Amneal Pharmaceuticals jobs - 768 jobs

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.

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR‑T cell therapies have changed the paradigm, but we're not finished yet. Join Kite and help shape where our business and medical science goes next. You'll play a key role in the development of new cancer therapies and in creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Job Description We are seeking a highly motivated individual to join us as the Associate Director of Marketing focused on the LBCL indication. The Associate Director will play an important role in developing HCP promotion, cultivating an integrated LBCL strategy, and implementing a cross‑functional tactical plan to support and grow Yescarta's LBCL indication. This person will report to the head of LBCL within Kite's US Commercial Department. Key Responsibilities of the Associate Director of Marketing - Yescarta include: Develop and optimize brand strategies and marketing tactics using market research and analytics, ensuring accurate փmeasurement of promotional tactics. Oversee the development and execution of annual brand plans, including long‑term strategic imperatives and short‑term tactical priorities. Champion cross‑functional alignment and ensure seamless execution across key stakeholders. Develop and deliver differentiated brand and marketing concepts and materials, aligning with the brand's purpose, target customer needs, and industry trends. Collaborate with the Promotional Review Committee (PRC) to create compliant and effective promotional tactics and ensure their effective implementation. Formulate, develop, and implement strategic plans while escalating market challenges and barriers to leadership, proposing appropriate solutions. Exhibit a “roll up your sleeves” attitude, demonstrating the ability to follow through on projects within tight timelines. Adapt and thrive in an ambiguous, transformational environment. Demonstrate leadership excellence in project management, effectively managing multiple projects and priorities, including agency collaboration and budget management. Travel domestically up to 50%. Basic Qualifications Advanced degree (PharmD, PhD, or equivalent) with 5+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR Master's Degree知 2+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR Bachelor's degree with 10+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR Associate Degree and 12+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR High Schoolandaş Diploma/GED and 14+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing. Preferred Qualifications MBA or other advanced business degree. 8+ years of pharmaceutical or biotechnology experience. Experience in marketing research and / or pharmaceutical sales. Prior hematology / oncology or cell therapy experience, with in‑depth knowledge and experience in franchise‑specific market preferred. Ability to leverage data to conduct analyses and use complex analytical tools to drive decisions. Demonstrated excellence in project management and effectively managing multiple projects / priorities. Ability to successfully work with external agencies, including advertising, public relations and medical education vendors to develop programs and materials. Familiarity with marketing fundamentals, strategy, sales and commercial policies and practices. Compensation & Benefits The salary range for this position is: $177,905.00 心 $230,230.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligibleеспублик for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Equal Employment Opportunity Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual yenye orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the влияет-era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. Location & Remote Work Job Level: Associate Director Remote Type: Onsite Required Job Type: Full‑time Location: Santa Monica, CA #J-18808-Ljbffr

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 Medical Science Liaison (MSL) for Amneal's Central Territory (CO, MO, KS, NE, UT, WY, ID, MT) is a field-based professional with scientific, clinical, and therapeutic area expertise. This role is responsible for providing medical and scientific support for Amneal's marketed products, new indications for current products, and compounds in development. The incumbent engages in scientific exchange with medical and scientific experts, including healthcare professionals and managed markets customers across the assigned states. This is a field-based role, located in the Central US area. Candidates can be living in any state within the territory listed as this is a remote/field-based position. Essential Functions: Develops peer-level relationships with medical and scientific experts, including healthcare professionals and managed markets customers. Delivers appropriate clinical and scientific information that clinically differentiates Amneal products; provides clinical support and delivers data presentations regionally and nationally. Provides actionable information that enhances the value and appropriate use of Amneal products to internal stakeholders. Responds to customer inquiries to ensure focused and balanced clinical and scientific information that supports the appropriate use of Amneal's products and services. Trains and mentors within therapeutic area, providing performance guidance and coaching. Additional Responsibilities: Adheres to internal standard processes and complies with regulatory and compliance requirements. Sustains expertise in disease state management, emerging therapies, and the competitive landscape. Demonstrates project leadership and management in and across field team and therapeutic area. Education: Advanced degree (PhD, PharmD, or MD) in the biological sciences is required; neuroscience preferred. Experience: A minimum of 5 years of industry experience or relevant postdoctoral or clinical experience in the biological sciences, pharmacology, or medicine is required. Neurology experience is preferred. Skills: Demonstrated expertise in discussing scientific content and context to multiple audiences. - Intermediate Excellent project management ability. - Intermediate Excellent oral and written communication and interpersonal skills. - Intermediate Strong leadership capabilities. - Intermediate Experience in pharmaceutical industry. - Intermediate Specialized Knowledge: Knowledgeable on using resources for accessing scientific and clinical information. Knowledgeable on using Microsoft Office Programs (Word, Excel, Outlook and PowerPoint) Location/Travel: Remote Work with Frequent Travel required 60-70% Field Work: Travel to meet HCPs, attend conferences, or support clinical sites. 20-30% Remote Work: Virtual meetings, data analysis, content review. The base salary for this position ranges from $160,000 to $180,000 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.

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: Marketing Job Sub Function: Advertising & Promotions Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: We are searching for the best talent for a Technical Documentation Specialist. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech This person will work closely with the IFU Operations team, Product Managers, and project originators across the enterprise to assist in global company growth by providing documentation that serves our customers and meets local, federal and international regulations and guidance. The Technical Documentation Specialist will prepare instructions for use manuals and other supporting documents that communicate complex and technical information to customers. This position has overall responsibility for producing and maintaining IFUs and ensuring the accuracy and visual quality of layouts, graphics, and copy. This position may also work with Regulatory, Advanced Clinical Training & Support, Product Management, Engineering, Quality, and other functions. Key components of the position include: Adheres to brand and style guides Creates new IFUs and updates existing IFUs based on drafts and redlines provided by project originators Creates new graphics as required and stores appropriately in Veeva Vault Creates translated sections of IFUs based on translated copy provided by certified translation vendor Checks quality of own work including copy editing for grammar, punctuation, consistency, clarity, and style as defined by the company guidelines, and incorporates feedback from proofreaders Receives task assignments in Roadmunk tool, dispositioning and updating status to ensure tracking is always up to date Stores and distributes design files and final documents in accordance with operational processes and procedures Prepares documents for printing, including reviewing proofs Drafts and communicates release notes as IFUs are produced or updated Exercises excellent service standards and maintains high customer satisfaction through resolving problems by explaining the best solution, expediting corrections or adjustments to provide resolution Develops knowledge of other roles and responsibilities on the team, and provides support and coverage for other team members as needed Participates in team and project meetings, and contributes to continuous improvement of processes, tools, and workflows as a member of a small but mission-critical team Qualifications: Associate's or Bachelor's degree in graphic design or a related discipline 1-3 years' experience with graphic design and technical document creation in a regulated product development environment Demonstrated strong project management skills and multi-tasking capabilities Strong attention to detail Ability to clearly communicate ideas and information (oral and written) and work collaboratively. Ability to adopt new tools and technologies Adobe InDesign experience required 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, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is 79,000 to 127,650. 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 (401k).This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year. 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. Holiday pay, including Floating Holidays - up to 13 days per calendar year. Work, Personal and Family Time - up to 40 hours per calendar year. For additional general information on Company benefits, please go to: - ********************************************* This job posting is anticipated to close on January 11, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Required Skills: Preferred Skills: Advertising, Analytical Reasoning, Brand Identity, Brand Positioning Strategy, Brand Recognition, Business Behavior, Communication, Content Marketing, Customer Intelligence, Data Analysis, Data Reporting, Design Mindset, Execution Focus, Financial Analysis, Integrated Media Planning, Leverages Information, Marketing Campaign Management, Organizing, Problem Solving, Researching, Sales Promotions

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.

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: R&D Operations Job Sub Function: Clinical/Medical Operations Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Sr. Field Clinical Engineer - Shockwave Medical to join our team. This role is fully remote with 80% travel. 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 *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Sr. Field Clinical Engineer is responsible for the development and execution of site-specific recruitment strategies that result in meeting enrollment targets for Shockwave Medical clinical trials. In addition, the Sr. Field Clinical Engineer will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL). The Sr. Field Clinical Engineer will play a critical role in clinical studies including device training, case support, and ensuring timely data collection for clinical programs. This work is accomplished with oversight, requires contact with internal stakeholders, frequent travel to clinical trial sites, works closely with physician advisors, and is critical to business success. Essential Job Functions * Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. * Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms. * Provide clinical and technical support for key study investigators and clinical leaders at assigned sites. * Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues. * Administrative activities including training to procedures at site level. * Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals. * Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools. * Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked. * Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals. * Partner with assigned physician advisors to create and deliver recruitment strategies. * Partner with vendors that support recruitment activities. * Other duties as assigned. Requirements * Bachelor's Degree in a scientific field of study or equivalent work experience. * Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional Cardiology or surgical procedures in a cardiovascular Lab. * Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials. * Thorough knowledge of Good Clinical Practice (GCP) is required. * Ability to attain and maintain hospital credentials. * Ability to work in a fast-paced environment while managing multiple priorities. * Operate as a team and/or independently while demonstrating flexibility to changing requirements. * Experience with electronic data capture (EDC) systems. * Must have excellent verbal and written communication skills. * High attention to detail and accuracy. * Able to manage multiple project teams with guidance * Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.) * Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America. * May be required to lift up to 25 pounds. 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, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Business Behavior, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Coaching, Communication, Ethical and Participant Safety Considerations, Innovation, Laboratory Operations, Office Administration, Preclinical Research, Problem Solving, Project Management, Project Schedule, Research and Development, Study Management The anticipated base pay range for this position is : $106,000.00 - $170,200.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). For additional general information on Company benefits, please go to: - ********************************************* This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year

Career CategorySafetyJob DescriptionJoin 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. Global Safety Medical Director - Hematology/Oncology What you will do Let's do this. Let's change the world. In this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The GSO is accountable for the overall safety profile and all product-related decisions and results for assigned products supporting Hematology-Oncology portfolio. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed. Validate safety signals and lead safety signal assessments Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.) Prepare/review core and regional risk management plans including additional risk minimization measures Prepare/review safety sections of periodic aggregate reports Provide safety input to protocols, statistical analysis plans, and clinical study reports Prepare/review safety sections of new drug applications and other regulatory filings Serve as safety expert on Evidence Generation Team for assigned products Inspection Readiness What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: MD or DO degree from an accredited medical school AND Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred Qualifications: Product safety in the bio/pharmaceutical industry or regulatory agency Previous management and/or mentoring experience Experience in the study/research and/or treatment of Oncology disease states What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include: A 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 Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. 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. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. 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 243,245.00 USD - 319,267.00 USD

Career CategoryCollege JobJob DescriptionJoin 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. Undergrad Intern - Inclusive Global Health and Impact (Summer 2026) What You Will Do Let's do this. Let's change the world. This internship will be approximately 12 weeks and includes both project-based and experiential learning. The intern will be an integral member of the Amgen Inclusive Global Health and Impact (IGHI) Team, which is dedicated to embedding impact at every step of the value chain-from molecule to market-by uniting science, strategy, and multi-sector partnerships As a member of Amgen's IGHI Team, your work will be highly collaborative across multiple teams and levels within Amgen, including Representation in Clinical Research (RISE), Access to Health (ATH), and Health Impact. Additionally, you will have the chance to work cross-functionally with Research & Development, Corporate Affairs, Government Affairs, Health Equity, Advocacy Relations, Diversity, Inclusion & Belonging, and others. You will be uniquely responsible for one or more key projects that will advance the IGHI mission, including the following: Developing a project charter to map out objectives and identify key stakeholders, timelines, and deliverables Leveraging your analytical, leadership, communication, and interpersonal skills to work in teams, identify problems, conduct research, develop recommendations through qualitative and quantitative analysis, and deliver final projects Presenting your deliverables/findings through various forums including an intern-wide poster session and a final readout to executive management You will also be engaged in learning activities, networking with colleagues across the company, and enjoying full access to Amgen's Employee Resource Groups What We Expect of You We are all different, yet we all use our unique contributions to serve patients. The collaborative individual we seek is hard-working with these qualifications: Basic Qualifications: Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria: 18 years or older Currently enrolled in a full-time Bachelor's Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent Completion of one year of study from an accredited college or university prior to the internship commencing Enrolled in a full-time Bachelor's degree program following the potential internship or co-op assignment with an accredited college or university Must not be employed at the time the internship starts Student must be located in the United States for the duration of the internship OR co-op Preferred Qualifications Pursuing a degree in Health Sciences, Psychology, Sociology, Communications, Business Administration, Public Health or a similar field Strong written and verbal communication skills Strong interest in public health, community health, social sciences, health equity, health policy, health communications, DEI (diversity, equity and inclusion), and/or other related fields Strong organization and time management skills What You Can Expect of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The base pay range for this opportunity in the U.S. is $24.70 - $28.30 per hour. Build a network of colleagues that will endure and grow throughout your time with us and beyond. Bring your authentic self to the table and become the professional you're inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities. Participate in executive and social networking events, as well as community volunteer projects. Apply now and make a lasting impact with the Amgen team. careers.amgen.com Please search for Keyword R-231691 In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. 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. Sponsorship Candidates must be authorized to work in the U.S. for the duration of this program. Sponsorship for future FTE roles is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. 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 -

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.

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.

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. *********************************************

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 CategoryInformation SystemsJob Description 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. Principal IS Business Analyst - Clinical Study Design and Analysis What you will do Let's do this. Let's change the world. Amgen is seeking a Principal IS Business Analyst to join the Clinical Study Design and Analysis (CSDA) product team. You will be responsible for "Run" and "Build" project portfolio execution, collaborate with business partners and other IS service leads to deliver IS capability and roadmap in support of business strategy and goals. The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Collaborates with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals. Captures the voice of the customer to define business processes and product needs. Works with Product Managers and customers to define scope and value for new developments. Collaborates with Engineering and Product Management to prioritize release scopes and refine the product backlog. Ensures non-functional requirements are included and prioritized in the product and release backlogs. Facilitates the breakdown of epics into features and sprint-sized user stories and participates in backlog reviews with the development team. Clearly expresses features in user stories and requirements so all team members and stakeholders understand how they fit into the product backlog. Translates complex business and technological needs into clear, actionable requirements for development teams. Ensures acceptance criteria and definition of done are well-defined. Works closely with UX to align technical requirements, scenarios, and business process maps with user experience designs. Stays focused on software development to ensure it meets requirements, providing proactive feedback to stakeholders. Develops and executes effective product demonstrations for internal and external stakeholders. Maintains accurate documentation of configurations, processes, and changes. Serves as a liaison between global DTI functional areas and global development scientists, prioritizing their needs and expectations. Manages a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree and 2 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Master's degree and 4 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor's degree and 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Associate's degree and 10 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR High school diploma / GED and 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Preferred Qualifications: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery through technology. Experience with Agile software development methodologies (Scrum). Excellent communication skills and the ability to interface with senior leadership with confidence and clarity. Experience in writing requirements for the development of modern web applications. Experience in writing user requirements and acceptance criteria in Agile project management systems such as JIRA. Good-to-Have Skills: Demonstrated expertise in a clinical development domain and related technology needs. Experience in managing product features for PI planning and developing product roadmaps and user journeys. Familiarity with low-code and no-code test automation software. Technical thought leadership. Ability to communicate technical or complex subject matters in business terms. Experience with Jira Align. Knowledge of cloud platforms (AWS, Azure/Databricks, GCP) and enterprise infrastructure technologies. Experience with DevOps, continuous integration, and continuous delivery methodologies. Professional Certifications: SAFe for Teams certification (preferred). Soft Skills: Able to work under minimal supervision. Skilled in providing oversight and mentoring team members, with a demonstrated ability to delegate work effectively. Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include: A 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 Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. 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. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. 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 143,358.00 USD - 173,256.00 USD

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: R&D Product Development Job Sub Function: Industrial Design & Human Factors Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America Job Description: About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech The J&J MedTech Industrial Design, Human Factors, User Experience (IDHF/UX) organization is seeking a multi-faceted, exceptionally talented, user-centered Senior Human Factors Engineer who is passionate about improving the quality of people's lives through transformational user experiences. Our global design team leverages Human Centered Design (HCD) philosophies to advance care and meet the needs of the MedTech industry by placing users at the center of our design and usability process. We design solutions that span the full episode of care and balance the needs of various users (surgeons, hospital staff, patients and caregivers) through consistent, seamless, and optimized physical and digital experiences across our portfolio. The IDHF/UX team is comprised of Human Factors Engineers, Industrial Designers, UX/Interaction Designers, Information Designers and Design Strategists. Our team leads contextual research to discover unmet user needs, create usability specifications, requirements, and iteratively test with stakeholders through a robust usability engineering process. Job Summary and Responsibilities: * Our IDHF/UX team leads contextual research to discover unmet user needs, create usability specifications and requirements, and iteratively tests with stakeholders throughout a robust formative and summative usability process. * Leads or supports human factors efforts for programs from concept through post market release, supporting and influencing usability activities for product lines and programs with minimal oversight. * Support user research and insights discovery through design thinking, planning, coordination, observation, data collection, analysis, documentation and collaboration with cross-functional teammates throughout a robust usability engineering process. * The position will interact closely with multiple product development teams across multiple platforms to complete the necessary usability research and documentation and partnering with business leaders/stakeholders to ensure success. * Develop a good understanding of intended use environments through field visits at multiple locations, and gain insight into intended user types through direct interactions with users * Work on problems of diverse scope that impact broader program team and business and leads projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for evaluations. * Mentors' others on project deliverables and supervises/directs third party contractors/consultants; including reviews of deliverables to ensure accuracy. Qualifications Education: * BS/BA Degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, Anthropology, or equivalent; Post-Graduate Degrees (MS, PhD) are a plus and will be considered as part of the applicant's professional experience. Experience and Skills Required: * Minimum of 5 years' human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer interactions is required. * Experience in the planning and execution of all aspects of the HFE process including ethnographic research, formative and summative studies, documentation for design control and risk management, including moderating of studies is required. * Familiarity with FDA, ISO, AAMI, and other relevant usability regulations and standards. Preferred: * Strong knowledge of human factors principles; working knowledge of task and use-related risk analysis methods. * Knowledge of user interface and user experience principles for hardware and software, workload, human perception and cognition. * Basic knowledge of anthropometrics, biomechanics, and physiology. * Experience consolidating user feedback into concise, meaningful design insights and actionable recommendations. * Experience in ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries. * Experience performing root cause analysis for use-related problems. * Experience partnering with R&D, Marketing and Development teams to define and act as a guardian in upholding the best usability practices. * Medical Device product development or experience is a strong plus. * Clinical experience and/or professional experience/degrees in software development and/or GUI development is a strong plus. Other: * Must be able to commute into the Cincinnati, Ohio or Raritan, NJ office at least three days per week. * Ability to travel up to 20%, domestic and international is required. 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: The anticipated base pay range for this position is : Salary range $92,000 - $148,350 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

Career CategoryRegulatoryJob Description HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity Live What you will do Let's do this. Let's change the world. In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. To lead GRTs within Amgen's GRAAS organization To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product's Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions) Ensure consistency of evidence-based global product communication (eg, regulatory submission documents) Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood Lead GRTs and product teams in formal and informal communications with regulatory agencies Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy Represent Amgen Regulatory on external partnership teams at the product level Lead regulatory process improvements and initiatives Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 5 years of regulatory experience in biotech or science OR Master's degree and 8 years of regulatory experience in biotech or science OR Bachelor's degree and 10 years of regulatory experience in biotech or science Preferred Qualifications: Contemporary obesity experience desired Demonstrated ability to lead regulatory aspects of highly complex programs in late development Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application Ability to lead and build effective teams Strong communication skills - both oral and written Ability to understand and communicate scientific/clinical information Ability to anticipate and mitigate against future strategic issues and uncertainties Ability to resolve conflicts and develop a course of action Cultural awareness and sensitivity to achieve global results Planning and organizing abilities Able to prioritize and manage multiple activities Ability to make complex decisions and solve problems Ability to deal with ambiguity Organizational savvy Negotiation skills 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. 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 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. #Obesity . Salary Range 216,805.00 USD - 259,624.00 USD

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.

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. Education: Bachelors Degree (BA/BS) Chemistry or related science - Required Master Degree (MS/MA) Chemistry or related science - Preferred Experience: 3 years or more in pharmaceutical experience (with Bachelor's Degree) 1 year or more in pharmaceutical experience (with Master's Degree) Skills: Enthusiasm and dedication to learn and adopt new analytical techniques. - Intermediate Written and verbal communication and presentation skills. - Intermediate Ability to set priorities and to follow through on commitments utilizing organizational skills. - Intermediate Microsoft Office and ability to learn additional software/programs as needed. - Intermediate Meet deadlines under pressure. - Intermediate Able to work in a team environment. - Intermediate Creativity to solve technical and compliance problems. - Intermediate Specialized Knowledge: Broad knowledge of modern analytical equipment and techniques. Extensive experience in cGMP laboratory testing. Hands-on experience with HPLC, GC, TLC, and MS. Methods development experience. Experience writing the standard operating procedures (SOPs) and test methods.