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We are seeking a detail-oriented Account Representative - Customs Brokerage (Entry Writer) to support daily international logistics operations in Franklin Square. This role is responsible for coordinating and executing shipments while ensuring compliance with U.S. Customs and other government agencies. You will serve as a key liaison between customers, internal teams, and regulatory bodies to ensure timely and accurate clearance of goods into the United States. • Act as the primary customer service liaison between the company and clients, • Process U.S. Customs entries and Other Government Agency (OGA) filings, • Open and manage shipment files in CargoWise and/or AS400 systems, • Classify commercial invoices using HTS (Harmonized Tariff Schedule), • Ensure compliance with U.S. regulatory agencies (FDA, EPA, FCC, Fish & Wildlife, etc.), • Communicate with internal departments, carriers, vendors, and government agencies, • Coordinate shipments with airlines, ocean carriers, forwarders, and agents, • Track and trace shipments, providing updates and resolving issues, • Convert and verify shipment weights, volumes, and foreign currencies, • Maintain accurate documentation and filing systems, • Assist customers with inquiries, complaints, and shipment updates, • Handle accounting-related processes accurately and on time, • Review and prepare documentation to meet regulatory and carrier requirements, • Minimum 3 years of customs brokerage experience (or equivalent combination of education and experience), • Strong knowledge of U.S. Customs regulations and OGA requirements, • Experience with freight clearance processes Ready to make an immediate impact? Apply now! What We Offer: Hunter Hamilton offers comprehensive benefits packages (medical, dental, vision, long and short-term disability, 401k, etc.). We strive to deliver genuine support throughout the duration of the recruiting process, through the length of the assignment, and beyond! The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs. Hunter Hamilton is a high-performance professional search firm specializing connecting finance, HR, operations, and legal talent with leading employers. Hunter Hamilton is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Hunter Hamilton offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Hunter Hamilton is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at . By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Regulatory Affairs Program Manager leads crossfunctional regulatory projects from strategy through execution, ensuring that all products meet global regulatory requirements and are launched on schedule. This role partners closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission timelines, and drive successful product approvals worldwide. Essential Functions • Design, plan, and manage cross-functional and ongoing regulatory programs, defining schedules, milestones, deliverables, resources, and risk-mitigation strategies., • Function as a Regulatory Affairs point of contact for internal teams, translating regulatory requirements into clear and actionable objectives., • Coordinate crossfunctional project teams, ensuring alignment with regulatory objectives and strategy. Track and report program status to senior leadership and external partners., • Conduct regulatory intelligence to anticipate changes in laws, guidance, and standards. Assess impact on products/processes and communicate findings., • Identify risks early, develop mitigation plans, and resolve issues that could impact timelines or approvals., • Foster a culture of continuous improvement and regulatory excellence., • Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates., • Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in sciences, business, project management or a related field with 7+ years of relevant progressive experience is required., • 5+years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred., • 3+years managing complex, multiregional regulatory programs is preferred. Knowledge, Skills, & Abilities • Understanding and knowledge of FDA and other major healthauthority requirements, a plus., • Proven ability to work with crossfunctional teams, manage budgets, and deliver on schedule., • Excellent written and oral communication skills., • Strong analytical and problemsolving abilities., • Proficiency with MS Office suites and project management tools. Working Environment / Physical Environment • This position works on-site, • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer., • Lift and carry materials weighing up to 30 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $141,300 (entry-level qualifications) to $157,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

The Department of Radiology at the Vagelos College of Physicians and Surgeons, part of Columbia University Irving Medical Center, is seeking a clinical diagnostic medical physicist to join our clinical medical physics group, which provides diagnostic imaging physics services to NewYork-Presbyterian Hospital and offsite locations. Join a collegial team and play a significant role in advancing medical imaging at one of the nation's top academic medical centers. The successful candidate will report directly to the Chief of Medical Physics. Salary range is$130,000 - $200,000. Compensation and academic rank will vary based on credentials, expertise, and experience. Columbia offers a generous benefits package, including college tuition and childcare reimbursement, tuition exemption for faculty members who wish to pursue graduate programs, generous retirement plans, and excellent health and dental coverage. Columbia University Irving Medical Center consists of a main campus with a 1300-bed hospital located in Manhattan, a community hospital, and several satellite medical offices. The imaging equipment consists of 21 MRI units, 20 CT scanners including 5 PET/CTs and 3 SPECT/CTs, 23 special procedures suites, 37 fixed radiography and R/F rooms, 10 digital mammography units, and a large number of mobile radiographic, mobile fluoroscopy, and ultrasound units. In total, there are more than 225 X-ray tubes. The diagnostic radiology physics group is comprised of 2 PhDs and 4 MS-level physicists, as well as two medical physics assistants. ACR accreditation is maintained for mammography, MRI, ultrasound, nuclear medicine, PET, and CT. Most of the equipment and facilities have recently been modernized. Job Responsibilities: • Conduct acceptance testing, periodic diagnostic x-ray equipment testing, and quality assurance surveys across a wide range of modalities, including CT, mammography, general radiography, fluoroscopy, MRI, and ultrasound., • Oversee radiographic technologist QA programs, PDM QA review, and contribute to ACR accreditation for CT, mammography, MRI, and ultrasound., • Prepare and maintain equipment testing records to comply with regulatory standards from NYC-DOH, NYS-DOH, MQSA, FDA, TJC, ACR, and other pertinent bodies., • Provide guidance on CT and MRI imaging protocol optimization, CT dose tracking, and MRI safety practices, including evaluation of MR-conditional devices and site safety audits., • Engage in educational activities, teaching radiology residents, and training healthcare staff on, e.g., phantom scans related to equipment quality assurance., • Collaborate with other departments and liaise with inspectors and regulators to maintain compliance and excellence in diagnostic imaging services. Education and Experience: • MS or PhD in medical physics, radiological physics, or a related field., • Preferred Mammography MQSA certification., • Having, or being eligible for, NYSED licensure in diagnostic radiological medical physics., • Clinical experience in diagnostic imaging quality assurance, preferably in a university hospital setting., • Extensive experience with a wide range of radiology imaging equipment, including CT, mammography, general radiography (CR/DR), fluoroscopy (II/FPD), MRI, and ultrasound., • In-depth understanding of the rules, guidelines, and standards of regulatory and accrediting bodies., • Exceptional communication skills in all means of communication, capable of effective interaction at all levels of hospital staff across a multitude of departments., • Board certification in diagnostic medical physics by the American Board of Radiology (ABR)., • If not already NYS licensed, must obtain NYS licensure in diagnostic medical physics within 6 months of starting. The above salary range represents Columbia's good faith and reasonable estimate of possible compensation at the time of posting. Columbia University is an Equal Opportunity Employer / Disability / Veteran Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Experienced Clinical Research Associate - Full-Service Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands. Summary of role The Radiopharmaceutical Production Technologist II is responsible for producing radiopharmaceutical products in a just-in-time, GMP-regulated environment to support clinical and commercial supply. This role ensures safe handling of radioactive materials, strict adherence to aseptic techniques, and reliable execution of manufacturing processes. Technologist II participates in daily production, equipment and cleanroom readiness, isolator operations, batch record execution, and deviation support. This position is based in New Jersey and requires a presence on-site, and open to applicants authorized to work for any employer within the United States. Key Responsibilities/Essential Functions • Execute and verify daily radiopharmaceutical production activities according to approved batch records and SOPs., • Support production readiness including manual cleaning of cleanrooms, environmental monitoring, and isolator sterilization., • Perform manufacturing operations using automated and manual synthesis systems., • Conduct aseptic dispensing of individual product vials within isolator cells, • Prepare and stage materials while maintaining traceability., • Maintain and prepare production equipment and cleanrooms, • Assist in deviation investigations and inspections, • Participate in qualification and validation activities., • Follow all radiation safety and PPE requirements., • Support Investigation Review Board and Change Control Review Board meetings as required., • Remain current and apply knowledge of FDA CFR 210/211 and other regulatory standards and guidance in the pharmaceutical industry. Basic Qualifications • Bachelor's degree in a scientific discipline with 1-3 years of GMP cleanroom manufacturing experience OR 5-7 years of equivalent experience Other Requirements • Aseptic fill-finish experience, including familiarity with aseptic manufacturing technologies and facilities is preferred., • Willingness to work with radioactive materials., • Experience with radiopharmaceuticals (I-131, Lu-177, etc. or PET F-18, Cu-64) preferred., • Ability to work in controlled manufacturing environments with PPE., • Understanding of GMP/GLP principles., • Knowledge of hazardous material safety and cGMP requirements., • Strong attention to detail and documentation accuracy, • Previous lab experience in Manufacturing and/or Quality Control at aseptic processing facility is preferred., • Previous experience in Quality, Compliance and/or Manufacturing of radiopharmaceutical products is preferred., • Handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures and use personal and protective equipment provided. Core Values The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone's health is in our hands Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until May 1, 2026. Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at ___. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the ___ notice from the Department of Labor.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Position Summary The Quality Control Technician II performs acceptance testing and inspection activities on in-process and finished goods to ensure products meet established requirements. This role is responsible for executing testing and inspection tasks accurately, documenting results in a timely manner, and supporting quality system compliance in a regulated manufacturing environment. The position is onsite 5 days a week. This is a first shift position with hours from 6am-2:30pm. There may be a possibility for overtime via extended hours or weekends. Job Responsibilities and Essential Duties • Perform functional acceptance testing, destructive, non-desand inspections on products assembled on the manufacturing floorin accordance withapproved procedures and test methods., • Perform destructive and non-destructive testing on in-process and finished goods (e.g., Visual Inspection, Seal Width, Length, Water Entry Pressure, Instron Testing, Radial Burst, Borescope, Spectrophotometry)., • Conductindependentreview of Shop Floor Paperwork (SFP) to verify completeness and accuracy prior to product release or further processing., • Identifyand subject non-conforming materials to the NCMR processin accordance withestablished quality procedures., • Ensure all testing is performed according to established procedures, protocols, quality standards, and regulatory requirements., • Read,comprehend, and follow job instructions, procedures, protocols, and work-related documents, including verbal and written directions., • Train Inspectors on acceptance testing methods, applicable procedures, and newly implemented policies, as assigned., • Assess daily priorities and adjustownwork schedule as needed to support operational requirements., • Performadditionalduties as assigned; responsibilities listed are not exhaustive. Minimum Requirements • High school diploma or equivalent required;Associate orBachelor'sdegree in science, Math, Business, ora relatedfield preferred., • Minimum of 2 yearsof experience in a quality function or regulated environment, or a bachelor's degree or Certified Quality Technician (CQT) certification., • Ability to perform functional testing, inspections, and basic measurements accurately., • Prior Instron testing experience or prior training in one of the following Instron operator courses-Series IX, Merlin, or Blue Hill-is preferred., • Competence in reviewing documentation for completeness and compliance., • Ability to perform basic math across multiple units of measure., • Ability to use electronic quality systems and databases (e.g., SAP) for data entry and record maintenance., • Strong attention to detail and commitment to data integrity., • Effective verbal and written communication skills., • Ability to work collaboratively in a team environment., • Demonstrated flexibility and willingness to learn new tasks and procedures., • Ability to work independently, manage multiple priorities, and adapt to changing workflows., • Ability tolift upto 40 pounds occasionally and handle materials, test fixtures, and equipment., • Ensures environmental consciousness and safe practices areexhibitedin decisions, • Use of computer and telephone equipment and other related office accessories/devices to complete assignments, • May work extended hours during peak business cycles, • Must be able to perform repetitive motions, including frequent use of hands, wrists, and fingers for sample preparation, testing, and instrument operation., • Must be able to remain in a stationary or standing position for extended periods during testing., • Close visual acuity required for sample preparation, reading measurements, and data verification. #LI-JF1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

The Department of Radiology at Columbia University Irving Medical Center/NewYork-Presbyterian is seeking a full-time nuclear medicine radiologist to join our growing Division of Nuclear Medicine. This is a great opportunity for a clinician-scientist with ambition to grow a career in research and administration. Compensation and academic rank will vary based on credentials, expertise, and experience.Salary range starts at$400,000(for a faculty member in the first year out of fellowship). Columbia University offers a generous benefits package. This position has been created to accelerate the clinical, academic, and research program in Molecular Imaging and Therapy at Columbia. Physicians with a track record or demonstrable strong interest in translational molecular imaging will be preferred. The successful candidate will independently cover a busy service when on clinical rotation and actively lead a research program after a startup period, where dedicated research time and resources will be made available. We provide active mentorship from departmental leaders. Other responsibilities include participation in resident and fellowship education, participation in interdisciplinary conferences, and collaboration with clinical colleagues. The PET Center imaging resources include 3 state-of-the-art PET/CT scanners, available for clinical and research use. Dedicated research facilities include a Molecular Imaging Center that houses 2 cyclotrons, 3 PET/CT cameras, and a cGMP facility capable of production of radiopharmaceuticals for research/clinical use, along with a dedicated regulatory office to expedite FDA approval. Modifications to the facility to enable cGMP production of compounds suitable for MR imaging/spectroscopy are feasible. The Division faculty interpret over 3,000 PET/CT scans and perform almost 500 research imaging cases annually. We work in partnership with colleagues in the medical center's many highly regarded departments and centers, including the renowned Gertrude H. Sergievsky Center for the investigation of diseases of the central nervous system, the Taub Institute for research on Alzheimer's disease and the aging brain, the Department of Neurology, the Cerebrovascular Center of the Neurological Institute, the Department of Neurological Surgery, the NCI-designated Herbert Irving Comprehensive Cancer Center, the Department of Radiation Oncology, the Department of Psychiatry, the New York State Psychiatric Institute, and the Department for Biomedical Engineering. The Department of Radiology at Columbia University Irving Medical Center has more than 100 full time faculty and performs over 800,000 imaging exams each year in state-of-the-art facilities that extend from northern Westchester to New York City. Our hospital, New York-Presbyterian, is a tertiary and quaternary care center ranked as one of the best in the country and New York City, treating a wide range of patients from the NYC tristate area and across the world. Columbia University is an exciting hub of innovation and technology, with many opportunities to collaborate with other departments and schools. Columbia University offers a highly competitive benefits package, including college tuition and childcare reimbursement, tuition exemption for faculty members who wish to pursue graduate programs, generous retirement plans, and excellent health and dental coverage. Continuing Medical Education/conference days are apportioned by academic rank and are negotiable to fit candidate needs. More information about the department can be found on the Columbia Radiology website. Please reach out with any questions to: Noor Ahmad, MD, Vice Chair of Clinical Operations at . The position requires a Nuclear Radiology fellowship-trained diagnostic radiologist or board certification in nuclear medicine. The candidate must be fellowship trained in nuclear medicine and preferably board certified in both Diagnostic Radiology and Nuclear Medicine and must also be eligible to practice medicine in the State of New York. Columbia University is an Equal Opportunity Employer / Disability / Veteran Pay Transparency Disclosure The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Principal Product Manager & Team Lead is a senior strategic leader within the Cardiovascular Surgery (CVS) business, responsible for high-level ownership of a broad and complex product portfolio. This role drives portfolio strategy, lifecycle performance, upstream marketing, voice of the customer interface, and cross-functional execution while ensuring alignment with business growth objectives and financial commitments. In addition to portfolio leadership, this position serves as the Team Lead for the Wayne Cardiovascular Surgery Product Management team and may directly manage Product Managers. The role provides mentorship, establishes operational rigor, and ensures excellence in product management execution within a highly regulated medical device environment. The individual must possess extensive medical device product management experience in highly regulated environments and demonstrated clinical marketing expertise. Job Responsibilities and Essential Duties • Hold high-level responsibility for a broad and strategically significant Cardiovascular Surgery product portfolio., • May directly manage a defined portfolio and/or individual Product Managers., • Drive full product lifecycle management from concept through commercialization and post-launch optimization., • Ensure portfolio alignment with strategic priorities and financial targets., • Optimize portfolio mix based on growth, profitability, clinical relevance, and competitive dynamics., • Serve as Leader for the Wayne Cardiovascular Surgery Product Management and PA Marketing/Training team., • Provide mentorship and coaching locally and across ACT product management teams., • Establish performance expectations and foster accountability., • May directly supervise and manage Product Managers., • Contribute to business strategy development and translate strategic objectives into actionable portfolio roadmaps., • Lead multi-year product planning aligned with innovation pipelines and commercial growth objectives., • Identify new market opportunities and unmet clinical needs., • Support Annual Operating Plan (AOP) and Long-Range Plan (LRP) development., • Provide oversight of major product management initiatives., • Lead governance for complex, high-impact programs including launches and lifecycle initiatives., • Manage risks, dependencies, and milestone adherence., • Develop and support robust business cases for capital investments (CAPEX)., • Track product and portfolio performance relative to approved CAPEX requests post-launch., • Monitor revenue, margin, ROI, and forecast performance., • Implement corrective strategies when performance deviates from projections., • Direct customer interface to understand customer experience and key requirements; resulting in strong messaging and customer strategy., • Lead market analytics initiatives across the portfolio., • Establish frameworks for competitive intelligence, pricing strategy, and market share analysis., • Leverage clinical marketing expertise to translate clinical evidence into compelling value propositions that drive the product management funnel activities., • Drive data-informed decision-making that enhances customer centricity., • Own creation and updates of all local product management procedures and support ACT standards., • Establish best practices for lifecycle management and launch excellence., • Ensure compliance with global regulatory and quality system requirements. Minimum Requirements • Bachelor's degree in Business, Engineering, Life Sciences, or related field required., • MBA or advanced degree preferred. Required Knowledge, Skills and Abilities • 10+ years of progressive medical device product management experience, • Extensive experience in highly regulated environments (FDA, EU MDR, global regulatory frameworks)., • Clinical marketing experience required, including surgeon engagement and clinical data translation., • Demonstrated success managing complex medical device portfolios., • Prior people leadership or team lead experience preferred. #LI-JF1 #LI-Hybrid Targeted salary range: $210,000- $245,000, depending upon experience and location +30% bonus target About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Prepare and maintain 510(k) submissions and other required regulatory filings, where applicable. Oversee product registrations, technical documentation, and regulatory records. Monitor evolving FDA, FTC, and other relevant regulatory requirements and provide practical guidance to internal stakeholde

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

Quality Manager Needed For Leading Manufacturing Company This Jobot Job is hosted by: Kevin Finlay Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $100,000 - $130,000 per year A bit about us: My client is a leading manufacturing company who is actively growing! They are looking to add a Quality Manager to their team to lead our quality assurance initiatives and enhance our operational standards. Why join us? Benefits: • Competitive salary with performance-based bonuses and salary reviews., • Comprehensive health, dental, and vision insurance plans., • Generous retirement plan options, including company matching contributions., • Paid time off and flexible work arrangements to help maintain a healthy work-life balance., • Opportunities for professional growth, training programs, and conferences. Job Details Key Responsibilities: • Formulate, document, and execute comprehensive quality assurance policies and procedures tailored to meet industry-specific standards., • Design and lead quality improvement programs that focus on reducing defects and enhancing product reliability, collaborating with cross-functional teams to align quality goals with business objectives., • Lead, mentor, and manage a diverse team of quality assurance specialists, fostering an environment of continuous learning and improvement., • Conduct regular workshops and training sessions on emerging QA methodologies, tools, and compliance regulations to ensure the team remains proficient in current practices., • Oversee the creation and implementation of rigorous testing plans and protocols, ensuring they are executed effectively to validate product performance and safety., • Conduct regular audits of production processes, employing statistical process control to pinpoint inefficiencies and facilitate corrective actions., • Analyze quality metrics and performance data, generating detailed reports that provide insights into trends, root causes of issues, and areas for improvement., • Utilize advanced data analysis software to create dashboards and visual representations of quality data for executive presentations., • Ensure that all QA activities and documentation comply with industry regulations such as ISO 9001, FDA, or other relevant standards., • Bachelor’s degree in Engineering, Quality Assurance, or a related field; a Master’s degree is highly desirable., • A minimum of 7 years of experience in quality assurance management,, • Comprehensive knowledge of quality management systems (QMS), methodologies, and relevant regulatory requirements (e.g., ISO standards, Good Manufacturing Practices)., • Proficient in data analysis tools, statistical methods, and quality improvement techniques such as Six Sigma or Lean Manufacturing. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

Quality Manager Needed For Leading Manufacturing Company This Jobot Job is hosted by: Kevin Finlay Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $100,000 - $130,000 per year A bit about us: My client is a leading manufacturing company who is actively growing! They are looking to add a Quality Manager to their team to lead our quality assurance initiatives and enhance our operational standards. Why join us? Benefits: • Competitive salary with performance-based bonuses and salary reviews., • Comprehensive health, dental, and vision insurance plans., • Generous retirement plan options, including company matching contributions., • Paid time off and flexible work arrangements to help maintain a healthy work-life balance., • Opportunities for professional growth, training programs, and conferences. Job Details Key Responsibilities: • Formulate, document, and execute comprehensive quality assurance policies and procedures tailored to meet industry-specific standards., • Design and lead quality improvement programs that focus on reducing defects and enhancing product reliability, collaborating with cross-functional teams to align quality goals with business objectives., • Lead, mentor, and manage a diverse team of quality assurance specialists, fostering an environment of continuous learning and improvement., • Conduct regular workshops and training sessions on emerging QA methodologies, tools, and compliance regulations to ensure the team remains proficient in current practices., • Oversee the creation and implementation of rigorous testing plans and protocols, ensuring they are executed effectively to validate product performance and safety., • Conduct regular audits of production processes, employing statistical process control to pinpoint inefficiencies and facilitate corrective actions., • Analyze quality metrics and performance data, generating detailed reports that provide insights into trends, root causes of issues, and areas for improvement., • Utilize advanced data analysis software to create dashboards and visual representations of quality data for executive presentations., • Ensure that all QA activities and documentation comply with industry regulations such as ISO 9001, FDA, or other relevant standards., • Bachelor’s degree in Engineering, Quality Assurance, or a related field; a Master’s degree is highly desirable., • A minimum of 7 years of experience in quality assurance management,, • Comprehensive knowledge of quality management systems (QMS), methodologies, and relevant regulatory requirements (e.g., ISO standards, Good Manufacturing Practices)., • Proficient in data analysis tools, statistical methods, and quality improvement techniques such as Six Sigma or Lean Manufacturing. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

Medical Device Leader! Principal Quality Engineer Opportunity! This Jobot Consulting Job is hosted by: David DeCristofaro Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $65 - $85 per hour A bit about us: We are a leading medical device company that operates privately and is committed to enhancing the care and quality of life of patients with kidney disease. Our goal is to create cutting-edge solutions that enable patients and their healthcare providers to manage kidney disease with ease. Why join us? • Company Equity!, • Excellent medical, dental, & vision package!, • 401(k) with a match!, • Generous PTO!, • Opportunity to make a difference in people's lives! Job Details We are seeking a dynamic and experienced Principal Quality Engineer to join our team. This role will be responsible for leading the quality engineering initiatives ensuring ongoing safety, efficacy, and compliance of medical devices as they enter the market. The ideal candidate will have a strong background in quality engineering within the Medical Device industry, with a focus on FDA regulations, ISO 13485, CAPA, and other regulatory and compliance requirements. Responsibilities: 1. Lead the development and implementation of quality systems in compliance with FDA and ISO 13485 regulations., 2. Analyze and manage Corrective and Preventive Actions (CAPA) to ensure effective resolution of quality issues., 3. Utilize problem-solving methodologies such as Fishbone or DMAIC to identify root causes and implement corrective actions., 4. Maintain the FDA Quality Management System Reporting (QMSR) and ensure that all quality metrics are met or exceeded., 5. Provide consultation to various departments on quality systems, regulatory compliance, and risk management., 6. Conduct internal and external audits to ensure compliance with regulatory standards., 7. Lead and oversee post-market surveillance programs., 8. Collaborate with cross-functional teams to drive continuous improvement initiatives., 9. Lead the review and approval of design and process changes, ensuring compliance with quality standards and regulatory requirements. Qualifications: 1. Bachelor's degree in Engineering, Quality Assurance, or a related field is required., 2. Minimum of 12 years of experience in a quality engineering role with strong medical device industry experience., 3. Extensive knowledge of FDA regulations, ISO 13485, Fishbone, DMAIC, 8D, and/or FDA QMSR., 4. Expertise in post-market quality system activities including complaint handling, vigilance/adverse event reporting, HHE, and post-market surveillance., 5. Conduct and lead complex investigations and implement CAPA., 6. Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is preferred. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

About Ogilvy Ogilvy, part of WPP, has been creating impact for brands through iconic, culture-changing, value-driving ideas since the company was founded by David Ogilvy 75 years ago. It builds on that rich legacy through Borderless Creativity - innovating at the intersections of its advertising, public relations, relationship design, consulting, and health capabilities with experts collaborating seamlessly across over 120 offices in nearly 90 countries. Ogilvy currently ___ as the #1 global agency network for creative excellence and effectiveness by WARC, signifying its ability todeliver creative solutions that drive unreasonable impact for clients and communities.Ogilvy is a WPP company (NYSE: WPP). For more information, visit___, and follow us on , About WPP WPP is the trusted growth partner for the world's leading brands. We unitecutting-edge media intelligence and data solutions, world-class creativity, next-generation production, transformative enterprise solutions and expert strategic counselin a single company -powered by exceptional talent and our agentic marketing platform, WPP Open,to help our clients navigate change, capture opportunity and deliver transformational growth. For more information, visit___. OGILVY HEALTH: WE INSPIRE PEOPLE AND BRANDS TO IMPACT THE WORLD Guided by this vision, Ogilvy Health, part of WPP, combines borderless creativity, scientific precision and cultural fluency to build healthcare's most influential movements. We drive measurable impact and category-defining growth for brands ready to shape what's next. Our approach is powered by fearless creativity that dares to be different, sparks emotional connections, and inspires action, ensuring cultural resonance. Scientific precision translates complex data into stories that resonate, while our impact-obsessed mindset focuses on delivering real-world outcomes. For more information on us, visit___, or follow Ogilvy Health on___,,. About The Role We are looking for a dynamic, flexible, and experienced Group Creative Director to champion modern creativity, uniting earned, social and influence, within health. This role goes beyond the standard adaptation of marketing and advertising campaigns for PR and social use. It is about conceiving and executing groundbreaking creative ideas that are inherently designed to generate attention, conversation, and advocacy offline and online. You will lead a team of talented creatives, inspiring them to think beyond paid media and embrace the power of authentic engagement to build brand love and drive health outcomes. What You'll Do • Visionary Leadership:Define and champion the agency's "earned first " creative philosophy, ensuring it is integrated into all relevant client strategies and creative development processes., • Creative Direction & Excellence:Lead the development and execution of innovative, high-impact culture-first creative campaigns and concepts that are strategically sound, socially relevant, and designed for channel-specific organic amplification offline and online., • Team Leadership & Mentorship:Manage, mentor, and inspire a team of earned creatives (copywriters, art directors, content creators, community managers) to push creative boundaries and deliver exceptional work. Foster a collaborative and innovative team environment., • Strategic Partnership:Collaborate closely with strategy, account, social and influence, and media teams to ensure creative concepts are aligned with client objectives, audience insights, and omnichannel best practices., • New Business Development:Drive new business pitches, showcasing the agency's expertise in earned, social and influence-led creativity, championing a nimbler and trend-forward approach to creative, and helping to secure new clients., • Client Relationship Management:Present and defend creative concepts to clients, building strong relationships and acting as a trusted advisor on earned social strategies., • Trend Spotting & Innovation:Stay at the forefront of trends, creators, emerging platforms, and best practices in earned and social media. Proactively identify new opportunities for clients and the agency., • Campaign Strategy & Development:Oversee the development of dynamic campaigns from concept to creation, including an understanding of diverse content formats optimized for social platforms, short-form video, long-form video, activation moments, interactive content, influencer collaborations, and community-driven initiatives., • Performance & Optimization:Work with analytics teams to understand the performance of campaigns, identify insights, and optimize creative for maximum earned impact., • 10 years of progressive experience in creative roles within a PR, social, advertising or marketing agency, with at least 3-5 years specifically focused in Healthcare, • Proven track record of developing and executing highly successful "earned first" campaigns that generated significant organic impact., • Strong understanding of both the healthcare industry and the creator economy, the regulations (e.g., FDA, HIPAA, FTC), and the unique challenges and opportunities of communicating this information., • Exceptional leadership and team management skills, with a passion for mentoring and developing creative talent., • Deep expertise across earned media (traditional media and creator brands) and major and emerging social media platforms (TikTok, Instagram, X, Facebook, LinkedIn, Reddit, YouTube, etc.) and a keen understanding of their audience behaviors., • Proficiency in various content creation tools and platforms (e.g., Adobe Creative Suite, video editing software)., • Excellent presentation, communication, and interpersonal skills, with the ability to articulate creative vision and strategy effectively to clients and internal teams., • Strategic thinker with a strong analytical mindset, able to translate data and insights into actionable creative solutions. Ogilvy celebrates its people. Fully. Enthusiastically. Unhesitatingly. We'll empower you with the tools you'll need to succeed. We'll give you the autonomy to seek out new paths and better ways of doing things. We'll support you with colleagues who are experts in their disciplines, drawn from across the Ogilvy network. And we'll provide opportunities for you to do work of which you'll be proud, with people you'll be proud to call your teammates. #LI-SH The base salary range for this position at the time of this posting is indicated below. Individual compensation varies based on job-related factors, including location, business needs, level of responsibility, experience, and qualifications. We offer a competitive benefits package, click ___ for more details. Pay Range$125,000—$295,000 USD At Ogilvy, our people are at the heart of what we do: a creative agency that sparks game-changing ideas across culture and business through collaboration, integrity, and a celebration of self-expression. We believe in building powerful teams with purpose - and we relentlessly curate transformative initiatives that make our commitment to fairness, and equity a reality. Our ultimate mission is to leave a positive impact on the world, creating a better future for all, while supporting and uplifting the global communities we serve. This is central to our mantra of Borderless Creativity. Ogilvy is an equal opportunity employer and considers applicants for all positions without discrimination or regard to particular characteristics. We are committed to fostering a culture of respect in which everyone feels they belong and has the same opportunities to progress in their careers. If you need any assistance seeking a job opportunity, or if you need reasonable accommodation with the application process, please contact us at . Please note that this contact is only for candidates who are requesting accommodation. Emails for other purposes, including application status requests, will not receive a response.

This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally:Quality Management Systems (including complaint management, CAPAs, deviations, change control,

This assistant will also need to set and arrange off site meetings - for example, Regulatory arranges the rehearsal meetings in preparation for FDA meetings. Seasoned professional at executive level.

Additional responsibilities include: Advise suppliers, biotechnology, and pharmaceutical companies on FDA regulatory compliance matters Counsel health systems and healthcare providers on reimbursement issues, fraud and abuse laws, and healthcare regulatory compliance programs Provide strategic guida

A public pharmaceutical company in New York seeks an experienced FDA Regulatory/Commercial lawyer to serve as Assistant General Counsel. Candidates should have a JD, 10+ years of experience in pharmaceutical law, and strong analytical and communication skills.

Job Description About the Company LTS Lohmann Therapy Systems is a global leader in transdermal and oral thin‑film drug delivery technologies. Our teams have pioneered breakthroughs such as the first contraceptive patch, nicotine patch, oral active ingredient film, and Parkinson’s patch. When you join LTS, you become part of a team that continues to shape the future of patient care and bring life‑changing therapies to market. At LTS, our purpose drives everything we do: We CARE. We CREATE. We DELIVER. We’re committed to fostering an employee experience that reflects our innovation — supportive, collaborative, and empowering. Across our New Jersey and Minnesota locations, you’ll work alongside knowledgeable experts on diverse projects in an environment where every day is different and your contributions truly matter Job Summary LTS is seeking a talented Director of Production Management to lead and optimize our Converting and Packaging manufacturing operations. This role plays a critical part in ensuring operational excellence, regulatory compliance, safety, quality, and efficiency within our production environment. The Director will oversee managers and senior supervisors, drive both short‑term performance and long‑term strategy, and partner closely with Operations, Quality, and Engineering teams to deliver high‑quality products that meet our customers’ expectations. This is a full time, onsite role located in West Caldwell, NJ What You Will Do: • Lead and develop managers and senior supervisors across Packaging and Converting operations., • Ensure all activities comply with cGMP, FDA, and DEA regulations., • Drive daily production performance, including scheduling, resource allocation, problem‑solving, and on‑time delivery., • Champion safety initiatives and quality programs to maintain a safe, compliant workplace., • Optimize production efficiency and cost‑effectiveness while meeting regulatory and customer requirements., • Collaborate with the Director of Manufacturing on labor planning and resource utilization., • Support development and oversight of cost control reports, manpower plans, and operating budgets., • Achieve financial objectives through effective planning, monitoring, and forecasting., • Coordinate cross‑functional support to ensure smooth workflow and operational alignment., • Partner with the VP of Operations to deploy Optimization and Reliability Engineers to improve quality and efficiency., • Enhance customer satisfaction by reducing delinquencies and improving delivery performance., • Build strong customer relationships through proactive communication and support., • Lead integration of new technologies and systems across Production, Operations, Quality, and Engineering., • Bachelor’s degree in Process Engineering or a related field., • 10–14 years of pharmaceutical industry experience., • Strong understanding of cGMPs, SOPs, and FDA/DEA regulations., • At least 3 years previous management and leadership experience in a manufacturing environment., • Excellent communication, analytical, and problem‑solving skills., • Proficiency in Microsoft Word, Excel, and PowerPoint., • Experience in packaging and converting environments, • SAP S4HANA experience helpful If this sounds like you, we want to hear from you! LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job Description Our client in Fairfield, NJ is looking for a Senior Product Release Engineer for a Full time position. Pay is $110-125k annually DOE Responsibilities: • Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements., • Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs., • Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes., • Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities., • Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities., • Understand and meet Regulatory (FDA) requirements and processes for development., • Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s., • Bachelor’s degree in mechanical engineering or biomedical engineering., • Minimum of 10 years of medical device experience., • Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products., • Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact on company objectives.

Job DescriptionPharmacist in Charge About PersonalRx 🌐 PersonalRx is a patient-first, service-driven pharmacy dedicated to improving lives through personalized medication management and reliable home delivery. By combining technology, clinical expertise, and regulatory excellence, we ensure every prescription is filled accurately and on time. Join our growing team and help shape the future of pharmacy care. Position Overview PersonalRx is seeking an experienced and motivated Pharmacist in Charge to lead our East Rutherford, New Jersey pharmacy operations. This role carries full accountability for regulatory compliance, pharmacy operations, and team performance while maintaining a strong focus on patient-centered care. The ideal candidate brings deep pharmacy operations experience, strong leadership skills, and a proactive approach to quality, compliance, and continuous improvement. Key Responsibilities * Serve as the designated Pharmacist-in-Charge (PIC)/ with full accountability for pharmacy operations * Ensure compliance with all New Jersey Board of Pharmacy, state, and federal regulations, including DEA, Medicare, and Medicaid requirements * Lead, mentor, and support a team of 5–10 pharmacists and pharmacy technicians * Partner with the Operations Manager to streamline workflows, improve productivity, and maintain exceptional service levels * Collaborate with executive leadership on strategic initiatives, service expansion, and operational improvements * Manage pharmacy inventory, including procurement, storage, and controlled substance accountability * Oversee quality assurance programs, audit readiness, and continuous process improvement initiatives * Serve as the primary contact for regulatory inspections, audits, and third-party payer reviews * Evaluate, implement, and oversee pharmacy technology systems; ensure staff training and compliance * Resolve escalated patient issues while maintaining a high standard of patient-centered care Qualifications * Doctor of Pharmacy (PharmD) or equivalent degree from an accredited institution * Active, unrestricted New Jersey pharmacist license (required) * Minimum 5–7 years of pharmacy operations experience, including 2+ years in a PIC or leadership role * Strong knowledge of USP, DEA, FDA, and NJ State Board of Pharmacy regulations * Proven experience managing teams and workflows in a complex pharmacy environment * Proficiency with pharmacy management systems and related software * Excellent communication, organizational, and leadership skills * Demonstrated commitment to patient safety, quality, and service excellence Preferred Qualifications * Experience in specialty, long-term care, or mail-order pharmacy * Familiarity with Medicare Part D and third-party payer processes * Strong analytical, reporting, and process-improvement skills Compensation & Benefits * Competitive salary: $135,000 – $150,000 (commensurate with experience) * Paid time off and paid holidays * Professional development support and continuing education reimbursement * Collaborative, mission-driven work culture Why Join PersonalRx? At PersonalRx, you’ll have the opportunity to make a meaningful impact every day—enhancing medication safety, improving patient outcomes, and leading a talented pharmacy team in a supportive, growth-oriented environment. Apply today! A member of our leadership team will review your application promptly. PersonalRx is an EOE Powered by JazzHR 5L1wi41I2r

Job DescriptionPosition Description: Dr. Praegers was founded in 1994 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job DescriptionPosition Description: Dr. Praegers was founded in 1992 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job Description Hi, we're Nuts.com! Nuts.com is a self-funded, profitable, rapidly growing multi-channel DTC specialty food and wellness company with over 550 people on our team. We're changing the landscape of snacking on nuts, dried fruit, chocolate and more! We planted our roots in Newark, New Jersey during the Great Depression, selling premium nuts on Mulberry Street's open-air market. We've come quite a long way since then, taking our multi-generational family business online in 1999. Even after 96 years, we continue to pride ourselves in expertly sourcing the highest quality foods and treating our customers like family. What's our team like? We're driven, collaborative and entrepreneurial. Energy and passion power our business and we look for candidates who share in that excitement to help us continue to build something special. The role: We are seeking a dedicated and experienced Sanitation Lead to join our team. The Sanitation Lead will oversee the daily activities of the Cleaning & Sanitation Associates, ensuring that all areas of our facility—including production areas, kitchens, restrooms, and common areas—are cleaned, sanitized, and maintained to the highest health and safety standards. This is a "working lead" role; the ideal candidate will possess strong leadership abilities to mentor staff but is also willing to perform physical sanitation tasks when necessary. You will play a critical role in maintaining compliance with OSHA, FSMA, and GMP standards. This role reports to the Sanitation Supervisor. How you'll make an impact * Team Leadership & Scheduling: Lead a team of Cleaning & Sanitation Associates to ensure efficient cleaning operations. Develop and implement daily/weekly sanitation schedules to ensure full facility coverage. * Training & Mentorship: Train sanitation staff on proper cleaning methods, chemical safety, and SOPs. Verify that staff are competent in operating equipment, including floor scrubbers, forklifts, and scissor lifts. * Inspection & Auditing: regularly inspect and monitor cleaning procedures to ensure compliance with company standards and industry regulations. Conduct regular internal audits to identify areas for improvement. * Inventory Management: Monitor inventory levels of cleaning supplies, PPE, and chemicals; order replacements as needed to prevent shortages. * Equipment Maintenance: Ensure that all cleaning equipment (PIVs, scrubbers) is properly maintained, charged, and in good working order. Report mechanical issues to maintenance immediately. * Safety & Compliance: Work closely with Quality Assurance and Health & Safety to ensure strict adherence to HACCP, allergen control, and GMP protocols. Ensure proper waste management and hazardous material disposal. * Documentation: Maintain accurate records of cleaning logs, chemical usage, and staff training as required for regulatory inspections (FDA, SQF, etc.). * Schedule Flexibility: Must be flexible to work different shifts. This position follows a four-day shift either day or overnight based on business needs. What you'll bring: • Required:, • 2+ years of sanitation experience in a manufacturing or food production setting., • Proven experience in a leadership role (Lead, Senior Associate, or Supervisor)., • Ability to walk and stand for extended periods., • Ability to lift up to 50 lbs., • Ability to climb stairs and ladders comfortably., • Ability to work in tight spaces and at varying heights (using scissor lifts or ladders)., • Education: High School Diploma or GED., • Experience:, • Industry Knowledge: Strong understanding of health and safety regulations, including OSHA, FSMA, HACCP, and GMPs., • Equipment Proficiency: Must be proficient in operating (and willing to train others on) Powered Industrial Vehicles (forklifts, scissor lifts, pallet jacks) and industrial floor scrubbers., • Physical Requirements:, • Key Skills: Strong attention to detail, ability to solve problems under pressure, and excellent organizational skills., • Highly Preferred:, • A high-growth and rewarding role in a foundationally strong and rapidly evolving business, • Hourly Pay Range: $22.00 - $23.00/hour based on experience, • Excellent benefits including a 401K Match, • Paid Maternity, Adoption and Paternity leave Nuts.com is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.

Job DescriptionNow Hiring: Inventory Associates – Pharmaceutical Manufacturer Please read the entire post; application instructions are located at the very bottom. ¡Sí, hablamos español! Shifts Available:1st Shift: 7:00 AM – 3:15 PM 2nd Shift: 3:00 PM – 11:15 PM 3rd Shift: 11:00 PM – 7:15 AM Pay Rate: $20.00 per hour Locations: • East Hanover, NJ, • Perform daily inventory counts and reconcile discrepancies in the warehouse management system (WMS)., • Receive, inspect, and verify inbound pharmaceutical materials against packing lists and purchase orders., • Store, organize, and label inventory according to lot numbers, expiration dates, temperature requirements, and GMP guidelines., • Pick, stage, and prepare materials for production and order fulfillment while maintaining full traceability., • Monitor product shelf life and identify soontoexpire or nonconforming inventory for quality review., • Maintain accuracy when using RF scanners and material handling equipment (training provided)., • Follow all cGMP, FDA, and company SOPs to ensure compliance and product integrity., • Keep work areas clean, organized, and compliant with pharmaceutical safety and sanitation standards., • Background check and drug test may be required., • Ability to work in a fastpaced, GMPregulated warehouse environment. #ZIP

Job DescriptionBenefits: • Free Parking, • Short-Term and Long-Term Disability, • Flexible Spending, • Life and Accidental Death and Dismemberment, • 401(k), • 401(k) matching, • Competitive salary, • Dental insurance, • Health insurance, • Paid time off What is Natco Pharma USA? Based in Northern New Jersey, we are a fast-growing, innovative specialty pharmaceutical company, distributing solutions for both retail and institutional needs from leading global manufacturers. Were revolutionizing the U.S. pharmaceutical industry by making high-quality medicines more accessible and affordable. As a subsidiary of Natco Pharma Ltd., a global leader with a presence in over 50 countries, we are proud to bring top-tier pharmaceutical products to the American marketplace. Who are we looking for? We are seeking an experienced and hands-on Associate Director, Quality to lead and oversee the U.S. Quality function. This is a high-visibility role responsible for leading U.S. Quality and compliance activities, supporting external manufacturing partners, and upholding the highest standards of CGMP and product quality. In this lean, entrepreneurial environment, the Associate Director will serve as the primary Quality authority for U.S. operations, overseeing regulatory interactions, audit readiness, and product release activities. In this role, you will • Support and coordinate Natco Pharma Limited and Natco Pharma USA ("NATCO") regulatory and pharmacovigilance initiatives., • Support qualification of Natco CMO and 3PL vendors. Perform scheduled CGMP audits of CMOs and 3PL vendors., • Supervise site audits of Natco by FDA, NJ regulatory agencies,. and customers. Prepare and submit CAPA responses to FDA until final approval and closure., • Monitor direct contacts with 3PL's including contract laboratories, LSL, SafetyCall. Maintain company and customer documents., • Approve and release Natco Pharma Limited and Natco Pharma USA, as applicable, CMO Master Batch Records, packaging and shipping authorizations, Change Controls, Deviations, OOS Investigations, Stability Program, COAs, COCs for finished product release for distribution., • Work with Safety call to document all product inquiries, complaints, and adverse events., • Review labeling., • Prepare, review and revise SOPs, • Personnel Training, • 10-15% travel timeYou must have, • B.S. in a science discipline, • Minimum of 10 years experience in the quality/compliance finished dosage form drug product area, • Good communication skills Disclaimer Natco Pharma USA is a proud Equal Employment Opportunity employer and encourages applicants from all walks of life. All employment decisions are based on business needs, job requirements and individual qualifications without regard to race, religion, creed, color, sex, pregnancy, childbirth or related medical conditions, national origin, age, ancestry, veteran status, liability for military service or military status, disability, mental illness, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), unemployment status (with respect to job advertisements), affectional or sexual orientation, gender identity or expression, marital, domestic partnership, or civil union status, lawful activity outside the workplace during non-work hours, such as the use of tobacco products, or any other characteristics protected by law. Come join our team!

Job Description Job Title: Microbiologist Job Description The Microbiologist will conduct routine microbiological testing and analysis for water, bulk pharmaceutical chemicals, and drug products. Responsibilities include collecting samples, preparing standards/controls, media, and sample solutions, and maintaining appropriate records. Responsibilities • Collect purified water samples from various USP Purified Water Loops used to manufacture or test drug products., • Perform microbiological testing on water, bulk pharmaceutical chemicals, drug products, and components, as well as finished products., • Conduct method suitability testing on finished products using traditional methods according to procedures, document results, and report appropriately., • Prepare media used in the microbiological testing of bulk pharmaceutical chemicals, drug products, and components., • Analyze and read microbiological test results while ensuring proper data integrity and adherence to GLP/GMP principles., • Perform growth promotion testing for purchased and prepared media., • Sample raw materials and/or finished products for microbial testing., • Prepare laboratory investigation reports, excursions, and/or non-conformance evaluations., • Collect environmental samples for microbiological analysis., • Conduct aseptic samplings for evaluation of compressed air and cleaning/sanitization processes., • Perform basic identification of microorganisms (Gram stain)., • Maintain the cleanliness and organization of the laboratory., • Prepare samples for shipment to an outside contract laboratory for microbiological testing., • Perform related support activities and duties as assigned., • Follow all Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements., • Perform laboratory tasks using general microbiological laboratory techniques and procedures., • Follow internal sampling methods and quality control systems., • Perform general mathematics (addition/subtraction/multiplication/division, dilutions, proportions, percentages)., • Proficiency in microbiological testing, aseptic techniques, and gram staining., • Bachelor’s degree in Biology, Microbiology, or a related science field from an accredited college or university., • 6 months to 1 year of related laboratory work experience in a regulated environment., • Ability to multi-task and manage time effectively., • Strong communication and customer service skills. 5% Target Bonus annually Medical, Dental, Vision, 401k match, etc. Workplace Type This is a fully onsite position in Orangeburg,NY. Application Deadline This position is anticipated to close on Apr 10, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Job DescriptionNovellis Health is seeking a skilled and compassionate Mammography Technologist to perform high-quality mammographic imaging for screening and diagnostic purposes. The ideal candidate will have a strong technical background, attention to detail, and a patient-focused approach to care. Key Responsibilities • Perform mammographic imaging procedures in accordance with physician orders and regulatory standards., • Position patients safely and effectively to ensure comfort and optimal image quality., • Operate and maintain mammography equipment, ensuring proper function and cleanliness., • Review and verify patient information, imaging protocols, and exam requisitions., • Collaborate with radiologists and medical staff to support accurate image interpretation and reporting., • Maintain required documentation, quality assurance records, and compliance with FDA and MQSA regulations., • Educate and reassure patients throughout the imaging process, addressing questions and concerns with professionalism., • Monitor inventory of imaging supplies and assist with ordering as needed.Qualifications, • ARRT certification in Radiography (R) and Mammography (M) required., • Valid New York State Radiologic Technologist license required., • Minimum 1 year of mammography experience preferred; new graduates with strong clinical training will be considered., • Knowledge of MQSA, ACR guidelines, and radiation safety standards., • Excellent communication skills and ability to work collaboratively in a small team environment., • Strong patient care orientation and attention to detail.

Job Description Location: This role is onsite at CPMI in Miami, FL If you are not local to Miami, let's discuss how to get you there! This is a newly created role at an amazing, top clinical research site located in Miami, FL About Company: Who is ERG? ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. About the Role: We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs. Core duties include staff management, protocol review, quality assurance, and overall study supervision. Responsibilities: • Lead and mentor the clinical operations team to promote a collaborative and efficient environment., • Ensure protocol compliance and maintain high-quality standards across studies., • Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies., • Oversee human resources functions, including staff evaluations, recruitment, and training., • Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies., • Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators., • Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation., • Conduct study closeout procedures., • Perform additional duties as needed to adapt to the evolving needs of CPMI., • Bachelor's degree in a scientific or healthcare-related field, • 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role., • Strong understanding of FDA, ICH, and GCP regulations and guidelines, • Strong communication, organizational, and leadership skills., • Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software., • In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out, • Phase I or early phase experience Our comprehensive benefits package includes: • Health insurance, • Dental & Vision Insurance, • Matching 401k Retirement Plan, • Paid Time Off (PTO)

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

Job DescriptionThis is a temporary 6-month contracted W2 position. The pay range for this position is $70-$85/hr (depending on prior experience) Job Functions: • Applies expertise as an emerging authority in the mechanical engineering discipline., • Conceives and develops solutions to difficult analytical and pneumatic/mechanical/electrical design problems., • Participates in establishing system or component design objectives and writes portions of complex specifications and engineering reports., • Reviews and helps to develop product specifications, • Conducts conceptual design studies using MCAD and other applicable design tools. Collaborates with other engineering functions, • Develops prototype hardware using internal manufacturing resources and outside vendors, • Tests product to verify that designs meet specification requirements such as environmental, regulatory and safety requirements, • Generates documentation supporting the design, • Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software., • Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable., • Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable., • Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data., • Experience with electronic document control systems in medical device and/or medical equipment design and development., • Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis., • Ability to create and meet scheduled timelines (manage and coordinate tasks as required)., • Ability to work in a team environment., • Strong communication skills., • Familiarity with dimensioning and tolerance, thermal and structural analysis, and vibration testing/analysis, • Intermediate knowledge of FDA, IEC and UL standards relating to medical electronic equipment, • Strong technical and analytical ability, verbal and written communication skills, ingenuity and creativity, interpersonal and project management skills, • Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM’s and oscilloscopes, • BSME or MSME and a minimum of 10 years of related experience in design/product development of electro pneumatic assemblies including technical supervision of sub-projects, • Formal training in basic and advanced topics in Solid Works is strongly preferred, • Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat, • Advanced proficiency with SolidWorks, MCAD/CAE software and database management software preferred, • Advanced proficiency with Microsoft Visio and Microsoft Project preferred Important Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to . Powered by JazzHR QpHnpP1sVI

Job Description Scope: The Chief Scientific Officer (“CSO”) provides critical scientific direction for IDX, with leading edge research and development programs that enable delivery of novel and competitive molecular cancer diagnostic products/services to the marketplace. The CSO ensures the highest levels of quality, with strict adherence to best research practices and regulatory requirements. S/he works closely with other members of the IDX Team and our strategic partners in addition to leading interdisciplinary teams. Essential Duties and Responsibilities: • Provide critical scientific direction, • Establish IDX's scientific vision and lead all aspects of the company's scientific strategy and product development, • Provide visible leadership for the company within relevant science and technology communities, • Serve as IDX’s chief scientific expert, keeping the Team apprised of scientific developments that can influence our mission - internally and externally., • Identify, evaluate and develop strategic collaborations with industry (especially pharma), academia, and government institutions to leverage the Company’s R&D efforts, • Protect and oversee development of intellectual property, • Direct Internal Research & Development, • Develop research agenda and product pipelines for Company based upon market need, • Lead and direct interdisciplinary teams - internal and external - to resolve complex scientific problems on time and within budget, • Ensure rigorous and successful validation of clinical trials for all new assays, products and related services, • Ensure all regulatory approvals and accreditations including compliance with GLPs, GMPs and FDA, if required, • Develop abstracts, papers and presentations for “A” level peer review in support of the company’s R&D and clinical activities, • Develop, implement and meet IDX R&D budget, as well as grant milestones and budget requirements, • Represent Company and serve as Expert Voice at Conferences and Scientific Meetings, as well as, with Customer Audiences, • Serve as chief technical spokesperson in all forms of communication: e.g., conference calls, written communication, emails, • Strong leadership and administrative skills for managing interdisciplinary teams to deliver projects on time and within budget, • Excellent writing skills, • Ability to engage the scientific community, government agencies, and other stakeholders relative to IDX's science program, • Successful delivery of technical presentations at seminars, conferences and meetings, • Demonstrated success in grant writing, • Demonstrated principal leadership in innovative strategic alliances, • Nationally recognized scientific leader and credible expert in field of molecular genetics with publications in major peer-reviewed journals and presentations at major conferences, • MD, PhD or MD/PhD with strong emphasis in molecular biology, pathology and/or oncology, • 7+ years in a senior leadership role including prior CSO or Head of R&D with experience in commercial laboratory environment, • Experience in running large clinical trials and/or FDA regulated environment New York State Certificate of Qualification Medical License (MD candidates) Supervisory Responsibilities: Works closely with CMO and Clinical Laboratory Director Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations can be made to enable individuals with disabilities to perform the essential functions. Work may require sitting for long periods of time; also stooping, bending and stretching for files and supplies. Work may require using stairs to access other departments when necessary. Occasionally lifting files or paper weighing up to 30 pounds. Requires manual dexterity sufficient to operate a keyboard, operate a calculator, telephone, copier and other such office equipment. It is necessary to view and type on computer screens for prolonged periods of time. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing essential functions of this job. Reasonable accommodations can be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office environment.

Job Description HIGH-LEVEL OVERVIEW The Import Account Manager oversees the import entry process for clients in the food and wine business ensuring timely and compliant entries with U.S. Customs and other government agencies rules and regulations. This is a hybrid/remote position based near Hazlet, NJ. EXPECTATIONS • Prepare and file ISF and Customs entries, monitoring status and coordinating deliveries, • Ensure compliance with CBP regulations and all applicable PGAs (FDA, USDA, EPA, etc.), • Manage customer SOPs and invoice process to maintain strong customer relations, • Liaise with U.S. Customs and other government agencies as needed, • Manage entry audits and post-entry processes, • Act as the main point of contact for clients regarding complex entry issues, • License Customs Broker or Certified Customs Specialist preferred, • 3+ years of experience in customs brokerage and import/export operations, • In depth knowledge of import regulations; HTS, GRIs, COO, Valuation, FTA, AD/CVD, etc., • Experience with PGAs: primarily FDA and USDA, • Strong attention to detail, organization, and customer service skills, • Ability to work independently and collaborate with a team, • Experience with ACE and Descartes IES or similar import software, • Proficient in MS Office, Word, Outlook, Excel and TEAMS

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the product and process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description Role Summary You will lead and manage biostatistical activities across a complex portfolio of gene therapy studies and other projects. You will collaborate with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans, and providing biostatistical input into clinical development plans, scientific publications and presentations, and regulatory filings. You will be responsible for the analysis of interim and final data sets and will oversee data and programming deliverables accountable by the CRO. A remote working model may be considered for exceptional candidates. Primary Responsibilities • Author statistical analysis plans in conjunction with the clinical team, • Responsible for biostatistical activities for a complex portfolio of clinical studies for gene therapy programs., • Where applicable, oversees and directs statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with own team, other Biostatistics team members, CROs, and cross-functional partners. Ensures appropriate statistical consultation on trial design and study endpoints and timely and well-executed authoring of statistical analysis plans., • Align the requirements for data reporting, tables, listings, and figures required for interim and final reports, including topline reports and final clinical study reports., • Where applicable, oversees, and contributes to completion of all technical and operational statistical activities for a portfolio of clinical trials. Directs internal and external teams in the definition, execution and completion of statistical activities for disease or therapeutic area products of considerable complexity., • Contribute to clinical study designs and clinical development planning for the portfolio., • Where applicable, advises or otherwise ensures timely and appropriate advice to internal and external partners on statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results., • Ensures timely and appropriate gathering, organization, and analysis of different data sources to enable delivery of the statistical analysis plan and clinical study endpoints for clinical studies., • Reviews and approves biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation., • Typically takes a lead in special projects that can benefit multiple biostatistics team members, such as new methodologies, processes, technology and other tools, and may also lead the development and / or implementation of SOPs and related documentation., • Provide statistical leadership in clinical study team setting., • May independently present at department, project team, or Sr. Management meetings., • Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and LEXEO’s SOPs. Required Skills and Qualifications, • PhD in biostatistics or related discipline with 8+ years (10+ years with MS) relevant experience in statistical analysis of biomedical data using SAS or equivalent software in the biopharma industry or a related environment, • Extensive biomedical statistical analysis experience and experience working with relevant software., • Experience developing software and other tools to support statistical analysis of biomedical or related data. Strong proficiencies in software and other tools used typically used by Biostatistics., • Demonstrated excellence in complex project management and effectively managing multiple projects and priorities., • Experience working with CROs for data and programming deliverables., • Experience leveraging AI and machine learning to enhance clinical trial design, analyses and decision-making is preferred., • Expert-level of knowledge of biostatistics, as evidenced by independence in assuming responsibilities for complex Phase 1-3 gene therapy projects., • Extensive knowledge of statistical designs, applicable to clinical trials in rare disease which allow for robust study results in smaller datasets., • Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes., • In-depth understanding of the cross-functional roles and responsibilities involved in drug development., • Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures., • Strong communication and organizational skills., • Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees., • Ability to handle multiple development programs simultaneously., • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills., • Excellent written and verbal communication skills demonstrated by ability to present clear instruction/direction., • Analytical and problem-solving capabilities., • Collaborative and collegial work style.

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSUMAMRYThe Packer is responsible for accuracy of bag weights, sealing and labeling of bags, coding of bags, checking to be sure the correct bags are being packed, and ensuring volume of output. They are also responsible for keeping the work area neat and clean. Packers may be assigned other duties as needed by the Manager/Supervisor.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Operate the pack line in an efficient manner to meet operating targets for efficiency, downtime, and minimal rework, • Repair pallets of finished product as they occur (broken bags, missing labels etc.), • Operate Forklift, • Pull pallets of flour from packing line and place them accurately in designated storage areas with proper scanning using Scanwork, • Operate tote packer; fill totes with farina, whole wheat, flour, etc., • Understand and use Scanworx inventory system in regards to warehouse packing supplies and finished product movements, • Understand policies and procedures set forth by BSM, USDA & other applicable food production entitiesQUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • Must have operational knowledge of packing equipment, including a Packer, Check-Weigher, Stacker/Bundler, Palletizer, and Stretch Hooder, • Must be capable of trouble-shooting common issues and communicating problems to maintenance/management, • Must be Forklift Certified, • Must be able to communicate in English, both verbal and written, • Must be able to perform basic math functions, with or without the aid of a calculator, • Must be capable of learning computer entry, • Must be an independent worker with self-initiative to carry out job functions, • Must be willing to rotate shifts and cover absences if requiredPHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • Must be able to work in an environment, which has extremes in temperature, • Must be able to climb ladders, • Must have physical dexterity to perform basic repair functions, • Must be able to stand for extended periods of time, • Must be able to bend, stoop, kneel, crouch, twist and crawl frequently, • Must be able to frequently lift and/or move 50 pound bags, • Vision requirements are close vision, distance vision, color vision and depth perceptionWORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly exposed to moving mechanical parts, and fumes or airborne particles. The employee is exposed to vibrations. The employee is occasionally exposed to high precarious places. The employee will be exposed to extremes in temperature, both hot and cold. The work environment is noisy, at times in excess of 100 decibels.FOOD SAFETY / SECURITY AND QUALITY REQUIREMENTSThe Company is committed to producing and delivering defect free products that are in compliance with all applicable legal and regulatory requirements and are of the highest levels of food safety, quality and productivity. To ensure this, all employees are required to be trained on and adhere to the FDA Current Good Manufacturing Policies as set forth by the Company as they pertain to personnel practices, equipment and facilities. It is also vital that all employees be aware of their work environment and prevent any accidental or intentional adulteration of the products produced at the facility.FULL-TIME/PART-TIME: Full timeSALARY: $25.49AVAILABILITY: Open AvailabilityPOSITION: Packing OperatorNUMBER OF OPENINGS: 2LOCATION” Strike Force Staffing- Clifton, NJ

Job DescriptionThis position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Schedules and monitors daily operation of department based on projected client demands., • Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices., • Approval of investigations and documentation of non-confirming events and OOS., • Recommends process improvements to achieve greater efficiency within the department and between sites., • Participates in department and cross functional meetings., • Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness., • Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Direct reports: QC Analysts (Approximately 8-10 reports), • Other duties as assigned.REQUIREMENTS, • BS degree in Science or relevant field;, • 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent., • Strong knowledge of FDA and EU regulatory standards. cGMP experience required., • Strong knowledge of analytical test methods and philosophies., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office and LIMS, • Competencies/Candidate Profile, • Acts decisively, • Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively., • Builds and maintains relationships, • Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders., • Communicates effectively, • Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback., • Fosters continuous improvement and innovation, • Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies., • Fosters integrity and honesty, • Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically., • Supervises and manages performance, • Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues., • Manages projects and functions, • Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication., • GxP/GDP TrainingWorking EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Must have the ability to work with specialized equipment.The employee must be able to comply with the company's personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification as well as annual re-qualification as a core competency requirement of their employment in this role. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Job Description: RBA is looking for a psychiatrist who will serve as a Principal Investigator to join their team on a PT basis, M-F. The PI ensures adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site. In executing these position responsibilities, the Investigator is guided by and promotes the adherence to FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies. The ideal candidate will be a Family Medicine or Internal Medicine Physician. Responsibilities: Employee Mentoring Responsibilities • Work with Site Director, Study Coordinator, and Recruitment Manager to develop effective programs for study enrollment., • Work with Site Director to ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines while performing study procedures on assigned studies., • Work with the Site Director to ensure the site has an adequate number of qualified staff, adequate facilities, and that the PI has adequate time to conduct the study., • Maintain a current, up to date curriculum vitae., • Maintain current licensure to practice., • Oversee all trial-related medical decisions or ensure that a qualified sub-investigator is available to do so., • Assess subject compliance with the test article and follow-up visits., • Assess subject's response to therapy., • Evaluate for adverse experiences per protocol guidelines., • Assist with rating scales., • Provide new information about the study or test article(s)., • Document deviations from the approved protocol., • Document and explain premature unblinding of the investigational product(s)., • Thoroughly familiar with the use of the investigational product(s)., • Education and experience, • M.D, D.O. required., • Requirements, • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner., • Knowledgeable in medical terminology to communicate with physician office and laboratory staff., • Skilled in working with potential sponsors to place research with the site., • Work effectively with a staff of clinical professionals and creates a productive, satisfying work environment., • Demonstrate the ability to initiate activity as required and making appropriate decisions within the constraints of study protocols and, regulatory requirements., • Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change., • Experienced negotiation skills, • Formal presentation skills, • Excellent persuasive/selling skills., • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines., • Excellent communication skills (interpersonal, written, verbal), • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

Job DescriptionSr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Hi, we're Nuts.com! Nuts.com is a self-funded, profitable, rapidly growing multi-channel DTC specialty food and wellness company with over 550 people on our team. We're changing the landscape of snacking on nuts, dried fruit, chocolate and more! We planted our roots in Newark, New Jersey during the Great Depression, selling premium nuts on Mulberry Street's open-air market. We've come quite a long way since then, taking our multi-generational family business online in 1999. Even after 96 years, we continue to pride ourselves in expertly sourcing the highest quality foods and treating our customers like family. What's our team like? We're driven, collaborative and entrepreneurial. Energy and passion power our business and we look for candidates who share in that excitement to help us continue to build something special. The role: The Quality Assurance Technician is responsible for the frontline monitoring of Food Safety and Quality policies, programs, and procedures. This role supports the facility in meeting quality assurance, food safety, and regulatory requirements by partnering with Operations to ensure the consistent production of wholesome, high-quality products. This position reports to the Quality Assurance Manager and serves as a key technical resource on the production floor, assisting in maintaining an "audit-ready" facility while ensuring constant compliance with SQF and FDA regulations. How you'll make an impact * Report and document any food safety or quality issues to the QA Manager and/or SQF Practitioner immediately. * Conduct pre-operational inspections and review checklists to release production areas for daily use. * Perform swabbing (ATP, allergen, biological, etc.), product sampling, and other quality testing. * Conduct daily audits on Good Manufacturing Practices (GMPs) to ensure compliance with 21 CFR 117 and Safe Quality Food (SQF) standards. * Inspect raw materials, work-in-progress (WIP), rework, and finished products; perform regular verifications including high-risk product checks and packaging audits. * Monitor the product hold-and-release process, providing documented reports and tracking data for non-conforming goods. * Assist in investigating deviations from procedures and customer complaints, and support root cause analysis to help prevent recurrence. * Support regular calibration and maintenance of essential facility equipment, such as scales and metal detectors. * Partner with the Sanitation team to verify effective cleaning and support operations staff with real-time food safety and product quality questions. * Actively support record-keeping programs (SafeFoods/EQMS/TraceGains) to ensure data integrity and accurate documentation. * Follow and enforce safety rules to prevent injuries; monitor the production floor for associate, visitor, and contractor GMP and Food Defense compliance. * Perform other tasks as assigned by FSQA management to support department and facility goals. What you'll bring: • Bilingual in English and Spanish is strongly preferred, • 2+ years of hands-on experience in a food manufacturing or packaging environment is desirable., • Ability to read, write, and speak English fluently to complete required safety documentation and reports., • Strong computer proficiency, including experience with Google Doc, Sheets, email, and Electronic Quality Management Systems (EQCMS)., • Ability to work comfortably with handheld devices, scanners, and computers for real-time data entry., • Ability to handle fast-paced situations and use good judgment to make quick, common-sense decisions about product safety., • Great organizational skills and a focus on getting details right every time., • Ability to work well with a team while being independent enough to speak up and enforce safety rules., • Ability to stand for long periods and work comfortably on a busy production floor. What we offer: • A high-growth and rewarding role in a foundationally strong and rapidly evolving business, • Hourly Pay Range: $19.00 - $20.50/hour based on experience, • Excellent benefits including a 401K Match, • Paid Maternity, Adoption and Paternity leave Nuts.com is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Facilitates information exchange, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by Allergan Aesthetics. Provide scientific expertise and serve as a point of contact for both external and internal leads in PRM. Gather and provide scientific insights to inform global strategic planning for PRM. Additional activities, special projects and assignments may be given, as required. As a result, the percentage of time spent across key duties and responsibilities will vary depending on project assignments and therapeutic area needs. Domestic and limited international travel will be required. External Relationships • Identify, establish, and maintain relationships with top tier thought leaders in the therapeutic area (TA) to establish a strong scientific presence in the clinical and academic communities. Ensure thought leader development and communication is optimized. Collaborate cross-functionally to establish scientific and clinical credibility with payers, managed market/market access and healthcare decision makers., • Provide meaningful and comprehensive external scientific communications both proactively and reactively, • Deliver assigned portfolio-related clinical presentations and participate in prioritized scientific meetings and congresses, • Execute Advisory Boards (face-to-face and virtual) based on scientific need and TA strategic plan, • Support global strategic plan country level scientific education needs including scientific exchange meetings, • Contribute to the review of research proposals and publications, • Contribute to the creation of materials and content used in scientific communications, • Scientific training of cross-functional hires as needed Strategic and Tactical Planning • The Senior Medical Science Liaison II serves as a scientific resource to support internal MSL and cross-functional scientific training, • Functions as a peer leader in exemplifying outstanding execution of the Senior Medical Science Liaison II role and acts as a key strategic field resource to internal Medical Affairs partners., • Contribute to the development and are directly responsible for the implementation of the TA Medical Affairs strategic and tactical plans:, • Deliver and communicate progress on project milestones, • Contribute to the planning and direct execution of broader functional activities that support the TA strategic plan, • Support assigned Core Teams within the TA as needed:, • Contribute to assigned sub-teams, • Represent TA on Clinical teamsQualifications, • PhD in an aligned field, or MD degree from an accredited US or foreign medical school with postgraduate medical training:, • MSL industry experience required, • Proven track record of success in medical affairs role Essential Skills and Abilities • Must have a working understanding of legal and regulatory guidelines (e.g., OPDP promotional regulations, Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws and other local applicable regulations), • Familiar with Medical Affairs principles, study design and scientific publications, • Proficient with electronic systems including Microsoft Office Suite, SharePoint, videoconferencing platforms, • Ability to prioritize and manage multiple projects, • Self-starter with ability to work independently with remote supervision, • Ability to work effectively in a team/matrix environment, • Ability to influence others without direct reporting relationships, • Ability to travel as required, • Demonstrated strengths in the following areas:, • Planning, organizational, project management and analytical skills, • Oral and written communication, • Time management, • Negotiation, • Conflict management and resolution, • Problem solving, • Attention to detail, • Interpersonal and networking skills, • Motivational skills, • Cross-cultural sensitivity, • Customer service orientation Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Description The Continuous Improvement Manager is responsible for leading, developing, and executing strategies to drive operational excellence across the medical device manufacturing organization. This role champions Lean, Six Sigma, and problem‑solving methodologies to improve product quality, reduce waste, enhance cost efficiency, and ensure regulatory compliance. The Continuous Improvement Manager partners closely with Manufacturing, Quality, Engineering, Supply Chain, and Regulatory Affairs to standardize processes and cultivate a culture of continuous improvement. Key Responsibilities Continuous Improvement Leadership • Develop and implement sitewide continuous improvement strategies aligned with business goals., • Facilitate Kaizen events, value stream mapping, root cause analysis (RCA), and other improvement workshops., • Mentor and train employees at all levels in CI tools, Lean thinking, and structured problem-solving., • Analyze production and quality performance to identify opportunities for efficiency, cost reduction, and throughput improvements., • Drive initiatives using DMAIC, PDCA, 5S, standard work, and other Lean/Six Sigma methodologies., • Ensure improvement projects support and strengthen compliance with FDA regulations (21 CFR Part 820), ISO 13485, and internal QMS requirements., • Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation., • Plan, execute, and sustain medium‑to‑large scale CI projects, ensuring milestones are met., • Develop business cases, project charters, and ROI analyses to justify improvement initiatives., • Promote a culture of operational excellence and accountability throughout the organization., • Create and maintain training materials, SOPs, and standardized processes., • Bachelor’s degree in Engineering, Manufacturing, Operations, or related field., • 5+ years of experience in continuous improvement, operational excellence, or process engineering within a regulated manufacturing environment (medical device preferred)., • Strong working knowledge of Lean, Six Sigma, and structured problem-solving tools., • Experience working within FDA-regulated or ISO 13485 environments., • Demonstrated success leading CI projects and cross-functional teams., • Excellent analytical, communication, facilitation, and change‑management skills., • Familiarity with statistical software (Minitab, JMP, etc.)., • Experience with automation, digital manufacturing tools, or Industry 4.0 technologies.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation, including prototype design and fabrication, and data generation through designed experiments. The Senior Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what’s necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities • Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use., • Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety., • Lead cross-functional teams to develop new products, address design issues, and maintain existing designs., • Apply strong problem-solving skills to find solutions to complex problems., • Work independently to plan and schedule own activities necessary to meet project timelines., • Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success., • Lead the creation of design history file documentation through the new product development process., • Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications., • Generate technical protocols/reports to support device safety and efficacy., • Invent/create concepts and designs and submit invention disclosures., • Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses., • Author protocols and reports including development studies and design verification/validation activities., • Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures., • Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data, • Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company., • Manage part-time staff as a research leader and mentor for ongoing research projects., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization., • Provide other project or product support as needed in order to support Cresilon’s business objective. Required Qualifications • BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline., • A minimum of 5+ years of product development experience is required., • A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred), • Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment., • Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans., • Experience leading complex product development initiatives from concept through product launch/release., • Good working knowledge of anatomy and surgical procedures is required., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies., • Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks, • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Requires strong leadership skills, excellent written and verbal communication and presentation skills., • Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007., • Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP), • Good understanding of statistical tools and validation/verification techniques., • Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required., • Legal authorization to work in the United States is required. Preferred Qualifications • An advanced degree (MS or Ph.D.) is strongly preferred., • Hands-on experience in product development with Class II and Class III medical devices., • Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs., • Experience with IDE and PMA submissions., • Six-Sigma green belt or black belt certification Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $100,000 - $160,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job DescriptionAs Senior Counsel, Advertising and Promotion, you'll be responsible for reviewing advertising, promotional, and other consumer-facing materials, ensuring they are compliant with FTC and FDA regulations and guidelines, and also manage a junior advertising and promotion attorney. You’ll partner closely with our Growth and Marketing teams to counsel on marketing content across the full spectrum of platforms, including websites, social media, podcasts, billboards, and TV. You have a strong knowledge of FDA and FTC advertising regulations and cases, and particularly with respect to prescription drugs and health products. You're smart, collaborative, and comfortable working in a dynamic environment while handling several projects at the same time. What You'll Do: • Serve as an internal subject matter expert on FTC and FDA advertising and promotion issues as they pertain to health products, and provide guidance to cross-functional teams to maintain compliance with FTC and FDA laws and regulations., • Sit on Ro’s collaborative medical-legal-marketing review process and review the creative assets for regulatory compliance. This content includes: Facebook and Google ads, website pages, national TV spots, podcast reads, billboards, contests and sweepstakes, and more., • Collaborate with cross-functional teams to support new strategic initiatives and advertising campaigns., • Stay abreast of changes in FDA and FTC regulations and industry trends in advertising, and monitor enforcement actions and relevant litigation., • Maintain company-wide guidelines and conduct trainings on advertising and promotion., • Provide guidance and oversight to an advertising and promotion attorney.What You'll Bring:, • Juris Doctor (JD) from an accredited law school., • Active member in good standing of a state bar association., • 5-8 years of experience practicing FDA and FTC law, and extensive expertise in the area of advertising and promotion of FDA-regulated products., • Exceptional analytical, research, and writing skills., • Strong communication and interpersonal skills, with the ability to build relationships across all levels of the organization., • Business-oriented mindset with the ability to translate legal advice into practical solutions., • Adaptable and able to thrive in a fast-paced, dynamic environment., • Self-starter with the ability to manage multiple projects simultaneously and meet deadlines., • Passion for the telehealth industry and a desire to make a meaningful impact.We've Got You Covered:, • Full medical, dental, and vision insurance + OneMedical membership, • Healthcare and Dependent Care FSA, • 401(k) with company match, • Flexible PTO, • Wellbeing + Learning & Growth reimbursements, • Paid parental leave + Fertility benefits, • Pet insurance, • Student loan refinancing, • Virtual resources for mindfulness, counseling, and fitnessWe welcome qualified candidates of all races, creeds, genders, and sexuality to apply. The target base salary for this position ranges from $215,500 - $264,000, in addition to a competitive equity and benefits package (as applicable). When determining compensation, we analyze and carefully consider several factors, including location, job-related knowledge, skills and experience. These considerations may cause your compensation to vary.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Senior Manager, Regulatory Affairs US Advertising and Promotion – Eye Care combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual shares knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies. Responsibilities: • Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner., • Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers. Summarizes findings, under supervision, in concise reports for distribution within AbbVie., • Oversees the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act., • Develops and guides implementation strategies for promotional activities, • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas, • Ensures departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports (where applicable). Manages direct reports (where applicable) and assists in the development, training and mentoring of staff members., • Effectively presents pertinent information to appropriate cross-functional groups, • Effectively delivers difficult messages to commercial organizations without damage to relationships, • Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) by fostering mutually beneficial interactions and exchange Qualifications • Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.), • Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.), • Experience working in a complex and matrix environment and exhibits strong negotiation skills, • Strong communication skills, both oral and written, • Experience in management capacity preferred, • Experience in US Regulatory Affairs Advertising and Promotion Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionSalary: $165,000-$185,000 Mamas Creations, Inc. (NASDAQ: MAMA) is a leading marketer and manufacturer of fresh deli prepared foods, found in over 8,500 grocery, mass, club and convenience stores nationally. The Companys broad product portfolio, born as MamaMancinis, from a rich history in Italian foods, now consists of a variety of high quality, fresh, clean and easy to prepare foods to address the needs of both our consumers and retailers. Our vision is to become a one-stop-shop deli solutions platform, leveraging vertical integration and a diverse family of brands to offer a wide array of prepared foods to meet the changing demands of the modern consumer. For more information, please visit . We have an excellent opportunity for a highly skilled and experienced leader to serve as the Senior Director, Plant Operations of our East Rutherford facility. You will be the senior site leader responsible for the overall performance, safety, Grandma Quality, controls, culture, and financial results of the manufacturing facility. This role serves as the plants general manager, accountable for translating enterprise strategy into consistent, disciplined execution with excellence at the site level. The Senior Director leads through people, systems, and standards, ensuring production, FSQA, maintenance, warehousing, and workforce leadership operate in alignment with Grandma Quality. This role balances results with responsibility, honoring Mamas heritage while building scalable, sustainable operations. Key Responsibilities • Own end-to-end plant performance, including safety, food safety, quality, service, cost, labor efficiency, and employee engagement., • Own overall plant efficiency and throughput performance, ensuring production capacity, labor models, and operating practices support enterprise targets., • Drive improvement in throughput, yield, and line performance by setting expectations, removing barriers, and holding leaders accountable for results., • Serve as the strategic leader for the site, translating enterprise priorities into clear site-level strategies, initiatives, and execution plans., • Partner with the Senior Manager, Production Operations to ensure production schedules and execution plans support optimal efficiency and service outcomes., • Own the plant operating budget, including labor, overtime, supplies, and controllable costs; ensure performance aligns with financial targets., • Balance cost discipline with Mamas commitment to Grandma Quality, safety, and employee well-being., • Use KPIs and financial data to evaluate performance, prioritize investments, and guide decision-making., • Partner with OpEx/CI to identify and sponsor continuous improvement initiatives that deliver measurable, sustainable gains in efficiency, throughput, and cost performance., • Ensure efficiency gains and cost improvements are sustainable and embedded into standard work and leadership routines., • Lead, coach, and hold accountable all direct reports, site functional leaders, and the downline., • Serve as the primary owner of plant culture, reinforcing values-based leadership, respectful supervision, and consistent accountability., • Ensure site execution aligns with enterprise standards of excellence and Grandma Quality while addressing location-specific risks and opportunities., • Partner with FSQA leadership to maintain strong food safety culture, regulatory compliance, and audit readiness., • Own site-level labor strategy, workforce planning, and performance management in partnership with People Operations., • Drive operational discipline through KPIs, operating practices, and structured problem-solving., • Partner with Reliability & Asset Management to support uptime, preventive maintenance execution, and capital improvements., • Support capital projects, expansions, and equipment installations at the site level., • Participate in operational diligence and integration activities related to acquisitions or expansions impacting the facility., • Serve as the primary escalation point for site risks, performance gaps, and employee relations matters., • Build strong cross-functional relationships that nurture trust, accountability, and pride in workmanship., • Collaborate closely with Senior Directors and plant leaders at other facilities to share best practices, standardize where appropriate, and drive enterprise-wide operational improvement., • Participate in cross-facility working groups, initiatives, and problem-solving efforts to strengthen consistency, performance, and scalability across the enterprise., • Champion collaboration between facilities while respecting site-specific strengths, constraints, and heritage., • Other related tasks, as necessary to drive results and support the business. Qualifications • Bachelors degree in Operations Management, Engineering, Business, or related field; or equivalent experience., • 15+ years of progressive leadership experience in manufacturing operations, preferably in food manufacturing or regulated environments., • 10+ years of experience leading multi-shift operations and managing leaders (managers/supervisors)., • Demonstrated experience owning site KPIs, budgets, labor planning, and operational performance improvement., • Expert usage of ERP systems. NetSuite preferred., • Strong working knowledge of food safety/regulatory environments (USDA/FDA), HACCP, GMPs, and audit readiness expectations., • Proven ability to lead through change while maintaining operational stability and culture., • Strong communication, planning, and cross-functional leadership skills., • Lean/Six Sigma knowledge/certification, preferred., • Bilingual (English/Spanish) highly preferred. Essential Physical Requirements • Ability to regularly walk, stand, and move throughout the manufacturing facility., • Ability to navigate stairs, catwalks, and uneven surfaces safely., • Ability to visually and audibly observe operations and employee practices., • Ability to wear required PPE (hair/beard nets, safety shoes, gloves, safety glasses, hearing protection)., • Ability to work in varying environmental conditions (heat, cold, noise, humidity)., • Ability to sit for extended periods while performing administrative work., • Ability to travel locally as required., • Ability to communicate clearly and effectively. We offer a comprehensive compensation package that includes a base salary (to $185k,) plus bonus eligibility, paid time off, holiday pay, medical, dental, vision, and life insurances, FSA, EAP, and 401(k.)