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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: White Plains, NY - Neurology Target area for territory is White Plains - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Westchester, White Plains, and the Bronx. 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: 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 _.

Job Title: Quality Assurance Manager - Food Safety Job Location: Jamaica-USA-11430 Work Location Type: On-Site Salary Range: $95,000.00 - 112,000.00 LSG Sky Chefs is one of the world’s largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted “Airline Caterer of the Year in North America” for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented employees. Our team members are the heart and soul of our success, consistently delivering exceptional culinary experiences and outstanding service to our clients and their passengers across North and Latin America. Ensure the food meets the standards set by regulatory health authorities and the company. The job incumbent is responsible for the implementation, auditing, assessing and training of food safety and quality management systems within the responsible Customer Service Center (CSC). Responsible for the development, deployment, implementation, and on-going execution of the food safety preventive controls program (Policies, SOPs, Hazard Analysis, HACCP Plan, Prerequisite Food Safety Programs, Traceability & Recall Process, Allergen Programs, and Associated Records) within the assigned facility. • Ensure compliance with regulatory requirements Food and Drug Administration (FDA) such as federal regulation, local regulation, United States Department of Agriculture (USDA), customer specifications and corporate food safety and quality standards, regional food safety and quality standards, taken appropriate corrective actions when needed., • Manage the food safety program and ensures that FDA FSMA preventive controls are effective and proper records are maintained., • Provide technical expertise relative to Hazard Analysis and Critical Control Points (HACCP), food safety, sensory and quality evaluations., • Conduct monthly-required assessments of the food safety program to ensure compliance., • Conduct routine microbiological testing as defined by food safety program., • Review and analyse weekly food safety documents including HACCP logs., • Utilization of the checklists to determine consistent fulfilment of required food safety program., • Support CSC leadership with inspection/audit readiness; coach CSC before, during and after all external, food safety, quality and sanitation inspections/audit., • Supervise pest control program and contract services and suppliers related to the food safety program., • Conduct appropriate investigations regarding food safety matters and support CSC management in providing detailed information to the customers., • Perform and document periodical checks on products and services to ensure quality standards are met., • Interface with functional areas (Operations, Production, Sales, and HR), Regional Quality Team, other quality managers to ensure sustainability of the food safety program., • Establish and maintain effective working relationships with internal stakeholders across all functions and suppliers, customers and regulatory authorities. Reporting • Monitor and prepare reports for the food safety and quality management system., • Insertion of monthly-required data in the company web based portal., • Collect and monitor all food safety and quality documents (e.g. environmental monitoring, sanitation verifications, chef table, portion control, equipment handling, ramp-on time and safety performance), • Keep manuals and documentation updated and implement new procedures and rules in a timely manner. Leadership • Possess excellent verbal and written communication skills, including the ability to communicate professionally in person, by phone and through email., • Must be able to work in a fast-paced environment while interacting with staff at all levels, and remaining positive, proactive and resourceful., • Demonstrates initiative and the ability to work efficiently and independently., • Able to read and understand food safety and quality reports and take appropriate action., • Must possess a high level of accuracy, attention to detail and is well organized., • Recruit, on-board, develop, coach, train, support, and evaluate the performance of the Food Safety staff., • Participate and support company sponsored initiatives such as Global Quality Standards (GQS), HACCP, Lean Manufacturing, Employee Safety, • Bachelor’s degree in Food Science, Food Microbiology, Chemistry, Biology or related fields., • Certified Preventive Controls Qualified Individual (PCQI) and Hazard Analysis Critical Control Points (HACCP), • Five or more years of experience in Food Safety roles with a minimum of 2 years management experience., • Technical proficiency in the areas such as of food microbiology, food chemistry, food safety, and food regulations., • Proven understanding of government regulations in relation to food processing as FDA FSMA, Current Good Manufacturing Practices (cGMP), HACCP regulations and USDA., • Proven analytical and leadership skills., • Strong interpersonal and communication skills., • Be a collaborative leader who inspires, manages, coaches and respects people., • Excellent verbal, written and organizational skills that combines with an aptitude for multi-tasking., • Knowledge of computer skills required, including use of technology (scanners, tablets, printers, copiers, etc.) and Microsoft Office programs, as well as cloud based systems. LSG Sky Chefs is an EEO and Affirmative Action Employer of Women/Minorities/Veterans/Individuals with Disabilities.

Job Summary The Regulatory Trade Compliance Manager is responsible for ensuring compliant and efficient importation of medical devices, medical kits, and other FDA-regulated products into the United States. This role serves as the primary bridge between Regulatory Affairs, Imports/Logistics, Legal, and Corporate Compliance to ensure that FDA import data and processes are accurate, consistent, and aligned across all internal systems, contract manufacturers, suppliers, and customs brokers. The position is being established to strengthen FDA import compliance and reduce detentions by creating standardized governance processes, improving data integrity, and developing effective working relationships with FDA import reviewers. The individual will own the end-to-end process for FDA import compliance, with a strong focus on ACE entry requirements, medical kit imports, and resolution of FDA Notices of Action. Job Description MAJOR RESPONSIBILITIES Serve as the Regulatory Affairs subject matter expert for FDA import requirements and ACE submissions for medical devices and medical kits. Provide regulatory guidance to Imports and Logistics teams to ensure accurate FDA data transmission through the Automated Commercial Environment (ACE). Oversee and validate FDA entry data elements including FDA Product Codes, Intended Use Codes, Affirmations of Compliance (AofC), Establishment Registration Numbers, Medical Device Listing (MDL) numbers, Manufacturer and importer identifiers. Act as the escalation point for complex FDA import questions and compliance determinations. Serve as the process owner for FDA import data integrity across the enterprise. Design and implement standardized processes to ensure consistency of FDA-critical data across Regulatory Affairs systems, ERP and master data systems, Trade compliance platforms, Broker instructions, Supplier and contract manufacturer documentation. Establish formal change-control processes to ensure that product updates, new listings, or regulatory changes are reflected in import data prior to shipment. Develop and maintain SOPs, work instructions, and internal controls related to FDA import compliance. Act as the internal expert on FDA import requirements for convenience kits, including determination of kit regulatory status, assignment of appropriate product codes, component-level listing considerations, multi-component admissibility requirements. Partner with Product Development, Sourcing, and Quality to ensure new or revised kits are structured and documented in a manner that supports FDA admissibility. Serve as the primary Regulatory Affairs contact for FDA detentions and Notices of FDA Action (NOAs). Lead root cause analysis and corrective actions to prevent recurrence of detentions. Partner with the Imports team to investigate and resolve FDA entry issues, including incorrect or inconsistent product codes, outdated or missing device listings, data discrepancies, supplier documentation gaps. Develop professional rapport with FDA import reviewers and compliance officers to facilitate timely resolution of entry reviews and questions. Track, trend, and report FDA detention metrics and drive continuous improvement initiatives. Partner with suppliers and contract manufacturers to ensure understanding of U.S. FDA import requirements. Support onboarding of new suppliers from an FDA import compliance perspective and ensure readiness prior to first shipment. Collaborate closely with Legal and Corporate Compliance teams to establish and maintain an enterprise governance framework for FDA import compliance. Participate in internal audits, compliance reviews, and investigations related to import activities. MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Regulatory Affairs, Life Sciences, International Trade, Supply Chain, or a related field Equivalent combination of education and experience will be considered Certification / Licensure Work Experience Minimum 5 years of experience in FDA-regulated industry Demonstrated experience creating and implementing business processes and governance controls Experience managing import compliance for medical kits / convenience kits Knowledge / Skills / Abilities FDA medical device import and registration requirements ACE entry submissions and troubleshooting Resolution of FDA detentions and Notices of Action Ability to analyze FDA entry failures and determine regulatory root causes Experience translating regulatory requirements into operational processes PREFERRED JOB REQUIREMENTS Certification / Licensure Customs Broker License or trade compliance certification Work Experience People management experience Experience interacting directly with FDA import compliance officers Experience with SAP GTS or similar trade compliance systems Background partnering with Legal and Compliance on governance initiatives Knowledge / Skills / Abilities Experience supporting FDA inspections or audits Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $116,000.00 - $174,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

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

Job Summary JOB SUMMARY Key contributor within the organization that monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure Medline is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs. Responsible for managing an automated risk-based trending system that will help the organization foresee risks as well as objectively proving that risk controls are effective. Provide expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls to be compliant with EU MDR along with satisfying FDA, ISO 13485, and ISO 14971 risk management related processes throughout the product life cycle. Collaborate with Medline’s R&D team during design and development, manufacturing teams to implement appropriate risk controls, post-market surveillance teams to determine if new risks have arisen, and Regulatory Affairs to support FDA inspections. Job Description MAJOR RESPONSIBILITIES: Analyze and normalize multiple streams of data to gauge the health of the risk management system. Work with Subject Matter Experts (SMEs) to create a framework for Risk-based dashboards to be used for real-time decision-making and management reporting. Provide detailed input to stakeholders on how to implement risk controls as well as create and implement controls Identify inefficiencies in Medline’s global quality management system. Take action to address identified inefficiencies. Develop timelines for all projects and ensure that deadlines and goals are being met. Frequently update management and team on progress. Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion. MINIMUM JOB REQUIREMENTS Education Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree. Work Experience At least 2 years of QA/QE experience in a cGMP Device or environment. Complete device life cycle experience related to design, production, use of a device, and ISO 14971. Experience with Data visualization tools/business intelligence tools such as Tableau, Power BI, or Qlik. Experience leading multiple, complex projects. Knowledge / Skills / Abilities Strong ability to manage multiple priorities. Self-starter attitude. Good oral and writing skills. Ability to work independently and as a team in an efficient manner. PREFERRED JOB REQUIREMENTS Education Masters of Science – Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field. Certification / Licensure Six Sigma certification. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Medline is hiring a Senior Data Analyst to ensure high levels of data quality, integrity, and governance, enabling product recall, regulatory, and quality data to effectively support business operations and compliance requirements. This is an exciting opportunity to build high impact analytics, dashboards, and data governance solutions that directly support patient safety and FDA readiness across manufacturing, supply chain, and quality teams. Ideal for a hands on, senior analyst who thrives in regulated environments and wants to make a visible, enterprise level impact. Job Description Major Responsibilities Ensure high levels of data quality, integrity, and governance so product recall, regulatory, and quality data effectively support business operations and compliance requirements. Design, develop, and deliver post‑market surveillance and recall analytics, dashboards, tools, and insights to support patient safety, recall execution, and regulatory compliance. Establish and maintain master data standards, procedures, and a recalls reporting framework, including data collection, validation, governance, and a single source of truth aligned with applicable regulations and the Quality Management System (QMS). Analyze manufacturing, inventory, shipping, distribution, and customer data to identify affected products and customers and ensure end‑to‑end traceability during recall events. Support recall execution activities—including product holds, inventory containment, scrapping, return‑to‑vendor, and disposition or termination requirements—in partnership with Quality, Manufacturing, Supply Chain, Logistics, Customer Service, and Regulatory Affairs. Monitor, track, and report on data quality metrics; perform ongoing analysis, audits, and investigations to identify errors, risks, or gaps and drive corrective and preventive actions. Engage with business leaders to assess and communicate the business and regulatory impact of data quality issues or recall process gaps and recommend improvements. Identify, lead, and implement continuous improvement initiatives through process mapping, system enhancements, and adoption of best practices. Respond to time‑sensitive and escalated data and reporting requests related to recalls, quality events, and regulatory inquiries. Support FDA inspections and other regulatory agency inspections or information requests by providing accurate, well‑documented, and timely data. Maintain departmental SOPs and documentation related to data management, analytics, and reporting standards. Minimum Job Requirements Education Bachelor’s degree in a business‑related field such as business, supply chain, operations, engineering, or information systems. Work Experience 4+ years of experience in data management, data analysis, or reporting. Demonstrated experience driving data or tooling improvements from requirements gathering through validation and release. Prior experience working in a regulated industry required (medical device, MedTech, healthcare, pharmaceutical, or similar strongly preferred). Experience supporting product recalls, post‑market surveillance, quality events, or regulatory compliance activities preferred. Proven ability to work cross‑functionally and manage multiple priorities while delivering accurate results within tight timelines. Knowledge / Skills / Abilities Demonstrated knowledge of data manipulation, analytics, and reporting tools including Excel, SQL, Access, and Power BI / Microsoft Fabric. Experience developing data collection, automation, and reporting solutions, including use of Power Apps. Knowledge and experience with SAP, Smartsheet, and other ERP or reporting platforms. Strong understanding of data quality, governance, validation, and audit readiness in regulated environments. Ability to analyze complex information, prioritize critical data, and deliver clear, actionable insights. Strong communication skills with the ability to translate data for technical and non‑technical stakeholders. Experience driving continuous improvement initiatives and implementing process or system enhancements. Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint. Ability to work independently and provide leadership, coaching, and mentoring to others. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

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

Job Title: Director, Regulatory Affairs Location: Remote Duration -3 months Description: Provides senior regulatory leadership and strategic guidance to support late-stage clinical development programs, ensuring alignment with global regulatory requirements. Acts as the primary regulatory lead for a fast-paced biotech environment, partnering cross-functionally to drive regulatory strategy through Phase III and preparation for potential registration. Key Responsibilities: Lead global regulatory strategy for Phase III clinical programs, with a focus on vaccines. Provide hands-on leadership for regulatory submissions and interactions (e.g., FDA, EMA), including NDA/BLA readiness where applicable. Serve as interim Regulatory Affairs Lead, ensuring continuity of ongoing programs and regulatory commitments. Advise internal stakeholders on evolving regulatory requirements and risk mitigation strategies. Support preparation, review, and delivery of high-quality regulatory documents and submissions. Act as key liaison with clinical, CMC, and executive teams in a high-pressure, fast-moving biotech setting. Qualifications: Extensive Regulatory Affairs experience (typically 12–15+ years) in biotech/pharma. Proven experience leading global regulatory strategy for Phase III clinical programs. Vaccine experience strongly preferred. Prior experience with NDA/BLA submissions or late-stage regulatory interactions is a plus. Demonstrated ability to operate effectively in fast-paced, high-pressure environments. Strong leadership, communication, and stakeholder management skills.

NEW Vice President Clinical Development Opportunity! This Jobot Job is hosted by: Audrey Block Are you a fit? Easy Apply now by clicking the "Quick Apply" buttonand sending us your resume. Salary: $350,000 - $400,000 per year A bit about us: We are a small biotech located in the greater Boston area. We are hiring a VP of Clinical Development with a strong background in Ophthalmology or Dermatology, and we ideally want someone with strong Phase II experience. Please apply if you fit the criteria below! Why join us? Competitive compensation Stock options Flexible schedule Established team with strong funding Opportunity for growth Job Details Job Details: Our company is seeking a Vice President of Clinical Development Ophthalmology to lead our team. This is an exceptional opportunity for a seasoned professional to apply their expertise in a dynamic and innovative environment. The successful candidate will be responsible for overseeing the clinical development of our therapeutics in the field of ophthalmology. This role requires a minimum of 5 years of experience in clinical development. Responsibilities: 1. Lead and manage the clinical development team in the design, execution, and interpretation of clinical studies. 2. Develop and implement clinical development plans for ophthalmic products, ensuring alignment with business objectives. 3. Maintain a thorough understanding of FDA regulations, GCP, and BLA processes, and ensure all clinical activities are compliant. 4. Collaborate with cross-functional teams including regulatory affairs, pharmacovigilance, and medical affairs to ensure a holistic approach to product development. 5. Direct the preparation of clinical portions of regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). 6. Oversee the selection and management of Contract Research Organizations (CROs) and other external vendors. 7. Present clinical development plans, study results, and project updates to senior management, regulatory agencies, and other stakeholders. 8. Keep abreast of emerging models in healthcare delivery; identify and define new and innovative strategies to achieve business goals and objectives. Qualifications: 1. MD, DO, or equivalent degree with a specialty in Ophthalmology would be ideal. 2. Minimum of 5 years of experience in clinical development within the pharmaceutical or biotech industry. 3. Proven experience with FDA regulations, Good Clinical Practice (GCP), and Biologics License Applications (BLA). 4. Strong knowledge of clinical trial design, implementation, and data interpretation. 5. Excellent leadership and team management skills, with the ability to inspire and motivate a diverse team. 6. Exceptional communication skills, both written and verbal, with the ability to articulate complex scientific concepts to a variety of audiences. 7. Proven ability to manage multiple projects, prioritize tasks, and meet deadlines. 8. Strong strategic thinking, problem-solving, and decision-making skills. 9. Willingness to travel as required. This role offers an exciting opportunity to contribute to our mission of improving patient lives through the development of innovative ophthalmic therapies. If you are a strategic thinker, a strong leader, and a dedicated professional with a passion for clinical development, we would love to hear from you. Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

Chemist II – FDA cGMP Analytical Lab | 100% Onsite | Growing Pharmaceutical Testing Laboratory This Jobot Job is hosted by: Andrew Kraig Are you a fit? Easy Apply now by clicking the "Quick Apply" buttonand sending us your resume. Salary: $70,000 - $80,000 per year A bit about us: Founded over 20 years ago and based in South Plainfield, NJ, we are an FDA-registered, cGMP-compliant analytical testing laboratory specializing in OTC drugs, pharmaceuticals, cosmetics, dietary supplements, and botanical products. We provide method development, validation, stability testing, and release testing services to support regulatory compliance and product quality. Our laboratory operates under strict FDA, DEA, ISO, and USP standards to ensure accurate, reliable analytical results for our clients. Why join us? Competitive Compensation: Market-aligned base salary (DOE) Stability & Growth: Established FDA-regulated analytical lab Hands-On Technical Role: Extensive instrumentation exposure (LC, GC, ICP-MS, UV, IR, dissolution, etc.) Regulatory Experience: Work directly in FDA cGMP-compliant operations Professional Development: Exposure to method development, validation & QA collaboration Team Environment: Work closely with Laboratory and QA associates 100% Onsite – Fully equipped laboratory setting Job Details Key Responsibilities and Duties Independently execute validated analytical methods using LC, GC, IR, UV, dissolution, viscosity, melting point, and related instrumentation Prepare samples of OTC drug, pharmaceutical, cosmetic, dietary supplement, and botanical products Process and review instrument data (LC, GC, ICP-MS, etc.) for QA-ready reporting Maintain detailed, compliant documentation in accordance with FDA cGMP requirements Support method development, verification, validation, and transfer activities Participate in investigations including deviations, OOS/OOT, and CAPA Maintain laboratory equipment including calibration and troubleshooting Adhere to OSHA, chemical safety, and waste disposal procedures Occasionally assist with microbiology-related activities (media prep, environmental monitoring, aseptic handling) You should have most of the following: Bachelor’s degree in Chemistry (required) Minimum 3–5 years of experience in an industry chemistry lab (FDA-regulated preferred) Strong hands-on experience with HPLC and GC methods Experience working in FDA cGMP environments Familiarity with USP, ICH, and related regulatory guidelines Experience participating in OOS/OOT investigations and CAPA Ability to work independently in a fast-paced lab setting Basic microbiology exposure (media prep, aseptic techniques, environmental monitoring) Must be legally authorized to work in the US Must be able to commute to South Plainfield, NJ (no relocation) This is a 100% onsite role Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

Job Summary Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Lead the authoring and executing of protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results. In addition, this role will coach and assist Pharma Validation Engineers through the validation process. Job Description Responsibilities: Responsible for revalidation, engineering studies to evaluate new products or components, change control assessments, and coordination of computer and method validations of applicable products in an FDA controlled environment. Plan, communicate and lead scientifically sound qualification/validation strategies for large scale projects. Perform engineering studies to determine if projects are feasible. Suggest OEE Improvements and suggestions as a member of the continuous improvement team. Communicate with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regard to the needs and status of assigned study execution activities. Manage vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols. Provide coaching and mentoring to Pharma Validation team. Develop, prepare and install equipment and revise test validation procedures/protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices. Develop and execute cleaning validations. Responsible for IQ/OQ and PQ phases. Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols. Develop timelines for all projects and ensure that deadlines and goals are being met. Frequently update management and team on progress. Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion. Compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements. Maintain all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems. Qualifications: Bachelor of Science Degree in Biology, Chemistry or Engineering. At least 4 years of validation experience in a cGMP Device or Drug environment. Experience with validations of USP water, controlled environments or equipment validations in a regulated environment. Experience with validation documentation and related change control. Ability to control and coordinate concurrent projects, competing priorities and critical deadlines. Experience assessing and initiating actions independently. Experience taking charge of a situation, team or project. Ability to build and maintain relationships within and between teams. Strong oral and writing skills. Preferred Qualifications: Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field. Six Sigma certification. Validation experience in a pharmaceutical or Medical Device manufacturing environment. Experience with NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) products. Experience with validation of various product types such as liquid products, solid dosage products, and multi-component products. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $73,000.00 - $110,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary This role must be located in the Chicagoland area. Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories. Perform internal audits of Medline divisions and manufacturing sites. Job Description MAJOR RESPONSIBILITIES: Plan, schedule and execute complex supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR, and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics, medical foods, and dietary supplements), as well as contract sterilizers, laboratories and raw material suppliers. - Evaluate Medline suppliers to determine approval status. Assist in development of Regulatory/Quality Management Systems for potential suppliers. Manage and participate in quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs. Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications, including novel products and services. - Plan, schedule and execute internal audits in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements. Conduct adequate CAPA follow-up for supplier and internal audits. Write audit reports and communicate results to upper management. Provide training and consulting services to internal departments to comply with Quality Management System requirements. Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies. Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers. Plan and coordinate travel for supplier and internal audits, both domestically and internationally. Education Bachelor’s degree in microbiology, chemistry, engineering or related field. Work Experience At least 2 years of experience auditing FDA regulated medical device or pharmaceuticals manufacturing or testing OR at least 3 years working in quality role within medical device or pharmaceutical manufacturing. Knowledge / Skills / Abilities Detail-oriented, with excellent oral and written communication skills. Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions. Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary. Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally). Preferred Qualifications: Experience with FDA regulations (21 CFR 820, 21 CFR 210/211). Experience with ISO 13485. Experience applying knowledge of process validation, method validation and sterilization processes. Experience in CAPA (Corrective and Preventive Actions) management. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Responsible for planning and executing regulatory activities and projects necessary to ensure compliance with state and federal licensing requirements for the distribution of drugs, medical devices, and other regulated products. Assist with development of policies and procedures, systems, and strategies related to regulatory licensing compliance. May review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete department goals. Job Description Responsibilities In support of business priorities, determine the requirements for obtaining and complying with state and federal licenses for the distribution of prescription drugs, medical devices, home medical equipment, and other regulated products. Prepare, complete, and submit licensing applications and documents to state and federal regulatory agencies. Research federal, state, or local licensing requirements through review of laws and regulations or by direct contact with regulatory authorities. Develop and implement improvements to processes and procedures related to licensing requirements. Communicate the requirements of regulations to internal or external customers Prepare routine reports, dashboards, and summaries for licensing compliance tracking. Collaborate with cross-functional teams to deploy quality processes and systems. Implement and coordinate the use of electronic documentation systems and train personnel. Present project objectives with team members, solve problems, and act as a regulatory resource and subject matter expert. Provide training to team members and other internal departments on Medline licensing procedures and processes. Required Experience Bachelor’s degree or a combination of education and experience At least 2 years of experience in regulatory affairs, licensing, quality assurance, quality, compliance, or legal. Knowledge / Skills / Abilities Intermediate skill level in Microsoft Suites (Excel, Word, Visio, Access, PowerPoint, Project). Ability to evaluate information to determine compliance with standards, laws, and regulations. Experience with Quality Management Systems and Document Control. Applied knowledge of state pharmacy/ wholesale drug distributor laws, NABP Drug Distributor Accreditation, FDA regulations, DSCSA, and other laws and regulations related to drug and medical device distribution. Experience collaborating with internal resources and external resources. Experience working through details of a problem, overcoming obstacles, and reaching a positive and successful solution Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $73,000.00 - $110,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements. Responsible for developing solutions to re-solve complex regulatory issues and for leading multifunctional teams in high-priority projects. Job Description MAJOR RESPONSIBILITIES: In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s). Identify factors that could impact the success or viability of new product launch in assigned market(s). Monitor changes in regulations that impact current or future requirements and overall compliance. Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, and solutions for specific products and scenarios. Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards. Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Participate in the development, review, and substantiation of product labeling and claims. Manage individual projects by providing direction on diverse regulatory pathways, defining timelines for tasks and project teams, and recommending future actions and solutions. Assist in the review and development of processes related to regulatory activities of responsibility. Assist in the establishment and maintenance of department databases, logs, and files necessary for ensuring ongoing compliance. Actively participate in internal and external audits when applicable. Education B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related. Work Experience At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets. Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files. Experience preparing responses and communicating with regulatory agencies. Knowledge / Skills / Abilities Understanding of the current Regulatory environment and demonstrating the ability to perform within. Applied knowledge of FDA regulations and guidelines. Ability to evaluate information to determine compliance with standards, laws, and regulations. - Position requires up to 10% travel. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $92,000.00 - $138,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Support Medline’s Supplier Quality operations by executing supplier qualification, monitoring, and performance activities for a global supply base. This role assists with supplier assessments, documentation review, audits, and issue resolution to ensure compliance with FDA regulations, ISO standards, and internal quality system requirements. The position partners cross functionally while developing foundational expertise in supplier quality and regulatory compliance. Job Description MAJOR RESPONSIBILITIES Conduct supplier audits to verify compliance with ISO 9001, ISO 13485, and applicable regulatory requirements related to high-risk vendors Support supplier qualification, requalification, and disqualification activities for moderate to high‑risk suppliers, including documentation review and approval routing Review and approve supplier quality records and compliance documentation in accordance with internal procedures Execute Supplier Corrective Action Requests (SCARs) by tracking actions, verifying evidence, and documenting effectiveness under supervision Assist with supplier communication related to quality requirements, documentation requests, and corrective actions to Medline’s internal business partners and external suppliers Provide technical guidance and training to suppliers on quality standards and best practices Support containment activities and investigations related to supplier nonconformances Utilize root cause analysis and risk management tools to prevent recurrence of issues Maintain accurate and timely records of supplier audits, performance reviews, nonconformances, and corrective actions Prepare routine reports, dashboards, and summaries for supplier quality performance and compliance tracking MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Engineering, Biology, Quality Management, or related field Work Experience 3–5 years in supplier quality, manufacturing quality, or similar role Knowledge / Skills / Abilities Knowledge of ISO standards, FDA regulations (if applicable), statistical process control (SPC), and quality tools (FMEA, PPAP, APQP) Strong communication, problem-solving, and negotiation skills Medical Device or drug experience Travel up to 25% (domestic and/or international) PREFERRED JOB REQUIREMENTS Certification / Licensure ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional Six Sigma Green Belt or higher Work Experience Supplier quality auditing Audit hosting experience Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary JOB SUMMARY This role will be the senior lead contributor within the organization that creates, monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure Medline is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs. This individual will collaborate with clinical, design engineering, regulatory, labeling, and international partners to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. Provide expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls to be compliant with EU MDR along with satisfying FDA, ISO 13485, and ISO 14971 risk management related processes throughout the product life cycle. Job Description MAJOR RESPONSIBILITIES Create and align global risk management processes to ensure that risks are being analyzed consistently. Evaluate the risks and act as an approver for the following processes: Change Controls, Failure Mode Effect Analysis (FMEA), Medical Device Reporting (MDR), Recalls, Health Hazard Evaluations (HHEs), and other major quality events. Effectively communicate risks to senior global management. Build effective relationships with quality and business partners. Lead cross-department collaboration with R&D, Manufacturing, and other sites on a global level to ensure all risks are adequately addressed with robust risk controls. Create and manage systems to analyze multiple streams of data to gauge the health of a quality or risk management system. Work with Subject Matter Experts (SMEs) to create a framework for Risk-based dashboards to be used for real-time decision-making and management reporting. Provide detailed input to stakeholders on how to implement risk controls as well as create and implement controls Identify inefficiencies in Medline’s global quality management system. Take action to address identified inefficiencies. Lead and ensure that deadlines and goals are being met. Frequently update management and team on progress. Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion. MINIMUM JOB REQUIREMENTS Education - Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree. Work Experience - At least 4 years of QA/QE experience in a cGMP Device or environment. - At least 2 years of direct risk management experience related to FDA regulated products. - Experience creating quality sub-systems and leading complex projects. Knowledge / Skills / Abilities - Ability to manage 5+ projects at a time. - Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner. PREFERRED JOB REQUIREMENTS Education - Masters of Science – Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field. Work Experience - At least 5 years of QA/QE experience in a cGMP Device or environment. Certification - Six Sigma certification. Knowledge / Skills / Abilities - Working understanding of FDA, GMP, ISO 13485, and ISO 14971 - Experience facilitating FMEAs - Systems or clinical engineering experience Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $92,000.00 - $138,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Job Summary Lead Medline’s supplier quality oversight for a global supply base. Own risk‑based qualification, performance management, scorecards, and audit execution for high‑risk suppliers; act as SME on purchasing controls (21 CFR 820 §820.50 and ISO 13485:2016 7.4) and represent Supplier Quality during internal/external inspections. Drive cross‑functional corrective and preventive actions and supplier development to improve quality, reliability, and compliance. Job Description MAJOR RESPONSIBILITIES Lead risk‑based supplier oversight across regions; set audit/monitoring depth by risk tier and product classification. Lead communication efforts related to high-risk suppliers with internal stakeholders. Own complex supplier qualifications and disqualifications for critical suppliers, including technical documentation reviews and potential on‑site assessments. Author and maintain supplier quality agreements and inspection plans with Procurement/Legal; ensure alignment with device regulations and regional requirements. Own the supplier scorecard program for assigned categories; analyze trends and drive SCAR/CAPA to effectiveness verification; escalate per governance. Work with quality support groups (ex. Risk Management, Design and Development, Post-Market Surveillance, etc) to proactively identify issues and lead the containment of them. Lead partnership with procurement, engineering, and operations teams to resolve supplier-related quality issues. Provide technical guidance and training to suppliers on quality standards and best practices. Troubleshoot in-depth vendor issues that impact multiple business units to improve the global supply chain and improve supplier processes. Mentor Quality Engineers/QEDP associates and coach divisional QA on supplier controls, SCAR quality, and problem‑solving methods. Maintain accurate records of audits, performance reviews, and compliance reports. Oversees scorecard program and executive quality metric dashboards Assist or perform audits associated with high-risk suppliers to ISO 13485, ISO 9001, and/or and applicable regulatory requirements. MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Engineering, Biology, Quality Management, or related field. Work Experience 6-8 years in supplier quality, manufacturing quality, or similar role. Knowledge / Skills / Abilities In-depth knowledge of ISO standards and FDA regulations Strong communication, problem-solving, and negotiation skills Ownership of CAPA or SCAR throughout its lifecycle Strong Medical Device or Drug regulatory experience Strong critical thinking abilities Experience with statistical process control (SPC), and quality tools (FMEA, PPAP, APQP). Travel up to 25% (domestic and/or international) PREFERRED JOB REQUIREMENTS Education Masters of Biology, Chemistry, Engineering, Quality Management, or similar field Certification / Licensure ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional Six Sigma Green Belt or higher Work Experience Front or backroom FDA or ISO audit experience Supplier quality auditing Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $101,000.00 - $152,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

Ad Promo Regulatory Advisor Job Number: 26-00770 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for an Ad Promo Regulatory Advisor for our client in Princeton Pike, NJ. ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity! Position Overview: The Ad Promo Regulatory Advisor plays a critical role in ensuring that all U.S. advertising, promotional materials, and external communications for marketed pharmaceutical products comply with FDA regulations and industry standards. This position partners closely with cross functional teams to provide strategic regulatory guidance, assess risk, and support compliant product promotion in a fast paced, matrixed environment. Responsibilities: Regulatory Review & Strategic Guidance: Provide expert regulatory advice and risk assessments on a broad range of advertising and promotional materials, sales training content, and external communications for assigned marketed products. Compliance Assurance: Ensure all promotional activities adhere to FDA regulations, approved product labeling, OPDP advisory comments, and relevant guidance documents. Partner with internal teams to proactively identify and mitigate regulatory risks. Regulatory Intelligence: Maintain current knowledge of U.S. federal and state laws, regulations, enforcement trends, and policy developments affecting pharmaceutical advertising and promotion. Translate regulatory changes into practical business guidance. OPDP Submission Management: Prepare and submit promotional materials to FDAs Office of Prescription Drug Promotion (OPDP) on Form FDA 2253, ensuring accuracy, completeness, and timeliness. Labeling Alignment: Collaborate with cross-functional partners and management teams to ensure updates to U.S. Prescribing Information are consistently reflected across all promotional materials and campaigns. Required Qualifications: Bachelor’s degree in a Life Science discipline required; advanced degree strongly preferred (MS, PhD, PharmD, or JD). Regulatory Experience: Minimum of 5-6 years of regulatory promotional review experience within the pharmaceutical or biotechnology industry. Expertise in Promotional Regulations: Demonstrated experience providing strategic regulatory direction to interdisciplinary teams on promotional strategies and materials. Strong interest and knowledge of FDA promotional regulations and guidance. Industry or FDA Experience: Broad hands on pharmaceutical experience or prior FDA regulatory experience (e.g., OPDP) is highly desirable. Project & Stakeholder Management: Proven ability to manage multiple complex projects, identify and resolve issues, deliver on commitments, and work effectively across multidisciplinary teams. Leadership & Organizational Skills: Strong leadership presence with the ability to influence, drive alignment, and deliver optimal business results in a dynamic, matrixed environment. Pay Rate: $95.82 - $101.63 / Hour If hired, you will enjoy the following ECLARO Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO If interested, you may contact: June Binuya junethel.binuya@eclaro.com 212-804-7476 June Binuya | LinkedIn Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.

Job Summary Job Description JOB SUMMARY: Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories. Perform internal audits of Medline divisions and manufacturing sites. Lead complex, critical, supplier regulatory projects involving cross-functional teams. MAJOR RESPONSIBILITIES: - Act as senior team leader to support Supplier QA Management and facilitate strategic achievement of Supplier Quality goals. - As a Subject Matter Expert, provide training and consulting services to internal departments to understand and comply with Quality Management System requirements. - Plan, schedule and execute complex and high-risk supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics, medical foods, and dietary supplements), as well as contract sterilizers, laboratories and raw material suppliers. - Evaluate Medline suppliers to determine approval status. Assist in development of Regulatory/Quality Management Systems for potential suppliers. - Plan, schedule and execute complex internal audits in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements. - Conduct adequate CAPA follow-up for supplier and internal audits. - Write audit reports and communicate results to upper management. - Plan and coordinate all travel for both supplier and internal audits, both domestically and internationally. - Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies. - Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers. - Manage and participate in quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs. - Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications, including novel and high-risk products and services. - Assist in integration of new acquisitions into Medline’s quality system. Perform due diligence audits for potential acquisitions. - Provide mentoring, coaching, and training to junior auditors, divisional QA team members, and divisional QA Managers. Assist in managing the rotational QA program. Education - Bachelor’s degree in microbiology, chemistry, engineering or related field. Work Experience - At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality role within medical device or pharmaceutical manufacturing. - Experience with FDA regulations (21 CFR 820, 21 CFR 210/211). - Experience with ISO 13485. - Experience applying knowledge of process validation, method validation and sterilization processes. Knowledge / Skills / Abilities - Detail-oriented, with excellent oral and written communication skills. - Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions. - Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary. - Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. - Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally). PREFERRED JOB REQUIREMENTS - Experience with USP 61/62 for Microbial Testing of Non-Steriles. - Experience applying knowledge of process validation, method validation and sterilization processes. - Experience in CAPA (Corrective and Preventive Actions) management. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $92,000.00 - $138,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

BARDA / Nonclinical Data Standards and Analytics Program/Technical Advisor (Mid-level) Description of Role: The Biomedical Advanced Research and Development Authority (BARDA) within the office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services (HHS) improves national preparedness for chemical, biological, radiological, and nuclear (CBRN) accidents and attacks, pandemic influenza, and emerging infectious diseases by supporting the development and acquisition of medical countermeasures (MCM) against these threats. BARDA is looking for a Nonclinical Data Standards and Analytics Program/Technical Advisor to support the Division of Nonclinical Development (DNCD), Data Operations Program. The ideal candidate is excited to develop, implement, and manage a data quality and compliance management program for contracted nonclinical research across BARDA’s programs and provide subject matter expertise in nonclinical data standards and advanced analytics to support the development and implementation of a Nonclinical Data Coordination Center (DCC) platform tool. This position focuses on implementation and governance of DCC datasets structured according to an extensive professional experience in CDISC Standard for the Exchange of Nonclinical Data (SEND), with emphasis on SEND Implementation Guide – Animal Rule (SENDIG-AR), 2019, and alignment with FDA Guidance 'Product Development Under the Animal Rule. This is a full-time, remote position that requires the ability to obtain Public Trust; Tier 2 clearance. Required Qualifications: Advanced degree (e.g., Ph.D., M.P.H., M.S.) in biological and/or chemical sciences such as medicine, pharmacy, life science fields (e.g., immunology, molecular biology, biochemistry, microbiology, or similar) Minimum eight (8) years of relevant industry and/or relevant postdoctoral experience in regulatory data standards and analytics Direct SEND implementation experience Client-focused approach to work; Ability to prioritize workload Ability to work well with a multi-disciplinary team of professionals; Flexible attitude with respect to work assignments and new learning Preferred Qualifications: Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred Experience with applying statistical and epidemiologic methods to nonclinical datasets, including survival analysis and cross-study integration a plus Quality control and quality assurance experience with nonclinical datasets a plus Responsibilities: Serve as technical SME for CDISC SEND and SENDIG-AR (2019) Develop validation criteria, business rules, and quality control procedures for DCC ingestion of SEND datasets Support design and implementation of DCC data architecture and metadata governance frameworks Establish data acceptance and rejection criteria aligned with regulatory expectations Contribute to DCC end user interface testing and acceptance criteria Assist in developing end user training and implementation plans Ensure alignment with Animal Rule regulatory requirements (21 CFR 314.600 and 601.90) Assist other contractors by translating regulatory requirements into operational data standards specifications Quality control of dataset packages Integrate knowledge of nonclinical study conduct to assure correct dataset output Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packages Communicate findings to team members and management Obtain proficiency with DNCD quality control workflows to include regulatory dataset [e.g. SEND] review, study report QC, and other reviews, as required Adhere to and/or assist in establishment/refinement of DNCD SOPs and business practice documents related to QC efforts Learn data audit practices with possibility to assist in remote data audits of BARDA contracted research Provide technical expertise to individual advanced research and development (ARD) and/or nonclinical project coordination teams (PCTs). Act as the primary data management contact for BARDA ARD/nonclinical PCTs supporting contracts issued to CHEM, RADNUC, and BIOLOGICAL network contract research laboratories (CROs) Coordinate with PCTs to determine intended use for data derived from contract(s) and establish data management plans intended to ensure data are fit for purpose Coordinate with PCTs to ensure data management plans are included within contract management plans and quality assurance project plans established by CRO contractors Develop strong PCT relationships that are driven by consistent study data analytic and management services in terms of quality and timeliness Advise CRO contractors on data delivery and format requirements Receive and review raw data from CRO contractors for completeness and quality according to established quality control standards Coordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs #CB

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

Job Description Who We Are: Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click's treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click's platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn. About the Role: As a Senior Director / Vice President of Market Access, you will be the backbone of the commercial organization. You will design the financial architecture of the product, shape the external policy and regulatory environments to support PDTs, and ensure long term viability of the PDT category. The role reports to the Chief Commercial Officer and will work closely with senior counterparts in the Medical Office and Strategy Office. We are looking for someone with a strong background in Policy and Market Access Operations to also develop the Click playbook for Prescription Digital Therapeutic (PDT) launches across multiple therapeutic areas. This position is based out of Click's headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities. We have a hybrid working model that consists of at least 4 days in office each week. Responsibilities: • Pricing & Contracting Strategy, • Architect and execute comprehensive US pricing strategies, including WAC-to-Net modeling and multi-year GTN (Gross-to-Net) forecasting to ensure sustainable brand profitability, • Design and negotiate innovative contracting frameworks to secure optimal formulary positioning., • Lead the Deal Evaluation process, utilizing rigorous financial sensitivity analysis to balance market share gains against rebate ceilings and price-protection liabilities.Reimbursement & Operations, • Engineer end-to-end payment flows that bridge the gap between contract execution and claims adjudication, ensuring seamless provider and pharmacy reimbursement., • Oversee operational pathways for claims processing, proactively identifying and resolving "bottlenecks" in the medical or pharmacy benefit triggers to minimize script abandonment.Patient Support & Distribution, • Design and scale the "Hub" infrastructure and Digital Pharmacy partnerships to optimize patient onboarding and speed-to-therapy., • Implement a high-touch patient contact model (Care Guides/Coaches) leveraging RWE (Real-World Evidence) to drive therapy persistence and long-term outcomesCommercial Effectiveness & Data Strategy, • Own the commercial data ecosystem, integrating real-time app data with traditional claims data, • Establish key performance indicators (KPIs) to monitor pull-through effectiveness, ensuring field teams are prioritizing the highest-yield payer segments., • Drive call planning, reach and frequency for sales team to execute in the field Government Affairs & Advocacy, • Lead lobbying efforts and advocacy coalitions to advance statutory coverage (e.g., Access to Prescription Digital Therapeutics Act) and shape the federal PDT landscape, • Develop and execute localized market access plans to open coverage pathways for specialized populations (e.g., Schizophrenia), navigating state-specific PDL (Preferred Drug List) processesCoding, Billing & Reimbursement Policy, • Coding & Compendia Management: Lead the strategy for HCPCS, CPT, and ICD-10 coding alignment; oversee successful listing in key drug compendia (First Databank, Medi-Span) to ensure automated billing, • Payer Dossier Development: Develop AMCP dossiers and Budget Impact Models (BIM) that substantiate the clinical and economic value proposition to P&T committees, • Policy Influence: Serve as the primary internal expert for PDURS (Prescription Drug Utilization Review) and Physician Fee Schedule updates to ensure long-term payment recognition Qualifications: At Click, we aren't just looking for talent; we are looking for the next evolution of the modern professional. To us, AI is not a future possibility, it is a present-day prerequisite. We expect every Click colleague to have seamlessly integrated AI into their professional workflow and personal productivity, using it as a force multiplier to move faster, think deeper, and deliver superlative results that were previously out of reach. If you do not yet view AI as an essential partner in your daily pursuit of excellence, you will find it impossible to keep pace with our mission. High performers who harness AI technology to transcend traditional boundaries and set new benchmarks for professional excellence will thrive at Click. • Bachelor's degree required; MBA, PharmD, or MPH preferred to navigate the complex intersection of business and clinical strategy, • 15+ years of progressive leadership within the pharmaceutical sectors, with a proven track record across Market Access and Pharma Commercial Operations, • Demonstrated success leading multiple brand launches, overseeing the journey from pre-approval market shaping to post-launch pull-through, • Strategic capabilities with the ability to conceive, develop and implement multi-dimensional roadmaps and business plans, • Deep understanding of the US payer landscape, with a preferred focus on Medicaid, state government accounts, and public affairs policy to navigate evolving legislative environments, • Sophisticated understanding of cross-functional ecosystems, including Sales, Marketing Analytics, Account Management, and Pricing and Contracting, • Exceptional communication and interpersonal skills, with the "emotional intelligence" required to drive consensus across diverse cultures and complex matrixed disciplines. Click Preferred Qualifications: • Knowledge of or experience with Digital Therapeutics and/or Prescription Digital Therapeutics is considered a plus, • Experience in other commercial functions (Marketing, Sales Enablement) Compensation: The base salary range for this position is between $180,000 - $280,000. The final base salary will be dependent upon skills, experience and location. In addition to the base salary, Click Therapeutics offers an annual performance-based cash bonus and a generous equity package. Benefits: The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space. Competitive Salary with Annual Review | Cash Bonus | Stock Options | 5% 401(k) matching | Medical | Dental | Vision | Life Insurance | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fertility Support | Fitness Reimbursement | Bike Membership | Professional Development Stipend | DoorDash and Catered Lunches | Parent Benefits | LinkedIn Learning | Gemini Enterprise Stack | Industrious Workspaces | Commuter Subsidies | Flexible Work Arrangement | Choice of Mac or Windows | Sponsored Company Events | Office Snacks and Beverages | Much More… Equal Employment Opportunity: Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics. Recruitment Phishing Scams: Fake job advertisements and offers are increasingly appearing on the internet. If you have encountered a job posting or have been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond and report it to the Federal Trade Commission and the FBI at https://www.ic3.gov/Home/ComplaintChoice. Please be mindful of the following: • Click Therapeutics will only reach out to you through an "@clicktherapeutics.com" email address.Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver's License Number) via a messaging application (like that used on the LinkedIn platform or Microsoft Teams)., • Click Therapeutics will conduct interviews face-to-face over Zoom., • All job postings will be listed on the Click Therapeutics official career page.

Job Description Role Summary Lexeo is seeking an experienced and motivated professional to lead and build our Clinical Operations function as a key member of our development team. This individual will report to the Chief Medical Officer and will ensure that studies are completed on time and within budget in accordance with corporate objectives. This is a hands-on role and will be required to build excellent working relationships with various internal and external groups. If you enjoy being a part of a growing team and an entrepreneurial environment in which your work will have a meaningful impact on clinical trial progress for novel gene therapies, we want to hear from you! Primary Responsibilities • Collaborate with Lexeo CMO, R&D leadership, Weill Cornell research staff, Lexeo clinical, quality, and regulatory colleagues, CRO partners and other vendors to conduct clinical trials that meet corporate goals, • Evaluate and develop optimal outsourcing model for implementation of trials including selection of CROs and other vendors/ external partners. Oversee development of requests for proposals, negotiate and approve contracts and work orders, and review invoices prior to submission for approval, • Develop, maintain, and report on program budgets, including long-range forecasting, in support of Lexeo’s financial goals, • Monitor study-specific timelines, key deliverables, and implement strategies to optimize the efficiency of trial conduct, • Provide oversight of the CROs to avoid issues or rapidly adapt to challenges of feasibility/start up, slow recruitment, resourcing, site management, etc. Required Skills and Qualifications, • Advanced degree preferred and 10+ years of experience in the pharmaceutical or biotech industry within clinical operations and trial management, • Experience leading global clinical trials; rare disease/gene therapy trial experience preferred, • Thorough knowledge of development program management from IND- through NDA/BLA, including inspection readiness, • Extensive experience in CRO/ vendor selection and oversight, budget projection and management, establishing clear milestones, ensuring high-quality data delivery and report generation, • Advanced working knowledge of all relevant guidelines, including ICH, GCP, FDA, • Experience working in a fast-paced environment, • Excellent communication skills and ability to influence across multiple functions Compensation is dependent on qualifications and experience About Lexeo Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact. Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home. Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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

The (Senior) Medical Director (MD) - will provide strategic leadership to develop Clinical Development Plan (CDP), working closely with partners in Pre-Clinical, Regulatory, Safety, Stats, & Project Management. Core responsibilities will encompass developing & implementing the Clinical Development Plan and providing leadership to new product development from IND to submission. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Candidate must possess passion for science and patients, as well as entrepreneurial drive along with strong hands-on experience to help the organization succeed. MAJOR RESPONSIBILITIES AND DUTIE • SProvide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical progra, • mDesign Comprehensive Development Plans (CDPs), clinical trials and protocols and execute in accordance with applicable Good Clinical Practice (GCP) regulations, • .Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc., • )Define project timelines & deliverable, working closely with cross functional team and assure that deliverable is completed on time, on budget and according to the highest quality, ethical and professional standards, • .Identify project risks with input from the cross functional teams, and support resolving issues, • .Provide therapeutic area medical and scientific expertise to study teams and key stakeholders, • .Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning, • .Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision, • .Lead & author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs and clinical expert reports with high quality, • .Interact with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums, • .Performs all duties in keeping with the company’s core values, policies and all applicable regulations, • .Ensure data review quality (e.g. patient eligibility, Protocol Deviation review, efficacy and safety review) and data accuracy, • .Conduct safety review and safety follow up, • .Interpret data and ensure CSR quality/Briefing book quality, • .Interact with the HA and IRB/EC and Answers to medical questions raised by EC/IRBs and sites; identify the need of protocol amendment and maintain appropriate compliance with protocols, • .Interact with the participant Principle Investigators on protocols, • .Conduct literature research and competitive intelligence tracking for assigned projects . QUALIFICATIO • NSMD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific are, • a;5 or more years of pharmaceutical experience in Clinical Development for (Senior) Medical Directo, • r.Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV require, • d.Knowledge of Oncology is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research repor, • tsKnowledge of GCP, clinical trial design, statistics, and regulatory and clinical development process, • esExcellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategie, • s.Experience in biotech is preferre, • d.Willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environmen, • t.Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagemen, • t.Ability to be flexible and adapt quickly to the changing needs of the organizatio, • n.Superior interpersonal skills, & communication skills ensuring full alignment of cross functional team, • s.Highly collaborative & effective influencing skills and the ability to operate across multiple geographie s.

Join Our Family at Village Super Market: Food Production Operations Director Role Open About Us: For over 80 years, Village Super Market has been a staple in the tri-state area, renowned for our commitment to quality, service, and community. As a growing entrepreneurial company, we blend our rich history with forward-thinking strategies to ensure a thriving future. About the Role: The Food Production Director oversees all food production, sanitation, quality assurance, and operational functions. This role ensures full compliance with USDA, FDA, FSIS, SQF, HACCP, SSOP, and GMP standards while driving operational excellence, cost control, efficiency, and continuous improvement. What You’ll Do: • Lead daily food production operations, ensuring quality, efficiency, and on-time output in a fast-paced manufacturing environment, • Maintain strict compliance with GMPs, USDA/FSIS, FDA, SQF, and all food safety programs, • Drive performance by monitoring productivity, reducing waste, improving yields, and optimizing labor costs, • Oversee and develop team members through scheduling, training, coaching, and performance management, • Manage SAP production activities including manufacturing orders, inventory reconciliation, and system training, • Own documentation and reporting across production, quality, sanitation, and maintenance, • Lead new product commercialization from scale-up through first production runs, ensuring accuracy and compliance, • Partner cross-functionally with FSQA, R&D, Maintenance, and Procurement to solve problems and improve processes, • Support audits and act as a key liaison for regulatory agencies and food safety standards, • Foster a culture of safety, accountability, teamwork, and clear communication across shifts What We’re Looking For: • 10+ years of experience in food manufacturing or production operations, • Strong knowledge of food safety regulations (GMPs, USDA, FDA, HACCP, SQF), • Hands-on leadership experience managing teams in a high-volume environment, • Experience with SAP or similar ERP systems in a production setting, • Proven ability to drive efficiency, reduce waste, and improve operational performance, • Strong problem-solving, communication, and organizational skills, • Comfortable working in a fast-paced environment with a flexible schedule Why Village Super Market? • Family-Led Leadership: At Village Supermarket, you are more than just an employee—you are family. Our leadership style fosters a supportive and inclusive environment where every voice is heard and valued., • A Legacy of Excellence: Since 1937, we have been dedicated to providing exceptional service and products to our community. Join us in continuing this tradition of excellence., • Tri-State Presence: With locations across the tri-state area, we offer a unique opportunity to make a significant impact on a diverse and vibrant market., • Entrepreneurial Growth: We are not just a supermarket—we are an incubator for innovation. Here, you will have the freedom to explore new ideas and drive initiatives that shape our future., • Community Involvement: We believe in giving back. Be part of a company that is deeply invested in the communities we serve through various charitable endeavors and local partnerships. What We Offer: • Competitive Salary and Benefits: We provide a comprehensive compensation package that reflects your expertise and contributions., • Professional Development: Enjoy opportunities for growth and advancement within the company., • Supportive Work Environment: Join a team that values collaboration, creativity, and mutual respect. Salary Range: $170,000 - $197,000

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

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

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

We’re hiring an F&B Health & Safety Manager at JFK Airport to lead food safety, workplace safety, and regulatory compliance across a fast-paced, high-volume airport dining environment. In this role, you’ll play a key part in protecting both guests and associates by driving safety standards, strengthening operational practices, and fostering a strong culture of compliance across multiple restaurant units. Key Responsibilities Regulatory Compliance & Risk Management • Stay current on all applicable federal, state, and local health and safety regulations (e.g., OSHA, FDA Food Code, FSMA), • Partner with QA and Risk Management to implement regulatory updates and ensure compliance across all units, • Analyze Workers’ Compensation and General Liability claims to identify trends and drive corrective actions Operational Oversight • Conduct regular site visits to monitor food safety and workplace safety practices, • Identify risks, ensure proper use of PPE, and verify equipment safety and maintenance, • Ensure all required safety signage and documentation are accurate and up to date Training & Culture Building • Lead and deliver health and safety training programs for associates and management, • Reinforce learning through ongoing coaching, shift meetings, and safety initiatives, • Manage ServSafe certification and compliance processes, • Chair the Safety Team and drive engagement in safety programs Continuous Improvement • Investigate incidents and compliance gaps to determine root causes, • Develop and implement corrective action plans to prevent recurrence, • Build relationships with local and state health departments as proactive compliance partners Collaboration & Reporting • Work cross-functionally with Operations, HR, QA, and Risk Management teams, • Maintain accurate records including training logs, incident reports, and compliance documentation, • Participate in company-led safety initiatives, audits, and training sessions Work Environment & Schedule • Exempt position reporting to the Director/Senior Director of Operations, • Requires flexibility to work rotating shifts, including openings, peak hours, and closings, • Regular on-site presence across multiple restaurant units Qualifications Experience & Education • High school diploma required, • 5+ years of food safety and workplace safety experience in the restaurant industry Certifications (required or to be completed within 30 days of hire) • OSHA certification, • ServSafe Manager Certification, • ServSafe Alcohol & Allergens (or state equivalents), • OSHA #7505 Incident Investigation, • MIT Level 1 Food & Workplace Safety, • HAZMAT / Bloodborne Pathogens (BBP) training Skills & Competencies • Strong knowledge of OSHA, FDA Food Code, FSMA, and public health protocols, • Excellent analytical and problem-solving abilities, • Proven experience conducting audits and implementing corrective actions, • Strong communication skills with the ability to influence at all levels, • Effective trainer, coach, and facilitator, • Highly organized with strong attention to detail At HMSHost, we’re committed to supporting our team with meaningful benefits and career growth opportunities: • Comprehensive health, dental, and vision coverage, • Generous paid time off (vacation, flex days, sick leave), • Paid holidays, • Meal and transportation benefits, • 401(k) with company match, • Company-paid life insurance, • Tuition reimbursement, • Employee assistance program, • Career development and advancement opportunities, • Employee referral bonus program Apply today and take the next step in your health & safety career with HMSHost! Avolta, including Dufry, HMSHost Corporation, Hudson, and affiliates (“the Company”), is an equal opportunity employer. It is the Company’s policy to ensure equal employment opportunity in all aspects of employment and to comply with anti-discrimination laws and regulations. The Company prohibits discrimination and harassment of any type and provides equal opportunities to applicants and team members without regard to actual or perceived race, color, creed, age, religion, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, national origin, disability, military service and veteran status, ancestry, citizenship status, marital status, protected medical condition as defined by applicable state or local law, genetic information, or any other basis protected by applicable federal, state or local laws and ordinances (referred to as “protected characteristics”).

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.

Position – Aseptic Technician Location – Pearl River, NY Contract – 8 Months with a possibility of extension Summary: The main function of an Aseptic Technician is to support the manufacturing of sterile pharmaceutical products by performing tasks in controlled environments using aseptic techniques. A typical Aseptic Technician ensures product integrity and compliance with regulatory standards through meticulous attention to cleanliness, documentation, and process control. Job Responsibilities: • Perform aseptic gowning and operate in cleanroom environments., • Prepare, sterilize, and transfer materials and equipment into cleanrooms., • Execute aseptic filling, compounding, and packaging processes., • Monitor environmental conditions and report deviations or contamination risks., • Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP)., • Maintain accurate batch records and documentation., • Participate in cleaning, sanitization, and routine maintenance of cleanroom areas., • Support quality assurance and validation activities. Skills: • Knowledge of aseptic techniques and cleanroom protocols., • Strong attention to detail and adherence to procedures., • Ability to work in a sterile, regulated environment for extended periods., • Familiarity with GMP, FDA, and other regulatory requirements., • Good communication and teamwork skills., • Basic computer and documentation skills. Education / Experience: • High school diploma or GED required; associate degree or technical training in life sciences preferred., • 2-4 years of experience in aseptic processing, pharmaceutical manufacturing, or a related field.

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

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

Title: Aseptic Technician - II Location: Pearl River, NY Duration: 9 months (Temporary/contract-to-permanent potential) Work Environment & Schedule On-site, 5 days per week Standard hours: ~8:30 AM – 4:30/5:00 PM (non-batching periods) During production cycles: Early starts (~7:00 AM) Second shift shifts (up to midnight) Frequent schedule adjustments (~20 times/year) Occasional weekend work when needed (e.g., batch issues) Training duration: extensive (can take 6 months to 2+ years to fully ramp) Roles require long-term commitment due to complexity Candidates should be aligned with expectations and not seeking short-term exposure only Key Responsibilities: Execute downstream operations including: • Sterile filtration, • Aseptic filling in isolators, • Lyophilization (freeze-drying), • Vial sealing and final processing, • Perform visual inspection of vials for: Glass defects, Product defects, Container integrity, • Support buffer preparation activities as needed, • Operate and monitor isolator and aseptic equipment, • Ensure strict adherence to safety and sterility standards, • Contribute to: Documentation and reporting, • Process optimization, • Troubleshooting of manufacturing issues, • Collaborate with upstream teams to continue production flow, • Requires use of advanced PPE (including full cleanroom/isolator suits) Required Qualifications • Bachelor’s degree preferred in: Biology, Chemistry, Engineering, or related field (Equivalent experience may be considered), • Ability to follow complex procedures and work in sterile environments Preferred Qualifications Experience with: • Aseptic techniques, • Cleanroom environments, • Pharmaceutical manufacturing, • Strong time management and attention to detail Ideal Candidate Profile • Entry-level or early-career professional, • Detail-oriented with strong procedural discipline, • Able to work in highly controlled environments, • Comfortable with schedule variability and hands-on production, • Strong communication and documentation skills Description: • The main function of an Aseptic Technician is to support the manufacturing of sterile pharmaceutical products by performing tasks in controlled environments using aseptic techniques., • A typical Aseptic Technician ensures product integrity and compliance with regulatory standards through meticulous attention to cleanliness, documentation, and process control., • Job Responsibilities: Perform aseptic gowning and operate in cleanroom environments., • Prepare, sterilize, and transfer materials and equipment into cleanrooms., • Execute aseptic filling, compounding, and packaging processes., • Monitor environmental conditions and report deviations or contamination risks., • Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP)., • Maintain accurate batch records and documentation., • Participate in cleaning, sanitization, and routine maintenance of cleanroom areas., • Support quality assurance and validation activities Skills: • Knowledge of aseptic techniques and cleanroom protocols., • Strong attention to detail and adherence to procedures., • Ability to work in a sterile, regulated environment for extended periods., • Familiarity with GMP, FDA, and other regulatory requirements., • Good communication and teamwork skills., • Basic computer and documentation skills. Education/Experience: • High school diploma or GED required; associate degree or technical training in life sciences preferred 2-4 years of experience in aseptic processing, pharmaceutical manufacturing, or a related field

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

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

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

Join a Global Leader in Workforce Solutions – Net2Source Inc. Who We Are Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price. Title-Manufacturing Scientist/Engineer (Downstream) Duration-9 months contract Location- Pearl River,NY,USA,10965 On-site, 5 days per week Standard hours: ~8:30 AM – 4:30/5:00 PM (non-batching periods) During production cycles: Early starts (~7:00 AM) Second shift shifts (up to midnight) Frequent schedule adjustments (~20 times/year) Occasional weekend work when needed (e.g., batch issues) Temporary/contract-to-permanent potential Training duration: extensive (can take 6 months to 2+ years to fully ramp) Roles require long-term commitment due to complexity Candidates should be aligned with expectations and not seeking short-term exposure only • Summary:The main function of an Aseptic Technician is to support the manufacturing of sterile pharmaceutical products by performing tasks in controlled environments using aseptic techniques., • A typical Aseptic Technician ensures product integrity and compliance with regulatory standards through meticulous attention to cleanliness, documentation, and process control., • We are seeking an entry-level to early-career Manufacturing Scientist/Engineer to support sterile filling and final drug product operations for antibody-drug conjugates in a pharmaceutical setting. This role focuses on aseptic processing, isolator technology, and final product preparation., • Job Responsibilities: Perform aseptic gowning and operate in cleanroom environments, • Prepare, sterilize, and transfer materials and equipment into cleanrooms, • Execute aseptic filling, compounding, and packaging processes, • Monitor environmental conditions and report deviations or contamination risks, • Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP), • Maintain accurate batch records and documentation, • Participate in cleaning, sanitization, and routine maintenance of cleanroom areas, • Support quality assurance and validation activities, • Skills:Knowledge of aseptic techniques and cleanroom protocols, • Strong attention to detail and adherence to procedures, • Ability to work in a sterile, regulated environment for extended periods Familiarity with GMP, FDA, and other regulatory requirements, • Good communication and teamwork skills, • Basic computer and documentation skills, • Ability to follow complex procedures and work in sterile environments Education/Experience: • High school diploma or GED required; associate degree or technical training in life sciences preferred, • 2-4 years of experience in aseptic processing, pharmaceutical manufacturing, or a related field., • Bachelor's degree preferred in: Biology, Chemistry, Engineering, or related field (Equivalent experience may be considered) Ideal Candidate Profile • Entry-level or early-career professional, • Detail-oriented with strong procedural discipline, • Able to work in highly controlled environments, • Comfortable with schedule variability and hands-on production, • Strong communication and documentation skills Key Responsibilities • Execute downstream operations including:, • Sterile filtration, • Aseptic filling in isolators, • Lyophilization (freeze-drying), • Vial sealing and final processing, • Perform visual inspection of vials for: Glass defects, Product defects, Container integrity, • Support buffer preparation activities as needed, • Operate and monitor isolator and aseptic equipment, • Ensure strict adherence to safety and sterility standards Contribute to: • Documentation and reporting, Process optimization, Troubleshooting of manufacturing issues, Collaborate with upstream teams to continue production flow, • Requires use of advanced PPE (including full cleanroom/isolator suits) Preferred Qualifications • Experience with: Aseptic techniques, Cleanroom environments, Pharmaceutical manufacturing, • Strong time management and attention to detail Why Work With Us? We believe in more than just jobs—we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter. Our Commitment to Inclusion & Equity Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics. Awards & Recognition • America's Most Honored Businesses (Top 10%), • Fastest-Growing Staffing Firm by Staffing Industry Analysts, • INC 5000 List for Eight Consecutive Years, • Top 100 by Dallas Business Journal, • Spirit of Alliance Award by Agile1 Ready to Level Up Your Career?

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

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

PRIMARY FUNCTION The Senior Director/Executive Director, Regulatory Affairs role will establish Regulatory Affairs function within HUTCHMED International. He or She will support the global product team in the development of sound global registration strategies for our pipeline which can lead to a successful approval of our product/s within US and EU. The ideal candidate will be utilizing therapeutic area regulatory expertise to provide high quality, timely and decisive regulatory guidance to facilitate global product team's decisions on development and/or lifecycle planning. MAJOR RESPONSIBILITIES AND DUTIES • Responsible for preparation, approval and timely submission of regulatory filings, including but not limited to IND, (s)NDA, meeting briefing packets and other HA inquiries., • Develop submission strategies and filing timelines in partnerships with global product team, functional heads, project leaders and external collaborators., • Serve as the primary point of contact for HUTCHMED with US FDA and other health authorities as appropriate; and inform global product team and management of communications with health authorities as appropriate., • Prepare the global product team members for all heath authority meetings, teleconferences, presentations by proactively identifying potential questions/answers, gain alignment on responses and organize rehearsals, as appropriate, • Serve as the meeting facilitator for all health authority meetings., • Coordinate with global product team functional heads within HUTCHMED and CRO partners, as appropriate, to address any questions from health authorities in the US and Europe. QUALIFICATIONS • BS degree in scientific or health sciences discipline (e.g., pharmacy, clinical pharmacology or public health or related scientific discipline), • Advanced degree preferred, PhD, PharmD, • Minimum 10 years industry experience; 2-4 years management, • Successful track record of US and EU filings, INDs, NDAs, BLAs, sBLAs and product approvals, • Good understanding of regulatory policy, GCP and ICH guidelines, • Knowledge of drug development processes in US and EU and awareness of evolving regulatory reform initiatives, • Good leadership, organization & communication skills

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