree in chemistry, Chemical Engineering, Pharmaceutical Sciences, Biology, or related scientific/technical discipline (or equivalent experience); advanced degree preferred., • 10+ years of experience in radiopharmaceutical, sterile, or biologics/pharmaceutical GMP manufacturing, including direct experience with radiochemistry/radiosynthesis operations and/or aseptic processing in a regulated environment., • Demonstrated success applying Operational Excellence/Lean methodologies (e.g., 5S, value stream mapping, visual management, Kaizen, standard work) and structured problem solving to improve quality, throughput, and reliability., • Working knowledge of GMP documentation systems and quality processes, including deviation management, change control, investigations, CAPA, and batch record review/release support., • Experience supporting or leading qualification/validation activities (equipment, utilities, facilities, computerized systems) and process validation/continued process verification in a GMP environment., • Proven ability to lead technical discussions with Quality and regulators/auditors, including inspection readiness, clear written responses, and effective presentation of manufacturing control strategies., • Demonstrated ability to lead, coach, and influence cross-functional teams in a fast-paced, time-critical operations environment. Preferred Qualifications • Demonstrated knowledge of safety procedures for working in hazardous chemical and radiological environments, including radiation protection principles (ALARA), contamination control, and required monitoring practices., • Strong knowledge of cGMP requirements, including aseptic behaviors and sterility assurance principles (as applicable), environmental monitoring, cleaning/sterilization practices, and qualification/validation expectations., • Knowledge of radiochemistry and relevant analytical methods/instrumentation (e.g., HPLC, GC, radio-TLC, dose calibrators, endotoxin testing) and understanding of automated synthesis and dispensing equipment, with ability to support troubleshooting and continuous improvement., • Detailed knowledge of applicable regulations and standards (e.g., GMP, OSHA, NRC/state radiation control, and relevant industry guidance), with demonstrated commitment to quality culture and data integrity., • Strong interpersonal and communication skills, including the ability to translate complex technical topics for diverse audiences and to author clear, compliant technical documentation., • Ability to support a time-sensitive, just-in-time manufacturing schedule, including flexibility for off-hours decision-making during deviations/events and occasional travel to support network activities, suppliers, or partners. Core Values The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone's health is in our hands, • Own the solution and make it happen The pay range for this position is between $172,000 and $287,000 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until June 28, 2026. Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at _. Lantheus is an E-Verify Employer. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the _ notice from the Department of Labor.

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands. Summary of role We are seeking an experienced Associate Director Quality Control (QC) to lead analytical laboratory operations supporting radiopharmaceutical manufacturing and product development at our site in Springfield, NJ. The ideal candidate is a proactive leader with strong technical expertise, comprehensive understanding of industry practices, regulatory requirements, and a commitment to safety, quality and continuous improvement. This position is based in Springfield, New Jersey and requires a presence on-site. This position is open to applicants authorized to work for any employer within the United States. Responsibilities Strategic Leadership & Operational Oversight • Develop and execute strategic plans for the QC function, leveraging expertise to drive decisions that align with business objectives., • Manage departmental goals to ensure reliable product supply, adherence to company policies, and successful project execution., • Oversee budgeting, scheduling, and performance standards to support operational efficiency and compliance. Laboratory Management • Ensure all aspects of laboratory operations are effectively managed, including training, scheduling, inventory, equipment maintenance/calibration, and safety., • Maintain validated methods and qualified equipment, ensuring all QC testing and data management activities comply with SOPs, cGMPs, and regulatory standards., • Monitor performance metrics and trends to identify opportunities for improvement. Systems & Technology • Ensure effective use of electronic systems such as ERP, QMS, LIMS, and lab equipment software., • Serve as system administrator or alarm notification contact for area-specific software and monitoring systems. Team Development & Performance • Develop frontline managers into high-performing leadership teams through active mentorship., • Build and manage a high-performing team through effective staffing, training, performance reviews, and workload balancing., • Foster a culture of continuous improvement, compliance, and technical excellence., • Develop and implement employee development plans to enhance skills, support succession planning, and mitigate operational risks. Cross-Functional Collaboration • Act as a liaison with other departments and management levels to support operational decisions and strategic planning., • Lead team meetings, facilitate VPM efforts, participate in GEMBA walks, and apply Lean/Project Management tools. Policy & Compliance • Establish and interpret operating policies and procedures for the QC function., • Ensure inspection readiness and compliance with global regulatory requirements (e.g., FDA, USP/EP/JP)., • Interface with regulatory inspectors, client and internal auditors, ensuring timely resolution of commitments. Quality Systems Management • Oversee timely and effective use of QMS tools including training, investigations, deviations, CAPAs, SOP revisions, change controls, and protocols., • Serve as lead investigator, SOP owner, change control author, or protocol study lead as needed., • Resolve complex technical and compliance issues independently, leveraging internal and external expertise. Safety & Environmental Stewardship • Promote and enforce safety protocols, ensuring proper use of protective equipment and safe handling of hazardous materials., • Proactively identify and address safety and environmental risks within the laboratory environment. Basic Qualifications • Requirements include a B.S. in relevant scientific/technical discipline, advanced degree or technological certificates preferred but not required., • 12+ years' experience of progressively more responsible laboratory management in a related scientific/technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment, or equivalent., • Deep understanding of QC operations, regulatory requirements, and industry best practices with proven leadership in managing complex laboratory environments and cross-functional teams., • Prior direct experience engaging with health authorities is required., • Recognized as a subject matter expert within the organization, with the ability to solve advanced problems and guide others. Other Requirements • Flexibility with scheduling requirements for staff and manage support to include evenings, weekends, shifts, and holiday coverage, including during adverse weather conditions., • Manage and direct staff who work with (or in proximity to) potentially hazardous chemical, radiological, and or biological materials. Core Values The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone's health is in our hands, • Own the solution and make it happen The pay range for this position is between $139,000 and $232,000 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until June 20, 2026. Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at _. Lantheus is an E-Verify Employer. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the _ notice from the Department of Labor.

Job Description FreightTAS LLC, a leader in international freight forwarding and logistics recruiting, is looking for a dedicated Ocean Import Agent to join our team in Long Beach, CA, and Cranford, NJ. This full-time position offers a dynamic work environment where experienced professionals can manage and coordinate ocean import shipments efficiently. Key Responsibilities • Manage the preparation and processing of ocean import shipments, ensuring accuracy and compliance., • Coordinate with carriers, overseas agents, customs brokers, and clients to facilitate smooth cargo movement., • Prepare and review all necessary documentation including Bills of Lading, customs entries, and clearance paperwork., • Ensure compliance with all U.S. Customs regulations and pertinent import laws and standards., • Communicate effectively with clients regarding shipment status, delivery timelines, duties, taxes, and regulatory requirements such as FDA codes and HTS classifications., • Maintain accurate records in CargoWise and other company systems., • Assist in resolving issues related to shipment delays, documentation discrepancies, or customs complications. Requirements • 3-7 years of experience in ocean import operations within freight forwarding or related logistics fields., • Knowledge of ocean freight processes, customs clearance procedures, and regulatory compliance., • Experience with CargoWise, a MUST, • Strong organizational skills with attention to detail and ability to manage multiple shipments simultaneously., • Excellent communication and interpersonal skills to work with diverse stakeholders., • Familiarity with U.S. customs regulations, duties, taxes, and trade compliance is essential. Benefits • Medical, dental, and vision insurance, • 401(k) with company match, • Life, short-term, and long-term disability coverage, • Paid vacation, sick time, and holidays, • Flexible/remote options for high-performing sales reps, • Competitive base salary + strong commission structure, • Annual performance bonuses, • Company laptop and mobile reimbursement, • Ongoing sales, compliance, and technology training, • Supportive, fast-moving culture with strong operations backing

Job Description Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. Summary of role We are seeking an experienced Associate Director Quality Control (QC) to lead analytical laboratory operations supporting radiopharmaceutical manufacturing and product development at our site in Springfield, NJ. The ideal candidate is a proactive leader with strong technical expertise, comprehensive understanding of industry practices, regulatory requirements, and a commitment to safety, quality and continuous improvement. This position is based in Springfield, New Jersey and requires a presence on-site. This position is open to applicants authorized to work for any employer within the United States. Responsibilities Strategic Leadership & Operational Oversight • Develop and execute strategic plans for the QC function, leveraging expertise to drive decisions that align with business objectives., • Manage departmental goals to ensure reliable product supply, adherence to company policies, and successful project execution., • Oversee budgeting, scheduling, and performance standards to support operational efficiency and compliance. Laboratory Management • Ensure all aspects of laboratory operations are effectively managed, including training, scheduling, inventory, equipment maintenance/calibration, and safety., • Maintain validated methods and qualified equipment, ensuring all QC testing and data management activities comply with SOPs, cGMPs, and regulatory standards., • Monitor performance metrics and trends to identify opportunities for improvement. Systems & Technology • Ensure effective use of electronic systems such as ERP, QMS, LIMS, and lab equipment software., • Serve as system administrator or alarm notification contact for area-specific software and monitoring systems. Team Development & Performance • Develop frontline managers into high-performing leadership teams through active mentorship., • Build and manage a high-performing team through effective staffing, training, performance reviews, and workload balancing., • Foster a culture of continuous improvement, compliance, and technical excellence., • Develop and implement employee development plans to enhance skills, support succession planning, and mitigate operational risks. Cross-Functional Collaboration • Act as a liaison with other departments and management levels to support operational decisions and strategic planning., • Lead team meetings, facilitate VPM efforts, participate in GEMBA walks, and apply Lean/Project Management tools. Policy & Compliance • Establish and interpret operating policies and procedures for the QC function., • Ensure inspection readiness and compliance with global regulatory requirements (e.g., FDA, USP/EP/JP)., • Interface with regulatory inspectors, client and internal auditors, ensuring timely resolution of commitments. Quality Systems Management • Oversee timely and effective use of QMS tools including training, investigations, deviations, CAPAs, SOP revisions, change controls, and protocols., • Serve as lead investigator, SOP owner, change control author, or protocol study lead as needed., • Resolve complex technical and compliance issues independently, leveraging internal and external expertise. Safety & Environmental Stewardship • Promote and enforce safety protocols, ensuring proper use of protective equipment and safe handling of hazardous materials., • Proactively identify and address safety and environmental risks within the laboratory environment. Basic Qualifications • Requirements include a B.S. in relevant scientific/technical discipline, advanced degree or technological certificates preferred but not required., • 12+ years’ experience of progressively more responsible laboratory management in a related scientific/technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment, or equivalent., • Deep understanding of QC operations, regulatory requirements, and industry best practices with proven leadership in managing complex laboratory environments and cross-functional teams., • Prior direct experience engaging with health authorities is required., • Recognized as a subject matter expert within the organization, with the ability to solve advanced problems and guide others. Other Requirements • Flexibility with scheduling requirements for staff and manage support to include evenings, weekends, shifts, and holiday coverage, including during adverse weather conditions., • Manage and direct staff who work with (or in proximity to) potentially hazardous chemical, radiological, and or biological materials. Core Values The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone’s health is in our hands, • Own the solution and make it happen The pay range for this position is between $139,000 and $232,000 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until June 20, 2026. Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com. Lantheus is an E-Verify Employer.

Job Description Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Summary of role As a key member of the Evergreen Manufacturing site senior leadership team, the Director, Internal Manufacturing provides technical and operational leadership across radiopharmaceutical manufacturing (e.g., RLT, PET and isotope products). This role is accountable for robust, compliant, and reliable manufacturing performance through the end-to-end product lifecycle—from process design and tech transfer through routine commercial execution and continuous improvement—while ensuring operations remain in full cGMP compliance and aligned with all applicable Federal, State, and local laws and regulations. This Technical Leader partners closely with Quality, Engineering, Employee Health and Safety, Radiation Safety, Supply Chain, Chemistry Manufacturing and Controls/Regulatory, and external partners to deliver safe, on-time product and to advance technical capability, capacity, and operational excellence. This position is based in New Jersey and requires a presence on-site 5 days per week, and open to applicants authorized to work for any employer within the United States. Responsibilities • Provide day-to-day technical leadership for Evergreen Manufacturing Operations and the MSAT team, ensuring safety, quality, service, cost, and people performance is measured, analyzed, and improved to meet business objectives. Scope includes production teams, facilities, RSO/EHS, and manufacturing process support. Establish and govern key metrics (e.g., right-first-time, batch release cycle time, deviation rate, OEE, EM performance) and use leading indicators to anticipate and mitigate risks to product supply., • Contribute to site and network strategy for radiopharmaceutical manufacturing, including capacity planning, capital investment, facility/utilities strategy, sourcing, make/buy decisions, partnering models, and development of technical capabilities required for just-in-time manufacturing and cold-chain distribution., • Develop and maintain deep technical expertise in radiopharmaceutical manufacturing (RLT, PET and isotope products), including radioactive material handling and controls, radiochemistry/radiosynthesis, automated synthesis platforms, aseptic processing, sterile filtration/fill-finish interfaces (as applicable), in-process controls, and analytical/quality attributes. Ensure technical knowledge is translated into robust procedures, training, and standardized ways of working., • Lead and/or sponsor capital projects and technical upgrades from concept through execution, including user requirements, design review, risk assessments, vendor management, commissioning/qualification/validation (CQV), and readiness for GMP use. Ensure changes are implemented through compliant change control and support rapid issue resolution during start-up., • Serve as a key manufacturing technical representative during regulatory interactions and inspections (e.g., FDA, EMA and other agencies). Ensure sustained inspection readiness, effective responses to information requests, and timely completion of CAPAs. Partner with CMC/Regulatory on dossier content (as applicable) related to manufacturing, process validation, control strategies, and comparability/changes., • Demonstrate visible, hands-on leadership and effective cross-functional influence. Implement and sustain tiered daily management, escalation pathways, and structured problem-solving to drive timely decisions and alignment. Ensure managers maintain active two-way communication and engagement programs to sustain commitment and performance., • Champion radiation, chemical safety, and environmental compliance. Ensure proper handling, storage, and disposition of radioactive and other hazardous materials; maintain effective radiation protection practices (dosimetry, contamination control, radiometric monitoring, ALARA). Ensure training, supervision, and emergency response readiness to protect employees and the environment; promptly report, investigate, and correct hazards., • Ensure a safe work environment for all employees, contractors, and visitors at the Evergreen site. Monitor the condition of the facilities and implement improvements where necessary to reduce safety risks. Champion behavior based safety and create a culture in which everyone’s actions in the plant preserve and protect the safety of themselves and others., • Model company values and a culture of accountability, transparency, and continuous improvement, with an uncompromising focus on patient safety, product quality, and reliable supply., • Attract, retain, and develop technical talent and frontline leaders through coaching, training, and succession planning. Build and maintain technical competency in radiochemistry, aseptic/GMP behaviors, deviation writing, problem solving, and data-driven decision-making., • Own and drive robust Quality and issue management systems: lead/oversee deviations, investigations, OOS/OOT, root-cause analyses, CAPA development and effectiveness evaluation, ensuring timely closure, prevention of recurrence, and continuous improvement while protecting product supply and compliance., • Lead manufacturing technical activities for new product introductions and tech transfers, including process characterization, control strategy implementation, PPQ support, operator training, and readiness-to-execute for clinical and commercial supply., • Govern technical change control and validation lifecycle activities for manufacturing processes, equipment, facilities, utilities, and computerized systems, including continued process verification and periodic review of process performance and product quality., • Advance manufacturing automation, data systems, and data integrity practices (e.g., MES/EBR, equipment integration, trending/analytics) to improve right-first-time performance, compliance, and throughput in a time-critical radiopharmaceutical environment., • Partner with Supply Chain, QC, and external suppliers/CMOs to ensure materials and services meet technical and quality requirements (e.g., isotopes/targets, precursors, sterile components). Support supplier qualification, performance management, and resolution of quality events impacting supply. Basic Qualifications • Bachelor’s degree in chemistry, Chemical Engineering, Pharmaceutical Sciences, Biology, or related scientific/technical discipline (or equivalent experience); advanced degree preferred., • 10+ years of experience in radiopharmaceutical, sterile, or biologics/pharmaceutical GMP manufacturing, including direct experience with radiochemistry/radiosynthesis operations and/or aseptic processing in a regulated environment., • Demonstrated success applying Operational Excellence/Lean methodologies (e.g., 5S, value stream mapping, visual management, Kaizen, standard work) and structured problem solving to improve quality, throughput, and reliability., • Working knowledge of GMP documentation systems and quality processes, including deviation management, change control, investigations, CAPA, and batch record review/release support., • Experience supporting or leading qualification/validation activities (equipment, utilities, facilities, computerized systems) and process validation/continued process verification in a GMP environment., • Proven ability to lead technical discussions with Quality and regulators/auditors, including inspection readiness, clear written responses, and effective presentation of manufacturing control strategies., • Demonstrated ability to lead, coach, and influence cross-functional teams in a fast-paced, time-critical operations environment. Preferred Qualifications • Demonstrated knowledge of safety procedures for working in hazardous chemical and radiological environments, including radiation protection principles (ALARA), contamination control, and required monitoring practices., • Strong knowledge of cGMP requirements, including aseptic behaviors and sterility assurance principles (as applicable), environmental monitoring, cleaning/sterilization practices, and qualification/validation expectations., • Knowledge of radiochemistry and relevant analytical methods/instrumentation (e.g., HPLC, GC, radio-TLC, dose calibrators, endotoxin testing) and understanding of automated synthesis and dispensing equipment, with ability to support troubleshooting and continuous improvement., • Detailed knowledge of applicable regulations and standards (e.g., GMP, OSHA, NRC/state radiation control, and relevant industry guidance), with demonstrated commitment to quality culture and data integrity., • Strong interpersonal and communication skills, including the ability to translate complex technical topics for diverse audiences and to author clear, compliant technical documentation., • Ability to support a time-sensitive, just-in-time manufacturing schedule, including flexibility for off-hours decision-making during deviations/events and occasional travel to support network activities, suppliers, or partners. Core Values The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone’s health is in our hands, • Own the solution and make it happen The pay range for this position is between $172,000 and $287,000 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until June 28, 2026. Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com. Lantheus is an E-Verify Employer.

Job Description Auto-Chlor is now hiring an Electrical Engineer-Equipment Design to lead our engineering development initiatives. We’re looking for a leader who will contribute to our “People First” culture. This position would work in-office full-time at our facility in MEMPHIS, TN. What’s in it for you? RELOCATION ASSISTANCE OFFERED We understand that great talent can come from anywhere. That's why we offer: • Up to 60 days of temporary housing, • Reimbursement for moving and travel expenses, • Support with general relocation needs, • A people first culture where contributions and collaboration are encouraged and celebrated., • A competitive salary up to $150k annually with an excellent benefits package., • Ongoing wellness initiatives to improve your health and well-being. What are some of the day-to-day responsibilities? • Develops and implements solutions for dishwasher and dispensing innovation projects, including both new equipment development and existing equipment innovation. Projects vary in duration from two months to over a year based on Project Brief requirements., • Administers regulatory compliance with agencies such as NSF, CSA, UL, BOCA, ASSE, UPC, and Federal, State, and Local authorities. Provides support to the field sales team on regulatory issues, with an emphasis on maintaining customer equipment operation without disruption to business., • Provides technical support to field sales team, contractors, consultants, engineers, and architects., • Develops and manages technical documentation for design control and field use. Requirements: • Bachelor of Science in Engineering Degree or comparable years of work experience., • 5-10 years of electrical and electronic design experience, along with experience working with regulatory agencies. Experience in the commercial appliance industry is preferred., • Embedded Software/hardware design, • Knowledge of codes and standards for plumbing, sanitation, electrical, and building (NSF, CSA, UL, BOCA, ASSE, UPC, FDA), • Electrical/electronic circuit design, • CAD Modeling – Autodesk Inventor Preferred Location: 746 Poplar Ave Memphis, TN 38105

Job Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. Roles and Responsibilities • Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsors., • Can develop SAPs and iSAPs text and shells with no supervision., • Produce and present external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction., • Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments., • High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques., • Has the ability to apply drug development knowledge during production of complex statistical analyses., • Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study., • Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers., • Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management., • Perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations., • Ability to create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams., • Understand the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint)., • Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician., • Is familiar with and stays current with the latest industry practices and updated regulatory guidelines., • Write blogs and/or white papers for posting on the company website.Requirements, • Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred., • Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required., • Submission experience (ISS/ISE)., • Has high level knowledge of drug development as it pertains to biostatistics., • Expert knowledge of scientific principles and concepts., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Good organizational skills., • High proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Excellent problem-solving skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements., • Good understanding of CROs and scientific & clinical data/terminology, & the drug development process. Powered by JazzHR JwI5EB7jHW

Job DescriptionSummary: The Clinical Research Assistant will assist the Clinical Research Coordinator and the Principal Investigator with administering activities to facilitate clinical research, which may include working with an affiliate or collaborating research sites. Exercises judgment within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor. Always maintains subject and document confidentiality, understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures by performing the following duties.Duties and Responsibilities: • Assists with the creation and completion of study related documents and new study preparation., • Assists with the completion of regulatory submissions and maintains regulatory files as directed., • Acts as a secondary liaison with sponsors., • Assists with the preparation for study monitor visits as directed., • Completes case report forms as directed., • Creates reports as requested., • Completes study directed assessments with patients to include, but not limited to adverse events, test article (TA) handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment., • Assists with subject screening and recruitment as directed., • Updates Clinical Trial Management Software (CTMS) as directed., • Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume., • Interacts with internal and external personnel to include, but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.Education/Experience:High school diploma or general education degree (GED); or two to four years related experience and/or training; or equivalent combination of education and experience.Certificates and Licenses:, • Clinical research certification preferredKnowledge, Skills, and Other Abilities:, • Ability to demonstrate competence in oral and written communication, • Bilingual (English/Spanish) preferred, • Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor, • Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner, • Medical knowledge, including medical terminology, • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization., • Must have knowledge of Microsoft Office Word, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and Electronic Case Report Form systems.Work Environment and Physical Demands:The work environment and 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., • Work is performed in an office/laboratory and/or a clinical environment., • Exposure to biological fluids and/or bloodborne pathogens., • Personal protective equipment required such as protective eyewear, garments, and gloves., • Occasional travel may be required domestic and/or international., • Ability to work in an upright and/or stationary position for 6-10 hours per day., • Frequent mobility required., • Occasional squatting, kneeling, or bending., • Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.Perks of working at Summit Pinnacle Clinical Research:, • 401k, • Medical, dental, vision, long term disability, short term disability, FSA, and life insurance, • 3 weeks of paid time off, • 14 paid company holidays, • Scrub voucher (specific positions apply), • And more!Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

Job Description Hi, we're Nuts.com! Nuts.com is a self-funded, profitable, rapidly growing multi-channel DTC specialty food and wellness company with over 550 people on our team. We're changing the landscape of snacking on nuts, dried fruit, chocolate and more! We planted our roots in Newark, New Jersey during the Great Depression, selling premium nuts on Mulberry Street's open-air market. We've come quite a long way since then, taking our multi-generational family business online in 1999. Even after 96 years, we continue to pride ourselves in expertly sourcing the highest quality foods and treating our customers like family. What's our team like? We're driven, collaborative and entrepreneurial. Energy and passion power our business and we look for candidates who share in that excitement to help us continue to build something special. The role: The Quality Assurance Technician is responsible for the frontline monitoring of Food Safety and Quality policies, programs, and procedures. This role supports the facility in meeting quality assurance, food safety, and regulatory requirements by partnering with Operations to ensure the consistent production of wholesome, high-quality products. This position reports to the Quality Assurance Manager and serves as a key technical resource on the production floor, assisting in maintaining an "audit-ready" facility while ensuring constant compliance with SQF and FDA regulations. How you'll make an impact Report and document any food safety or quality issues to the QA Manager and/or SQF Practitioner immediately. Conduct pre-operational inspections and review checklists to release production areas for daily use. Perform swabbing (ATP, allergen, biological, etc.), product sampling, and other quality testing. Conduct daily audits on Good Manufacturing Practices (GMPs) to ensure compliance with 21 CFR 117 and Safe Quality Food (SQF) standards. Inspect raw materials, work-in-progress (WIP), rework, and finished products; perform regular verifications including high-risk product checks and packaging audits. Monitor the product hold-and-release process, providing documented reports and tracking data for non-conforming goods. Assist in investigating deviations from procedures and customer complaints, and support root cause analysis to help prevent recurrence. Support regular calibration and maintenance of essential facility equipment, such as scales and metal detectors. Partner with the Sanitation team to verify effective cleaning and support operations staff with real-time food safety and product quality questions. Actively support record-keeping programs (SafeFoods/EQMS/TraceGains) to ensure data integrity and accurate documentation. Follow and enforce safety rules to prevent injuries; monitor the production floor for associate, visitor, and contractor GMP and Food Defense compliance. Perform other tasks as assigned by FSQA management to support department and facility goals. What you'll bring: • Bilingual in English and Spanish is strongly preferred, • 2+ years of hands-on experience in a food manufacturing or packaging environment is desirable., • Ability to read, write, and speak English fluently to complete required safety documentation and reports., • Strong computer proficiency, including experience with Google Doc, Sheets, email, and Electronic Quality Management Systems (EQCMS)., • Ability to work comfortably with handheld devices, scanners, and computers for real-time data entry., • Ability to handle fast-paced situations and use good judgment to make quick, common-sense decisions about product safety., • Great organizational skills and a focus on getting details right every time., • Ability to work well with a team while being independent enough to speak up and enforce safety rules., • Ability to stand for long periods and work comfortably on a busy production floor., • Schedule Flexibility: Must be flexible to work different shifts. The working schedule is subject to change based on business needs. Flexibility to work a full-time schedule between the hours of 6:00 am-5:30 pm Ability to work any shift and overtime as needed to support 24/7 or seasonal production demands. What we offer: • A high-growth and rewarding role in a foundationally strong and rapidly evolving business, • Hourly Pay Range: $19.00 - $20.50/hour based on experience, • And all the Nuts.com snacks your heart desires + a 40% employee discount EEO STATEMENT Nuts.com is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.

Job Description Salary: $95,000.00 - $100,000.00 Other Forms of Compensation: N/A What makes FLIK click What makes FLIK click? Our people. The decisions, actions and attitudes of our associates earn the trust and loyalty of our clients every day. We know how to pick them and we know how to grow them. It starts with hiring people who share our passion for food and hospitality. Once we find the right talent, we encourage, value and recognize their contributions. We keep our people renewed, excited and engaged by providing hands-on training and educating them about the latest trends. We give them a stake in successfully raising the bar. Our people love what they do and they love sharing their passion. Join our team and see the FLIK difference. Where a job isn’t merely a job but the start of a career where you can flourish. Job Summary Job Summary: The Quality Assurance Manager is responsible for development and maintenance of all QA programs, meeting USDA, FDA and customer requirements and ensuring the quality and safety of supplied goods. Must have strong knowledge in Preventive Controls for Human Food. A strong background in manufacturing, quality assurance and strong understand of FSMA is a must. Key Responsibilities: • Contributes to development and execution of product food safety and quality programs to support the organization’s goals of operational excellence, customer/client satisfaction, financial performance, market leadership, and preferred employer., • Responsible for developing and on-going maintenance of the Food Safety Plan. Must be able to identify deficiencies and implement new strategies., • Ensures all HACCP, GMP’s, sanitation preventive controls, supply chain preventive controls and all other prerequisite food safety standards are met according to USDA, FDA, FSIS, FSMA and corporate requirements., • Must have extensive knowledge of the facilities process flow and engage personnel in all areas of food safety and quality within the flow., • Manages Allergen Preventive Controls Program ensuring accurate allergen labeling on finished food products and prevention of allergen cross contact., • Manages the written recall program., • Ensures complete traceability of incoming raw materials and finished product while managing lot code tracking., • Ensures labeling programs is accurate in accordance with allergens, ingredients and nutritional information., • Oversees all food safety audits conducted by government and third party agencies., • Responds to customer safety and quality concerns as needed. Preferred Qualifications: • At least 6 years of directly related experience required in Quality Assurance and Food Safety manufacturing role., • Experienced in prepared foods manufacturing a plus., • HACCP program development and FSMA is a must., • HACCP certification, Preventive Controls for Human Food (PCQI) and GFSI auditor certification a must., • Regulatory experience preferred, with a clear understanding of local health department regulations, standards, and inspection expectations., • Flexibility to travel to support other locations, including participation in regulatory inspections, audits, and operational support visits., • Experience with corrective action plans (CAPs) and complaint investigations, including documentation, root cause analysis, and follow‑up., • Strong understanding of required third party audit and GFSI audit scheme programs and standards., • Working knowledge of food processing and distribution regulations, i.e. FDA and USDA/FSIS, and industry practice., • Experience developing and motivating personnel., • Track record of food safety/QA success in any of the following focus areas a plus: meat, poultry, seafood, processed foods, distribution, proprietary/private-label product development and/or monitoring., • B.S. degree in food technology, food science, or related curriculum and/or experience required., • Ability to function effectively within a fast-paced, diverse and evolving corporate culture is necessary., • Proficient in Microsoft Office applications and ability to learn various software and web-enabled programs., • Must be a strong, persuasive communicator and coach, with the ability to relate to other professionals, peers, and field operators, both technical and non-technical., • Strong data management, reporting, and technical writing skills. Apply to Flik today! Flik is a member of Compass Group USA Click here to Learn More about the Compass Story Associates at Flik Hospitality are offered many fantastic benefits. • Medical, • Dental, • Vision, • Life Insurance/ AD, • Disability Insurance, • Retirement Plan, • Paid Time Off, • Holiday Time Off (varies by site/state), • Associate Shopping Program, • Health and Wellness Programs, • Discount Marketplace, • Identity Theft Protection, • Pet Insurance, • Commuter Benefits, • Employee Assistance Program, • Flexible Spending Accounts (FSAs), • Paid Parental Leave, • Personal Leave Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws. For positions in Washington State, Maryland, or to be performed Remotely, click here or copy/paste the link below for paid time off benefits information. https://www.compass-usa.com/wp-content/uploads/2023/08/2023WageTransparencyFlikHospitality.pdf Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. Certain positions may require Florida Level 2 background screening. Details: https://info.flclearinghouse.com/ Applications are accepted on an ongoing basis. Flik maintains a drug-free workplace. Req ID: 1530187 Flik Hospitality Group Steven Goldberg [[req_classification]]

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Regional Sales Director is a first-line sales leadership role responsible for building, developing, and leading a high-performing specialty sales team supporting the launch and growth of an innovative mental health therapy. This leader will drive regional execution of commercial strategy by partnering with certified treatment centers, psychiatrists, and integrated care systems while ensuring alignment with regulatory, safety, and patient-access frameworks. The Regional Sales Director will play a critical role in shaping a new therapeutic category, and creating a culture of integrity, collaboration, and patient-centricity. Location: Remote in New York (New York, NY, Philadelphia, PA, Newark, NJ). Reports to: Director, National Sales. Roles and responsibilities (Include but are not limited to): • Recruit, onboard, and lead a team of Territory Account Managers, • Foster a high-accountability, psychologically safe culture that promotes coaching, development, and collaboration, • Set clear expectations and performance standards aligned with company launch objectives, • Drive successful regional execution of the commercial launch strategy and identify opportunities to expand the treatment ecosystem, • Ensure field readiness around clinical data, patient identification, treatment protocols, and site-of-care logistics, • Foster strategic relationships with psychiatrists, treatment centers, behavioral health systems, academic centers, and Key Opinion Leaders (KOLs), • Partner cross-functionally with Medical Affairs, Market Access, Training, Patient Support, etc., • Provide field insights to inform brand strategy and launch optimization, • Analyze regional performance metrics and develop action plans to drive results, • Manage regional budgets, forecasting, and territory alignment, • Conduct regular field coaching to strengthen clinical selling skills and consultative engagement with mental health providers Candidate Profile: • Bachelor's degree required (advanced degree preferred), • 8-10+ years of pharmaceutical or biotech sales experience, • 5+ years of first-line sales leadership experience, • Demonstrated success launching specialty or neuroscience therapies, • Experience in psychiatry, CNS, or behavioral health markets, • Experience launching therapies requiring site certification, REMS, or specialized administration models and/or a background working with IDNs, academic medical centers, and specialty treatment sites, • Experience building teams in startup or pre-launch biotech environments 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$180,000—$230,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description About MMS Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. Senior Biostatistician: Responsibilities: • Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams., • Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies., • Review ADAM and TLFs; work with client and programmers to resolve comments., • Strong programming and logic skills (working knowledge of SAS), • Ability to apply drug development knowledge during production of high quality statistical analyses., • Perform sample size calculations for a variety of scenarios and study designs., • Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor., • Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas., • Understand the various tools that we work with, • High level knowledge of drug development as it pertains to biostatistics., • Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician., • Review the statistical section of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor’s protocol with minimal support, • High proficiency with MS Office applications, • Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation., • Provide ICH guideline based input as applicable to statistics., • Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers.Requirements:, • College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required., • Minimum of 5 years’ experience in Biostatistics or similar field required., • Expert knowledge of scientific principles and concepts., • Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses., • Strong SAS programming, SAS base, SAS macro experience., • Thorough knowledge and understanding of clinical data preferred., • Strong experience with data and production of TLGs., • Excellent scientific writing skills., • Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements., • Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission. Powered by JazzHR vG51XmhQd9

Job Description Summary: The Quality Associate will perform independent examination (i.e., audit) of multiple trial related activities and documents, to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported, according to the protocol, standard operating procedures (SOPs), GCPs and the reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.). The Quality Associate is responsible for building and maintaining effective working relationships with internal staff/external vendors. The ideal candidate will be responsive, thoughtful, self-motivated, highly organized, and a team-player. This role reports directly to the VP of Compliance. Under supervision of a mentor/coach, the Quality Associate will be responsible for: Duties and Responsibilities: Quality Duties: • Responsible for quality control checks on study documents related to the conduct of the clinical trial in different therapeutic areas and phases, • Audits phases of laboratory and clinical studies, reports, and performs related duties (e.g., issues findings and QA statements), • Will also support training for site staff, this include creating and presenting quality content., • Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, Data Services), • Assist with writing QA audit or QC reports, • Works with internal clinical research team to ensure that inspection findings are clearly communicated and understood, • Evaluates inspection finding responses to ensure they are written to address the findings appropriately, • Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced, • Introduction to in-life audits, process audits, and vendor audits, • Identifies and communicates opportunities for process improvement based on audit and inspection observations, • Maintains necessary documentation of QA records and study files, • Notifies management of observed quality and compliance trends in the areas inspected, • Interprets GCP, and associated regulatory documents to facilitate auditing and process improvement recommendations, • Carries out appropriate self-development efforts as directed, • Performs other related duties as assigned Regulatory Duties: • Ensures that the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to theconduct of clinical pharmaceutical and device protocols, • Maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures, • Works under limited supervision to assure compliance with federal regulations relating to human subject research, • Understands and applies ethical principles and multiple regulations to clinical research protocols, • Review study protocols, informed consent documents, and other study-related documentation, to assure conformance with all applicable requirements, • Prepares, maintains, and provides oversight to all research-related regulatory documents, • Populates and coordinates the entire process of initial regulatory documents' submission to the IRB, sponsors, and state or federal regulatory offices as necessary, • Compiles study information and submits initial, continuing, and final reports to the IRB and/or sponsor, • Prepares applicable submission forms and submits updated documents, including but not limited to amendments, addendums, investigator's brochures, safety information, form FDA 1572s, and informed consent documents, • Accurately files and maintains all necessary logs within the regulatory binder(s), assists in and manages the archival of clinical trial documents/records, • Prepares for monitoring visits and audits, • Manages and updates employee curriculum vitas and ensures copies of all current and applicable medical licenses are on file, • Creates error free written documents and reports such as cover letters, notes-to-file, and memos, • Exercises judgement within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor, • Interacts with internal and external personnel, including but not limited to physicians, nurses, research staff members, administration staff, industry sponsor representatives, IRBs, central laboratory/imaging personnel, and clinical trial patients and attends site initiation visits, • Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume, • Other duties as assigned Duties, responsibilities, and activities may change, or new ones may be assigned at any time. Qualifications: • Bachelor’s Degree in scientific area of study or equivalent combination of education, training, and experience, • Previous experience in a clinical research environment or equivalent work environment, • 2-4 years of previous experience as regulatory and/or quality associate in clinical research, • Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) preferred, • Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint), • Familiarity with clinical trial management system software, preferably Clinical Research IO, • Basic medical knowledge, including medical terminology, • Demonstrated competence in oral and written communication, • Must complete CITI and GCP training certification, • Demonstrated organizational skills and outstanding time management, including keen attention to detail, • Possess impeccable integrity and personal and professional values that are consistent with PCR’s high standards and mission, • Comply with the company policies, code of ethics, and guiding values at all times Competencies: • Strong analytical and problem-solving skills, • Detail oriented with the ability to perform at a high level of accuracy, • Proactive at identifying and addressing issues in real time, • Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner, • Must handle confidential matters and sensitive information with discretion and judgment, • Ability to research regulatory issues and provide recommendations for resolution, • Ability to handle multiple projects simultaneously, • Ability to manage small projects and work independently, • Ability to understand and interpret clinical research protocols and other applicable sponsor documentsWork Environment and Physical demands: The work environment and 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 accommodation may be made to enable individuals with disabilities to perform the essential functions. • Work is performed in an office/laboratory and/or a clinical environment., • Exposure to biological fluids and/or bloodborne pathogens., • Personal protective equipment required such as protective eyewear, garments, and gloves., • Travel between two NJ sites is required, • Ability to work in an upright and/or stationary position for 6-10 hours per day., • Frequent mobility required., • Occasionally squatting, kneeling, or bending., • Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.Salary and Benefits: Summit Pinnacle Clinical Research provides each of our team members with opportunities for personal and professional growth in a team-oriented working environment. We offer competitive pay, excellent benefits, and the chance to grow professionally in the healthcare industry. The salary range for this position will be commensurate with experience. • 401k, • Medical, dental, vision, long term disability, short term disability, HSA, and life insurance, • 3 weeks of paid time off, • 14 paid company holidays, • Scrub voucher (specific positions apply), • And more! Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

Job DescriptionJob Title: REMOTE Territory Sales Manager – Specialty Chemicals & APIsCompensation: $100,000–$130,000 base + performance incentives Location: Remote (U.S.) Industry: Specialty Chemicals / APIs / Pharmaceutical Intermediates Overview A global manufacturer of specialty chemicals and pharmaceutical ingredients is expanding its North American commercial team. This is a high-impact sales role focused on growth within key verticals including iodine derivatives, intermediates for anti-cancer and contrast media, and active pharmaceutical ingredients (APIs). The role is modeled on a proven sales structure used for similar markets, emphasizing relationship management, business development, and strategic positioning across nutraceutical, pharma, and fine chemical sectors. Key Responsibilities Drive sales growth across the North American territory for specialty and pharmaceutical-grade chemical ingredients. Identify, target, and close new business opportunities across the following categories: Iodine derivatives Anti-cancer drug intermediates X-ray and contrast media intermediates APIs and stomach-related APIs Develop and maintain relationships with key accounts, distributors, and manufacturers. Collaborate closely with global production and regulatory teams to ensure compliance and delivery. Analyze market trends and identify high-value prospects for long-term partnerships. Represent the company at key trade shows and industry events (e.g., IBIE, CPhI, SupplySide West). Prepare detailed reports and forecasts for executive management. Qualifications Bachelor’s degree in Chemistry, Chemical Engineering, or related field (advanced degree a plus). Minimum 5 years of experience in B2B sales of specialty chemicals, APIs, or pharmaceutical intermediates. Proven track record of achieving revenue goals and building strategic partnerships. Familiarity with regulated markets (FDA, REACH, GMP) preferred. Exceptional communication, negotiation, and presentation skills. Self-motivated, entrepreneurial mindset; able to operate with minimal supervision. Compensation & Benefits Base salary between $100,000 and $130,000, depending on experience. Performance-based commission and annual bonus structure. Health coverage, paid time off, and travel reimbursement. Long-term growth opportunity with a global chemical leader expanding in the U.S. market.

Job Description Overview Who we are— Transcat is a dynamic, innovative, growing company that has been recognized as the leading calibration and compliance services provider in North America and beyond. With over 1,000 employees—in technical, consulting, operational, sales, finance, and corporate roles—we have stood the test of time by delivering on our Trust in Every Measure promise to our customers in vital industries, including life sciences, aerospace, defense, energy, and utilities. We fulfill this promise through our employees, who live Our Values every day, the Transcat Way. Our employees are at the center of the rewarding, challenging, and life-changing work we do for our customers and those they serve. Are you ready to join a company where the work you do makes a difference, and where you can grow in your career? Here’s what Transcat has to offer— • Work that matters., • A values-based culture where people care about each other and the work they do together., • Flexibility, • Training and development to accelerate learning and career advancement., • Competitive compensation and benefits, including paid time off, health insurance, tuition reimbursement, retirement, stock purchase plan, and MORE! We are Searching for— A Maintenance and Reliability Engineer, to serve as a key technical resource supporting clients in optimizing maintenance and reliability programs, driving performance improvements, and sustaining asset health. You will balance hands-on maintenance leadership with analytical reliability strategies that reduce downtime, extend asset life, and improve overall equipment effectiveness (OEE). This is an on-site position with occasional travel up to 25% of the time. You will report directly to our Maintenance and Reliability Service Leader. Responsibilities Essential Duties and Responsibilities • Adhere to stringent regulatory requirements, such as FDA regulations, ensuring all activities and equipment meet industry standards for quality and safety., • Lead and execute preventive and predictive maintenance activities on production, utility, and process equipment., • Conduct data-driven analyses of equipment reliability trends and develop improvement recommendations., • Implement and sustain CMMS processes including PM optimization, asset hierarchies, and work management best practices., • Support and facilitate root-cause analysis (RCA) and corrective action implementation., • Partner with cross-functional teams (engineering, operations, quality, EHS) to align M&R initiatives with business goals., • Support regulatory compliance (FDA, GMP) and ensure documentation meets company and industry standards., • Coordinate vendor and contractor support for maintenance and reliability improvement activities., • Contribute to MRO spare parts management, bill of materials accuracy, and lifecycle cost reduction., • Participate in continuous improvement and digital transformation initiatives leveraging data visualization, AI, or BI tools. Qualifications Required Knowledge, Skills and Abilities • 3 – 5 years of experience in maintenance and/or reliability engineering., • Experience with either SAP or Hexagon is preferred., • Demonstrated experience in preventive and predictive maintenance programs., • Working knowledge of reliability analysis methods and continuous improvement tools., • Proficiency with Computerized Maintenance Management Systems (CMMS)., • Understanding of mechanical, electrical, pneumatic, and hydraulic systems., • Experience with MRO and spare parts management and BOM development., • Knowledge of EHS and GMP regulations., • Familiarity with Business Intelligence tools (Spotfire, Power BI, Tableau) or AI technology., • Strong verbal, written, and presentation skills; proficiency in Microsoft Office platforms (Excel, Word, PowerPoint)., • Able to travel up to 25% of the time. Preferred: • Bachelor’s or Associate degree in a STEM field or trade certification in instrumentation, mechanical, electrical, or related engineering field., • Life Science experience., • Certified Reliability Leader (CRL) or Certified Maintenance & Reliability Professional (CMRP) certification. If this sounds like you, apply today! Equal Opportunity and Non-Discrimination Transcat is an equal-opportunity employer and prohibits discrimination based on any protected status. As required by United States law, all qualified applicants will receive consideration for employment without regard to age, color, disability, genetic predisposition or carrier status, national origin, race, religion, sex (including pregnancy, sexual orientation, and gender identity), status as a protected veteran, or as a member of any other protected group or activity under federal, state, and local law. We will make reasonable accommodations for employees with disabilities to enable them to perform the essential functions of their position unless doing so poses an undue hardship to the company or a direct threat to health or safety. Contingencies All offers of employment are contingent upon successfully completing all pre-employment requirements, which include verification of identity and employment eligibility, and when applicable, a motor vehicle driving record report.

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