Impulse Dynamics jobs

Supplier Quality Engineer Marlton, NJ Hope is Here! Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company's Optimizer Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany. There are 64 million patients struggling with Heart Failure worldwide. When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope. The only options down the road are extremely invasive. CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. This is not a job, It is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy. The Supplier Quality Engineer is responsible for ensuring supplier compliance with purchasing controls, qualification standards, and continuous monitoring requirements. This role involves collaboration with internal teams and suppliers to uphold regulatory standards, drive quality improvements, and mitigate risks in the supply chain. In addition to compliance tasks, continuous improvement initiatives are a key focus, ensuring that processes evolve to enhance efficiency and effectiveness. How You'll Add Value * Purchasing Controls Compliance: Maintain and oversee purchasing controls compliance, ensuring proper documentation of supplier performance and continuous monitoring files. * Supplier Qualification & Monitoring: Lead supplier qualification initiatives, assess ongoing performance, and ensure adherence to regulatory and company standards. * Training & Education: Provide education and training to company personnel and suppliers on purchasing control applications to sustain long-term compliance. * Product Development Support: Collaborate with engineering teams to guide supplier selection and documentation of requirements for new materials and components. * Regulatory Alignment: Ensure selected suppliers meet regulatory requirements, possess recognized credentials, and demonstrate competency for intended purchasing needs. * Supplier Performance & Corrective Actions: Manage and analyze supplier corrective action reports, monitor performance trends, and provide insights for site-level management reviews. * Supplier Audits: Conduct remote and onsite supplier audits to verify compliance, identify risks, and drive continuous improvement. * Continuous Improvement Initiatives: Engage in continuous improvement activities within the function and areas of responsibility. Beyond compliance, focus on enhancing processes, identifying opportunities for efficiency, and driving meaningful improvements. * Pre-Market Activities Collaboration: Work closely with Product Development teams to support pre-market activities, ensuring supplier selection, qualification, and documentation align with regulatory and business requirements. What You're Bringing with You * Bachelor's degree in engineering, supply chain management, or a related field. Background in electronics/electrical engineering is preferred. * Experience in supplier quality management, auditing, and regulatory compliance. * Strong understanding of purchasing controls, supplier qualification processes, and corrective action management particularly with contract manufacturing. * Excellent communication, problem-solving, and analytical skills. * Ability to collaborate effectively with cross-functional teams and external suppliers. * ISO 13485 Certified Lead Auditor or CQA required Skills & Abilities * Excellent skills in written and verbal communication, and ability to interact with all levels of the * organization and suppliers * Superior organizational abilities and the ability to maintain deadlines. * Ability to take initiative * Ability to build team relationships and interface in a multi-disciplinary environment * Ability to translate technical requirements and specifications to external suppliers * Working knowledge of software programs; Microsoft Word, PowerPoint, Excel, Project * Position requires some travel, international and domestic (Up to 50%) Our Commitment to You Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that's enjoyable, thorough, and fair. That's our way of inspiring the innovative brightest minds. Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference. Equal Opportunity Employer Statement: Impulse Dynamics is an equal opportunity employer. Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities. Compensation & Benefits Annual Base Salary Range: $ 100,000 - $ 115,000 * Full Coverage Medical Benefits - Employee + family contribution is 100% covered by Impulse Dynamics. * Paid Vacation, floating holidays, and sick time. * Paid Holidays * 401k Match (up to 6%) * Annual bonus eligibility Unless specifically indicated communicated otherwise in writing, all employees are "at-will" employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee's employment.

Territory: Toms River, NJ - Multi-Specialty Target city for territory is Toms River - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Atlantic City, Lakewood, Burlington. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable, and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! We are seeking a dynamic and results-driven sales professional with a proven track record of success who is looking to grow with LundbeckOur ideal candidate will have the ability to be a specialty product expert with an understanding of requisite market complexities in order to be successful promoting our products to stakeholders in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management where applicable. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually Self-starter, with a strong work ethic, tenacity, and outstanding communication skills Adaptability: Ability to embrace change and work collaboratively in a fast-paced team environment. Problem-Solving: Proven analytical skills to identify solutions and overcome obstacles. Data Analysis: Strong computer and technical skills used in analyzing data to develop both short- and long-term goals aligned with business objectives. Must live within 40 miles of territory boundaries Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck Ability to lift, bend, push, pull and move items including, but not limited to equipment, pharmaceutical samples, and any other work-related materials up to 25 lbs. with or without reasonable accommodation. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Recent documented successful experience selling to general practitioners (GPs) and primary care centers. Prior experience promoting and detailing products specific to CNS/neuroscience Previous experience working with alliance partners (i.e., co-promotions) TRAVEL: Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range $108,000 to $125,000 and eligibility for a sales incentive target of $39,000. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

Base Salary: $150K USD + Bonus | Full-Time | Remote Globally recognized, publicly traded full-service CRO that's redefining clinical research across continents. With a footprint in over 30 countries and a workforce of 10,000+, this organization partners with thousands of biopharma and medtech innovators to bring cutting-edge therapies to market. From oncology to rare diseases, their pipeline is as diverse as their team. Leveraging AI-powered platforms and real-world data, they're not just conducting trials-they're shaping the future of medicine. If you're a Clinical Project Manager looking to lead global studies in a collaborative, tech-forward environment, this is your chance to thrive. Key Responsibilities Lead and manage global Phase I-IV clinical trials across cardiovascular and oncology indications Oversee cross-functional teams including biometrics, regulatory affairs, medical writing, and pharmacovigilance to ensure seamless trial execution. Develop and maintain project timelines, budgets, and risk mitigation strategies. Serve as the primary point of contact for sponsors, vendors, and internal stakeholders. Ensure compliance with ICH-GCP, FDA, EMA, and local regulatory requirements. Utilize AI-enabled tools and platforms to optimize trial design and operational efficiency. Contribute to business operations including budgeting, forecasting, and resource planning. Mentor junior team members and foster a culture of excellence and innovation. Qualifications Minimum 10 years of experience in clinical research, with at least 6 years as a Clinical Project Manager. Must have direct experience managing both cardiovascular and oncology studies. Experience across multiple phases, preferably Phase II-III. Global trial management experience is essential. CRO experience strongly preferred. Strong understanding of drug development processes and clinical trial regulations. Valid and current GCP certification required. Solid knowledge of local regulatory requirements in the U.S. and/or EU. Proven experience in budgeting and business operations related to clinical project management. Excellent communication, leadership, and problem-solving skills. If you or someone you know fits this experience and shows interest, we'd love to speak with you!

Data Analyst Department: Client Operations Reports to: EVP, HUB Operations FLSA: Exempt The Corporate office operating hours are Monday through Friday 8:30 am - 5:00 pm EST. Primary Function: The incumbent is responsible for the data outreach, data capture/loading, and data reporting per specific program requirements. Job Scope and Major Responsibilities: Reach out to member pharmacies to gather missing data, clarify data inconsistencies, and offer technical assistance/expertise if necessary Identify, investigate, and resolve data anomalies using SQL or other statistical analysis software Ensure that Asembia's data reports meet program requirements and are delivered in a timely manner by making necessary changes to improve data accuracy Process daily/monthly/quarterly master data functions as assigned Provide ad hoc data analysis to internal and external parties as requested Append pharmacy data reports to the Asembia database using applicable data rules to ensure quality of input through various stages of the data-loading process. Communicate findings of data investigations and manage expectations for internal and external stakeholders The timely submission of accurate data to appropriate parties. Maintaining a high level of customer service for Asembia's customers - manufacturers and members' pharmacies. Successful collaboration with other Asembia team members to attain a common goal. Attendance and schedule adherence is critical. Adhering to company policies and procedures. Possess a professional demeanor, focused on respectful communication, a positive and reliable attitude, and responsible behavior. This includes dressing appropriately, being punctual, maintaining composure, and demonstrating accountability for your actions. Working outside of core business hours may be required. Other duties as assigned. Compliance with the provisions of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, as amended (“HIPAA”). Qualifications: Bachelor's Degree required. B.A./B.S. Information Systems or similar field preferred. Minimum 2 years of experience working with pharmaceutical data in a team-driven environment Advanced Excel skills (building Macros, pivot tables & pivot charts, writing formulas, etc.). Proven track record with taking ownership of data investigations and seeing them through to resolution, preferably using SQL or other statistical analysis. The candidate must have client-facing experience and be able to articulate themselves clearly and concisely in their verbal and written communications. Excellent presentation and collaboration skills. Reliable and consistent attendance and schedule adherence is required. Asembia is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, natural origin, ethnicity, religion, gender, pregnancy, marital status, sexual orientation, gender identity and expression, citizenship, genetic disposition, disability or veteran's status or any other classification protected by State/Federal laws .

Primus Pharmaceuticals is seeking an Area Business Manager in the Newark, NJ market with a passion for improving patients' lives and overcoming barriers to prescribing innovative products. Primus Pharmaceuticals is a unique, innovative company that empowers providers and patients with prescription brands that maintain the highest level of safety without compromising efficacy. General Information Base salary with an uncapped monthly bonus potential - FAVR car allowance, corporate credit card, iPad, cell, paid time off, 401K match, and full benefits package. Prior sales experience of a minimum of 2 years is required. Bachelor's degree is required. Must reside in the Austin, TX area and those who reside outside the coverage radius will not be considered. Roles & Responsibilities Meet or exceed sales targets within an assigned territory by developing and executing a comprehensive business plan focused on key accounts. Identify and engage key influencers, ensuring meaningful interactions with top-target healthcare professionals. Plan and coordinate sales activities to ensure consistent and strategic territory coverage. Deliver compelling, clinically focused presentations on product(s) to physicians and healthcare professionals. Develop a strong understanding of the healthcare delivery system, including physician networks, pharmacy personnel, and clinical staff within each account. Maintain strong knowledge of products, competitors, and market trends at both local and regional levels. Analyze market dynamics and set strategic short- and long-term goals to drive sales performance. Collaborate with cross-functional teams including sales colleagues, marketing, and brand teams, to enhance customer engagement. Effectively manage territory budgets to support sales and promotional activities. Complete administrative responsibilities accurately and on time. Implement brand strategies and sales tactics within the designated territory. Actively participate in training and professional development programs. About Primus Pharmaceuticals, Inc. Primus innovates in prescription nutritional therapies targeting metabolic causes of chronic diseases across rheumatology, dermatology, and women's health. We develop and commercialize first-in-class products and novel deliveries in Rx drugs, medical foods, and medical devices to fill key unmet needs with universal patient access not provided by traditional pharma. Visit our website at *****************

The Document Control/QA Specialist will be responsible for maintaining the lifecycle of validation documents within an automated system. This role involves performing quality reviews of validation protocols, ensuring compliance with internal and regulatory standards. Key Responsibilities: • Manage validation documentation in automated systems, including document control and archiving. • Perform quality reviews of IQ/OQ/PQ protocols, test scripts, and validation reports. • Collaborate with the CQV and engineering teams to ensure documentation aligns with project milestones. • Assist in audits and inspections by providing necessary documentation. • Ensure all document control activities comply with FDA, cGMP, and internal quality standards. Requirements Qualifications: • Bachelor's degree in Life Sciences, Engineering, or related field. • 8+ years of experience in document control and quality assurance in pharmaceutical settings. • Expertise in validation documentation management and quality review processes. • Strong understanding of regulatory requirements, including FDA and cGMP. • Excellent attention to detail and organizational skills. • TOP review and compilation

**Customer Engagement Model** Otsuka America Pharmaceutical, Inc. has launched a new customer engagement approach designed to better deliver on patient, caregiver, and HCP needs in an evolving healthcare environment. The new model is built around where patients get their care-locally, with the intent to better serve patients, caregivers, and healthcare providers, delivering a higher quality experience that ultimately is focused on improving patient care. The local "ecosystem approach" creates a unified focus among account management, medical, patient access and market access to engage local healthcare systems and identify opportunities to improve the patient experience. Through this matrix model, customers will now experience more coordinated and seamless care with digital-enabled support to bridge care gaps. In Otsuka's evolved customer engagement model, a Health Science Associates (HSA) will engage HCPs through a variety of in-person, virtual and digital tools, offering expanded expertise regarding products and the approved conditions they treat. Otsuka's Clinical & Scientific Liaison (CSL) will provide deep clinical expertise on-demand and will engage healthcare providers to offer personalized education on disease state, thought leadership and real-world evidence. A Patient Education Liaison (PEL) works to inform, educate, and enhance the experience of patients throughout their care continuum. The HSAs are led by Ecosystem Leads and grouped into regional areas. Ecosystem Leads are led by Regional Leads with significant autonomy to assess unique market priorities and customize decisions that reflect local customer needs. In the future, Otsuka will also be shifting to a team-based approach to drive customer engagement quality, accountability, and cohesion around patients and healthcare providers. Ultimately, it is all about putting customers at the center of everything they do. **Position Overview** **- Medical** **Science Liaison** **(Senior Manager)** As an integral member of the ecosystem team for Otsuka's new ecosystem-based customer engagement model, the Medical Science Liaison (MSL), Sr Mgr contributes to the development of the ecosystem strategic business plan and identifies key stakeholders that are vital to the ecosystem. The Medical Science Liaison (MSL) is a credible partner responsible for providing clinical, scientific and health economic information related to disease states and the appropriate utilization of approved Otsuka products within an ecosystem. This field-based position will engage with Key Influencers (KIs), Local Practice Leaders (LPLs), healthcare providers, and patients' groups within their ecosystem, to further patient outcomes aligned with the overarching objectives of Otsuka. In collaboration with their ecosystem partners, CSLs contribute to the customization of the region business strategy to meet local ecosystem needs and are responsible for the medical and educational requirements of their customers. In addition, CSLs may be responsible for covering multiple products within a therapeutic area, as well as engaging in broad clinical and scientific discussions that impact patient care, resulting in rich customer insights shared within the ecosystem. **There are 2 positions available** **Key Activities and Responsibilities** + As part of the ecosystem team contributes a clinical and scientific perspective to the local execution plan that addresses ecosystem, and customer challenges, issues, and opportunities, to bring about improved patient care and outcomes. This extends to include coordination around execution of field activities. + Build, cultivate, and leverage external relationships with key scientific and medical customers and organizations within their ecosystem to ensure strong understanding of evolving healthcare trends, disease state, Otsuka products, systems, and services across the ecosystem landscape, including KIs, LPLs, Key Decision Makers (KDMs) and Patient Advocacy. + Maintain a comprehensive understanding of the ecosystem to ensure alignment with Otsuka's patient-centric strategy and priorities, including provision and delivery of optimal patient care. + To be a credible source of evidence-based information that demonstrates the value of Otsuka and its products from the clinical, economic, and humanistic standpoint and works in partnership with providers, payers, and other key stakeholders to apply practical real-world solutions to improve patient outcomes. + Build and cultivate important internal working relationships across the matrix team to ensure an enterprise approach when working with customers. Be accountable to regional Field Medical Affairs leadership to shape and execute on local medical strategies within planned timelines. + Actively contribute to planning, content development, and dissemination of disease state information to customers in the field on a regular basis using the remote customer engagement platform. + Disseminate disease state and healthcare landscape information to customers in the field on a regular basis utilizing remote customer engagement platform. + Responsible for delivering the training and evaluation of promotional and disease state speakers. + Serve as part of Otsuka's internal speaker bureau in support of product educational needs across the ecosystem. + Collect and submit medical insights that drive decision making and prioritization of evidence generation efforts and healthcare solutions, including sharing at the local ecosystem level. + Assist with Otsuka's clinical trials program, including registrational, post-marketing and Investigator-Sponsored Trials (ISTs), health economic outcomes research, other specific medical collaborations; provide clinical expertise and feedback regarding operational management of clinical trials to ensure optimal site selection and performance. + Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. **Qualifications** + Advanced degree in Pharmacy, Medicine, Biological Sciences, Health Services Research or Public Health, (PharmD., M.D., PhD. or D.Ph.) is required. + Relevant therapeutic area knowledge is required. + Understanding of the interconnectivity of health systems, overall delivery of patient care and experience working with healthcare professionals and other decision makers. + Minimum of 3-5 years related work experience (clinical, health system or industry) + Outstanding business acumen; knows the industry, Otsuka's business model and value proposition, key competitors, and other marketplace factors/dynamics. Able to identify solutions with the overall goal of improved patient outcomes. + Excellent communication and collaboration skills; exhibits professional maturity, confidence, and competence. Strong conflict resolution skills: proven ability to achieve conflict resolution effectively and quickly with affected parties and work in a cross-functional environment. + Knows how to summarize and communicate complex information and business objectives in a concise and effective way during presentations and other interactions. + Understanding of industry legal, regulatory, and compliance landscape + Ability to work in an ambiguous environment undergoing transformation. + Demonstrates behaviors aligned with the Otsuka Corporate Brand including Perseverance, Unconventional Thinking, and Humility. + Business travel, by air or car, up to 70% of time depending upon size of ecosystem. + Preferred living location is key city in ecosystem. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Pharmaceutical Sales Specialist for the Primary Care Team, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives! Accountabilities • Develop and demonstrate knowledge of clinical disease states and treatment guidelines. • Effectively communicate product information to healthcare professionals. • Execute call plans and Brand Strategy by translating data to actionable insights. • Adapt to and demonstrate a thorough understanding of AZ Selling Model. • Analyze data and trends to build insightful and actionable business plans for your assigned sales territory. • Build relationships and credibility with Primary Care healthcare professionals to effectively position products by establishing unmet needs, clinical differentiation, and fair balance of our Brands. • Leverage multiple channels including digital platforms and face-to-face engagements to drive meaningful customer interactions. • Open to receiving guidance and seek insights for growth and development. Essential Skills/Experience • Bachelor's Degree • 0 - 2+ years of demonstrated Sales or B2B, or Commercial experience • A valid driver's license and safe driving record Essential Skills and Capabilities • Customer Focus: Strong customer relationship management skills with the ability to understand and address customer needs. • Business Acumen: Ability to analyze and interpret complex data to develop strategic sales plans. • Technical Aptitude: Proficiency in using digital tools and platforms to engage with healthcare professionals. • Adaptability: Flexibility and adaptability to changing market conditions and customer needs. • Collaborative: Ability to work effectively in a team environment and collaborate with cross-functional teams. Desirable Skills/Experience • Experience selling to general practitioners (GPs) and primary care centers • In-depth understanding of the healthcare industry and primary care operations At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We shape the future by spotting scientifically-led commercial opportunities and acting now to operationalize and scale them. Driven by the solutions we bring to the healthcare ecosystem, we make an impact at every step of the patient journey, improving their experience and outcomes. Our team thrives on energy and pace, constantly thinking big to answer new challenges. We lead Commercial to provide solutions that make a difference, improving our patients' experience and health outcomes. Join us in making a difference in patients' lives - apply today! Date Posted 19-Nov-2025 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

1. Equipment & Facility Maintenance Lead maintenance of OSD manufacturing equipment such as blenders, granulators, fluid bed dryers, sifters, mills, tablet presses, capsule fillers, coating pans, dust collectors, compressors, chillers, boilers, AHUs, and dehumidifiers. Implement robust Preventive Maintenance (PM) and predictive maintenance programs. Conduct breakdown investigations and implement corrective actions. Ensure critical facility systems (HVAC, electrical, plumbing, fire systems, BMS/EMS) are maintained and operate to required standards. 2. Regulatory Compliance & Documentation Ensure compliance with FDA, cGMP, 21 CFR Part 11, OSHA, and related regulatory requirements. Maintain records including PM logs, calibration reports, service documentation, change controls, deviations, and CAPAs. Support internal and external audits (FDA, DEA, ISO, and customer audits). 3. Utilities & HVAC Systems Management Manage key utilities such as compressed air, nitrogen, vacuum, HVAC, chilled water, steam, and RO/DI water systems. Ensure qualified and compliant environmental controls for classified OSD manufacturing areas. Maintain pressure cascades, temperature and humidity controls, and HEPA-filtered air systems. 4. Equipment Qualification & Validation Work with Validation and QA teams on IQ/OQ/PQ protocols. Manage requalification schedules and ensure equipment remains in a validated state. Provide engineering assessments for change controls. 5. Safety, Risk Management & Compliance Ensure adherence to OSHA, NFPA, and site safety requirements. Implement safety programs including LOTO, confined space, hot work, and electrical safety. Conduct incident investigations and lead corrective actions. 6. Spare Parts & Vendor Management Maintain optimum inventory of critical spare parts. Manage vendors, annual maintenance contracts (AMCs), and service agreements to control maintenance costs. Evaluate and onboard modern technologies and suppliers. Qualifications & Experience Education: Bachelor's degree in mechanical, Electrical, Chemical, or Industrial Engineering (or equivalent). Preferred: Master's degree or certifications such as CMRP or PMP. Experience: 8-15 years of engineering and maintenance experience in OSD pharmaceutical manufacturing. Strong knowledge of manufacturing and packaging equipment, utilities, HVAC, and cleanroom systems. Experience with FDA/DEA audits and equipment validation. Must have a valid work permit.

About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our B&P Neurology team as a Data Analyst and you'll lead one or several late phase studies, or lead an indication for a complex compound, under supervision of statistical project leader and/or team leader. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Contribute to the design and analysis of both early- and late-phase clinical trials by applying advanced statistical methods and data analysis techniques. Support the development, evaluation, and implementation of innovative statistical methodologies to address complex problems in clinical research. Work collaboratively under the guidance and mentorship of senior-level statisticians, gaining hands-on experience in study planning, data interpretation, and the preparation of statistical reports and publications. About You Basic Qualifications: Currently enrolled and pursuing PhD in Statistics or Biostatistics at an accredited college or university Candidates must have completed at least two years of graduate coursework and be working on a dissertation toward a PhD in Statistics or Biostatistics Experience with SAS and R Must be able to relocate to the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship Preferred Qualifications: Effective oral and written communication skills Experience with python is a plus Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Exposure to cutting-edge technologies and research methodologies Networking opportunities within Sanofi and the broader biotech community. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Associate Specialist, Value Stream Cryo Operations is responsible for the Cryopreservation, movement, storage, control of manufacturing patient materials, and support of Liquid Nitrogen storage tanks and equipment at the CAR T manufacturing facility in Summit, NJ. This includes but is not limited to, cryopreservation, storage, inventory control, chain of custody, and material tracking. **Shift Available:** + Wednesday - Saturday (with e/o Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m. **Responsibilities:** + Handling patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal. + Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures. + Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures. + Performing sample queries and periodic storage reports, as required. + Assisting management with investigations and deviations related to sample management. + Collaborating with other departments to identity and implement process efficiencies. + Maintaining metrics for the Value Stream Cryo Operations group. + Facilitating cold chain transfers of material, as required. + Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs). + Maintains timing according to the production schedule to ensure on-time Cryopreservation support. + Cryopreserve Patient material daily, store and manage Inventory of material in LN2 storage locations. + Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs. + Maintains timing according to the production schedule to ensure on-time logistics. + Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively. + Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities. + Records patient material handling data and information in a clear, concise, format according to proper GDPs. + Able to problem solve with minimal supervision. + Works in a team based, cross-functional environment to complete tasks required by shift schedule. + Other duties may be assigned, as necessary. + Available to work OT when business requires. + Willing to work staggered day shift hours. **Knowledge & Skills:** + Basic mathematical skills. + General understanding of cGMPs. + Technical writing capability. + Proficient in MS Office applications. + Inventory control and/or management + Background to include an understanding of biology, chemistry, medical or clinical practices is a plus. **Basic Requirements:** + Bachelor's degree with no prior experience. + Or associate/ Medical Technical degree and 1-2 years of Manufacturing or Operations experience. + Or High School diploma/GED and 3-4 years of Manufacturing or Operations experience. + Experience with cold chain sample storage and transfer. + Knowledge of cGMP/FDA regulated industry. BMSCART, #LI-Onsite If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. **Compensation Overview:** Summit West - NJ - US: $31.90 - $38.65per hour The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: + **Health Coverage:** Medical, pharmacy, dental, and vision care. + **Wellbeing Support:** Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). + **Financial Well-being and Protection:** 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. **Work-life benefits include:** Paid Time Off + US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) + Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. ***Eligibility Disclosure:** T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. **Supporting People with Disabilities** BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to ************************** . Visit careers.bms.com/ (****************************************** eeo-accessibility to access our complete Equal Employment Opportunity statement. **Candidate Rights** BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* **Data Protection** We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at **************************************** . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ******************** . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1596185 : Associate Specialist, Value Stream Cryo Operations **Company:** Bristol-Myers Squibb **Req Number:** R1596185 **Updated:** 2025-12-25 02:35:16.367 UTC **Location:** Summit West-NJ Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Job Description Develop initial or update safety signal detection and management documents for global developmental and marketed products to support and enhance appropriate signal detection activities and robust safety evaluation Review and/or develop relevant epidemiology sections and/or papers for relevant conferences and/or peer-reviewed journals as assigned Develop or support development of instruments for epidemiological assessment strategies and safety surveillance in coordination with Biostatistics Participate in plan/design, execute or contribute to development of observational studies and interventional studies for assigned global developmental and marketed products Develop epidemiological assessment and safety surveillance plan for assigned projects or studies Review epidemiology data in supporting the development of risk management plan/risk evaluation and mitigation strategies (REMS) and other safety related documents Contribute to the design, implementation, and management of safety studies and clinical trials Search and review epidemiological data and safety literature in supporting development of Ad hoc or regular safety submissions Accountable for epidemiology sections of investigator's brochures, risk management plans, aggregate safety reports (DSUR and PSUR), and responses to health agency's inquiries for global development and post-marketing products Perform safety data evaluation and risk assessment for assigned drug products Provide or contribute to the materials used for Safety meetings including but not limited to the Clinical Safety Team, Data Monitoring Committee, Global Safety Data Monitoring Committee, Data and Safety Monitoring Board (DSMB) Contribute epidemiology input to GST Working Group meetings, Signal Detection meetings and other Global Drug Safety and Evaluation Center (GDSEC) meetings as assigned Performs other departmental duties as assigned Qualifications Education: Graduate degree (PhD, MD, MS, MPH) in a relevant field is required: Doctoral degree with at least 2 years of industry experience, academia, and/or regulatory agency Master's degree with 6+ years of experience in a national/local public health agency, regulatory agency, biopharma, and/or the medical device industry (including at least 1 to 2 years of biopharma or medical device industry experience) Professional Experience: Experience and training in public health, pharmacy, health services research, health outcomes research, epidemiology, biostatistics or other relevant fields Familiarity and experience with the development and implementation of epidemiology research strategies Expertise in Biostatistics, Epidemiology/ secondary database analyses (e.g., claims, national survey data, etc.), Psychometrics Demonstrated experience as a member of a product or project team Experience in scientific writing of peer-reviewed, academic and/or public health literature Familiarity with Drug Development and Phase 1-4 clinical trials Knowledge and Skills: Strong understanding of research methodology and statistics, as well as strong technical writing, and strong ability to critically review published scientific literature Strong verbal and written communication, presentation skills, including experience Critical thinking and problem-solving skills, ability to set priorities and develop strategies/studies to answer complex research questions Experience managing multiple projects, often complex in nature and with both internal and external stakeholders under short timelines Ability to analyze and interpret safety data Good understanding of advanced design and analysis techniques used in the analysis of secondary data (e.g., matching, multivariate regression, meta-analysis, etc.) Ability to conceptualize the presentation of results (e.g., develop layout of tables and figures for inclusion in analysis plans) Working knowledge of 2 or more secondary database types (e.g., claims, surveys, electronic medical records) Working knowledge/ability to use standard statistical packages (i.e. SAS, STATA, etc) Ability to contribute to written processes to ensure consistent and quality deliverables Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:

Job Title: Microbiology, Manager The Microbiology Manager is responsible for overseeing the daily operations of the Microbiology laboratory and leading strategic planning for the lab and its staff. This individual serves as the subject matter expert on contamination control and microbiological testing of parenteral drug products. The role involves significant participation in customer and regulatory audits, client interactions, site metrics meetings, site-wide improvement projects, budgeting, and data review and interpretation, including protocols, investigations, and laboratory documentation. The manager is accountable for the entire laboratory team and handles staff management duties such as performance reviews, disciplinary actions, and ensuring proper training. Operating with limited supervision, this position requires the ability to work independently as well as collaboratively on cross-functional teams. Essential Duties and Responsibilities: Develop and maintain leader standard work in the laboratory Align and maintain staff shift schedules with required manufacturing support functions Demonstrate expertise in CGMP guidelines, ISO 17025, and USP microbiological testing, especially USP , , , , , and Maintain laboratory policy and procedure manuals; assist in developing and validating procedures and document preparation Ensure timely completion of projects, CAPAs, and investigations Manage, conduct, and/or delegate the final review and approval of environmental and microbiological test results, including those from contract labs, to support lot disposition and deliverables as prioritized by site leadership Oversee compliance guideline reviews, industry trend assessments, customer projects (method transfer, development, etc.), validation efforts, expansion projects, and continuous improvement initiatives Act as SME to lead collaboration between departments to trend and continuously improve site Contamination Control Strategy and Environmental Monitoring Program Represent the department during regulatory, customer, and internal audits; ensure timely response to audit observations and execution of related CAPAs Develop and execute training on laboratory methods, instrumentation, and aseptic technique Build and evolve the department Training Matrix to align with industry standards and best practices Write and revise Microbiology and other relevant SOPs as required Provide technical input on product testing issues and instrumentation/equipment Ensure laboratory compliance with cGMP through inspections of monitoring systems and equipment Ensure proper recording and review of data Test the integrity of raw materials or finished products Conduct and document failure and complaint investigations Serve as liaison to service, calibration, and technical representatives Facilitate revision and release of controlled documents Facilitate mandatory reviews of SOPs and month-end reports Provide oversight for projects to update/maintain official document templates Direct and manage the Change Control System Read and interpret SOPs to ensure compliance Maintain up-to-date training records Perform other duties as assigned Education and/or Experience: Bachelor's Degree in Microbiology or related field Minimum of five (5) years of experience in microbiology or related field within a GMP-regulated environment Minimum of two (2) years of experience in a microbiology leadership role Previous experience with pharmaceutical cleanroom environments Knowledge of 21 CFR 211 and EU Annex 1 cGMP requirements Preferred Experience: Five (5) years of experience in a microbiology leadership role Five (5) years of microbiology laboratory experience within a GMP-regulated setting Supervisory Responsibilities: This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. It also involves fostering a positive work environment, providing guidance and support to team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives. Language Skills: The ideal candidate should have the ability to read and interpret various documents, including safety instructions, standard operating procedures, technical procedures, and governmental regulations. Strong written and verbal communication skills are essential, along with effective presentation skills to successfully present information and respond to questions from managers, clients, customers, and the general public.

Job Title: Digital Consumer Experience Design About the Job Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you'll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve. About Sanofi EDGE: Sanofi EDGE - Building a Healthier Future, Together At EDGE, we're revolutionizing how individuals manage their health and well-being. We believe that lasting health behavior change is best achieved through a supportive ecosystem that includes not only clinical guidance but also the encouragement and practical assistance of a user's care circle. Our platform empowers individuals to set meaningful health goals, track their progress, and connect with their support network, all grounded in evidence-based principles and a deep understanding of human motivation. We're a passionate team dedicated to creating a user-centered experience that drives meaningful health outcomes and fosters long-term engagement. The Opportunity: We are seeking a talented and passionate UX/UI Designer to join our growing product and experience team. As a key member of the team, you will play a crucial role in shaping the user experience of our health management platform. You will be responsible for translating user needs, business requirements, and strategic goals into intuitive, engaging, and effective design solutions. You will collaborate closely with product managers, engineers, and researchers to create a seamless and empowering experience for our users and their care circles. Ideally, you will bring experience designing for consumer health applications, understanding the unique challenges and opportunities within this space. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Lead and contribute to the end-to-end design process, including detailed UI specifications and visual design. Develop a deep understanding of our users, their motivations (in formed by self-determination theory), and their care circle dynamics through user research, usability testing, and data analysis in collaboration with product and user research team members. Create user flows, wireframes, prototypes, and high-fidelity mockups that effectively communicate design ideas and solutions. Design intuitive and accessible user interfaces that are consistent with our brand guidelines and design system. Collaborate closely with product managers to define product features and translate them into user-centered design solutions. Work effectively with engineering teams to ensure the successful implementation of designs. Participate in design reviews and provide constructive feedback to other team members. Stay up-to-date with the latest UX/UI trends, best practices, and technologies, particularly within the digital health landscape. Contribute to the evolution and maintenance of our design system. Advocate for the user throughout the product development lifecycle. About You Qualifications: Bachelor's degree in Design, Human-Computer Interaction (HCI), or a related field, or equivalent professional experience. Proven experience (ideally 3+ years) as a UX/UI Designer, preferably with experience in consumer-facing digital products. Strongly preferred: Experience designing for consumer health applications, with an understanding of health data privacy (e.g., HIPAA), accessibility standards (e.g.,WCAG), and user behavior in health management. A strong portfolio showcasing user-centered design solutions and demonstrating a clear understanding of UX principles and UI best practices. Proficiency in industry-standard design and prototyping tools (e.g., Figma, Miro, Adobe XD). Excellent communication, collaboration, and presentation skills. Ability to work independently and as part of a cross-functional team in a fast-paced environment. A strong understanding of user-centered design methodologies and the ability to translate research insights into actionable design decisions. A passion for improving people's lives through thoughtful and effective design. Familiarity with agile development processes. Bonus Points: Experience designing for behavior change or social support platforms. Knowledge of self-determination theory and its application in digital product design. Experience working with design systems. Understanding of front-end development principles (HTML, CSS, JavaScript). Experience using AI to create workflow efficiency To Apply: Please submit your resume and a link to your online portfolio showcasing your relevant work. In your portfolio, please highlight projects that demonstrate your user-centered design process and your ability to solve complex design challenges. If you have experience in consumer health, please specifically call out those projects. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $125,250.00 - $180,916.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

NO THIRD PARTIES WILL BE CONSIDERED We have a 20+ year relationship with our client Long-term Contract Rates: Hourly W2 or C2C options Technical Product Owner (TPO), Enterprise Quality, Data, Intelligence & Automation Position Overview: We are looking for a proactive and results-oriented Technical Product Owner (TPO) according to the High-Performance Team (HPT) model to spearhead the end-to-end execution of Enterprise Quality's Data, Intelligent Automation, and Artificial Intelligence products and platforms as part of the Data, Intelligence & Automation (DI&A) team. The ideal candidate will play a key role in informing the product development strategy for various DI&A products and platforms, ensuring alignment with broader business strategies & overall business objectives, and delivering DI&A products that drive business value. Key Responsibilities Act as the TPO for multiple Enterprise Quality products and platforms, driving the product vision and strategy to meet stakeholder needs. Collaborate with cross-functional stakeholders (Quality Organizations, TQ, ISRM, and TS), functional product groups, and HPT chapter expert services to gather requirements, prioritize features, and deliver comprehensive analytics solutions. Define and manage the product backlog, ensuring that user stories and acceptance criteria are clear and actionable. Translate business requirements into technical specifications, working closely with data engineers and developers to ensure the timely delivery of enhancements and features. Manage the total cost of ownership (TCO) of products, drive cost optimization, and identify cost-reduction opportunities while maintaining operational efficiency Monitor platform performance, identify areas for improvement, and recommend enhancements to support informed decision-making. Conduct regular QBRs/stakeholder reviews and gather feedback to continuously enhance the product/platform's capabilities and user experience. Stay informed about industry trends and best practices in data, advanced analytics, artificial intelligence, and intelligent automation, assessing new technologies as appropriate. Lead training sessions and workshops for users to promote platform adoption and maximize its potential. Create a compelling value proposition to secure development budget, demonstrating a clear understanding of the project benefits and key results. Responsible for maintaining portfolio information in Nexus, Assess Management, Lean IX, ITSM, and IAM. JJT Lead for SOX application(s) within the scope of the role. Education: A minimum of a Bachelor's degree in information technology, Management Information Systems, Data Science, or a related field is required. An advanced degree is preferred. Experience & Skills: A minimum of 2 - 3 years in roles that create a tangible business impact through Data, Intelligent Automation, and Artificial Intelligence (including Data Science, Machine Learning, Generative AI, Agentic AI, Langflow, and other relevant technologies) is required. A minimum of 5 years of IT-related experience is required. Proven experience in digital product management, preferably in a data analytics environment, along with strong analytical skills to analyze and evaluate data and to drive appropriate recommendations and decisions for senior leaders and sponsors. Understanding of Laboratory Systems (i.e., LIMS, SDMS, etc.) and/or Quality Management Systems (i.e., QMS, Complaints, Document Management, etc.) would be considered valuable assets. Excellent communication and interpersonal skills, capable of engaging effectively with stakeholders at all levels. Experience with Agile methodologies and tools (e.g., Scrum, JIRA) is strongly recommended. Experience with several of the following technologies: Microsoft Azure, Databricks, OpenAI's GPT, Neo4j, Alation, PostgreSQL, Python, PySpark, AI-powered Business Intelligence (BI) and data visualization tools (Tableau, Power BI, ThoughtSpot) - strongly recommended. A demonstrated ability to manage multiple priorities in a fast-paced environment. Excellent written and oral communication skills, with strong interpersonal skills and a team-oriented approach. Ability to influence, negotiate, and communicate effectively with internal and external stakeholders across complex matrix organizations. THIS IS A HYBRID ROLE: 3 DAYS PER WEEK IN CENTRAL NEW JERSEY - commutable distance to central New Jersey is required.

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE The Associate Director, Regulatory Affairs Strategy - Safety and Toxicology will develop and execute product safety strategies that drive business innovation while ensuring regulatory compliance. This role will provide leadership and guidance for regulatory submissions, health authority interactions, new product development, and existing product maintenance as well as overseeing raw material and formula clearance for product safety and compliance. The ideal candidate will combine strong regulatory knowledge with hands-on experience to ensure product safety over the full life cycle of a diverse portfolio of healthcare and consumer regulated products including but not limited to drugs, devices, cosmetics, surface sanitizers and disinfects. ESSENTIAL FUNCTIONS AND BASIC DUTIES Contributions Lead Product Safety and Toxicology team in developing and executing safety strategies for new product development and maintenance of existing products to ensure successful commercialization across product life cycle Develop and execute non-clinical safety strategies to generate pre-clinical data for new product development marketing authorization applications Investigational/New Drug Applications (IND/NDA) Medical Devices Pre-Market Notifications (510(k)) Pesticides - FIFRA §3 Develop and execute non-clinical safety strategies for qualifying impurities and new inactive ingredients Assess non-clinical safety data and advise project teams on potential in-vitro and in-vivo clinical and non-clinical safety study requirements Design, coordinate and monitor in-vitro and in-vivo clinical and non-clinical safety studies Ensure studies comply with Good Laboratory Practice (GLP) standards and FDA and HC recognized regulatory guidelines Author and review non-clinical sections of regulatory submission documents (IND/NDA/510(k)/FIFRA §3) Prepare, oversee, and deliver raw material and formulation toxicological risk assessments, safety clearances, and Consumer Products Safety Reviews (CPSR) Prepare, oversee, and deliver Safety Data Sheets (SDS) for drugs, devices, disinfectants, cosmetics and cleaning products Represent Product Safety in cross-functional new product development (NPD) teams Represent PDI at industry meetings related to safety (SOT, PCPC, HCPA) Monitor trends, emerging regulations, guidance, and best practices (regulatory intelligence) related to safety compliance and product development Communicate and collaborate in acting on regulatory intelligence that has potential to impact the business Ensure products meet all the necessary Federal and State safety regulations and reporting requirements for U.S. and CA Oversee 1 direct report to: Review, approve, and certify all formulation raw ingredients, nonwovens, packaging, and fragrances for intended use, country of launch (U.S./CA), and compliance with latest regulations and customer requirements Generate Safety Data Sheets (SDS) by reviewing formulations and developing safety, precautionary, and first aid language Ensure supplier compliance by updating Raw Material Information Review (RMIR), nonwoven, packaging, and fragrance requirements according to the latest regulatory and customer requirements Obtain third party seals of approval from EPA Safer Choice, EPA Design for Environment (DfE), National Eczema association (NEA), United States Department of Agriculture Biobased (USDA), and Environmental Working Group (EWG) Provide support for safety related claims e.g. Non-Animal Tested Declaration, Food Allergen Declaration, “Free from” Declaration Provide support for compliance requirements (e.g. Modernization of Cosmetics Regulation Act of 2022 (MoCRA) Safety Substantiation, IFRA 52 nd Amendment (2026), Hazard Communication Standard (SDS) Updates; California CFFIRKA allergen reporting requirements) Cross-Functional Support Collaboration: Work closely with multidisciplinary teams, including R&D, Clinical, Manufacturing, and Quality functions to integrate safety findings/plans into the overall drug development strategy, align regulatory submissions with development and operational plans, and ensure project timelines are met. Problem Solving: Generate hypotheses and investigative strategies to address any safety concerns or unexpected findings that arise during the non-clinical phase. Participate: in health authority interactions (FDA, Health Canada) by contributing to meeting materials and supporting response strategies. Operational Excellence Maintain and strengthen safety documentation, templates, and SOPs to support consistent, high-quality safety assessments and strategies. Partner with cross-functional colleagues to identify process improvements and leverage tools that enhance efficiency and accuracy in development and maintenance projects. Mentorship and Collaboration Provide guidance and support to junior regulatory staff where applicable, sharing expertise and best practices. Foster collaborative relationships internally and with external partners/sponsors. PERFORMANCE MEASUREMENTS Achievement: consistent delivery of complete, accurate and on-time high-quality technical work with minimal issues Ownership: Independent and proactive management of assigned projects to ensure complete, accurate and timely completion Collaboration: Effective teamwork and communication across functions to achieve shared objectives Innovation: Introduction of creative solutions and contributions to process improvements and new product ideas QUALIFICATIONS EDUCATION/CERTIFICATION Bachelor's degree in life sciences, pharmacy, or related field required; advanced degree (PharmD, PhD, MS) and/or CCCTO or DABT certifications a plus REQUIRED KNOWLEDGE Solid knowledge of FDA safety regulations; experience with ex-US authorities (Health Canada) desirable Demonstrated ability to contribute to safety strategies and regulatory submissions across multiple phases of development EXPERIENCE REQUIRED 8-10 years of safety experience in pharmaceuticals, biotech, medical devices, or pesticides including submission experience in IND/NDA, 510(k), FIFRA §3 or equivalent SKILLS/ABILITIES Strong organizational skills with attention to detail, quality, and timelines Excellent written and verbal communication skills; ability to work in cross-functional teams Excellent organizational, prioritization abilities, tracking and follow-up skills Ability to complete projects on time and handle multiple parallel projects in a fast-paced environment Good analytical and problem-solving abilities, communication and interpersonal, and record keeping skills Strong attention to detail Ability to handle multiple tasks / projects simultaneously and bring them to completion on time Self-starter with ability to think and act independently and to make sound decisions Fast learner with a flexible style and the ability to adjust to changing business priorities Ability to interface with internal and external contacts at all levels Great flexibility and ability to work well with shifting priorities WORKING CONDITIONS Environment: Corporate office with on-site R&D laboratories Work Schedule: Hybrid (4-days/week onsite, 1-day/week remote) SALARY RANGE: $150,000 - $180,000 annually BENEFITS PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes: Medical, behavioral & prescription drug coverage Health Savings Account (HSA) Dental Vision 401(k) savings plan with company match and profit sharing Basic and supplemental Life and AD&D insurance Flexible Spending Accounts (FSAs) Short & long-term disability Employee Assistance Program (EAP) Health Advocacy Program PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts. At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

Hope is Here! Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM, which is delivered by the company's Optimizer systems. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany; Pearl River, N.Y.; Beijing, China and Montevideo, Uruguay. There are ≈ 64 million patients struggling with heart failure worldwide. When heart failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope. The only options down the road (LVAD or heart transplant) are extremely invasive and rarely used. CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. This is not a job; it is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and are qualified for CCM therapy. The PROSPECT campaign is a direct to patient advertising and awareness campaign designed to help CCM eligible patients help themselves to this life-changing therapy. This campaign requires an orchestrated sequence of patient identification and nurture that is managed principally by Impulse Dynamics' NEXUS call center. Nexus connects CCM indicated patients to providers by activating and enabling a network of the best medical device and therapy awareness representatives in the world to educate the cardiology community. Patient Success Associate - (FTE) Impulse Dynamics has recently built out a Direct-to-Patient marketing function and is receiving a high volume of inbound inquiries from potential patients. To help field this demand, create a world-class patient experience, and ensure patients' needs are being met, we are building our internal Patient Success capabilities and looking to hire our first Patient Success Associate to help drive this impactful program. This role will combine technical and business acumen while connecting with patients and internal teammates to drive CCM awareness across the U.S. This position is contract-to-hire with the intent to move to full-time employment in early 2024, or sooner. As a Patient Success Associate, you will support qualified PROSPECT patients through their CCM journey while aiming for maximum efficiency and effectiveness. You will also ensure that process and technology is utilized to a maximum and that your patient "book of business" is organized and professionally managed. An excellent Patient Success Associate must be an organized, reliable, and a results-driven professional. They must possess a practical mind to solve problems on the spot, partnered with an ability to see the big picture for individual growth and development opportunities. And they must execute reliably on their own volition. As the Patient Success Associate, you must have excellent customer service and communication skills. Reporting to the Sr. Patient Success Operations Manager, the Patient Success Associate will be a partner in supporting the daily patient outreach function for all interested PROSPECT patients, and work with our field teams to help ensure that CCM implant goals are met or exceeded. A best-in-class patient success function will be critical to our ability to deliver on Impulse Dynamics' mission. Please apply if: * You are passionate about improving the lives of patients through the provision of novel therapies in the heart failure community. * You love working in and with high performing teams. * You are driven, influential, and energetic. * You will hit the ground running as a high-performing Patient Success Associate and are excited to partner in improving our operational function. * You thrive in a changing environment and find yourself consistently solutioning through establishing best practices. Essential Functions The Patient Success Associate will: * Ensure the achievement of all established KPIs. * Meet or exceed pre-established monthly enrollment goals. * Build and establish best practices regarding the handling of patient objections and concerns. * Be responsible for special projects and other duties as assigned by the Sr. Patient Success Operations Manager. * Nimbly address inquiries and objections. Minimum qualifications: * 2+ years of experience in a patient-centric environment. * Bachelor's degree from an accredited institution. * Experience with Salesforce, Tableau, and 8x8 or similar telephony systems. * Previous experience in customer service and/or patient experience in a telephonic environment. * Previous experience working remotely or with autonomy. Preferred qualifications: * Excellent written communication skills to ensure information continuity with field teammates. * Highly collaborative with field teammates to ensure exceptional patient experience, and with the Patient Success leadership in your work to build the Patient Success team. * Growth mindset towards your professional development at Impulse Dynamics. * Growth mindset towards leading within the Patient Success function. * Embrace change and constantly stretch comfort zone in the spirit of continuous improvement. * Identify and collaborate to solve complex problems while driving Patient Success continuous improvement. * Passionate about Impulse Dynamics' vision to improve the lives of heart failure patients using cardiac contractility modulation CCM. * Experience training others, particularly for engaging in conversation with the intent to move patients through a funnel or similar functions. * Nursing experience, specifically with the Heart Failure population. * Fluency in another language (ideally Latin-American Spanish). Our Commitment to You Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that's enjoyable, thorough, and fair. That's our way of inspiring the innovative brightest minds. Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference. Annual Base Salary Range: $ 65,000 - $ 70,000 * Full Coverage Medical Benefits - Employee + family contribution is 100% covered by Impulse Dynamics. * Paid Vacation, floating holidays, and sick time. * Paid Holidays * 401k Match (up to 6%) * Annual bonus eligibility Unless specifically indicated communicated otherwise in writing, all employees are "at-will" employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee's employment. Equal Opportunity Employer Statement: Impulse Dynamics is an equal opportunity employer. Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

Supplier Quality Engineer Marlton, NJ Hope is Here! Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM , which is delivered by the company's Optimizer Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany. There are 64 million patients struggling with Heart Failure worldwide. When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope. The only options down the road are extremely invasive. CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. This is not a job, It is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy. The Supplier Quality Engineer is responsible for ensuring supplier compliance with purchasing controls, qualification standards, and continuous monitoring requirements. This role involves collaboration with internal teams and suppliers to uphold regulatory standards, drive quality improvements, and mitigate risks in the supply chain. In addition to compliance tasks, continuous improvement initiatives are a key focus, ensuring that processes evolve to enhance efficiency and effectiveness. How You'll Add Value Purchasing Controls Compliance: Maintain and oversee purchasing controls compliance, ensuring proper documentation of supplier performance and continuous monitoring files. Supplier Qualification & Monitoring: Lead supplier qualification initiatives, assess ongoing performance, and ensure adherence to regulatory and company standards. Training & Education: Provide education and training to company personnel and suppliers on purchasing control applications to sustain long-term compliance. Product Development Support: Collaborate with engineering teams to guide supplier selection and documentation of requirements for new materials and components. Regulatory Alignment: Ensure selected suppliers meet regulatory requirements, possess recognized credentials, and demonstrate competency for intended purchasing needs. Supplier Performance & Corrective Actions: Manage and analyze supplier corrective action reports, monitor performance trends, and provide insights for site-level management reviews. Supplier Audits: Conduct remote and onsite supplier audits to verify compliance, identify risks, and drive continuous improvement. Continuous Improvement Initiatives: Engage in continuous improvement activities within the function and areas of responsibility. Beyond compliance, focus on enhancing processes, identifying opportunities for efficiency, and driving meaningful improvements. Pre-Market Activities Collaboration: Work closely with Product Development teams to support pre-market activities, ensuring supplier selection, qualification, and documentation align with regulatory and business requirements. What You're Bringing with You Bachelor's degree in engineering, supply chain management, or a related field. Background in electronics/electrical engineering is preferred. Experience in supplier quality management, auditing, and regulatory compliance. Strong understanding of purchasing controls, supplier qualification processes, and corrective action management particularly with contract manufacturing. Excellent communication, problem-solving, and analytical skills. Ability to collaborate effectively with cross-functional teams and external suppliers. ISO 13485 Certified Lead Auditor or CQA required Skills & Abilities Excellent skills in written and verbal communication, and ability to interact with all levels of the organization and suppliers Superior organizational abilities and the ability to maintain deadlines. Ability to take initiative Ability to build team relationships and interface in a multi-disciplinary environment Ability to translate technical requirements and specifications to external suppliers Working knowledge of software programs; Microsoft Word, PowerPoint, Excel, Project Position requires some travel, international and domestic (Up to 50%) Our Commitment to You Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that's enjoyable, thorough, and fair. That's our way of inspiring the innovative brightest minds. Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference. Equal Opportunity Employer Statement: Impulse Dynamics is an equal opportunity employer. Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities. Compensation & Benefits Annual Base Salary Range: $ 100,000 - $ 115,000 Full Coverage Medical Benefits - Employee + family contribution is 100% covered by Impulse Dynamics. Paid Vacation, floating holidays, and sick time. Paid Holidays 401k Match (up to 6%) Annual bonus eligibility Unless specifically indicated communicated otherwise in writing, all employees are “at-will” employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee's employment.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Associate Specialist, Value Stream Cryo Operations is responsible for the Cryopreservation, movement, storage, control of manufacturing patient materials, and support of Liquid Nitrogen storage tanks and equipment at the CAR T manufacturing facility in Summit, NJ. This includes but is not limited to, cryopreservation, storage, inventory control, chain of custody, and material tracking. Shift Available: Wednesday - Saturday (with e/o Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m. Responsibilities: Handling patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal. Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures. Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures. Performing sample queries and periodic storage reports, as required. Assisting management with investigations and deviations related to sample management. Collaborating with other departments to identity and implement process efficiencies. Maintaining metrics for the Value Stream Cryo Operations group. Facilitating cold chain transfers of material, as required. Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs). Maintains timing according to the production schedule to ensure on-time Cryopreservation support. Cryopreserve Patient material daily, store and manage Inventory of material in LN2 storage locations. Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs. Maintains timing according to the production schedule to ensure on-time logistics. Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively. Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities. Records patient material handling data and information in a clear, concise, format according to proper GDPs. Able to problem solve with minimal supervision. Works in a team based, cross-functional environment to complete tasks required by shift schedule. Other duties may be assigned, as necessary. Available to work OT when business requires. Willing to work staggered day shift hours. Knowledge & Skills: Basic mathematical skills. General understanding of cGMPs. Technical writing capability. Proficient in MS Office applications. Inventory control and/or management Background to include an understanding of biology, chemistry, medical or clinical practices is a plus. Basic Requirements: Bachelor's degree with no prior experience. Or associate/ Medical Technical degree and 1-2 years of Manufacturing or Operations experience. Or High School diploma/GED and 3-4 years of Manufacturing or Operations experience. Experience with cold chain sample storage and transfer. Knowledge of cGMP/FDA regulated industry. BMSCART, #LI-Onsite If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Summit West - NJ - US: $31.90 - $38.65per hour The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients' lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.