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Job Description Join the world's largest early phase oncology clinical research network! The START Center for Cancer Research is revolutionizing cancer treatment through groundbreaking clinical trials that bring hope directly to patients. With an impressive global footprint spanning the United States, Spain, Portugal, and Ireland, we've completed over 1,300 studies that have led to 43 FDA/EMA approved therapies—including being the first to treat a patient with Keytruda, the most effective cancer drug in medical history. Unlike traditional Academic Medical Centers that reach only 20% of cancer patients, START brings cutting-edge trials directly to community hospitals where most patients receive care. By joining our team, you'll be part of an organization that's truly changing lives and shaping the future of cancer treatment worldwide. Learn more at STARTresearch.com. We are hiring an Infusion Nurse for our newly established START New York office located in Lake Success, NY at 450 Lakeville Road, Lake Success, NY 11042. As part of our exciting expansion to Long Island, you'll have the unique opportunity to help shape our newest location from the ground up. The Infusion Nurse is responsible for providing direct patient care to individuals who are participants in research protocols that are conducted at START. The Infusion Nurse uses appropriate professional judgment and decision-making in planning and providing care. Nursing care is to be delivered in a manner consistent with the Standard Operating Procedures and standards of practice, and professional evidence-based standards. Work Schedule: Business hours are 8:00 AM to 4:30 PM, Monday through Friday, with some flexibility required to accommodate patient schedules and clinical trial needs. Compensation Range: The anticipated hourly rate for this position is $39.42 - $44.23 per hour, depending on experience and qualifications, and based on a 40-hour workweek and annualized salary range of $82,000 to $92,000. This role is not commission-based. A full job description is available upon request. Essential Responsibilities • Patient Care: Administer chemotherapy, immunotherapy, and investigational agents per protocol; perform venipuncture, IV insertion, central line management, ECG collection, and vital signs monitoring., • Participant Support: Educate patients about clinical trials, procedures, drug administration, and potential side effects; prioritize patient dignity, safety, and welfare., • Observation and Documentation: Assess patient well-being, document adverse events, and respond to emergencies using nursing standards., • Protocol Compliance: Collaborate with the study team to complete all study-related procedures, including drug administration, labs, and ECGs., • Planning and Communication: Prepare clinic supplies, maintain EHR quality standards, and communicate changes in patient status to providers., • Mentorship and Collaboration: Train and mentor staff; interact positively with peers, patients, and families while respecting cultural diversity and confidentiality., • High School Diploma or GED., • Licensed Registered Nurse in New York., • Basic Life Support (BLS) certification, and AHA certified program., • 1 year of experience., • Oncology Certified Nurse (OCN)., • Clinical Trial and oncology experience., • Experience working with Microsoft Office, including Teams, Excel and Word., • Advanced Cardiac Life Support (ACLS) Certification, an AHA certified program. Can be obtained within 90 days of hire. 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 provided, • Robust retirement planning: 401(k) plan available with employer matching, • Financial security: Life and disability insurance for added protection, • Performance rewards: 10% annual bonus opportunity, • Career development: Educational assistance program to support your professional growth, • Flexible financial options: Health savings and flexible spending accounts offered, • Well-being and work-life balance: Generous paid time off policy, holidays and weekends off 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 as we establish our newest center of excellence in Lake Success. 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.

Exposure to FDA approved cleaning chemicals.

Job DescriptionJob Description Schivo Medical located in Plainview New York, manufactures a diverse range of essential medical technology solutions. Working with us, you will be manufacturing or supporting the manufacture of a vast array of different products including robotic surgery instruments, neurosurgical tools, and cardiovascular closure devices that treat chronic disease in new ways so people can live better and longer. As an employee of Schivo Medical, you will tackle a wide array of problems, including some of the world’s greatest medical challenges. You will be part of a company committed to helping you build a fulfilling and rewarding career. Job Summary: The Manufacturing Manager is responsible for the management and oversight of Production Operations for our Plainview facilities. This role ensures that all Manufacturing activities meet customer requirements, quality standards, and regulatory requirements (e.g., FDA, ISO 13485). The ideal candidate will have strong leadership skills, a deep knowledge of manufacturing processes, and a commitment to continuous improvement in a fast-paced environment. Key Responsibilities: • Manufacturing Management, • Lead all Manufacturing operations to meet and exceed KPIs in productivity, quality, cost, safety, and customer service., • Build and maintain an effective operations management system grounded in Lean and Growth principles., • In conjunction with site leadership, deliver on the site’s Annual Operating Plan, aligning with broader business goals., • Compliance & Quality, • Ensure adherence to FDA regulations, ISO 13485 standards, and Good Manufacturing Practices (GMP)., • Work closely with Quality Assurance and Regulatory teams to support audits, validations, and documentation., • Drive manufacturing team level engagement, resolve people issues proactively, and promote a positive, accountable team culture., • Manage and develop a high-performing team, ensuring the right skills, behaviours, and mindset are in place., • Lead, coach, and develop a team of supervisors, technicians, and operators. New Product Introduction In conjunction with engineering and quality, the introduction of new products, processes, and technologies into manufacturing. Qualifications: • Bachelor’s degree in engineering, Manufacturing, Life Sciences, or a related field., • 5+ years of experience in a medical device or regulated manufacturing environment, with at least 2 years in a leadership role., • Skilled in developing cross-functional teams and building organizational capability., • Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP requirements., • Familiarity with Lean manufacturing principles; hands-on Lean experience highly desirable Proven ability to manage teams and meet Manufacturing targets in a highly regulated industry., • Proficient in SAP ERP, Microsoft systems and comfortable operating in a data-driven, KPI-focused culture. Preferred Skills: • Lean/Six Sigma certification (Green Belt or higher)., • Strong problem-solving, communication, and interpersonal skills, • Experience working in a CNC Production facility a plus Work Environment: • Primarily manufacturing floors with some office work., • Use of personal protective equipment (PPE) and adherence to cleanroom protocols as required., • 401(k), • 401(k)match, • Dental insurance, • Health insurance, • Vision insurance, • Generous Paid time off, • Employee referral program, • EAP Program, • Free coffee & tea daily Schivo Medical is an Equal Opportunity Employer. All qualified applicants will receive employment consideration without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.

Job DescriptionJob Title: Quality Engineer Reports To: Quality Manager Location: Hicksville, NY Salary: 100k-120k Position Summary: The Quality Engineer is responsible for maintaining, monitoring, and continuously improving key quality system elements to ensure compliance with regulatory standards and support manufacturing excellence. This role plays a critical part in upholding quality standards across ISO 13485:2016, ISO 9001:2015, AS 9100 Rev D, and FDA CFR Part 820. Key Responsibilities:Quality Systems Management * Manage and execute the Internal Audit Program. * Oversee the Non-Conformance (NC) and Corrective and Preventive Action (CAPA) systems. * Maintain and improve the Quality Document Control System. * Prepare and facilitate Management Reviews and Quality performance reports. * Support the Document Control Request process. Compliance & Regulatory Support * Ensure compliance with ISO 13485, ISO 9001, AS 9100, and FDA CFR Part 820. * Lead and participate in external audits. * Collaborate with QE/QC and Validation teams to ensure integrated quality system implementation. Data Analysis & Reporting * Monitor and analyze quality metrics such as non-conformances, scrap, yield, and repeat NRFT (Not Right First Time) issues. * Develop and present management-level reporting on quality performance. Project & Continuous Improvement * Lead and complete assigned Quality System Improvement Projects. * Support cross-functional quality improvement initiatives. General Responsibilities * Promote a culture of quality and compliance across departments. * Maintain work areas in accordance with GMP standards. * -Report maintenance and Health & Safety issues promptly. * Adhere to company Health & Safety policies, including PPE requirements. Required Qualifications: * Honours Degree in Quality, Mechanical, Manufacturing, or Production Engineering (or related field). * Minimum 5 years’ experience in quality assurance within a production environment. * Proven experience with GMP and ISO 13485. * Familiarity with FDA CFR Part 820 and ISO 9001 is desirable. * Proficient in MS Office and Quality Enterprise Systems. * Skilled in formal problem-solving tools (e.g., 5 Whys, Fishbone, A3). Pay Details: $100,000.00 to $120,000.00 per year Search managed by: Cara Kelly Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Job Description Job Title: Manufacturing/Operations Manager Department: Operations Employment Type: Full-Time Salary: 110-150k depending on experience Position Overview The Manufacturing/Operations Manager will oversee production operations ensuring all manufacturing activities align with customer expectations, quality benchmarks, and regulatory standards such as FDA and ISO 13485. This role requires a dynamic leader with a strong grasp of manufacturing systems and a passion for driving continuous improvement in a regulated, fast-paced setting. Primary Duties and ResponsibilitiesOperations Leadership * Direct daily manufacturing functions to achieve and surpass key performance indicators (KPIs) in areas such as output, quality, cost efficiency, safety, and customer satisfaction. * Establish and sustain a robust operations management framework rooted in Lean and Growth methodologies. * Collaborate with site leadership to execute the Annual Operating Plan in alignment with broader organizational objectives. Regulatory and Quality Compliance * Maintain strict compliance with FDA guidelines, ISO 13485, and GMP standards. * Partner with Quality Assurance and Regulatory Affairs to support audits, validations, and documentation processes. * Ensure all manufacturing practices meet health, safety, environmental, and quality management system (QMS) requirements. Team Development and Engagement * Cultivate a high-performance team culture through proactive issue resolution and employee engagement. * Lead and mentor a team of supervisors, technicians, and operators, fostering skill development and accountability. * Promote a collaborative and improvement-focused work environment. Process Optimization * Drive continuous improvement initiatives using Lean and Six Sigma tools in collaboration with cross-functional teams including Operational Excellence, Quality, Automation, and Engineering. * Implement process enhancements to boost efficiency and reduce waste. New Product Integration * Lead the seamless introduction of new products, processes, and technologies into the manufacturing environment in partnership with Engineering and Quality teams. Qualifications * Bachelor’s degree in Engineering, Manufacturing, Life Sciences, or a related discipline. * Minimum of 5 years’ experience in a regulated manufacturing setting, preferably medical devices, with at least 2 years in a leadership capacity. * Demonstrated ability to build and lead cross-functional teams. * In-depth understanding of FDA 21 CFR Part 820, ISO 13485, and GMP. * Practical experience with Lean manufacturing; hands-on application is a plus. * Proven track record of achieving manufacturing goals in a regulated industry. * Proficiency in SAP ERP and Microsoft Office; comfortable working in a KPI-driven environment. Preferred Qualifications * Lean/Six Sigma certification (Green Belt or higher). * Excellent analytical, communication, and interpersonal skills. Pay Details: $110,000.00 to $150,000.00 per year Search managed by: Cara Kelly Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 hiring a Pharmacokinetic (PK) Lab Technician for our new Lake Success location at 450 Lakeville Road, Lake Success, NY 11042. The PK Lab Technician operates to support the investigation team in adherence to phase 1 research protocols within the Standard Operating Procedures of the department. Under general supervision, this position performs laboratory receiving, processing, handling, storage and shipping procedures, equipment maintenance and inventory control within the Pharmacokinetic Department. Compensation Range: The anticipated hourly rate for this position is $21.63 to $26.44 per hour, depending on experience and qualifications. Essential Responsibilities: • Ensure compliance with Federal, State, and local laws for bio sample processing, handling, and shipping., • Receive, process, store, and ship biospecimens according to study specifications., • Prepare sample collection supplies and adhere to SOPs and GLPs., • Identify inconsistencies in sample data and take corrective actions, contacting the Nurse as needed., • Record data in electronic systems in compliance with SOPs and GLPs., • Process and ship tissue specimens; coordinate with healthcare providers to receive and prepare tissue., • High School Diploma., • General knowledge of medical terminology., • Strong attention to detail, organizational, and communication skills., • Ability to work independently and manage unplanned situations., • Proficient in Microsoft Office and quick to learn new software., • Associate or bachelor's degree in a chemical, physical, biological or clinical laboratory science or medical technology., • Experience in a laboratory setting, with a solid understanding of laboratory techniques and safety protocols., • Experience in data management., • Experience in logistics and operations. Business hours are 8:00 AM to 4:30 PM, Monday through Friday, with some flexibility required to accommodate patient schedules and clinical trial needs. This position is based at our new Lake Success center, where you'll have the exciting opportunity to help establish our laboratory operations from the ground up. 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 provided, • Robust retirement planning: 401(k) plan available with employer matching, • Financial security: Life and disability insurance for added protection, • Performance rewards: Annual 10% bonus opportunity, • Career development: Educational assistance program to support your professional growth, • 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 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 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. Be part of our exciting new Lake Success center and help establish our presence in this community. 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 SR CLINICAL RESEARCH COORDINATOR Job Description We are seeking a dedicated Clinical Research Coordinator to join our dynamic research team. The successful candidate will manage multiple research trials, including first-in-human through phase 3 trials, ensuring compliance with FDA guidelines and adherence to Good Clinical Practice (GCP). This role involves daily interactions with clinicians, sponsors, IRB, regulatory agencies, and other research professionals. As a subject/patient-facing position, strong communication skills are essential for collecting detailed clinical information and sharing it with the study team. The coordinator will be responsible for all aspects of trial conduct, including IRB submission, regulatory documentation, staff training, and overseeing subject enrollment. Responsibilities • Accurately prepare and maintain regulatory documents., • Prepare Informed Consent Documents with institutional language., • Interface with the IRB, preparing all required documents and submitting packages for review., • Collaborate with the recruitment team to create advertising plans and enroll subjects., • Monitor each subject’s schedule for compliance with the protocol., • Attend study meetings both internally and externally., • Train the study team on new and amended protocols., • Assist in operational planning for study visits, communicating needs to administration., • Create source documents to collect required data in RedCap and oversee team entries., • Assist in the execution of Informed Consent., • Enter data into study-specific databases., • Oversee the ordering, receipt, and maintenance of study supplies., • Communicate regular study updates with administration., • Oversee clinic activities as assigned., • Perform clinical activities as experience and delegation allow., • Clinical research coordination, screening, enrolling, and regulatory knowledge., • Proficiency in Microsoft Office products, including Excel., • Experience with clinical documentation and HIPAA guidelines., • RedCap and various clinical databases proficiency., • Associates or Bachelor’s degree in a clinical or scientific field, or clinical certificate/license, • Cardiology experience preferred, • Clinical skills, including phlebotomy, ability to take and record accurate vital signs, obtain EKG tracings, and familiarity with medical terminology preferred. The pay range for this position is $34.00 - $36.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in New Hyde Park,NY. Application Deadline This position is anticipated to close on Sep 12, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description We are working with a prominent, regional firm seeking a Litigation Associate with at least two years of experience to join their Medical and Life Sciences team in their New York City, Uniondale (Long Island), or White Plains office. Ideal candidates will have experience in defending general and premises liability matters for a variety of clients including senior living, health care, restaurant/building owners; as well as assist in product liability defense of manufacturers of prescription, over-the-counter and/or consumer-use FDA regulated products, pending in New York, New Jersey and federal courts. They will be responsible for matters from case inception to settlement or trial, including drafting memoranda, pleadings, discovery demands and responses, motions, and briefs; researching various factual and legal issues and collaborating with senior attorneys about strategies; drafting reports to clients, including deposition reports, medical record analyses, case analysis reports, and case valuations; managing discovery, including taking and defending deposition, and coordinating with and working-up expert witnesses; attending court appearances; preparing for trial and participating in courtroom and mediation/arbitration proceedings. The candidate must have experience with New York State Court and Federal Court practice, excellent oral and written communication skills, excellent research and writing skills, strong analytical and problem-solving skills, high level organizational skills, the ability to manage competing priorities, and the ability to function effectively in a fast-paced, team-oriented environment. New York Bar admission required. Admission to the New Jersey Bar is a plus! The firm offers a competitive base salary commensurate with experience, and a wide array of benefits, including medical, dental, vision, life insurance, flexible spending accounts, long term disability, short term disability, and a 401(k) plan. In addition, they provide a collaborative and supportive work environment; encourage and support integrity, diversity, collaboration, and professional growth; and provide the foundation and support for their attorneys to succeed such as mentoring relationships, comprehensive training and continuing education opportunities, the ability to work directly with partners and clients, and recognition for contributions to the firm's success. To be considered, please provide a resume, and law school transcript. Writing samples and cover letters are not required but are appreciated. All applications are confidential and NOT shared with employers without the candidate's permission. Oak Ridge Legal Search and the clients we work with are equal opportunity employers and provide equal opportunity to qualified applicants regardless of race, color, religion, national origin, age, gender, gender identity or expression, marital status, sexual orientation, ancestry, physical or mental disability, veteran status or any other legally protected class in accordance with all applicable laws. If a level of experience is indicated, this is a guideline only and does not preclude applications from candidates with more or less experience.

Job DescriptionAbout the job Seeking an experienced Product Development Manager with a strong background in engineering and project management to lead the development and innovation of Class I and Class II medical devices, particularly in the areas of RF generators, RF electrodes, endoscopic instruments, endoscopes, and drill systems. The ideal candidate will have significant expertise in medical device development, regulatory compliance, cross-functional project management, strong understanding of engineering, and supplier development and collaboration. Proven leadership skills are essential as the role will also involve working with our internal engineering team, cross functionally throughout the organization as well as clients and vendors both domestic and international to ensure the successful execution of projects. Key Responsibilities: • Lead, mentor and leverage a multidisciplinary team of engineers to establish product objectives, timeline and resources while fostering a culture of collaboration innovation and continuous improvement., • Troubleshoot/resolve issues and ensure task completion by establishing priorities validating solutions and reaching a conclusion with functional managers and team members., • Contribute as a leader to the strategic direction of product innovation, focusing on cutting-edge technologies while providing regular updates to senior management., • Oversee the design, prototyping, testing, and validation of medical devices, including RF generators, electrodes, endoscopes, drill systems, instrumentation, etc. Interact with clients (surgeons) and senior leadership for ensuring adherence to design controls and quality standards., • Ensure compliance with FDA, ISO, IEC, and other relevant standards and regulations worldwide during the product development process., • Plan, execute, and track R&D projects, ensuring timely delivery, meeting product specifications, and adhering to budgets., • Collaborate with cross-functional teams including Marketing, Sales, R&D, Regulatory Affairs, Quality Assurance, and manufacturing, to ensure the final product meets market needs and regulatory requirements, • Prepare technical documentation (e.g., design history files, risk management files, and verification/validation protocols) for regulatory submissions, • Partner with Regulatory Affairs to prepare submissions for FDA 510(k) or other regulatory approvals for medical devices, • Drive research of new materials, components, and manufacturing techniques to improve product performance, reduce costs, and ensure patient safety, • Partner with surgeons, physicians and industry professionals for clinical and device feedback to ensure product optimization for both surgeons and their patients., • Collaborate with domestic and international vendors/suppliers to identify, develop, and deliver necessary components, materials, and technologies for medical device projects, • Manage relationships with external suppliers and vendors, ensuring compliance with product specifications, quality standards, timelines, and cost structures, • Lead efforts for the search and evaluation of new or suitable suppliers/vendors to ensure access to high-quality materials, innovative technologies, and competitive pricing for product development, • Coordinate with suppliers to ensure that design requirements are communicated and met, and that all necessary certifications and documentation (such as material safety data sheets, regulatory approvals, etc.) are provided, • Stay current on industry trends, emerging technologies, and best practices related to medical devices, specifically in Class I and Class II devices, • Education: Bachelor’s or Master’s degree in Biomedical Engineering, Mechatronic Engineering, Mechanical Engineering, Electrical Engineering, or a related field. A Ph.D. is a plus, • 10+ years of experience in the medical device industry, with at least 5 years in R&D leadership roles (Manager), • Extensive hands-on experience in the development of Class I and Class II medical devices, including devices such as RF generators, RF electrodes, instrumentation, endoscopes, and drill systems, • Strong background in engineering disciplines such as electrical, mechanical, and/or biomedical engineering with expertise in medical device design and development, • Expertise in medical device design controls, risk management, project management, continuous improvement and validation/verification processes, • Strong understanding of engineering knowledge such as GD&T Principals and ability to read and interpret technical drawings., • In-depth knowledge of regulatory standards such as FDA 510(k), ISO 13485, IEC 60601, and other applicable medical device regulations, • Excellent communication, leadership, and problem-solving skills, with the ability to manage a diverse team, complex projects and collaborate across multiple departments, • Supplier and vendor management experience (domestic and international), with the ability to assess and select new suppliers, manage performance, and resolve any supply-related issues efficiently, • Computer Programs: MS Office Suite, SolidWorks, Project Management Programs, AUTOCAD, Unigraphics, NX, Creo, CATIA., • RF Engineering Knowledge: Familiarity with RF energy applications, design considerations for RF generators and electrodes, and related technologies in the medical device space, • Endoscopic Technologies: Experience with endoscopic instrument design, optics, and surgical tool integration, • Material Science: Knowledge of biocompatible materials and component selection for medical devices, particularly for implantation or prolonged exposure to the human body We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind 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 and local laws. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email . Powered by JazzHR wFf7vENGmg

Job Description Title: Regulatory Affairs Coordinator ???? Location: Nassau Candy Headquarters – Hicksville, NY [Hybrid] ???? Schedule: Full-Time Who We Are Nassau Candy is a leading manufacturer, importer, and distributor of specialty confections, gourmet foods, and private-label products. We serve top retailers and specialty markets across North America, delivering innovative, high-quality products backed by regulatory integrity and technical excellence. Our Regulatory Affairs team plays a critical role in ensuring compliance, accuracy, and customer satisfaction through meticulous food labeling and documentation standards. What We’re Looking For We’re seeking an Entry-Level Regulatory Affairs & Supplier Compliance Coordinator who is detail-oriented, organized, and eager to learn. This role is perfect for recent graduates or individuals with up to 1 year of experience in regulatory, quality, or compliance within the food industry. You’ll support the Regulatory Affairs and Quality Assurance functions by assisting with supplier documentation, product labeling, and compliance requirements—gaining hands-on experience while contributing to our mission of delivering safe, compliant, and trusted products. Key Responsibilities ???? Supplier Approval & Documentation * Assist in collecting and reviewing supplier questionnaires, certifications, and food safety documentation (HACCP, GFSI). * Maintain and update the Approved Supplier List (ASL). * Organize supplier files and ensure records remain accurate and up to date. ⚖️ Regulatory Support * Support the review of product labels, packaging, and marketing materials for compliance. * Assist with ingredient statements, nutrition panels, and allergen information. * Help manage label verification sheets and departmental records. ????️ Compliance & Customer Support * Prepare and update product specifications, allergen statements, and regulatory documents. * Respond to customer and internal inquiries with accurate product details. * Assist with internal and external audits. * Track certification renewals and regulatory deadlines. Qualifications ???? Education & Experience * Bachelor’s degree in Food Science, Food Technology, Nutrition, Biology, Chemistry, or related field. * Up to 1 year of regulatory, quality, or compliance experience (internships and academic projects accepted). * Basic knowledge of U.S. food regulations (FDA, USDA, FSMA) preferred (training provided). ???? Skills & Tools * Strong organizational skills and attention to detail. * Proficiency in Microsoft Office (Word, Excel, Outlook). * Excellent communication and teamwork abilities. Preferred Skills * Familiarity with food labeling requirements or food safety concepts. * Exposure to GFSI-recognized schemes (SQF, BRC, FSSC 22000). * Willingness to learn regulatory software (e.g., Nutritionist Pro, ESHA/Trustwell). * Strong written communication and documentation skills. Why Join Us? At Nassau Candy, you’ll gain hands-on experience in regulatory affairs and supplier compliance, working alongside seasoned professionals in a dynamic food industry environment. If you’re passionate about food safety, regulatory compliance, and starting your career in a collaborative and growth-oriented team, we’d love to hear from you.

Job Description About The START Center for Cancer Research Join the world's largest early phase oncology clinical research network! The START Center for Cancer Research is revolutionizing cancer treatment through groundbreaking clinical trials that bring hope directly to patients. With an impressive global footprint spanning the United States, Spain, Portugal, and Ireland, we've completed over 1,300 studies that have led to 43 FDA/EMA approved therapies—including being the first to treat a patient with Keytruda, the most effective cancer drug in medical history. Unlike traditional Academic Medical Centers that reach only 20% of cancer patients, START brings cutting-edge trials directly to community hospitals where most patients receive care. By joining our team, you'll be part of an organization that's truly changing lives and shaping the future of cancer treatment worldwide. Learn more at STARTresearch.com. We are hiring a Clinical Research Coordinator, RN, for our Lake Success location. The Clinical Research Coordinator, RN supports early phase oncology trials under senior research staff guidance. This role ensures accurate, timely research conduct, adhering to protocols, regulatory standards, and patient safety. Responsibilities include direct patient interaction, data collection, maintaining Good Clinical Practice (GCP), overseeing multiple protocols, and coordinating patient participation. The CRC, RN implements and completes protocol requirements, ensuring accurate, up-to-date information is provided to the team. Compensation Range: The anticipated hourly rate for this position is $39.42 - $44.23 per hour, depending on experience and qualifications, and based on a 40-hour workweek and annualized salary range of $82,000 to $92,000. This role is not commission-based. A full job description is available upon request. Work Schedule: Business hours are 8:00 AM to 4:30 PM, Monday through Friday, with some flexibility required to accommodate patient schedules and clinical trial needs. This position is based at our new Fort Worth center, where you'll have the exciting opportunity to help establish our laboratory operations from the ground up. Location: 450 Lakeville Road, Lake Success, NY 11042 Essential Responsibilities: • Communicate regularly with Study Sponsors, CROs, and staff regarding protocol status, questions, and concerns., • Monitor day-to-day study conduct to ensure protocol, SOP, and Good Clinical Practice compliance., • Review and create trial forms to ensure protocol compliance., • Maintain organized study files with standardized labeling and filing procedures., • Implement protocols and amendments, training staff on patient treatment and management., • Assist with patient screening, eligibility determination, and informed consent process., • Associate’s degree in Nursing and RN license in state of New York., • 2 years of clinical research experience, with a basic understanding of oncology Phase 1 trials., • Strong attention to detail, accuracy in data collection, and ability to meet deadlines., • Excellent organizational, time-management, and communication skills., • Bachelor’s degree in Nursing., • Comprehensive health coverage: Medical, dental, and vision insurance provided, • Robust retirement planning: 401(k) plan available with employer matching, • Financial security: Life and disability insurance for added protection, • Flexible financial options: Health savings and flexible spending accounts offered, • Well-being and work-life balance: Generous paid time off policy, holidays and weekends off, • Annual performance bonus: 10% annual bonus opportunity, • Educational assistance program: Support for your continued professional development 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 DescriptionDescription: About the role The Quality Assurance Manager will play a pivotal role in managing the development, implementation and sustainment of the Quality Processes and Systems relating to Global QA and Cell and Gene Therapy (C&G) products. Job Duties: • Provide strategies to address compliance gaps or determine enhancements to cross-functional quality system., • Lead and manage complex projects/teams within corporate objectives and project timelines and participates in cross-functional projects in Quality expert and leader role., • Be the Mentor, the Global QA-SME, and the single point of contact for the headquarters, all branches, depots, extensions, third party service providers and suppliers, as needed., • Design and train organization for C&G to comply with various regulatory and client requirements. Train the trainers across the company., • Effectively collaborate as part of a multidisciplinary team to develop novel processes for C&G logistic services., • Provide support to Quality Department projects such as in the Commissioning and Qualification activities for the new cGMP facility builds., • Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions., • Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends., • Establish and maintain the internal/external audit program, host/represent in client audits, review and approve the audit plans, report, and CAPAs, and ensure that the CAPAs are executed according to the plans., • Implement and monitor the routine systems, procedures, and records to support cGMP, GCP, GDP and disposition of G&G shipments/products., • Contributes towards the development of the Quality System infrastructure for C&G., • Perform records review in a cGMP manufacturing environment with a focus on novel challenges of C&G, as needed., • Support review of documents such as records, methods and validation protocols/reports., • Participate in quality investigations, assessments, and evaluations of quality records such as deviations, CAPAs, and change controls., • Provide hands-on QA support and oversight to internal staff to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements., • Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.Requirements:, • Bachelor of Science degree, preferably in a Biological Science related field., • Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required., • Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems teams., • Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products., • Strong knowledge of current industry trends and the ability to use the latest technologies., • Successful in mentoring people managers., • Minimum of 3 years’ experience in a cGMP/GCP/GDP role supporting Cell Therapy Products., • Production knowledge of biotech products for clinical use in humans is required., • Direct experience with quality investigations, assessments, reviews and/or evaluations of quality events such as CAPA’s, deviations, change control, etc., • Excellent communication and interpersonal skills with the ability to influence to positive resolutions., • Strong decision making and problem-solving abilities with the ability to identify creative solutions.

Job DescriptionJob Title: Compounding AssistantJob Description Support the preparation and mixing of pharmaceutical bulk products. Carry out additional departmental tasks as needed, including cleaning, sanitization, and other assigned duties. Follow established Manufacturing Instructions, Standard Operating Procedures (SOPs), and Good Manufacturing Practices (GMPs) to assist compounders in operating mixing tanks, compounding kettles, mills, mixers, pumps, and other equipment used in the production of pharmaceutical products. Responsibilities • Transfer raw materials from staging or compounding areas and move bulk product to designated storage locations., • Assist in accurately weighing specified types and quantities of liquid or solid raw ingredients using automated dispensing systems or manual scales, in accordance with approved formulas., • Transfer completed batches into appropriate containers via pump or gravity for delivery to storage or other production departments., • Actively identify and question anomalies, using them as opportunities to deepen understanding and support problem resolution., • Collect bulk samples for laboratory analysis and assist with the handling, dispensing, and sampling of hazardous raw materials as needed., • Participate in the daily cleaning and sanitization of kettles, mixers, pumps, utensils, and compounding rooms., • Perform scheduled environmental monitoring in accordance with SOPs., • Support the weighing and mixing of sanitizing agents as required., • Complete all required batch documentation accurately and in a timely manner., • Compounding, • GMP, • Pharmaceuticals, • Mixing, • SOP, • Minimum of 1 year working with chemicals in a cGMP-regulated environment, • Proficiency in a dispensary or equivalent setting, • Strong English reading and comprehension skills to interpret detailed SOPs, formulas, and manufacturing instructions, • Basic math skills and familiarity with the metric system, • High School Diploma or GED required, Associate's Degree preferred, • Relevant pharmaceutical experience with a foundation in chemical handling and processing, • Capable of lifting up to 50 lbs and properly using half or full-face respirators, • May be required to wear full-body protective gear for extended periods when handling hazardous materials, • Able to sustain a high level of physical activity throughout the workday The work schedule is from 10 p.m. through 6:45 a.m. (Monday through Friday). Initial training for one month occurs on the first shift, which runs from 6 a.m. through 2:45 p.m. (Monday through Friday). The work environment is supportive of career growth and development, offering opportunities for internal mobility, mentorship, and training programs. Employees benefit from a culture of inclusion, integrity, and collaboration, with a strong emphasis on safety compliance, community involvement, and innovation. Job Type & Location This is a Contract position based out of Hicksville, New York. Pay and Benefits The pay range for this position is $22.00 - $23.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Hicksville,NY. Application Deadline This position is anticipated to close on Sep 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Full Time Histotechnologist needed in Long Island, New York! Apply now for an interview! Position Highlights: • Full-time, permanent job opportunity, • Full benefits package (401k, PTO, medical/dental/vision insurance), • Competitive pay, • Associate's Degree in Science (or higher), • ASCP (HT or HTL) or eligible to obtain, • Experience is preferred (but not required!), • NYS Licensure to work in the laboratory required Interested? Apply to this job or send a resume to for consideration! (REF: MK51913)

Job Description The START Center for Cancer Research ("START") stands as the world's largest early phase site network exclusively dedicated to oncology clinical research. Throughout our history, we've provided hope to cancer patients in community practices globally by offering access to cutting-edge trials across the US and Europe. With over 1,300 completed studies and research facilities in the United States, Spain, Portugal, and Ireland, START's mission is to accelerate the development of new anticancer drugs that improve quality of life and survival for patients with cancer—ultimately leading to its cure. Our impact is undeniable: over 43 therapies conducted at START locations have obtained FDA/EMA approval. While Academic Medical Centers conduct 80% of cancer trials but reach only 20% of patients, START bridges this critical gap—bringing innovative cancer trials directly 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 across eight clinical trial sites. Committed to accelerating the journey from trials to treatments, we deliver hope to patients, families, and physicians worldwide. In San Antonio, where START was founded, we treated the first patient ever with Keytruda—now recognized as the most effective cancer drug in medical history. Join Our Mission as Director, Investigational Drug Section (IDS) in Lake Success, Long Island, NY Are you ready to transform cancer care at the forefront of clinical innovation? We're seeking a visionary and experienced Director, Investigational Drug Section (IDS) to lead our pharmacy operations at our Lake Success, Long Island location. In this pivotal leadership role, you'll champion our pharmacy operations while ensuring rigorous compliance with regulations and internal SOPs. This career-defining opportunity combines strategic leadership—developing pharmacy staff and optimizing daily operations—with hands-on clinical expertise that directly impacts groundbreaking cancer research and patient outcomes. Join us in pioneering tomorrow's cancer treatments today. The annual base salary for this role is $180,000 - $229,000, reflecting the significant expertise and leadership required. Your compensation may vary based on your unique qualifications, experience, and market factors. Schedule: Monday through Friday, 8am-5pm How You'll Make an Impact • Spearhead collaboration with nursing, study operations, and site leadership to deliver exceptional patient care, optimize workflows, and drive operational excellence across multidisciplinary teams, • Ensure impeccable regulatory compliance with federal guidelines and internal SOPs for the IDS space and pharmacy operations, • Apply your pharmaceutical expertise to verify medication orders with precision, confirming accurate dosages, patient eligibility, complete labs, signed consent, and absence of drug interactions, • Lead medication preparation and dispensing, mentoring pharmacy technicians and implementing comprehensive safety protocols prior to drug release, • Elevate pharmaceutical care through patient counseling, supportive care education, and providing expert drug information to the healthcare team, • Strategically manage drug inventory and documentation, including tracking usage, ordering, storage, and maintaining Phase I medication accountability, • Drive protocol review and EMR accuracy, analyzing protocol changes, maintaining investigational records, and ensuring precise medication orders and patient home medication documentationWhat You'll Bring, • Degree from an ACPE accredited School of Pharmacy, • Current New York State pharmacy license, • Proven hospital/clinic pharmacy experience with a passion for oncology, • Demonstrated expertise with sterile compounding requirements for chemotherapy agents, USP<797>, USP<800>, laminar airflow hood(s) / biological safety cabinet(s), • Strong technical proficiency with Microsoft Office products, electronic medical record programs, pharmacy software, and study IRT systems, • Comprehensive knowledge of Good Clinical Practice (GCP) principles, • Sterile compounding & chemotherapy certification, • Intravenous sterile product training, • Experience in clinical trials and management of investigational drugsWhat Will Set You Apart, • Specialty residency in oncology and/or current BPS Board Certified Oncology Pharmacist (BCOP), • Complete health coverage: Medical, dental, and vision insurance to keep you and your family healthy, • Financial security: Robust 401(k) plan with generous employer matching to build your future, • Peace of mind: Life and disability insurance for financial protection, • Flexible financial planning: Health savings and flexible spending accounts, • Work-life harmony: Generous paid time off, flexible schedule options, and work arrangements tailored to your needs Join us in our mission to conquer cancer, one clinical trial at a time. Apply today to become part of our life-changing work. We are an equal opportunity employer that celebrates 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.

Location: Hicksville, NY Contract Duration: 18 months Pay Rate: • 2nd Shift Packaging: $22/hr., • 3rd Shift Packaging: $23/hr. Shift Information • Training: Must be available to work 1st shift (6:45 a.m. – 3:30 p.m.) for the first 4 weeks., • After training, candidates will be assigned to either:, • 2nd shift (3:00 p.m. – 11:45 p.m.), or, • 3rd shift (10:30 p.m. – 7:15 a.m.), depending on availability., • Includes one 45-minute lunch and two 15-minute breaks per shift. Job Purpose Responsible for performing various inspecting, labeling, and packaging operations. Operates machines that execute one or more packaging functions, such as packing or bundling. Major Accountabilities • Handle packaging line components and monitor for defects., • Inspect filled containers/packages to ensure adherence to specifications., • Weigh finished products to detect missing components., • Clear line culls and document all discarded components., • Prepare shippers, inspect finished products, and pack into shippers; seal, label, and stack., • Fill cartons, carriers, or shippers by hand with products, labels, literature, or applicators., • Perform machine cleaning tasks during or post-operation., • Maintain compliance with SOPs, GDP, cGMPs, safety policies, and training requirements., • Verify lot codes and expiration dates on all packaging components and finished goods., • Execute packaging line assignments, meeting throughput and quality standards., • Support other lines/roles to maintain operational efficiency., • Conduct rework/re-inspection with a focus on identifying product defects., • Perform housekeeping duties including sweeping, mopping, and cleaning equipment and facility surfaces., • Make minor equipment adjustments and document work performed., • Train new employees as required. This role may involve handling hazardous materials (flammable, corrosive, toxic, etc.). If so, OSHA HAZWOPER training (8, 24, or 40-hour) may be required. Alternatively, employees will be trained per RCRA 40 CFR 265.16. Annual refresher training is provided. Key Performance Indicators (Knowledge, Skills & Abilities) • Solid English reading comprehension and communication skills to interpret cGMPs, SOPs, and equipment instructions., • Basic math skills; ability to count components, waste, and finished goods accurately., • Commitment to the Safety Program, including proper use of PPE., • Proactively report safety, quality, and equipment performance issues., • Ability to work independently or in teams (e.g., for continuous improvement initiatives)., • Perform duties with a team-oriented mindset and mutual respect., • Demonstrate initiative and ability to work autonomously., • Willingness to develop and learn new skills for advancement opportunities. Ideal Background • Education:, • High School Diploma or GED required., • Associate’s degree preferred., • Equivalent experience may be considered in lieu of a high school diploma., • Physical Requirements:, • Ability to lift 30 lbs. and maintain a high level of physical activity.

We are drug free workplace, regulated by the FDA, required to follow Federal Guidelines; therefore in order to start as well as maintain employment, you must be able to successfully clear drug screening processes, which include testing for all illegal substances per Federal Guidelines. Assist with P

Exposure to FDA approved cleaning chemicals.

Fortune 500 pharmaceutical company.GForce Life Sciences to provide a Senior Project Manager (SPM) who will provide senior level leadership in planning, budgeting, and overall management of major capital projects and initiatives from conceptualization through design, bidding, construction, commission

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