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Job Description An international plant-based manufacturing company is seeking a QC Specialist. This position requires a BS degree in Food Science or a similar field, plus at least 3 years of experience in a food-related industry. • $25/hr. plus full benefits and bonus, • Sunday – Friday morning, 09:00 pm – 06:00 am, • Somerset, NJ, • Training period (3 months) will be on the 1st shift (8am – 5pm) Requirements of the QC Specialist: • B.Sc. in Food Science or related field (preferred), • 3+ years of experience in food-related industries, • Knowledge of Food Safety, cGMP, HACCP, SQF, FDA regulations, and FSMA/PCHF, • Basic skills in Microsoft Office (Excel, Word, PowerPoint, Email), • Self-motivated and disciplined, • English and Spanish proficiency (preferred but not required), • Ability to lift up to 40 lbs and work in hot, humid, cold, and wet conditions Responsibilities of the QC Specialist: • Test incoming raw materials, in-process products, and final goods, • Follow strict regulatory and internal guidelines, • Document and review quality control records, • Verify production processes and equipment, • Address quality issues with the team, • Maintain a clean and safe workspace, • Manage inventory of QC supplies, • Assist with audits, meetings, and recordkeeping as needed, • Perform other duties as required Employment Type: Direct Hire Schedule: Sunday – Friday morning, 09:00 pm – 06:00 am Training period (3 months) will be on the 1st shift (8am – 5pm) Lab, lab testing, raw material testing, GMP, QC, QA, Quality control, Food science, Food Safety, cGMP, HACCP, SQF, FDA regulations, FSMA/PCHF Company DescriptionFor over twenty years, TriCom Quest has been a leader in the employment consultant industry, providing staffing services for both employers and job seekers, at virtually every level - from entry to executive. Our service spans the United States, providing placements for a broad range of companies, including those headquartered in the Pacific Rim with satellite offices within the United States. Yet what makes us stand out from the employment "crowd" is our service. Whether you're hiring employees or in search of a job, TriCom Quest is committed to quality service, from the very first handshake to placement, and beyond.For over twenty years, TriCom Quest has been a leader in the employment consultant industry, providing staffing services for both employers and job seekers, at virtually every level - from entry to executive. Our service spans the United States, providing placements for a broad range of companies, including those headquartered in the Pacific Rim with satellite offices within the United States. Yet what makes us stand out from the employment "crowd" is our service. Whether you're hiring employees or in search of a job, TriCom Quest is committed to quality service, from the very first handshake to placement, and beyond.

Job Description Job Summary: The Director of Marketing will play a critical role in executing the commercial success of our allergy portfolio, including a potentially groundbreaking new treatment poised to reshape the standard of care for treatment of severe allergies/anaphylaxis. Reporting to the VP of Marketing, you will support the end-to-end marketing strategy across both Healthcare Provider (HCP) and Direct-to-Consumer (DTC) channels, ensuring compelling brand presence, seamless product launches, and sustained market growth. This role requires hands-on execution and tactical excellence. You'll manage key marketing initiatives, execute omnichannel campaigns, and collaborate effectively across Sales, Medical, Market Access, Regulatory, and R&D. The Director will serve as an important contributor to the commercial team, supporting the strategic direction and growth trajectory of the organization. Responsibilities: Strategic Execution & Brand Management • Execute marketing and brand strategies and tactical plans to support launch of pipeline products, including our anticipated first-in-class drug/device combination product, • Develop compelling product messaging and campaigns based on approved product labeling, • Support the development of HCP and patient marketing plans, tactics and resources, • Present marketing recommendations and tactical plans to senior leadership for input and alignment Campaign Development & Management • Execute omnichannel marketing campaigns across broadcast, digital, social, and experiential tactics to connect with patients, caregivers, and clinicians, • Manage advertising agencies and external partners to deliver high-quality brand creative, • Support pre- and post-launch tactical execution, from campaign development to performance optimization, • Ensure all marketing activities and communications are in full compliance with medical, legal, and regulatory guidelines Cross-Functional Collaboration • Build strong, collaborative relationships with key functional groups including sales, medical affairs, commercial analytics, legal, and regulatory, • Work closely with the Promotional Review Committee (PRC) to ensure all brand-related materials meet compliance standards, • Collaborate with sales teams to ensure field representatives are prepared and resourced with appropriate marketing materials, • Coordinate with commercial analytics to track campaign performance and optimize tactics Market Insights & Analytics • Generate customer insights through participation in qualitative and quantitative market research, • Analyze data from multiple sources to uncover actionable market insights, • Track key performance indicators (KPIs) and utilize insights to continuously refine marketing tactics, • Support budget management and resource allocation for assigned marketing initiatives Qualifications: Education & Experience • Bachelor's degree required; MBA or advanced degree preferred, • 8+ years in biotech or pharmaceutical marketing with experience supporting product launches, • Experience in rare disease therapeutic areas preferred, • Demonstrated experience in both HCP and consumer marketing tactics Technical Skills • Strong understanding of pharmaceutical marketing regulations and compliance, including FDA guidelines and industry best practices, • Experience managing agency partners and external vendors, • Proficiency in campaign development and execution across multiple channels, • Strong analytical skills with ability to interpret market research and performance data Leadership & Communication • Excellent written and oral communication skills, • Strong collaborative approach with ability to work effectively across functions, • Proven ability to manage multiple projects simultaneously and meet deadlines, • Self-starter with ability to work independently while supporting team objectives Personal Attributes • Thrives in dynamic environments with shifting priorities and ambiguity, • Detail-oriented with strong project management skills, • Results-driven with focus on achieving measurable outcomes, • Adaptable and resilient when facing unexpected challenges Preferred Qualifications • Experience in specialty pharma, allergy, or immunology therapeutic areas, • Previous rare disease marketing experience, • Experience with DNA medicine or novel therapeutic modalities, • Familiarity with both startup and established pharmaceutical environments, • Current residence in Northeast region with ability to travel as needed (~20-30%) The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $150,000 to $200,000 USD

Job DescriptionObjectivePerspective Therapeutics is seeking a highly motivated hands-on scientist with expertise in sterile injectable drug products to join our dynamic CMC drug product team. This role is critical in supporting the development of sterile injectable formulations and drug product process development from early development through scale-up and commercial manufacturing. The successful candidate will play a pivotal role in developing and optimizing injectable radiopharmaceutical formulations and associated manufacturing processes in a cGMP-compliant environment. Working in a fast-paced, integrated, and multidisciplinary environment, the successful candidate is expected to collaborate cross-functionally while also delivering strong independent contributions that support product advancement to late-stage clinical development and commercialization.Objective • Serve as the technical subject matter expert (SME) for formulation and drug product process development., • Conduct formulation/process development studies, including comparability, stability, and compatibility assessments., • Lead scale-up and technology transfer activities to support manufacturing., • Draft detailed study plans to ensure that work is performed efficiently and in a scientifically sound manner, • Monitor experiments (e.g. process development, formulation optimization) and ensure complex data are interpreted in a scientifically correct way, • Support filter and container closure integrity validation studies and other special studies as necessary., • Collaborate with cross-functional teams including Analytical, Quality, Regulatory, and Manufacturing., • Author formulation and process development reports, study protocols, and regulatory CMC module 3 documentation to support late-stage IND and NDA submissions., • Ensure all work is performed in accordance with company policies, procedures and safety standards., • Ensure documents follow relevant regulatory standards (e.g., FDA, USP, ICH) and CMC guidelines., • Troubleshoot and propose scientifically sound solutions in collaboration with internal teams., • Provide technical support during regulatory inspections and audits, as needed.QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.Education/Experience, • Ph.D. or M.S. or B.S. in Pharmaceutics, Chemistry, or related field, • 5-7 years of hands-on experience in formulation development and sterile drug product process development using quality by design (QbD) principles., • Strong understanding of aseptic processing, formulation characterization, excipient compatibility, and container-closure systems, • Experience with QbD principles and risk-based development approaches., • Pharmaceutical product life cycle management, • Deep expertise in regulatory frameworks (FDA, EMA), and clinical/commercial manufacturing., • Familiarity with GMP quality systems and electronic document management systems., • Experience in radiopharmaceuticals or isotope-based therapeutics is strongly preferred.Knowledge / Skill / Ability, • Ability to prepare detailed study protocols and interpret complex data sets across multiple techniques., • Excellent communication skills, including the ability to explain technical concepts to cross-functional teams., • Prior radiochemistry experience and knowledge of radioactive material handling are a plus., • Strong organizational skills, with the ability to manage multiple priorities and meet tight deadlines., • Work independently and proactively in a highly matrixed environment.Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions., • Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels., • May be required to sit or stand for long periods of 8+ hours a day while performing duties., • Willingness to complete safety training within allotted time limits, and work in a team-based environment., • May require travel to Iowa up to 10%. Powered by JazzHR WawpTpaAzu

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description We are seeking an experienced and highly motivated Raw Material Chemist to join our team. As a Raw Material Chemist, you will play a critical role in the testing, evaluation, and quality control of raw material samples. Your expertise will drive product innovation, quality assurance, and cost-effectiveness while ensuring compliance with industry regulations. Key Responsibilities: • Conduct detailed chemical and physical analyses of raw materials using techniques such as the following, including but not limited to:, • Spectroscopy (FTIR, UV-Vis), • Chromatography (HPLC, GC, TLC), • Dissolution, • Potentiometric Titrations / Assay, • Viscosity, • pH, • Conductivity, • Karl Fisher, • Specific Gravity, • Loss on Drying, • Residue on Ignition, • Oversee the quality control of incoming raw materials and ensure their compliance with company standards. Troubleshoot any material-related issues., • Proven ability to analyze raw material issues, identify root causes, and implement effective solutions., • Strong experience with HPLC and GC testing/techniques and Empower software, • Ability to troubleshoot instrument / equipment issues, • Perform method verifications / validations on new methods, • Perform calibration of instrument / equipment, • Maintain meticulous, accurate and precise records of specifications, test methods, testing data, results, and any deviations from standard procedures., • Evaluate test results for accuracy, • Review / Release raw data, documentation and results for Certificate of Analysis, • Prepare detailed reports for management and regulatory purposes., • Author / revise technical documents including but not limited to specifications, test methods, method verification / validation / transfer protocol or reports, SOPs, investigations, etc., • Ensure that all raw materials comply with industry regulations and safety standards, • Knowledge of current GMP, FDA regulations, ICH guidelines, ISO 17025 and other regulatory requirements as applicable., • Working knowledge of computer skills., • Strong attention to detail, ensuring accurate and precise testing and documentation., • Excellent written and verbal communication skills to effectively report findings and collaborate with cross-functional teams., • Ability to maintain a safe, clean, and orderly laboratory environment., • Ability to work independently and as part of a team, with minimal supervisionQualifications, • Education: Bachelor’s / Master’s degree in Chemistry or other science related field, • Experience: Bachelor’s: Minimum of 6 years or Master’s: Minimum of 4 years of experience in a raw material, chemistry, or quality control role, preferably in pharmaceuticals, manufacturing, cosmetics. Additional Information Positions are full-time, working Monday-Friday 8am-5pm, overtime as needed. Candidates currently living within commutable distance to North Brunswick, NJ are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options • Annual compensation between $90,000 and $100,000, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Job Description Position: Pharmacovigilance Supervisor Location: New Jersey (on-site) Salary: $80,000 to $100,000 per year FLSA Classification: Exempt Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit . Job Overview: The PV Supervisor will be a key member of the US PV Team making appropriate processes for the project according to regulations and SOPs, and managing PV projects and performing PV work independently. This person will have strong technical expertise, will be a collaborative team player and proactive problem solver. Additional tasks: • Manage PV projects independently, including communicating with clients, making project plan, prepare study-specific Safety Management Plans and controlling project progress., • Solve the problems of the PV project, and maintain good communication with clients., • Receive safety reports from various sources, appropriately processing case reports in the safety database, raising query, regulatory/site submission and follow up., • Safety updated report (DSUR, PSUR, etc.) writing and quality control., • Formulate literature search strategy and conduct literature search., • Support business bidding., • Attend department or project meetings and provide feedback on challenges/problems or successes., • Potentially responsible for establishing the PV team in the United States., • Bachelor's degree or other advanced degree in Medicine, Pharmacy, Nursing or equivalent Scientific or healthcare discipline or allied life sciences., • Minimum of 5 years of experience in pharmacovigilance, good experience and understanding of pharmacovigilance., • Knowledgeable of FDA PV regulations and relevant global regulations and guidance for clinical and post-marketing safety., • Experience in PV management of clinical trials., • Proficiency in Chinese (Mandarin/Cantonese) - including speaking, reading, and writing is highly desirable to effectively communicate with clients, stakeholders, and team members, and to manage documentation and correspondence in Chinese. Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You'll thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators. Comprehensive benefit package: As part of our commitment to your well-being, we offer a comprehensive benefits package: • Insurance including Medical, Dental & Vision with significant employer contributions, • Employer-funded Health Reimbursement Account, • Healthcare & Dependent Care Flexible Spending Accounts, • 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance, • 401k plan with generous employer match Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! #LI-JB1

Job Description The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population – leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many – by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda – the most effective cancer drug in medical history. We are seeking a Clinical Principal Investigator. The Clinical Principal Investigator (PI) is a physician-scientist responsible for the overall preparation, conduct, and management of sponsored projects, ensuring compliance with all regulatory requirements and institutional policies. This role will manage the development and execution of clinical trial protocols, contribute to data analysis, and maintain strong communication and alignment with sponsors. This role is based on site in East Brunswick, New Jersey. Essential Responsibilities • Manage early phase clinical trials by providing overarching medical direction and comprehensive medical reviews of protocols in conformance with the investigational plan and good clinical practice., • Provide medical and scientific feasibility of all new sponsor inquiries driving growth through strategic partnerships., • Lead and manage a matrix team of responsible for responsible for the conduct of early phase oncology trials., • Ensure the safety and well-being of all participants in the study at the trial site are protected., • Ensure data collected at the study site is credible and accurate., • Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected., • Develop close personal working relationships with Sponsors and Clinical Research Organizations involved in study conduct., • Provide expert guidance and support to clinical operations research staff and sponsor client., • Lead continuous quality improvement efforts for clinical research services, integrating best practices and fostering a culture of research excellence., • Develop and implement strategies to enhance patient recruitment and retention in clinical trials. Required Education and Experience: • M.D. or equivalent., • Board Certified in Hematology and/or Medical Oncology., • Clinical trials experience with a strong interest in drug development., • Ability to critically analyze clinical scientific data and literature., • Understanding of GCP principles, safety and adverse event reporting, FDA regulations, and biomedical research ethics., • A passion for providing excellent clinical care and for working in a collaborative / team-oriented environment. Preferred Education and Experience: • Previous experience with industry sponsored clinical trials., • Excellent communication skills, with experience in publishing and presenting at scientific meetings., • Translational research experience and familiarity with pharmacokinetics and pharmacodynamics. Best-in-Class Benefits and Perks We value our employees’ time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including: • Comprehensive health coverage: Medical, dental, and vision insurance options provided, • Robust retirement planning: 401(k) plan available with employer matching, • Financial security: Company-paid life and disability insurance for added protection, • Flexible financial options: Health savings and flexible spending accounts offered, • Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided, • Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture. More about The START Center for Cancer Research Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Job Description Job Description: We are seeking a detail-oriented and experienced QA/QC Specialist to join our team at an OTC) manufacturing company. The ideal candidate will be responsible for ensuring the quality and compliance of our products and processes with industry standards and regulatory requirements. This role involves working closely with cross-functional teams to monitor, evaluate, and continuously improve quality control procedures. If you are passionate about quality assurance and thrive in a fast-paced environment, we would love to hear from you! Key Responsibilities: • Quality Assurance (QA):, • Develop, implement, and maintain quality assurance processes and procedures., • Ensure compliance with regulatory standards (FDA, ISO, GMP, etc.) and company policies., • Conduct audits (internal and external) and inspections to identify and address non-conformities., • Collaborate with cross-functional teams to develop corrective and preventive action plans (CAPA)., • Quality Control (QC):, • Perform inspections and tests on incoming raw materials, in-process products, and finished goods to ensure adherence to specifications., • Maintain and calibrate testing equipment according to standards., • Document and analyze test results, providing insights for continuous improvement., • Manage product releases by reviewing QC data and ensuring all quality parameters are met., • Documentation & Reporting:, • Prepare and maintain detailed documentation, including SOPs, inspection reports, and quality records., • Ensure proper labeling, traceability, and documentation control for all materials and products., • Provide regular updates and reports on QA/QC performance to senior management., • Training & Support:, • Train staff on quality procedures, standards, and best practices., • Bachelor’s degree in Chemistry, Biology, Engineering, or a related field., • 3+ years of experience in quality assurance/quality control, preferably in [insert industry, e.g., manufacturing, pharmaceutical, cosmetics]., • In-depth knowledge of quality management systems (QMS) and regulatory requirements (e.g., FDA, ISO, GMP)., • Strong analytical and problem-solving skills., • Excellent attention to detail and organizational skills., • Proficiency with Microsoft Office and quality management software., • Certification in QA/QC or relevant is a plus.Company DescriptionHealth and Natural Beauty USA Corp has 30 years of co-packing and contract manufacturing expertise. Our state-of-the-art facility is cGMP registered and located in Piscataway, NJ. From custom product formulation and design to exclusive package engineering, our technology and development teams have the capabilities and innovative knowledge to deliver. Our patented formula of our own brand "SprinJene Natural toothpaste" is distributed all over the country and abroad.Health and Natural Beauty USA Corp has 30 years of co-packing and contract manufacturing expertise. Our state-of-the-art facility is cGMP registered and located in Piscataway, NJ. From custom product formulation and design to exclusive package engineering, our technology and development teams have the capabilities and innovative knowledge to deliver. Our patented formula of our own brand "SprinJene Natural toothpaste" is distributed all over the country and abroad.

Job Description WHY VITALIEF? Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. We are seeking a talented and enthusiastic Senior Clinical Research Financial Analyst to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients’ mission to impact and save lives. Reasons to work for Vitalief: • You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better., • Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees., • We give everyone a seat at the table – we encourage innovation., • Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually., • Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.Salary Range: $80,000 to $105,000 annually depending on experience level. Work Location: 100% remote role; company location is New Brunswick, NJ. We are only seeking candidates that reside in the EST or CST zones. Job Responsibilities: • Reporting to the Manager, Budget & Reimbursement, this financial analyst is responsible for preparing, maintaining, and negotiating budgets related to clinical trial activities., • Performs prospective reimbursement analysis according to CMS National Coverage Determination Decisions and all applicable billing regulations, third party requirements, industry standards, etc., • Works in conjunction with other departments of the firm, as well as representatives from other higher education institutions, sponsors, attorneys, governmental agencies, and principal investigators., • Requests clinical trial budgets and contracts documents from sponsors and CROs., • Reviews clinical trial protocols and develops internal budgets. Prepares clinical trial budget documents and memos. Determines whether each trial is a qualifying trial per CMS regulations, and assesses compliance with other regulatory requirements, including FDA and NIH guidelines., • Negotiates budgets with sponsors, interfacing with various internal departments as needed., • Facilitates clinical trial billing administrative start-up, insuring clinical research billing and regulatory compliance. Collaborate with Finance to coordinate documentation of each clinical trial account from the beginning of protocol submission to the end of the study utilizing OnCore CTMS system., • Performs regular audits of clinical trials to ensure that billing is complete and accurate and to ensure that the research project, database or protocol is carried out as outlined., • Develops and distributes monthly financial reports to senior leadership of clinical trial revenue activity including active clinical trials and research subjects.Required Skills:, • Bachelor’s Degree in Accounting, Finance, Business Administration or a related field., • 3 to 5 years of experience in the maintenance and review of budgetary and fiscal records including experience with computer-based accounting systems in a healthcare environment., • Experience managing Clinical Trials budgets is required., • Maintains working knowledge of CMS, DHHS, FDA, OHRP, NIH, OIG, HIPAA and IRB., • Demonstrates excellent interpersonal, oral and written communication skills. Strong organizational and detail-oriented skills., • Proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, PowerPoint and OnCore., • Continuously displays “can do” attitude cross functionally to contribute to the overall customer service plan., • Develops professional relationships will all customers and maintains professional composure and confidence during stressful situations.Preferred Skills:, • Experience with clinical contracts, budget development, variance analysis and research of financial data and transactions., • Experience in clinical research administration; knowledge of regulatory, financial and administrative requirements of third-party billing for clinical trials and accounting principles for research preferred., • Experience or training in clinical research budgeting, financial management and/or coding. #LI-DNP Powered by JazzHR SNHTAcjcUx

Job Description Job Summary: We are seeking a highly experienced and strategic Director of Advertising, Promotional & Labeling to lead regulatory review of promotional and labeling materials for both prescription and over-the-counter (dietary supplement) products in our growing biotech portfolio. This individual will chair/participate in the Medical, Legal, and Regulatory (MLR) Review Committee, ensure compliance with FDA regulations, and partner closely with Commercial, Legal, and Medical Affairs to drive compliant and impactful product communication strategies. This individual will provide guidance to the internal team and key stakeholders on the appropriate review/sign off based on the material’s purpose (e.g., disease state awareness, non-branded vs branded, investigational vs commercial vs over-the-counter products) and will also provide guidance on the appropriate use of social media in compliance with FDA’s expectations and current regulatory landscape. The Director of Advertising, Promotional & Labeling will additionally be responsible for the development and maintenance of product labeling for all products in our portfolio. This includes primary/secondary packaging, US prescribing information, Patient Prescribing Information, Instructions for Use, Supplement Facts, and Core Data Sheets. Responsibilities: • Serve as the regulatory lead for MLR, overseeing review, approval, and appropriate triaging of promotional advertising, and disease awareness materials directed to healthcare professionals, patients, consumers, and clinicians., • Interpret and apply FDA regulations (including OPDP guidance) and industry best practices for product promotion and labeling., • Collaborate cross-functionally with Commercial, Medical Affairs, Legal, and Compliance to align content with strategic messaging while mitigating regulatory risk., • Provide regulatory guidance on labeling development and maintenance, including the primary/secondary packaging, US Prescribing Information, Patient Prescribing Information, Instructions for Use (IFU), Supplement Facts, and Core Data Sheet. Ensure compliance with FDA labeling requirements., • Lead interactions with FDA regarding promotional submissions, advisory comments, and enforcement trends., • Monitor evolving regulatory landscape, guidance documents, and enforcement actions; translate into actionable insights for internal teams., • Develop and deliver internal training to ensure stakeholder awareness of applicable promotional requirements., • Support regulatory strategy for new product launches and lifecycle management across promotional platforms., • Lead and mentor junior regulatory team members as applicable. Qualifications: • Bachelor's degree in life sciences, pharmacy, or related field required; advanced degree (PharmD, PhD, JD, or MBA) preferred., • 10+ years of experience in Regulatory Affairs, including a minimum of 5 years in Advertising & Promotion review (MLR/PRC environment)., • In-depth knowledge of FDA regulations and OPDP standards for advertising and promotion of pharmaceuticals and over-the-counter (dietary supplements) products., • In-depth knowledge of FDA labeling requirements., • Proven experience as an MLR Chair or equivalent promotional review lead., • Experience preparing submissions to OPDP., • Excellent verbal and written communication skills with strong attention to detail., • Demonstrated ability to lead cross-functional teams and manage multiple priorities in a dynamic environment. Preferred Experience: • Experience with 505(b)(2), allergy/immunology disease space, rare disease, or CNS promotional strategies., • Experience with VEEVA PromoMats system., • Experience with FDA interactions., • Familiarity with international promotional and labeling requirements a plus. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $180,000 – $230,000 USD

Job Description Company Overview: We are a dynamic and innovative small biotechnology company dedicated to advancing oncology research through cutting-edge translational science. Our mission is to translate scientific discoveries into tangible therapeutic solutions that make a meaningful impact on cancer patients' lives. We are seeking a talented and motivated Translational Scientist to join our team and contribute to our mission-driven work. Position Overview: As a manager of clinical pharmacology you will be responsible for providing clinical pharmacology input in early (up to proof-of-concept stage) and late-stage clinical development. You will be responsible for representing clinical pharmacology function on drug development teams, providing input on the dose and the design of early and late-stage clinical trials, and for interacting with the clinicians and the clinical operations group for the execution of the clinical pharmacology components (PK, PD, biomarkers, etc) of the trials. In addition, you will be responsible for performing clinical PK/PD analyses, for providing subject matter leadership related to clinical ADME, pre-clinical to clinical extrapolation and selection of dose/regimen during early development. Additionally, you will be responsible for providing input on study design and leading the selection of doses for late-stage clinical studies. You will contribute to the preparation of the regulatory documents such as briefing books for pre-agency meetings, IBs, INDs, and IMPD dossiers, protocols, and clinical study reports. You will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Pharmacometrics and Physiological PK/PD Modeling and Simulation, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA. You will be responsible for working within the department level budget and resources. Support technical due diligence efforts for business development. Responsibilities: • Responsible for providing support for the preparation of the clinical pharmacology (PK, biomarkers, bioanalytical) sections of early and late-stage clinical protocols, Clin Pharm development plans, modeling & simulation plans, • Contribute to the preparation of the pre-IND, IND, IB and NDA/BLA documents, • Responsible for the pharmacokinetic and PK/PD data analyses using standard industry data analysis software, • Contribute to the design of early phase clinical trials (FIH to POC) and support project goals, • Responsible for recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling, • Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC, • Contribute to the design of late-stage clinical trials (POC-NDA/BLA) and support project goals, • Responsible for leading the dose selection for Phase II and III clinical trials based on PK, PD biomarker and efficacy data analysis from previous studies., • Responsible for the preparation of the PK/PD reports and clinical study reports, • Represent Clin Pharm function for the project team at the regulatory agencies during regulatory meetings., • Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions., • Provide oversight to vendors and ensure high quality deliverables that meet study/project timelines, • 3+ years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry., • Exposure to biologics drug development. Knowledge of basic and clinical immunology is plus., • Hands on knowledge of PK/PD and statistical analyses methods used in analyzing early clinical phase data., • Knowledge of general regulatory process and experience in contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA , EMA and other health authorities., • Excellent written and oral communication skills including good presentation skills. Qualifications: • Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacokinetics, pharmacology, or relevant life science discipline such as biology, immunology., • Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software., • Familiar with PK/PD concepts. principles and applications to support prospective dose/regimen recommendations for planned Phase 1, 2 and 3 trials., • Experience in preparing clinical pharmacology components of clinical study protocols and clinical study reports., • Knowledge of current practices and issues in the bioanalytical and drug metabolism areas., • Proficient in the use of Microsoft Word, Excel and PowerPoint. Travel: • Ability to travel domestic and internationally ≤ 20%. Benefits: Competitive salary commensurate with experience Comprehensive benefits package, including medical, dental, and vision coverage Opportunities for career growth and professional development Collaborative and dynamic work environment with a diverse team of scientists and clinicians Opportunity to make a meaningful impact on cancer patients' lives through innovative translational research

Job DescriptionJob Summary: The Intellectual Property (IP) will oversee all legal aspects related to patents, trademarks, copyrights, and trade secrets within the pharmaceutical sector. This role requires an individual with executive presence and strong patent & IP legal skills combined with a hands-on work ethic. The role requires expertise in patent law, FDA regulations, and pharmaceutical intellectual property protection. Must have the ability to work seamlessly in a cross-functional business environment, be highly innovative and be well-versed in pharmaceutical new product development processes, patent procurement, enforcement and monetization while staying aligned with the overall business strategy. An experienced patent practitioner with formulation development experience and a high-level of sophisticated judgment on patent matters and an ability to think strategically while managing through ambiguity to develop pragmatic solutions. Will be a team player who can build strong professional relationships with the pharmaceutical development team, corporate legal, senior executives, external counsel and colleagues at all levels across the organization. Responsibilities: • Examines patents, file histories, prior art, ongoing litigations, and citizen’s petitions to inform related strategies for the development of 505(b)(1) and 505(b)(2) product applications and/or potential product acquisitions., • Assists in assessing and guiding formulation development in view of patents and potential future strategic litigation (Hatch-Waxman inclusive)., • Secures freedom-to-operate and patent analyses for in-house products and potential product or technology acquisitions., • Assists R&D in the assessment of patents relating to bulk API, route of synthesis, finished dosage forms and polymorphs., • Designs and manages prior art searches for targeted technologies or products., • Partners with legal and regulatory affairs for the preparation of Orange Book listings and patent certifications along with the corresponding notice letters and detailed statements, • Drafts and file global patent applications and secures patent rights for same., • Provide legal counsel on trademark protection, copyrights, and trade secrets., • Oversee patent litigation and disputes., • A Juris Doctor from a recognized, accredited law school is required., • Minimum of a Masters’ Degree in Pharmaceutics, Chemistry, Biochemistry, or similar discipline., • Minimum of 10 years’ experience, preferably a combination of private and corporate practices, and including Hatch-Waxman experience., • 5+ years of experience in patent and intellectual property law, preferably in the pharmaceutical sector., • Strong knowledge of patent prosecution, FDA regulations, and IP litigation. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Job Description Job Description Date 02/2024 Location 1300 Airport Road, North Brunswick NJ Title Lead, Quality Control Chemist Department Quality Control Reports to Manager, Quality Control Laboratory FLSA (Exempt or Non-Exempt Exempt Role Overview The Lead, QC Chemist performs specific routine analysis of samples of raw materials, in process, and finished products according to established (official and/or in-house) test procedures. Testing assesses the strength, identify, purity of the test samples and/or raw materials. The Chemist prepares reagents, standards, and solutions and may monitor and verify quality in accordance with statistical process and other control procedures. The Chemist maintains & organizes testing’s and compliance while working in a fast-paced environment with changing priorities. Areas of Responsibility • Performs assigned sampling, physical, chemical tests and assay on raw materials, active dietary ingredients, in-process, finished, and stability products in an FDA regulated lab environment. Uses a variety of wet chemicals, physical and instrumental techniques as well as routine QC instruments HPLC, GC, IR, Auto Titrator, Bulk Density, UV Spectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer., • Troubleshoots HPLC, GC, QC instruments for specific tests in order to assist in determining the root cause of aberrant results and help in performing Lab investigations / OOS., • Evaluates daily raw data sheets for product samples and release, if needed., • Coordinates annual review of STPS / SOPS as per USPL procedures., • Prepare new methods and test procedures for new or existing raw materials and finished products., • Ensures compliance with company and customer specifications as well as federal, state and local regulatory requirements., • Perform floor supervision of QC Chemists for routine testing, if required., • Prepares and reviews QC related documents during and finishing of testing of sample. Submit all testing related documents like data sheets, chromatograms, spectras, instruments print outs in timely manner to Qc Documentation department to release the batch of raw material / finished product., • Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned., • Performs maintenance and calibrations of laboratory instruments /equipment, if required to help in-house calibrations., • Assures GMP compliance according to FDA CFR Part 111 and USPL SOPs / guidelines., • Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, GLP, documentation) when performing the assigned activity., • Trains new QC Chemists to perform instrumental testing., • Must be able to work extended hours as needed and occasional weekends., • Works in a safe and responsible manner to create an injury-free and incident-free workplace., • Complies with all job-related safety and other training requirements. Education & Qualification: • BS/MS in Chemistry or related scientific disciplines., • Five (5) years of basic chemistry techniques (can be academic) is a plus., • Ability to maintain integrity and honesty at all times and to communicate with transparency., • Ability to work independently or as part of a team., • Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11., • Strong working knowledge of Microsoft Word, Excel., • Good documentation practices and able to write simple, clear reports., • Meets commitments on time and practices time-management skills., • Seeks to identify continuous improvement needs., • Experience with Shimadzu LC2010, Nexera, GC2010, Thermo ICP-MS, Labsolution and Waters, • Ability to navigate office, lab, and/or plant floor working environments., • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances and leaning over equipment as well as kneeling on the floor to clean under the equipment., • Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators., • Work is regularly performed inside a laboratory environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents., • May execute up to 20% of their work at the bench level either standing or sitting on a stool., • Work performed in a standard office environment is without unpleasant or hazardous conditions. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. Office Hours: 8:30 AM - 5:00 PM 9:00 AM - 5:30 PM

Job Description Job Summary: The Director will be a key interface to the Aquestive business and support the Company’s efforts in identifying, establishing, maintaining and reviewing compliance risk controls and compliance strategy throughout the organization. The individual will report to the VP, Global Quality and Compliance and will serve as a leader and subject matter expert to drive the development and implementation of policies, procedures, processes, and training in accordance with applicable laws, regulations, guidelines, and codes. Responsibilities: • Work with management to promote a culture of compliance awareness and ethics throughout the organization, • Review organizational operations to develop, direct, execute and communicate the Company’s compliance strategy, • Advise and develop work plans, facilitating annual compliance reviews, responding to compliance queries and reports and work with the Human Resources on internal and external investigations related to reactive and proactive compliance or personnel issue, • Oversee and ensure follow-up and/or corrective action plans to compliance issues identified, • Partner with Commercial, Medical, Legal, and other functions as needed to develop and implement standards, policies, procedures, and processes that effectively manage compliance risk, • Oversee transparency reporting and adherence to Company policies associated with payments to healthcare providers, • Work with management to establish the development of specialized compliance training programs, curricula and tracking, and reporting via the Company’s learning management system, • Provide leadership and direction to business partners, advising on activities and programs to help ensure alignment with Company compliance policies and procedures, • Interact with regulatory agencies, internal and external advisors, and other internal control groups on compliance in order to determine specific needs and procedures, • Have knowledge of and monitor and identify emerging issues, developments in industry practices and standards and compliance risk trends and in relevant laws and regulations, including FDA, OIG, DOJ, Sunshine Act (Open Payments), and anti-kickback statutes, • Collaborate with other functions to develop, implement and establish continuous improvement of an effective compliance program, • Develop and deliver compliance reports to leadership teams and appropriate committees, • Represent Legal in MLR review of promotional materials, scientific communications, and engagement activities to ensure that regulatory, legal, and compliance standards are met, • Assist in executing compliance monitoring activities, • Assist in conducting investigations of potential compliance issues, • BS/BA degree required; Juris Doctorate degree (strongly preferred), • 10+ years of compliance expertise in the pharmaceutical industry, • Experience serving on MLR review committees, with demonstrated ability to assess promotional content for compliance with regulatory and legal requirements, • Knowledge of the laws, regulations, guidelines, and codes impacting the industry, and their application to a commercial business, • Knowledge of laws, regulations and codes related to government price reporting and DEA compliance, • Strong influencing skills and demonstrated ability to communicate effectively and present ideas and solutions to all levels of the organization, • Strong planning and organization skills with the ability to lead and manage multiple projects concurrently, • Must be self-motivated and possess strong interpersonal skills As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $160,000 to $200,000 USD

Associate Director, Regulatory Affairs – Biosimilar/BLA Description: Regulatory expert in the area of Biosimilar/BLA submissions including strategize, compile, review and manage/lead regulatory submissions. Subject matter expert in the area of Biologics. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives. Essential Functions: • Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules. Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and risks., • Lead and Manage Global Regulatory Submission Activities: Oversee submission planning, authoring, reviewing, and coordination for regulatory filings (e.g., BLA, MAA). Identify required documentation and ensure timely, high-quality submissions meeting global requirements., • Health Authority Interactions and Negotiations: Initiate and lead Health Authority interactions, including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory issues., • Provide Regulatory Guidance and Compliance Oversight: Offer strategic regulatory advice to cross-functional teams and ensure compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance documents., • Support Development, Submission, and Post-Approval Activities: Collaborate on development, submission, and post-approval activities from a regulatory perspective. Maintain partnerships with internal and external stakeholders to ensure smooth regulatory processes. Additional Responsibilities: Education: • Master Degree (MS/MA) Science degree (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) - Required Experience: • 11 years or more in Regulatory Affairs in Biosimilar/ BLA regulatory submissions

Job Title: Business Analyst with Salesforce CRM Location: New Brunswick, New Jersey NJ (Hybrid model) Work hours : EST time zone • Need Candidates from Pharma Domain/Health Insurance Only *GxP, FDA regulations and GDPR - Experience Mandatory Key Responsibilities: • Business Requirements Gathering. Collaborate with stakeholders to gather and document business requirements for key applications, • Work with the development team to design and develop solutions that meet business requirements, • Collaborate with the testing team to develop and execute test plans. Identify and report defects and issues, • Analyze existing processes and identify areas for improvement. Collaborate with stakeholders to implement process changes, • Should be able to work with tools like JIRA, ALM, Sharepoint, Confluence, ServiceNow ..etc on operations, application releases and projects, • Ensuring compliance with relevant regulatory requirements, such as GxP, FDA regulations, GDPR ..etc as applicable., • Develop and implement compliance programs to ensure adherence to regulatory requirements., • Experience on salesforce application projects Stephen Lead Talent Acquisition Specialist Email :

Responsibilities: The Regulatory Affairs Associate, with minimal guidance prepares, reviews and submits high quality annual reports with FDA within Annual report timelines and in accordance with regulatory guidelines and applicable federal laws.With minimal guidance, ensure to compile and complete t

Regulatory Affairs in Biosimilar/ BLA regulatory submissions. Provide Regulatory Guidance and Compliance Oversight: Offer strategic regulatory advice to cross-functional teams and ensure compliance with FDA, EMA, and Health Canada regulations. Associate Director, Regulatory Affairs Biosimilar/BLA.

Job Summary: The Intellectual Property (IP) will oversee all legal aspects related to patents, trademarks, copyrights, and trade secrets within the pharmaceutical sector. This role requires an individual with executive presence and strong patent & IP legal skills combined with a hands-on work ethic. The role requires expertise in patent law, FDA regulations, and pharmaceutical intellectual property protection. Must have the ability to work seamlessly in a cross-functional business environment, be highly innovative and be well-versed in pharmaceutical new product development processes, patent procurement, enforcement and monetization while staying aligned with the overall business strategy. An experienced patent practitioner with formulation development experience and a high-level of sophisticated judgment on patent matters and an ability to think strategically while managing through ambiguity to develop pragmatic solutions. Will be a team player who can build strong professional relationships with the pharmaceutical development team, corporate legal, senior executives, external counsel and colleagues at all levels across the organization. Responsibilities: • Examines patents, file histories, prior art, ongoing litigations, and citizen’s petitions to inform related strategies for the development of 505(b)(1) and 505(b)(2) product applications and/or potential product acquisitions., • Assists in assessing and guiding formulation development in view of patents and potential future strategic litigation (Hatch-Waxman inclusive)., • Secures freedom-to-operate and patent analyses for in-house products and potential product or technology acquisitions., • Assists R&D in the assessment of patents relating to bulk API, route of synthesis, finished dosage forms and polymorphs., • Designs and manages prior art searches for targeted technologies or products., • Partners with legal and regulatory affairs for the preparation of Orange Book listings and patent certifications along with the corresponding notice letters and detailed statements, • Drafts and file global patent applications and secures patent rights for same., • Provide legal counsel on trademark protection, copyrights, and trade secrets., • Oversee patent litigation and disputes., • A Juris Doctor from a recognized, accredited law school is required., • Minimum of a Masters’ Degree in Pharmaceutics, Chemistry, Biochemistry, or similar discipline., • Minimum of 10 years’ experience, preferably a combination of private and corporate practices, and including Hatch-Waxman experience., • 5+ years of experience in patent and intellectual property law, preferably in the pharmaceutical sector., • Strong knowledge of patent prosecution, FDA regulations, and IP litigation. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $180,000 to $220,000 USD

Job Summary: The Director will be a key interface to the Aquestive business and support the Company’s efforts in identifying, establishing, maintaining and reviewing compliance risk controls and compliance strategy throughout the organization. The individual will report to the VP, Global Quality and Compliance and will serve as a leader and subject matter expert to drive the development and implementation of policies, procedures, processes, and training in accordance with applicable laws, regulations, guidelines, and codes. Responsibilities: • Work with management to promote a culture of compliance awareness and ethics throughout the organization, • Review organizational operations to develop, direct, execute and communicate the Company’s compliance strategy, • Advise and develop work plans, facilitating annual compliance reviews, responding to compliance queries and reports and work with the Human Resources on internal and external investigations related to reactive and proactive compliance or personnel issue, • Oversee and ensure follow-up and/or corrective action plans to compliance issues identified, • Partner with Commercial, Medical, Legal, and other functions as needed to develop and implement standards, policies, procedures, and processes that effectively manage compliance risk, • Oversee transparency reporting and adherence to Company policies associated with payments to healthcare providers, • Work with management to establish the development of specialized compliance training programs, curricula and tracking, and reporting via the Company’s learning management system, • Provide leadership and direction to business partners, advising on activities and programs to help ensure alignment with Company compliance policies and procedures, • Interact with regulatory agencies, internal and external advisors, and other internal control groups on compliance in order to determine specific needs and procedures, • Have knowledge of and monitor and identify emerging issues, developments in industry practices and standards and compliance risk trends and in relevant laws and regulations, including FDA, OIG, DOJ, Sunshine Act (Open Payments), and anti-kickback statutes, • Collaborate with other functions to develop, implement and establish continuous improvement of an effective compliance program, • Develop and deliver compliance reports to leadership teams and appropriate committees, • Represent Legal in MLR review of promotional materials, scientific communications, and engagement activities to ensure that regulatory, legal, and compliance standards are met, • Assist in executing compliance monitoring activities, • Assist in conducting investigations of potential compliance issues, • BS/BA degree required; Juris Doctorate degree (strongly preferred), • 10+ years of compliance expertise in the pharmaceutical industry, • Experience serving on MLR review committees, with demonstrated ability to assess promotional content for compliance with regulatory and legal requirements, • Knowledge of the laws, regulations, guidelines, and codes impacting the industry, and their application to a commercial business, • Knowledge of laws, regulations and codes related to government price reporting and DEA compliance, • Strong influencing skills and demonstrated ability to communicate effectively and present ideas and solutions to all levels of the organization, • Strong planning and organization skills with the ability to lead and manage multiple projects concurrently, • Must be self-motivated and possess strong interpersonal skills As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $160,000 to $200,000 USD

Job Description As a NEMES Field Service & Installation Technician, you'll deliver exceptional on-site support for medical and non-medical equipment. This includes documentation of troubleshooting, diagnostics, maintenance, repair and resolution, and installations, while building customer relationships. You’ll work closely with healthcare professionals, as well as our service and office teams, often collaborating with fellow technicians and sales reps from affiliated companies. Reporting to the Field Service Manager and Office Manager, you’ll play a key role in ensuring equipment reliability in fast-paced healthcare environments. Key Responsibilities • Travel in local tri-state area, (Servicing NJ, Eastern PA, NYC & Surrounding Areas) to various healthcare sites to inspect, diagnose, troubleshoot, repair, and maintain medical and support equipment., • Perform installations and scheduled maintenance using technical manuals, schematics, and software tools., • Adapt work hours around hospital schedules—before or after standard hours, including some nights and weekends., • Respond to dispatches promptly and professionally, while accurately documenting service results., • Partner with other technicians and support teams on installations, scheduling, and troubleshooting., • Maintain accurate service records and ensure timely completion of reports, work orders, and expense submissions., • Manage inventory of equipment, replacement parts and company tools., • Collaborate with sales reps from sister companies to support service and installation efforts. Skills and Experience Required: * Basic electronics knowledge and mechanical aptitude; ability to learn new systems and technologies and knowledge of video, audio and data communication systems. * Flexibility to work evenings, weekends, and on-call as needed • Ability to troubleshoot and resolve technical issues, • Access to a reliable vehicle (mini-van, enclosed truck, or SUV preferred), Valid driver’s license with a clean driving record, • Experience using hand tools and diagnostic equipment (e.g., multimeter), • Ability to lift and move equipment and stand for extended periods of time, • Proficiency in Microsoft Office software and general computer literacy Preferred: • Experience with healthcare or surgical equipment repair, • Electrical and/or biomedical engineering background, • Familiarity with regulatory standards such as OSHA, FDA, and The Joint Commission, • Military technical training a plus Company DescriptionAs a NEMES Field Service & Installation Technician, you'll deliver exceptional on-site support for medical and non-medical equipment. This includes documentation of troubleshooting, diagnostics, maintenance, repair and resolution, and installations, while building customer relationships. You’ll work closely with healthcare professionals, as well as our service and office teams, often collaborating with fellow technicians and sales reps from affiliated companies. Reporting to the Field Service Manager and Office Manager, you’ll play a key role in ensuring equipment reliability in fast-paced healthcare environments.As a NEMES Field Service & Installation Technician, you'll deliver exceptional on-site support for medical and non-medical equipment. This includes documentation of troubleshooting, diagnostics, maintenance, repair and resolution, and installations, while building customer relationships. You’ll work closely with healthcare professionals, as well as our service and office teams, often collaborating with fellow technicians and sales reps from affiliated companies. Reporting to the Field Service Manager and Office Manager, you’ll play a key role in ensuring equipment reliability in fast-paced healthcare environments.

Job Description Job Summary: The Director, Trade & Distribution will be responsible for leading Aquestive’s trade and distribution operations to ensure timely and efficient delivery of products to the market. This role will work closely and collaboratively with internal and external stakeholders including third-party logistics providers (3PL), specialty pharmacies, distributors, and other strategic trade partners. The candidate must have experience in trade operations, inventory management, pharmaceutical distribution and channel analytics within the biotech or specialty pharmaceutical industry. This individual must have a demonstrated history of cross functional collaboration, problem solving and enhancing corporate culture. The position will report to the Vice President, Market Access, Trade & Patient Services. Responsibilities: • Lead trade operations and distribution channels, • Develop and implement distribution strategies to support the lifecycle of Aquestive products, • Monitor inventory levels and product movement to ensure adequate supply and demand alignment., • Serve as the primary contact for 3PL partners, specialty pharmacies, distributors, and other strategic trade and distribution partners, • Track, analyze and monitor vendor performance, monitor service level agreements (SLAs), and report KPIs to leadership., • Support demand planning and forecasting in collaboration with Supply Chain, Finance and Commercial teams., • Assist with pricing and contract administration related to trade and distribution partners., • Champion a culture of compliance by working closely with Legal, Regulatory, and Compliance to ensure all activities meet applicable laws and regulatory requirements, • Oversee budgeting and financial planning for all trade and distribution services, ensuring cost-effective dynamic execution., • Assist with the creation of necessary materials for sales force execution, in collaboration with Sales, Marketing, and other internal stakeholders, • Ensure compliance with regulatory requirements related to drug distribution (DEA, FDA, state licensing)., • Coordinate with internal teams, such as Supply Chain, Finance, Regulatory, Legal, Compliance to address operational issues and improve processes., • Proactively communicate market trends, policy changes, and emerging distribution strategies to key internal stakeholders Qualifications: • Bachelor’s degree required, supply chain, business, or related field preferred., • 10+ years of experience in pharmaceutical trade operations and distribution, • Experience with specialty pharmacy distribution, vendor relationships, and 3PL operations., • Knowledge of drug distribution regulations and compliance requirements., • Highly analytical with ability to turn data into strategic insights and process improvements., • Strong vendor management and negotiation skills., • Highly proficient in advanced Excel skills, • Excellent communication and problem-solving skills., • Willingness to travel as needed (approximately 20%), • This is a home office based position with expectations of being in office 3 days/week The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $160,000 to $200,000 USD