Amneal Pharmaceuticals jobs in Bridgewater, NJ - 384 jobs

The Senior Training Specialist plays a vital role in fostering a culture of learning and compliance at Amneal. This position ensures the accuracy and security of training records while driving the development of effective training programs that empower employees and contractors to succeed. Working closely with cross-functional teams, the Senior Training Specialist helps translate regulatory requirements into practical, engaging learning experiences. Beyond maintaining curricula and supporting audits, this role is about inspiring confidence, building knowledge, and strengthening quality standards across the organization. As a key contributor to Amneal's mission, the Senior Training Specialist not only supports compliance but also champions professional growth, making training a meaningful part of every employee's journey. Essential Functions: Evaluate change controls, CAPAs, and investigations to identify training needs. Develop training plans for new or revised SOPs; ensure SOPs are effective only after required training. Prepare, issue, and monitor training materials and curricula; maintain supplies and equipment. Deliver cGMP training (New Hire, Annual, classroom, and online) using Global Quality-approved materials. Collaborate with functional heads and cross-functional teams to update and maintain curricula. Create training modules using GMP guidance and deliver as required. Support the Quality Unit with training metrics, including preparation for Quality Review Board (QRB). Serve as key auditee during internal, customer, and regulatory inspections; provide requested documentation. Oversee SETE training staff for data entry and audit support. Coordinate with IT on LMS implementation, data migration, and management. Act as process owner for Amneal's learning management system (LMS) and support Amneal University program. Additional Responsibilities: Follows all organizational systems, programs, training, policies, and procedures as required and complies with relevant legal mandates. Seeks guidance as necessary. Actively supports and participates in the safety program, both for self-protection and the protection of other employees, by reading and abiding by all requirements in the Injury and Illness Prevention Program (I2P2). Carries out all responsibilities in an honest, ethical, and professional manner. Handles various other duties as delegated by direct supervisor/management. Education: Bachelors Degree (BA/BS) - Required Experience: 3 years or more in experience in GxP training, Quality Assurance, or related pharmaceutical/biotech roles Skills: Advanced proficiency in Microsoft Office Suite. Office 365 experience preferred. - Proficient Knowledge of compliance and audit requirements. - Proficient Ability to conduct research and apply relevant information to training programs that support organizational effectiveness. - Proficient Must be able to work in a fast-paced environment and thrive with ambiguity. - Proficient Ability to meet tight deadlines and effectively prioritize and juggle multiple concurrent projects - Proficient Must have a strong work ethic and a positive attitude. - Proficient Excellent communication skills, both verbal and written. - Proficient Results-driven achiever with exemplary planning and organizational skills, along with a high attention to detail. - Proficient Strong assessment, analytical, critical thinking, and problem-solving skills. - Proficient Innovative problem-solver who can generate workable solutions and address needs. - Proficient Specialized Knowledge: Comprehensive knowledge of Microsoft Office programs Experience with an e-Learning computer program a plus The base salary for this position ranges from $100,000 to $115,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

This role will be responsible for maintaining cleanliness and sanitation in our pharmaceutical manufacturing and office facilities. The Janitor will be responsible for ensuring a sterile environment in compliance with industry hygiene standards, including cleaning production areas, offices, restrooms, and common spaces. This role supports both the operational efficiency and safety of the facility, requiring adherence to strict protocols and the proper handling of cleaning chemicals and equipment. Essential Functions: Maintain the cleanliness and hygiene of the GMP facility in strict accordance with established Sanitation Standard Operating Procedures (SOPs). Collect and dispose of waste and recyclables from the facility in accordance with proper segregation and recycling procedures Clean floors, breakrooms, restrooms, and outer production areas using approved cleaning chemicals and equipment in a safe and compliant manner Maintain appropriate stock levels of paper products in lunchrooms and restrooms to ensure continuous availability and report any maintenance or safety issues to the Facilities Supervisor Additional Responsibilities: Assist with other areas of facility maintenance Assist with general upkeep of facility grounds and support special cleaning projects as assigned Education: High School or GED - Preferred Experience: 1 year or more in Warehouse and/or office janitorial experience Skills: Ability to read, write, and communicate in English at a level to facilitate the understanding terminology of the job - Beginner Ability to comprehend and follow written and verbal procedures or instructions, including SOPs and safety protocols - Beginner Have basic math skills - Beginner Strong attention to detail and a commitment to maintaining a clean and safe environment - Intermediate Physical ability to perform cleaning tasks, including lifting, bending, and standing for extended periods - Intermediate The hourly rate for this position ranges from $16.50-$20.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

We are seeking a Director / Lead External Manufacturing to lead operations for North America, to ensure reliable supply of commercial products and support new product launches. The position manages relationships with Contract Manufacturing Organizations (CMOs) and Contract Packaging Organizations (CPOs), driving operational excellence, compliance, and cost efficiency while collaborating with internal stakeholders across Quality, Supply Chain, Regulatory, Technical Services, and Commercial teams. Responsibilities: Supply Assurance & Operations * Coordinate with CMOs/CPOs to ensure on-time, in-full (OTIF) delivery of cGMP compliant, and quality reviewed and released FG and Bulk drug products to customers and markets * Determine supply priorities through interaction with the Global Supply chain and External Manufacturing (EM) team members on a regular basis and communication of these priorities and changes to the relevant CMO/CPO * Understand CMO's capacity constraints, bottlenecks, material shortages etc. in the short medium and long term, aid resolution of these constraints & escalate to the supply chain management as needed * Manage the commercial product lifecycle, including raw material changes, artwork updates, process revalidations, packaging changes, and shelf-life extensions * Prepare and provide accurate monthly forecasts, purchase orders, and stock-transfer orders to the CMO's manufacturing sites in-order to meet forecasted demand and target inventory/MOH levels * Lead/participate in cross-functional due diligence teams to assess new business opportunities and potential capabilities of a new CMO * Review, approve, and submit CMOs invoices for timely payments Alliance & Relationship Management * Build and sustain strong partnerships and business relationship through effective alliance management with supply chain counterparts * Negotiate and manage Master Supply/service agreements and ensure adherence to the terms and conditions of the contract agreement though collaborative partnerships. * Communicate any inventory risks to EM inventory control, SCM and finance teams in a timely manner, and develop plan for risk mitigation of anticipated backorders at relevant CMO Compliance & Documentation * Ensure all compliance-related documents, such as batch records, COC/COA, etc., for each order are accurate and available for Quality Assurance review and release * Arrange permits, state licenses, quality agreements, and service agreements to maintain GMP/GDP compliance * Review of CMO related change controls to understand the supply chain impact. Work closely with QA, regulatory, commercial and packaging teams to facilitate risk assessment & impact, along with approval process for the changes proposed/implemented at the CMO * Ensure the complete set of shipping documents is provided by the CMO/CPO including packing list, commercial/custom invoice, certificate of origin, BOL/AWB/HWB, EPICS file and all approved copies of COC's and COA's at the time of shipment Data & Systems * Facilitate set up and validate material and vendor master data in SAP and related systems * Support the entire order-to-commercial cycle with proactive issue resolution * Liaison and support DSCSA compliance and serialization requirements with CMO's Serialization team, collaborate with internal IT, and 3PL warehouse to ensure complete and timely implementation of GS1 EPCIS process to meet FDA requirements for new product launches and CMO's on-boarded Continuous Improvement * Lead cost optimization projects with partners to improve throughput and efficiency * Drive initiatives to mitigate supply chain risks and enhance operational resilience * Participate and drive Alternate Vendor Development (AVD) projects for evaluating and validating new API, excipients and RM vendors for dual-sourcing, cost savings and reliability optimization Qualifications Educational qualification: Postgraduate degree with specialization in Operations Management, Supply Chain Management or related field Minimum work experience: 10+ years of experience in cGMP pharmaceutical manufacturing or supply chain operations Skills & attributes: * Proven experience in contract manufacturing management in an international environment * Strong operational expertise in pharmaceutical supply chain and generics business model * Proficiency in SAP, MS Office, and MS Project * Demonstrated ability to work with urgency, meet timelines, and ensure compliance * Excellent leadership and relationship-building skills across multicultural, multilingual environments * Strategic thinking with strong execution capability * Negotiation and alliance management skills * Problem-solving and proactive risk mitigation * Ability to influence across functions and geographies Incumbent must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring visa transfer or sponsorship, now or in the future. Incumbent should be willing to work in person from our Princeton, NJ office Additional Information Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process. Our Work Culture Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. Equal Opportunity Employer An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. For more details, please visit our career website at ******************************** *

The Associate Sales Representative provides short-term territory coverage under the direction of a Region Business Manager. This role involves planning and executing sales activities, delivering presentations to healthcare professionals, and using approved marketing materials to drive product awareness and sales. The position requires frequent travel (80%+), including overnight stays, and candidates must live near a major airport. Responsibilities also include maintaining compliance with reporting and regulatory standards, participating in training, and supporting business planning efforts. Essential Functions: Under close supervision of the RBM, achieve all territory management, call activity goals and performance objectives for geographical assignment(s) including but not limited to call activity, sample and resource utilization, target reach and frequency, and sales performance. Under close supervision of the RBM, maintain proficient knowledge of promoted product disease states and indications. Deliver proficient sales presentations to a defined list of current and prospective customers with a frequency based on assigned call goals. Implement the Amneal selling model and process principles, including the DiSC personality profile when engaging with customers. Complete pre and post call analysis which positively impacts customer interactions. Regularly review and analyze all available sales data and utilize developmental budget funds Under close supervision of the RBM, adhere to all compliance policies and guidelines. Develop a daily call schedule to ensure efficient and comprehensive coverage of territory which may include a certain number of calls per day/week. Under close supervision of the RBM, complete administrative reports and meet related deadlines. Ensure proper safeguarding and care for company assets (laptop, iPad, fleet vehicle. etc.). Maintain the stated expectations of number of calls per day defined as face-to-face interactions, with healthcare providers focusing on top target customers. Enter calls immediately into Veeva System via iPad and check/respond to email daily. Education: Bachelors Degree (BA/BS) Business or a related field - Required Experience: 1+ year Sales Experience or experience in a Customer-Facing or Customer-Focused role Skills: Strong communication and presentation skills - Intermediate The base salary for this position ranges from $60,000 to $75,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

The Scientist-2 is a mid-level analytical scientist opportunity supporting the analytical development of pharmaceutical oral dosage form. The individual in this capacity performs analytical methods qualifications/validations, analyzes active pharmaceutical ingredients, excipients, and finished dosage forms using appropriate analytical methods and maintains/qualifies analytical equipment. Essential Functions: * Performs analysis and release of active pharmaceutical ingredients, excipients, in-process materials, and finished drug products to support the formulation development team, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs. * Develops and optimizes new and existing analytical methods for qualification and release testing of products. Develops stability indicating methods and performs methods validation. * Provides timely responses to all internal and external inquiries. * Ensures deadlines are met for product development schedules, and checks that technical and compliance requirements are met. * Evaluates, recommends, and implements new analytical technologies and instrumentation for testing. * Assists with training other members of the analytical development team. Additional Responsibilities: * Stays abreast of new developments in analytical technologies. Contributes to improvement in laboratory operations to increase efficiency and GMP compliance.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America Job Description: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are searching for the best talent for Data Integrity Specialist to be in Titusville, NJ or Raritan, NJ. The Data Integrity Specialist will provide technical expertise to ensure data is complete, consistent, accurate, trustworthy and reliable and these characteristics of the data are maintained throughout the data lifecycle. The Data Integrity Specialist will carry out duties in compliance with all local, state and federal regulations and guidelines (including FDA, EPA, DEA, OSHA, etc.) as well as all company and site policies and procedures. This role requires strong analytical and technical skills, with collaboration across departments and vendors to maintain high-quality data for reliable decision-making and regulatory compliance. The Data Integrity Specialist is responsible for designing, implementing and maintaining a data control strategy for the Stability Operations Laboratory (supporting Titusville and Raritan, NJ sites); act as the Subject Matter Expert on Data Integrity processes including Good Documentation Practices and drive compliance efforts; support the equipment lifecycle management team during instrument qualification activities by participating in process flow mapping and data integrity assessments for all instruments and equipment; and ensure laboratory data handling and storage adhere to relevant policies and regulations. The Data Integrity Specialist is accountable to manage and assure quality & compliance for lab equipment and instrumentation and ensure all regulatory commitments are met. They will act as a laboratory SME for data integrity issues that arise in the area of Equipment Lifecycle Management. This role supports the New Jersey Stability Laboratory locations, therefore routine travel between Titusville and Raritan sites is expected. Major Duties & Responsibilities General: * Maintain data integrity standards for all lab equipment and instrumentation * Support system upgrades, maintenance, and roll-outs of new systems, as needed * Ensure accuracy, completeness and cGMP compliance in laboratory documentation as it pertains to Data Integrity * Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations * Uphold our Credo values including creating a positive work environment * Train, develop, coach and mentor employees Data Integrity Support 80%: * Act as the Subject Matter Expert on Data Integrity including Good Documentation Practices, Good Manufacturing Practices and drive compliance efforts. * Act as site Data Integrity SME, ensuring ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Completeness, Consistency, Enduring, Availability/Traceability) across the data lifecycle. * Design, implement, and maintain a data control strategy for stability operations with responsibility for data classification, lineage, retention, archiving, and secure deletion per policy. * Lead data integrity risk assessments and influence cross-functional teams on Data Integrity improvements. * Maintenance and monitoring of Data Integrity at the Titusville and Raritan sites. * Enable and empower Critical Thinking & Risk Management at Titusville and Raritan sites to ensure active risk management, taking all aspects of patients' safety & product quality into account. * Work closely with management to propose/complete improvement activities. * Participate in the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols of lab instrumentation and data management applications as it relates to Data Integrity. * Contribute to Process Flow Mapping during instrument qualification and ensure documentation aligns with GAMP 5 and company policies. * Participate in efforts to improve and update computer system compliance including providing guidance on the deployment and management of laboratory data management computer systems * Ensure data management and storage adhere to relevant policies and regulations. Projects / Meetings 10%: * Represent the department in interdepartmental meetings in support of process improvement initiatives. * Assess talent by participating in panel interviews for QC job candidates * Provide input to / lead functional laboratory meetings * Interface with Global Quality Systems and IT, as needed * Provide input and take actions as a QC Technical representative at cross-functional meetings * Engage with Data Integrity Specialist, Global Equipment Lifecycle Management CoE and ELM peers at other sites to leverage practices across the J&J Innovative Medicine Laboratory network. * Support the development and execution of CREDO and Lean Lab action plans and initiatives Quality & Compliance 10% * Support internal audits and Health Authority inspections as a local SME * Ensure compliance to J&J Innovative Medicine Quality global and local procedures, regulatory/ Health Authority requirements, and industry standards * Complete and approve corrective and preventative actions (CAPA) as assigned * Maintain high level of familiarity with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and computer systems validation (e.g., GAMP 5, USP , 21 CFR Part 210/211 etc.). * Develop and review laboratory technologies procedures and verify their compliance with internal and external requirements Other Duties * Other duties as assigned by management Required Qualifications Required Minimum Education: University / Bachelor's Degree Minimum Required Years of Related Experience: 4-6 years Required Knowledge, Skills and Abilities: * Strong knowledge of data integrity principles (ALCOA+) * Ability to work with others in a team environment * Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems * Technical knowledge of computer system validation, instrument qualification (IQ/OQ/PQ), data management systems, Data lineage, Audit trails, and Regulatory documentation practices * Strong interpersonal and written/oral communication skills * Ability to quickly process complex information and often make critical decisions with limited information * Ability to manage multiple priorities daily while being flexible and responsive to frequently shifting priorities * Ability to independently manage a portfolio of ongoing projects * Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols * Proficiency with using Microsoft Office applications (Outlook, Excel, Word, Project and PowerPoint) Travel on the Job: Travel is expected to be split between Raritan and Titusville NJ sites. Percentage Traveled: up to 10% Type of Travel Required: Domestic (US) International Preferred Qualifications. Preferred Minimum Education: University / Bachelor's Degree Other: N/A Preferred Area of Study: Science, Engineering, IT or Related Preferred Related Industry Experience (if applicable): * Experience in a regulated environment with IT/data systems (LIMS/ELM/ELN/CDS) * Demonstrated ability to influence peers and drive change * Training in data integrity concepts, ALCOA+, and regulatory horizon scanning Preferred Knowledge, Skills and Abilities: * Creativity regarding basic problem solving and troubleshooting * The QC ELM Specialist shall have the capability to develop improvement ideas and independently implement associated solutions * Possesses the ability to positively influence peers, key stakeholders and management * Positive and optimistic with the ability to act as a pro-active change agent Key Working Relationships Internal * Frequent interaction with QC Analysts, peers in QC Lab Services, QC Supervisors and Managers and QC Stability Coordinators * Frequent interaction with Quality Assurance personnel * Frequent interaction with Global IT representatives, Maintenance and Facilities representatives, Environmental Health and Safety, and Global Quality Systems * Interaction with JSC Lab ELM COE members as needed External * Contractors supporting the NJ Stability Operations (Equipment contractors, analysts, etc.) * Interaction with regulatory agencies during inspections Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy The anticipated base pay range for this position is : $79,000.00 - $127,650.00 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: o Vacation - up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. *********************************************

Director, Business Development - Clinical Research Director, Clinical Business Development Full Time Remote-USA Based Reports to: Senior Vice President, Clinical Services Frontage Laboratories Inc. Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials. Frontage Clinical Services At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion. Responsibilities: Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization Ensure appropriate strategy/solution is proposed to clients Monitor actions and results against plans Lead client visits to the Frontage facilities Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities Monitor sponsor satisfaction by regular communication with the clients/sponsors Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (sales f orce) system Represent Frontage at trade shows and other meetings Education, Skills and Experience Required: BS degree or above, life science preferred. 3+ years' experience in a clinical operation role and /or 1+ years' experience selling early-stage clinical research services. Solid understanding of the principles of drug discovery and development. Knowledge and experience in DMPK & Safety Toxicology Knowledge and understanding of FDA, GCP, and ICH regulations and guidance Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel. Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities. Excellent oral and written communication skills. Ability to travel. Established industry client network is a plus. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Laboratory Technician Title: Laboratory Technician Reports to : Laboratory Manager Fulltime Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The laboratory technician performs a variety of laboratory procedures as required by the study protocol. Laboratory technicians are responsible for assisting the Laboratory Manager, Principal Investigator, Clinical Research Coordinators, and other medical professionals in the preparation and handling of specimens, analyzing results, and maintaining laboratory equipment. Laboratory Technicians ensure accuracy, quality control, and adherence to safety protocols, contributing directly to scientific research, development of new products, or medical diagnostics. Roles & Responsibilities: Performs routine laboratory procedures including specimen labeling, collection, processing, and shipping in accordance with established SOPs and/or study protocol under the supervision of the Laboratory Manager, Clinical Research Coordinator, Principal Investigator, and Sub-Investigators. Operate and maintain laboratory equipment such as centrifuges, pipettes, and refrigerators/freezers. Develop a strong working knowledge of the study protocols and flow chart of study procedures and implement study procedures in full compliance with protocol requirements. Maintain accurate and timely documentation in laboratory or study-specific documents, temperature logs, and shipping logs. Perform environmental monitoring and equipment temperature checks to ensure proper specimen storage conditions. Assist with inventory management, restocking supplies, and maintaining organized work areas. Ensure compliance with safety, quality, and regulatory standards (GCP and internal QA procedures). Support weekend and surge workload coverage as needed based on operational demands. Assist Laboratory Manager in any task as needed. Education, Experience & Skills Required: Associate or BS in biology, chemistry, or related area, or completion and certification of Lab Technician course from an accredited or allied health training school. 1 year of experience in clinical research laboratory or related medical field. Proficiency in laboratory techniques and laboratory equipment operation. Good communication skills. Excellent organization and planning skills. Salary and Benefits : Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job Description Medical Assistant/Phlebotomist Title: Medical Assistant/Phlebotomist Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Job Summary: Responsible for working under the guidance of the Principal Investigator and Sub-Investigators; Associate Director Clinical Operations; and Clinical Research Coordinators to perform study procedures required in clinical studies conducted on behalf of sponsors at the Frontage Clinical Services. Duties & Responsibilities: Perform study procedures (e.g., venipunctures, obtain and process biological specimen samples, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Principal Investigator and Sub-Investigators. Develop a high level of familiarity and knowledge of the study protocol and flow chart of study procedures. Develop a strategy for implementing study procedures in compliance with study protocols. Develops proficiency in the use of in-house eSource system (Clinspark). Assist Clinical Research Coordinators in any task as needed including, labeling, taping (e.g., sample collection and transfer tubes, safety labs, urine cups, etc.) and record and transcribing study data in the source documents. Maintains an up-to-date training record for SOP's and study conduct. Minimum Job Requirements & Qualifications: Educational/Training Requirement: Minimum High School Diploma or Equivalency Diploma (GED) Experience: 1 years' experience in a related medical position, certification as a medical assistant (CMA) preferred. Licenses/Certifications (if applicable): Certified Medical Assistant Certified Phlebotomist Knowledge, Skills, and Abilities (KSAs): Experience with EMR, MS Word, Excel, MS outlook. Work Environment: The position requires work in alternating shifts, e.g., mornings, afternoons, overnights, and weekends. Potential for exposure to radiation for radiolabel study. Salary and Benefits: Frontage Laboratories offers competitive compensation and benefits package. Salary: $20 - $24 per hour Benefits: 401k Employer Match Medical Insurance -High Deductible/HSA -Low PPO -High PPO Dental Insurance -Low PPO -High PPO Vision Insurance FSA (Medical, Dependent Care, and Commuter) Short Term Disability Long Term Disability Life Insurance Generous PTO Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Assist in performance of all Quality Assurance functions as outlined in the GLPs and PSL SOPs. Assist the Quality Assurance Director as needed during inspections by EPA, FDA or clients. Prepare records and assemble copies of documents requested by inspectors when advance notice is given and Sponsor and/or Laboratory Director approval is obtained. Conduct in-process study inspections and general facility inspections in the toxicology and chemistry laboratories as directed. Audit raw data and proofread report and tables against raw data for accuracy and for typing corrections. Audit final report to verify corrections. Amend and update Standard Operating Procedures as required using word processing system. File all QAU-related paperwork as directed. Select intervals for inspection for any regulatory test under the auditor's responsibility or as directed by QA Director, Laboratory Director, or President. Perform such inspections in accordance with the test schedule. When the time for conduct of intervals requiring inspection falls outside of normal working hours, this will be brought to the attention of the Study Director or QA Director in order that a suitable arrangement may be made. Ability to safely wear a respirator required. Other duties as assigned. Qualifications QA auditors will have experience in a laboratory regulated by FDA/EPA GLP standards. Experience in other quality standards such as cGMP or GCP will also be considered. Experience with acute toxicology, analytical chemistry, and/or general laboratory procedures is preferred. B.S. degree in biology, toxicology, animal science or related field and/or AALAS certification at the Technician level is also preferred. Experience in computer system validation and electronic data capture is desirable but is not required. The individual holding this position must be of the highest integrity and have a very strong sense of responsibility. Attention to detail is essential. He/she must be well organized, tactful, be able to work independently and maintain all records, documents, and schedules associated with quality assurance procedures and studies. Communication skills, especially written, are necessary. Proficiency with MSWord and Excel is required. He/she must have a current tetanus vaccination if required to access the vivarium. Additional Information Position is full-time, Monday-Friday 8am-5pm. Candidates within a commutable distance of South Brunswick, NJ are encouraged to apply. Compensation: $22.50-$25.50/hr Excellent full-time benefits including: Comprehensive medical coverage, dental, and vision options. Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

The Associate Process Engineer reports to the Technical Lead or head of Technical Services. Executes Process/Cleaning Validation/Study assignments as per directives. Creates protocols, data collection and analysis and prepare reports under supervision. Essential Functions: Prepare validation protocols & reports for manufacturing process and cleaning process qualification; data analysis and prepare reports; execute manufacturing process and cleaning process qualification/validation/study Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements Prepare and review manufacturing batch record and other engineering qualification documents as required Coordinate/oversee the development of new processes or troubleshoot existing ones Review Annual Product Review reports and plot trend analysis & APR reports Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) Assist in various audits Additional Responsibilities: Performs other functions as required or assigned. Complies with all company policies and standards. Initiation of Change Controls and Planned Deviations when required Reviews manufacturing/ Packaging batch records and Engineering qualification documents Performs other functions as required or assigned. Complies with all company policies and standards. Education: Bachelors Degree (BA/BS) Pharmaceutical/Chemical Engineering - Required Master Degree (MS/MA) Pharmaceutical/Chemical Engineering - Preferred Experience: 1 year or more in Pharmaceutical/Manufacturing Industry Skills: Excellent verbal and written communication skills. - Advanced Proficiency in MS Word/Excel/Powerpoint. - Advanced Multi-tasking. - Specialized Knowledge: Basic Analytical Knowledge desirable. 21 CFR, cGMP, basic manufacturing process knowledge. The salary for this position ranges from $65,000 to $80,000. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

The packaging mechanic will be responsible for the continuous functioning of various types of manufacturing packaging line systems and equipment within the Packaging and Manufacturing departments. The role will perform the setup of packaging equipment, routine maintenance, repair, minor electrical troubleshooting, and also partner with Engineering to install and commission new packaging lines. This role follows a 12-hour rotating schedule, working from 6:00 PM to 6:30 AM. Essential Functions: Troubleshoot and repair all packaging line systems and equipment including vertical form and fill bagging machines, rotary cartoners, weigh scales, tapers and conveyors. Partner with Engineering to install and commission new packaging lines systems. Perform system modifications of the existing lines as needed. Repair of packaging equipment. This includes root cause analysis problem identification, referencing technical documentation, assessment of material requirements, requisition placement, and actual repair. Responsible for the replacement of parts. Perform preventive maintenance to ensure all packaging equipment functions properly as well as follow and execute the preventative maintenance schedules. Provide accurate and timely documentation of work in the equipment logbooks, communications, and verbally to coworkers during shift hand offs Train team members on equipment issues to eliminate future occurrences. Education: High School or GED - Required Experience: 5 years Packaging equipment or related manufacturing equipment Skills: Solid understanding of cGMP practices and concepts, SOP, Lock Out Tag Out, and OSHA regulations required - Intermediate Ability to read, comprehend and follow SOPs written in English - Intermediate General mechanical and electrical troubleshooting skills necessary to diagnose, disassemble, repair and reassemble packaging equipment. - Intermediate Knowledge of packaging equipment set-up, adjustments, and packaging documentation is preferred. - Intermediate Must be able to wear personal protective equipment - Intermediate Maintain area orderly and clean during all operations within the facilities. - Advanced Flexible to work extended hours on weekends as required - Additional Requirements: Flexible to work extended hours when required. This position requires successful completion of an OSHA-compliant Respirator Fit Test. The hourly rate for this position ranges from $25.00-$35.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

A primary focus of this role is creating and modifying LIMS test plans to support QC activities while adhering to regulatory and data integrity guidelines. The LIMS Coordinator is responsible for tracking and managing laboratory inventories within the LIMS system and to perform and verify daily verification of laboratory data for accuracy and completeness, ensuring compliance with GxP standards before submission for review. Essential Functions: Register samples and input relevant test results, instrument data, and laboratory information into the LIMS system as per QC procedures. Manage laboratory inventories, ensuring timely replenishment and accurate record-keeping within the LIMS system as well as generate and run standard reports from the LIMS system for Laboratory Resource tracking. Perform and verify daily verification data for accuracy and completeness before submitting it for review. Create, troubleshoot and modify LIMS Test, worksheets, and test plans as needed to support QC activities. Train new peers in LIMS operations, including sample manager and resource modules. Assist QC personnel with sample registration and label generation using the LIMS software Additional Responsibilities: Performs other functions as required or assigned. Hands on to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests. Must understand and apply cGMP requirements applicable to quality control laboratory. Follow up on sample status and testing progress within the LIMS system. Participate in continuous improvement initiatives to optimize LIMS functionality and workflows. Education: Associate Degree - Required Bachelors Degree (BA/BS) Chemistry or related field - Preferred Experience: 1 year or more in Pharmaceutical/manutfacturing Skills: Proficient in laboratory informatics - Intermediate Strong understanding of regulatory compliance (FDA, GMP). - Intermediate Proficiency in inventory management systems and data analysis tools. - Intermediate Excellent organizational, communication, and problem-solving skills. - Intermediate The hourly rate for this position ranges from $22.00 to $26.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

Career CategoryCorporate ServicesJob Description Territory: New York City, Brooklyn, Manhattan Candidates can live anywhere within the territory. Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Patient Access Liaison - UPLIZNA IgG4-RD - Rare Disease Live What you will do Let's do this. Let's change the world. In this vital role you will provide logistical, non-medical educational assistance to patients and caregivers as well as office and site of care staff, including physicians, nurses, office managers and executives. Strong knowledge and demonstrated history of access and reimbursement for buy and bill/infused pharmaceutical products is required. The PAL works in highly visible, strong team environment to provide exceptional customer service on all levels. The PAL will work with the patient, the physician and the Site of Care to educate on next steps required to gain access to therapy. The PAL will also work to maintain relationships with patients and families, and by extension physicians and their staff and cross-functional partners to support ongoing compliance with therapy. The PAL will work with numerous internal teams, including Market Access, Medical Affairs, Advocacy, Marketing, and Site of Care to facilitate and improve patient access to insurance, medications, financial support, resources and more. Secure written or electronic patient HIPAA for patients in the assigned geography Develop relationships with patients and caregivers by engaging via phone, text, email, virtual or in person connections Assess individual needs of the patient and develop an appropriate education and resource plan of action, considering the patient's family and team of healthcare providers to empower the patient to become their own advocate Educate the patient on UPLIZNA coverage based on their benefits and the steps needed to gain prior authorization to ensure understanding of the process for medication access Provide information on co-pay assistance programs, national foundations, and free drug programs by sharing information to patients as appropriate and needed Provide proactive education to prescribers and sites of care upon patient enrollment on coverage for Horizon rare disease therapies, common prior authorization requirements, and coding and billings requirements Provide access and reimbursement education based on the enrolled patient's UPLIZNA benefits to physician offices and sites of care Educate the physician office and/or SOC on UPLIZNA coverage based on the patient's benefits and the steps needed to gain prior authorization to ensure understanding of the process for medication access Investigate access challenges pre and post-infusion to include support for denied claims and claim reviews Partner with Safety and PV and report AE's and product complaints through medical information. Work closely with the Horizon cross functional team including Case Managers, the Site of Care team, market access, matrix partners and external vendors Adhere to professional standards compliance guidance, policies and procedures, federal, state, and local requirements Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 2 years of patient services, and/or access and reimbursement, experience OR Master's degree and 4 years of patient services, and/or access and reimbursement, experience OR Bachelor's degree and 6 years of patient services, and/or access and reimbursement, experience Preferred Qualifications: Scientific background and ability to learn product and disease information. Nursing or other clinical background a plus Access and reimbursement for buy and bill products Orphan or Rare disease experience. Familiarity with HIPAA guidelines and FDA requirements. Familiarity with and Adherence to internal and OIG Compliance guidelines a must Ability to handle difficult patient cases and resolve hurdles. Ability to work in team environment and manage communication with case Liaisons and sales reps. Ability to respond immediately when necessary (within 24 hours) to prevent lapses in treatment. Strong analytical skills and ability to report on meaningful activity in the region. Proficient in Microsoft Office. Professional, proactive demeanor. Strong interpersonal skills and strategic mindset. Excellent written and verbal communication skills. Potential for up to 50% travel, including some overnight and weekend commitments. Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 178,336.00 USD - 201,298.00 USD

The QA Inspector monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. The QA Inspector must monitor and ensure all phases of drug manufacturing are in compliance with established specifications; receive, inspect, release and control of labels and outserts, to ensure quality compliance before, during and after each packaging run. Essential Functions: Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications. Maintaining detailed records of sampling, inspections and testing activities. Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA. Collection of packaged product samples for annual stability. Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures. Conduct in process testing per manufacturing and packaging batch record instructions. Prepare controlled / uncontrolled / packaged finished product samples for QC lab and QA retains, following detailed documentation procedures. Maintenance of standard weights required to perfomr daily verification of balances. Labeling component receipt, visual examination, counting, preliminary inspection and sampling. Preparation of labeling components/outserts inspection reports; quarantine and release labels and maintaining incoming components log and corresponding inventory cards. Issuance of labeling components/outserts according to packaging order and regular monitoring and auditing of label room. Fill out the QA final labeled product inspection report, final line clearance which includes labeling and packaging reconciliation paperwork. Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record Monitor facility and product environmental operating conditions Additional Responsibilities: Operate, maintain and calibrate Hardness tester, Friabilitor, Weight Variation system, weighing scales and balances, label counting machine, and Kirby Lester tablet counters according to established schedules and maintain detailed calibration records Collection of samples to reassay bulk finished product before expiration Work in a Contained Manufacturing area/facility following all precautions and procedures Visual inspection and preparation of report of all products for APR Other duties as assigned by management. Education: High School or GED - Required Experience: 1 year of Quality Assurance or related field Skills: High energy level and strong organizational skills. - Advanced A certain degree of creativity and latitude is required. - Intermediate Basic computer proficiency (Word and Excel ) - Intermediate Basic Math skills Excellent attention to details Process Improvement The hourly rate for this position ranges from $19.50-$23.50 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

The IT Contracts and Assets Lead serves as a critical resource in ensuring the effective and compliant management of IT procurement, vendor contracts, and IT asset oversight. This role collaborates with IT leaders, managers, Finance, and Procurement to align procurement and contracting activities with company policies, including Delegation of Authority (DOA) and procurement guidelines. The IT Contracts and Assets Lead will also ensure timely contract renewals, conduct thorough reviews of MSAs, SOWs, and related documentation to confirm clear objectives, deliverables, milestones, and resource requirements. Additionally, the position will play a proactive role in vendor negotiations to secure favorable terms and maintain a centralized repository for contracts, revisions, change orders, and associated Capital Authorization Requests (CARs).This role requires a blend of technical expertise, business acumen, and strong organizational and negotiation skills to deliver value to the organization and ensure compliance. Essential Functions: Procurement and Compliance Ensure all IT procurement aligns with corporate policies, including procurement and DOA guidelines. Monitor and enforce compliance across all vendor engagements, flagging risks or non-compliance for resolution. Act as the primary liaison between IT, Finance, and Procurement to streamline procurement processes. Contract Management Oversee all stages of vendor contract management, including reviews of Master Service Agreements (MSAs) and Statements of Work (SOWs), ensuring clarity in objectives, deliverables, payment milestones, and resource/staffing requirements. Support IT leaders in vendor negotiations, advocating for favorable terms that align with Amneal's strategic and operational goals. Ensure timely renewal of contracts, minimizing disruptions and risks associated with lapses. Proactively identify opportunities to consolidate or renegotiate contracts for cost savings and enhanced vendor relationships. Asset and Repository Management Maintain a centralized, well-organized repository for all IT contracts, revisions, change orders, and associated Cars. Track IT capital and operational expenditures related to procurement and vendor management. Develop and manage reporting tools to provide visibility into contract statuses, asset utilization, and compliance metrics. Collaboration and Stakeholder Engagement Partner with IT leaders and managers to understand business needs, translating them into actionable procurement and contract strategies. Act as a subject matter expert on procurement and contracting best practices for IT staff. Provide regular updates to the Global IT Operations Leader on procurement performance, compliance status, and vendor relationship effectiveness. Risk Management and Reporting Identify risks within contracts, including ambiguous terms, weak deliverables, or unfavorable conditions, and collaborate with stakeholders to resolve them. Regularly monitor and report on key performance metrics, including contract renewal timelines, compliance adherence, and vendor performance. Additional Responsibilities: Leadership and Autonomy: Operates independently with significant responsibility for contract oversight and procurement processes, ensuring alignment with broader organizational goals. Strategic Execution: Ability to prioritize and execute projects that drive cost savings, efficiency, and compliance. Problem Solving: Skilled at addressing complex issues in vendor contracts and procurement processes, ensuring timely resolution. Collaboration: Fosters strong working relationships across IT, Finance, Procurement, and external stakeholders to achieve shared goals. Education: Bachelors Degree (BA/BS) - Required Master Degree (MBA) - Preferred Experience: 5-7 years or more in 7 or more years of experience in IT procurement, contract management, or a similar role, preferably in a global organization. Demonstrated experience reviewing and negotiating vendor contracts, including MSAs, SOWs, and change orders. Hands-on experience managing procurement in compliance with DOA and corporate policies. Familiarity with capital authorization processes and tracking associated with IT projects. Prior experience in the pharmaceutical or biotechnology industry is a plus Skills: Contractual and Procurement Expertise: Strong understanding of procurement processes, legal language in contracts, and compliance requirements. - Advanced Negotiation Skills: Proven ability to negotiate favorable vendor terms, including cost reductions, performance guarantees, and flexible service terms. - Advanced Technical Aptitude: Familiarity with IT systems, software, and infrastructure as they relate to procurement and vendor contracts - Advanced Organizational Skills: Ability to manage multiple contracts, timelines, and stakeholders efficiently. - Advanced Communication and Collaboration: Excellent verbal and written communication skills, with a proven ability to work effectively with cross-functional teams and external vendors. - Advanced Analytical Thinking: Capable of analyzing vendor proposals and contracts for risks, inconsistencies, and opportunities for optimization. - Advanced Specialized Knowledge: Licenses: Certified Professional in Supply Management (CPSM)--Preferred Certified Technology Procurement Executive (CTPE)--Preferred The base salary for this position ranges from $130,000 to $145,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

The Senior Manager, IT Application Support will lead global support for Amneal Pharmaceuticals' enterprise and critical business applications, ensuring availability, performance, compliance, and user satisfaction across manufacturing, quality, R&D, supply chain, commercial, and corporate functions. This role manages a distributed team and strategic partners to deliver secure, compliant 24x6 support. The ideal candidate brings expertise in application operations, ITIL, vendor management, and regulated industry standards (FDA, SOX, GxP), with strong cross-functional collaboration skills. Essential Functions: Global Application Support Leadership * Lead Level 2 and 3 support teams across the US, India, and Ireland. * Ensure 24x7 coverage for critical applications with effective on-call and escalation protocols. * Oversee incident, problem, and change management in alignment with ITIL standards. Application Portfolio & Service Ownership * Maintain operational health, upgrades, patches, and performance of global applications, including: * ERP: JDE, SAP Business Objects * Quality: Caliber QMS, LIMS * Supply Chain: Coupa P2P, Manhattan WMS, Liaison EDI * Commercial: Veeva CRM, corporate and marketing websites Process Excellence & Continuous Improvement * Standardize support processes, runbooks, and documentation for global consistency. * Drive root cause analysis and implement preventive actions. * Promote automation, monitoring, and self-service to reduce manual effort and improve resolution speed. Stakeholder & Business Engagement * Act as the primary escalation point for application performance and support concerns. Additional Responsibilities: * Conduct regular service reviews with business units to assess satisfaction, gather feedback, and align on priorities. * Work closely with IT business partners to understand evolving needs and integrate them into support strategies. * Ensure application support activities comply with SOX, FDA, GxP, and ITGC requirements. * Maintain auditable change controls, incident records, and access management processes. * Support internal and external audits with timely and accurate evidence.

The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements. Essential Functions: Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor Performs re-qualification of equipment, facility and utilities as required under supervision Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution Draft Standard Operating Procedure(SOP) for new operational equipment Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service Works with equipment vendors to collect equipment manual and other required documents Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement. Additional Responsibilities: Assist with engineering projects and performs other duties as assigned. Education: Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required Experience: less than one year in 0-2 years of experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor degree. 1 year or more in Experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor degree. Skills: Proficient in MS Office. - Advanced Excellent technical writing skills. - Intermediate Excellent oral and written communication skills. - Intermediate Must be able for follow direction and execute assigned work independently, after initial training is completed. - Intermediate Ability to work both independently and in conjunction with a team - Advanced The base salary for this position ranges from $60,000 to $75,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

Clinical Research Nurse (per diem) Title: Clinical Research Nurse (per diem) Reports To: Executive Medical Director and Principal Investigator Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary: We are seeking a licensed and detail-oriented Clinical Research Nurse in support of clinical trials conducted at Frontage Clinical Services. in support of clinical trials conducted at Frontage Clinical Services. responsible for working under the guidance of the Investigators; Management, Study Coordinator and Supervisor, to perform study procedures required in clinical studies conducted on behalf of sponsors at the Frontage Clinical Services site in Secaucus. Responsibilities: Assist Clinical Study Coordinators in any task as needed. Administer Medications (including IV administration route) per doctor's and protocol instructions. Perform study procedures (e.g., venipunctures, obtain and process biological specimen samples, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Principal Investigator and Sub-Investigators, Director, Associate Director, and Clinical Research Coordinators. Record study data in the source documents. Evaluate and review study data to ensure accuracy and completeness. Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures. Develops a strategy for implementing study procedures in compliance with the study protocol. Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor. Responsible for maintaining emergency medication in the crash cart. Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator. Assists in the screening of research subjects to evaluate their eligibility for a clinical study. Creates and performs QC procedures. Assists in the reconciliation of IPs and maintaining accountability. Acts independently to determine methods and procedures on new assignments and may supervise the activities of other Clinical Services personnel (e.g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters.) Shows desire and initiative to increase knowledge and skills in clinical research. Education and Requirements Bachelors in Science in Nursing. Registered Nurse in the State of New Jersey Good communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, and Frontage Clinical Services and sponsor personnel. 1-3 years' experience in clinical research is desirable. Knowledge of FDA regulatory requirements is necessary, or mandatory on-job training will be required. Salary and Benefits: Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.