Trabajos cell therapy en Westfield, New JerseyCrear alertas

Job Description Shifts required and hours per week: (10-25 hours/week depening on the case) • We are looking for multiple therapists for multiple cases in the areas of Union, Linden, and Metuchen NJ, • Monday-Sunday morning, afternoon, & evening hours, • Potential daytime hours, • Hours subject to additional availability based on client needs, • Additional cases located in Linden & Metuchen with the following schedules:, • Linden, NJ:, • School Year Schedule:, • Friday (5pm - 8pm), • Saturday (11am - 2pm), • Sunday (11am - 4pm), • Summer Schedule:, • Wednesday (9am- 4pm), • Friday (5pm-8pm), • Saturday (11am-2pm), • Sunday (11am-3pm), • Metuchen, NJ:, • 2-3 days/week, year-round schedule, • Evening hours QUALIFICATIONS: • Required:, • Have a minimum of a Bachelor’s Degree, • Preferably in Education, Psychology or related field, • Minimum of 2 years of ABA experience., • Have access to a working cell phone, tablet, and/or laptop for data collections, • Possess a driver's license with reliable transportation and auto insurance for driving to clients., • Preferred:, • Have previous experience working with children and/or managing challenging behaviors with children., • CPI Certification (Crisis Prevention Intervention), • Alternatively, Successful completion of Safety Care/Handle With Care Training., • Be able to play and engage children., • Excellent interpersonal and communication skills - spoken and written., • Be CPR and First Aid certified. BENEFITS: • Flexible schedule, • Professional development assistance (RBT & Student BCBA supervision hours), • Health Insurance (Medical), • 401K Matching, • Paid Time Off, • Training and assessments to become successful Behavior Technicians/RBT., • Our training programs and evaluation systems are aligned with the standards for this credential per the Behavior Analyst Certification Board© PHYSICAL REQUIREMENTS: • Walking, occasional running, standing, sitting, kneeling, stooping, crouching, crawling, twisting, reaching above head, pulling, bending, and carrying up to 50 pounds., • Work may involve playing with children that can occur on the floor or settings where the furniture is child-size., • Diligently attending to the safety of the patient and surroundings is required., • Quick and sudden movements may be required., • Sustained physical exertion may be required for up to 45 minutes. JOB DESCRIPTION: • Under the supervision of a Board Certified Behavior Analyst©, the Behavior Therapist provides Applied Behavior Analysis, ABA, therapy services for children diagnosed on the autism spectrum. The Behavior Technician will:, • Implement programs based on ABA principles increasing communication, self-help, social and play skills., • Keep clients motivated to learn and provide reinforcement for achieved skills., • Accurately keep a record of client’s progress., • Manage challenging behaviors that occur., • Maintain confidentiality of client information., • Travel to client’s homes/community settings, as required for service delivery. Learn more about us: www.emittherapeutics.com \nCompany Description At EMIT Therapeutics, we're changing lives through compassionate, individualized, evidence-based ABA therapy. Our team empowers children and teens with autism to build meaningful communication, independence, and lifelong skills while reaching their fullest potential. We invest in our employees and foster a collaborative, supportive culture where clinicians are valued, mentored, and encouraged to grow professionally. If you're passionate about making a lasting impact while advancing your career, EMIT Therapeutics is the place for you. At EMIT Therapeutics, we're changing lives through compassionate, individualized, evidence-based ABA therapy. Our team empowers children and teens with autism to build meaningful communication, independence, and lifelong skills while reaching their fullest potential. We invest in our employees and foster a collaborative, supportive culture where clinicians are valued, mentored, and encouraged to grow professionally. If you're passionate about making a lasting impact while advancing your career, EMIT Therapeutics is the place for you.

Job DescriptionDescription: About Celularity Celularity Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous cell therapies derived from the postpartum placenta. Celularity leverages the placenta’s unique biology, immunologic properties and scalable availability to develop therapeutic solutions targeting fundamental mechanisms of aging and age-related disease. Quality Assurance • Lead and maintain a phase-appropriate Quality Management System (QMS) overseeing core quality processes including but not limited to deviations, CAPAs, change controls, document management, training, complaints and risk management., • Provide GMP and GTP quality oversight of internal operations ensuring compliance with FDA, EMA, all applicable GxP regulations, select state regulations and accrediting bodies, • Review and approve quality records, including investigations, batch documentation, validation packages and product disposition., • Manage and oversee the quality supplier program, quality agreements, vendor qualification activities and routine external audits., • Drive inspection readiness and lead all internal/external audits, responses to regulatory inspections, partner audits and quality improvement initiatives. Quality Control • Develop and execute analytical and microbiological quality control strategy supporting product development, manufacturing and clinical/investigational supply., • Oversee internal and external laboratory activities, including routine product testing, product visual inspection, microbiological testing, raw material testing and overall laboratory compliance programs., • Ensure timely execution of product testing, visual inspection and review of analytical and microbiological data supporting raw material qualification, batch release, stability programs and specification management., • Management of the environmental monitoring program, cleanroom sampling and contamination control strategies., • Oversight of external contract testing organizations., • Establish quality metrics, trending programs and continuous improvement initiatives to ensure product quality and compliance. Regulatory • Develop and execute regulatory strategies supporting process development, manufacturing operations and commercialization., • Lead preparation, submission and maintenance of regulatory filings, including INDs, amendments, annual reports, meeting packages and designation applications., • Serve as the primary liaison with regulatory authorities, coordinating responses and agency communications., • Monitor emerging regulatory requirements and industry trends assessing impact to business. Drive compliance update activities., • Partner with cross-functional teams to ensure regulatory requirements are assessed and incorporated into development, clinical and manufacturing planning.Requirements: Minimum Qualifications (Must have) • Bachelor’s degree in Life Sciences, Engineering, or related scientific discipline, • 10+ years’ of progressive experience in Quality Assurance, Quality Control, and/or Regulatory Affairs within regulated advanced therapeutic industries, • Demonstrated experience developing, maintaining and leading GMP-compliant quality systems and regulatory programs in a clinical-stage biotechnology environment, • Strong working knowledge of FDA, EMA, GxP and any applicable regulatory requirements governing product development and manufacturing. Expertise leading and managing internal and external audits of these regulations, • Successful track record supporting regulatory inspections, regulatory filings, agency communications, commercial readiness activities or product approvals., • Strong leadership, adaptability, communication and cross-functional collaboration skills with the ability to influence stakeholders at all organizational levels Preferred Qualifications • Direct experience supporting cell therapy, gene therapy, tissue engineering, regenerative medicine and/or biologics, • Experience in a fast-paced, scientific, start-up environment, • Dynamic individual with the ability to communicate and engage others., • Independent and self-starting., • Eager and adaptable. Working Conditions • Position primarily supports classified laboratory environments., • May be required to gown aseptically., • Open office environment outside of laboratory zones, • Fast paced, start-up environment which may periodically require work beyond standard business hours. Flexible schedule. *THIS ROLE DOES NOT PROVIDE RELOCATION *NO AGENCIES PLEASE

Quantifies and maintains materials in production dispensary. Maintains timing according to the production schedule to ensure on-time logistics. 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

Celularity Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous cell therapies derived from the postpartum placenta. Celularity leverages the placenta's unique biology, immunologic properties and scalable availability to develop therapeutic solutions targeting fundamental mechanisms of aging and age-related disease. Responsibilities: • Lead and maintain a phase-appropriate Quality Management System (QMS) overseeing core quality processes including but not limited to deviations, CAPAs, change controls, document management, training, complaints and risk management., • Provide GMP and GTP quality oversight of internal operations ensuring compliance with FDA, EMA, all applicable GxP regulations, select state regulations and accrediting bodies., • Review and approve quality records, including investigations, batch documentation, validation packages and product disposition., • Manage and oversee the quality supplier program, quality agreements, vendor qualification activities and routine external audits., • Drive inspection readiness and lead all internal/external audits, responses to regulatory inspections, partner audits and quality improvement initiatives. Quality Control: • Develop and execute analytical and microbiological quality control strategy supporting product development, manufacturing and clinical/investigational supply., • Oversee internal and external laboratory activities, including routine product testing, product visual inspection, microbiological testing, raw material testing and overall laboratory compliance programs., • Ensure timely execution of product testing, visual inspection and review of analytical and microbiological data supporting raw material qualification, batch release, stability programs and specification management., • Management of the environmental monitoring program, cleanroom sampling and contamination control strategies., • Oversight of external contract testing organizations., • Establish quality metrics, trending programs and continuous improvement initiatives to ensure product quality and compliance. Regulatory: • Develop and execute regulatory strategies supporting process development, manufacturing operations and commercialization., • Lead preparation, submission and maintenance of regulatory filings, including INDs, amendments, annual reports, meeting packages and designation applications., • Serve as the primary liaison with regulatory authorities, coordinating responses and agency communications., • Monitor emerging regulatory requirements and industry trends assessing impact to business. Drive compliance update activities., • Partner with cross-functional teams to ensure regulatory requirements are assessed and incorporated into development, clinical and manufacturing planning. Requirements: Minimum Qualifications (Must have) • Bachelor's degree in Life Sciences, Engineering, or related scientific discipline, • 10+ years' of progressive experience in Quality Assurance, Quality Control, and/or Regulatory Affairs within regulated advanced therapeutic industries, • Demonstrated experience developing, maintaining and leading GMP-compliant quality systems and regulatory programs in a clinical-stage biotechnology environment, • Strong working knowledge of FDA, EMA, GxP and any applicable regulatory requirements governing product development and manufacturing. Expertise leading and managing internal and external audits of these regulations, • Successful track record supporting regulatory inspections, regulatory filings, agency communications, commercial readiness activities or product approvals., • Strong leadership, adaptability, communication and cross-functional collaboration skills with the ability to influence stakeholders at all organizational levels Preferred Qualifications • Direct experience supporting cell therapy, gene therapy, tissue engineering, regenerative medicine and/or biologics, • Experience in a fast-paced, scientific, start-up environment, • Dynamic individual with the ability to communicate and engage others., • Independent and self-starting., • Eager and adaptable. Working Conditions • Position primarily supports classified laboratory environments., • May be required to gown aseptically., • Open office environment outside of laboratory zones, • Fast paced, start-up environment which may periodically require work beyond standard business hours. Flexible schedule. *This role does not provide relocation. *No agencies please.

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. Position Responsibilities • Serves as a clinical/medical contact in diligence-related conversations with target company scientific and clinical contacts, partnering closely with senior BD leadership, • Identifies and enacts best practices with minimal instruction, escalating judgment calls as appropriate, • Provides regular and timely updates to management and governance stakeholders, flagging risks and recommendations as they arise, • Leads literature review and competitive landscape assessment, translating findings into asset valuation and trial design benchmarking recommendations for prospective deals, • Leads development of the clinical development plan spanning early to late development, and presents recommendations to governance committees and development team leadership as required, • Leads clinical assessment of trial design elements (endpoints, statistical assumptions, enrollment criteria, patient population/eligibility risk) for target assets and precedent/competitor trials, providing clinical input on feasibility and valuation assumptions, • Leads the development of trial design and feasibility benchmarking materials (sample size, enrollment assumptions, country selection) and helps shape the medical narrative supporting asset valuation and deal feasibility assessments, • Leads clinical and medical input to diligence packages, including safety risk assessment, and present findings to BD leadership and governance committees, • Collaborates cross-functionally with Biostatistics, Regulatory, Commercial, Medical Affairs, and Clinical Pharmacology to inform clinical development and diligence assessments, • Serves as a therapeutic area medical resource across key cardiovascular areas (e.g., lipid management, coronary artery disease, stroke, and heart failure), providing input on portfolio and pipeline strategy, • Provides medical/ guidance to Clinical Scientists and other junior team members on assigned initiatives, • Identifies and escalate medical/safety risk considerations that could materially affect deal terms or timelines Accountabilities • Uses leading-edge knowledge to lead complex projects. Influences business and industry decisions that have an impact on the Company., • Directs the resolution of highly complex or unusual business problems, typically involving the innovation of new solutions. People Management Accountabilities • Provides leadership and direction through managers and/or expert-level individual contributors performing work in generally the same function., • Directly accountable for the performance and results of a department, cluster/mid-size market or site., • Develops department strategy and is accountable for execution of the department's business plan. Degree Requirements • MD (or equivalent) required; board certification/eligibility in a relevant specialty (e.g., cardiology, internal medicine) preferred. Six to eight years of clinical and/or industry experience preferred. MBA or business/finance coursework a plus, but not required Experience Requirements • Advanced knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations, • Advanced ability to interpret clinical and safety data to identify trends and inform deal-specific medical risk assessments, • Advanced medical writing skills and medical terminology, applied to diligence memos, deal narratives, and governance presentations, • Advanced planning/project management skills (develop realistic, effective medium-range plans across clinical development programs and deal timelines, managing competing priorities across multiple concurrent deals) Key Competency Requirements • Detail-oriented with commitment to quality and medical/scientific rigor, • Advanced knowledge of disease area, compound, and current clinical landscape, with the credibility to represent the therapeutic area externally, • Advanced knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees, including experience interfacing with these bodies, • Working knowledge of deal structuring norms (upfront/milestone/royalty structures) and asset valuation frameworks (NPV/eNPV, PTRS); prior BD/diligence experience a plus but not required, • Advanced critical thinking and problem-solving skills, with sound independent medical judgment under time pressure, • Adaptable / flexible (comfortable operating with ambiguity across multiple concurrent clinical and BD workstreams; leads with confidence and professionalism under shifting priorities), • Advanced skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., report generating tools); comfortable presenting complex clinical/medical concepts to non-clinical BD and executive audiences 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: Cambridge Crossing: $308,700 - $374,075 Madison - Giralda - NJ - US: $275,630 - $333,998 Princeton - NJ - US: $275,630 - $333,998 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 https://careers.bms.com/life-at-bms/. 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: The 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.

The Label Operations Manager at the S12 Cell Therapy manufacturing facility is responsible for implementing and managing the site Label Operations activities at S12 Summit West (Summit, NJ) in accordance with BMS policies, standards, procedures and Global cGMPs. Functional responsibilities include supervision of all label control activities for Cell Therapy Development and Operations (CTDO); Responsible for developing and maintaining a GMP compliant clinical and commercial label issuance and control process. The Label Operations organization is responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives. This organization supports the S12 facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis. Shift Available: • Wednesday - Saturday, Onsite Night Shift, 6 p.m. - 4:30 a.m. Responsibilities: • The Label Operations manager will lead team to ensure Label Management and align with Global and Regional Regulatory requirements., • Manage and motivate team members, build trust and cultivate a collaborative environment., • Oversee team responsibilities and maintain a state of compliance., • Work proactively to identify and address any label control compliance issues., • Oversees, supervises, coordinates and prioritizes daily activities of the Label Operations team located at Summit, NJ S12 facility., • Act as site lead for clinical and commercial label management related system implementation initiatives. Fully support projects within project timelines., • Assures job objectives are met on a timely basis., • Assures timely issuance of clinical and commercial in-process and final product labels for labeling operations., • Coordinates and prioritizes project deliverables to support new drug product launches, new market and other quality management activities as assigned., • Creates employee development plans, and oversight of functional area to assure adequate staffing., • Coach and mentor subordinates in the areas of training, disciplinary action, problem solving, and professional growth., • Provide support for activities using the electronic label issuance and control systems., • Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs while managing archival of batch records and GMP documentation for the site., • Perform gap assessments to identify process deficiencies, provide reports to document detailed findings and recommend potential solutions., • Develops and maintains quality metrics to monitor compliance., • Collaborates with stakeholders to develop appropriate actions to resolve quality system issues., • Responsible for developing, managing, and on-boarding requirement for new staff within label control., • Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements., • Performs supplemental investigations/projects as required by management. Knowledge & Skills: • Must have advanced GMP, Quality, compliance and risk management knowledge., • Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy., • Provide guidance to other employees in the interpretation of compliance and technical/scientific issues across most of the job function. Develop employees and coach them to bridge knowledge gaps., • Must have strong authorship and able to critically review reports while effectively providing input and expressing Quality Risk management principles., • Must be action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking., • Must be skilled in coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation., • Must possess an independent mindset and tenacity., • Leads teams and cross-functional project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of quality initiatives in terms of cross-functional teams; emerging as a leader contributing to BMS culture and values., • Demonstrated proficiency with PC-based office computers and standard Microsoft Office applications., • Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with manager for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team., • Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams., • Routinely recognizes and resolves quality issues informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures. Minimum Requirements: • B.S. Degree required. Equivalent combination of education and experience will be considered., • Minimum 5 years relevant work experience., • Minimum 2 years of leadership experience. Working Conditions: • Work is performed in a typical office environment, with standard office equipment available and used., • Work is generally performed seated but may require standing and walking for up to 10% of the time., • Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. Compensation Overview: Summit West - NJ - US: $103,560 - $125,495 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 https://careers.bms.com/life-at-bms/. 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. 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

ERP Implementation Site Data Lead.This role will support the implementation of a new ERP system across multiple cell therapy facilities in northern New Jersey.The site data lead will immerse themselves within these sites and with global functions to complete data cleansing, build standardization, an

Associate Director, CAR-T Site Supply Chain Product Planner. The Associate Director CAR-T Site Supply Chain Product Planner is a planning role in the Cell Therapy Operations Summit West (CTO SMVV) New Jersey manufacturing site. This role will report directly to Supply Planning Director and sit on th

As an Associate Director, this role will collaborate closely with cross-functional partnersincluding members of the Brand, Sales, Medical, and Access teamsto support data-informed decision-making and customer engagement. Adopt a continuous improvement mindset and support the identification of emergi

Location: Cell Therapy Operations, Summit, New Jersey.Purpose And Scope Of Position: This role is responsible for working on New Hire Orientation Program (NHOP) for the Summit West Cell Therapy Operations organization, as well as the accurate and timely processing of all training requests related to

Director, Regulatory CMC - Cell Therapy. Knowledge of pharmaceutical development, including advanced therapies and/ or, biologic, cell therapy upstream and downstream processes, analytical methods, and cell therapy products as applicable. From optimizing a production line to the latest breakthroughs

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. The Manager, CSV Cell Therapy supports the successful implementation and support of manufacturing and laboratory equipment and comput

Fully Remote • New Providence, NJ • Clinical Science & Operations DescriptionTransforming Cancer Therapy TogetherAt ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients' lives. ADC TherapeuticsADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other agents and in earlier lines of DLBCL therapy as well as in indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reach significantly more patients through expanded use. We are a team of approximately 150 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at and LinkedIn.The Senior Clinical Development Physician Contractor for the ZYNLONTA Program will work approximately 30-40 hours per week remotely (with a preference for New Jersey/East Coast based). Key Responsibilities:Medical Monitoring & Patient Safety Oversight — ZYNLONTA Program Serve as the medical monitor for ZYNLONTA studies providing real-time clinical judgment on eligibility, dose modifications, premedication compliance, and management of class-specific toxicities (e.g., effusions/edema, cutaneous reactions, hepatic abnormalities, hematologic toxicity).Perform detailed clinical data review of patient data profiles and other eCRF data (including drafting data queries, discussion of patient cases with Investigators, etc.)Lead ongoing benefit-risk assessment, including review of SAEs, AESIs (PBD-ADC class effects), and emerging safety signals; partner with Pharmacovigilance, DSMC/iDMC, and Biostatistics to ensure timely signal detection and risk mitigation.Cross-Functional PartnerPartner with Translational Medicine, Biomarkers, and Biostatistics to characterize patient outcomes on ZYNLONTA (including by COO/GCB vs. non-GCB, double/triple-hit status, prior CAR-T exposure, and age/frailty), informing label strategy and lifecycle planning.Quality, Compliance & Inspection Readiness Ensure all medical monitoring and sBLA activities are conducted in compliance with ICH-GCP, FDA/EMA regulations, and internal SOPs; maintain audit- and inspection-ready documentation of clinical decisions and benefit-risk rationale in preparation for pre-approval inspections (BIMO) and sponsor inspections.RequirementsMinimum Qualifications:MD required, MD/PhD preferredBoard certification in Hematology/Oncology (in U.S. clinic preferred)Some clinical experience treating aggressive B-cell lymphomas (DLBCL, HGBCL, transformed FL) strongly preferred15+ years of clinical R&D experience in biopharma (or a combination of clinical and industry experience)Direct experience with antibody-drug conjugates (ADCs) — particularly PBD-based or CD19-targeted agents Familiarity with the evolving DLBCL treatment landscape and ability to position ZYNLONTA strategically within it.Join Our Inclusive TeamADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/ProtectedVeterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.

Senior Project Manager Cell Therapy Development and Operations will influence and manage all aspects of initiating, planning, and executing complex, multi-disciplinary projects throughout the projects' lifecycle. Ensure the project teams for the assigned projects are following the current standards

The role will report to the VP, Global Commercial, Cell Therapy, Hematology with a dotted line to the ED, Global Commercial, Cell Therapy, Multiple Myeloma. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the care

Reporting to the Executive Director, Cell Therapy Multiple Myeloma, the Senior Director, WW Medical, Multiple Myeloma Cell Therapy will represent WW Medical Affairs as a therapeutic area expert and provide strategic scientific leadership for arlo-cel, our GPRC5D CAR T currently in clinical developme

Reporting to the Executive Director, Cell Therapy Multiple Myeloma, the Director, WW Medical, Multiple Myeloma Cell Therapy Pipeline will represent WW Medical Affairs as a therapeutic area expert and provide scientific leadership across MM CAR T assets at various stages of clinical development. Dire

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. This role is responsible for contract administration, data validation, analysis, processing and payment of rebates associated with Managed Care contracts. Primary duties include interpretation and evaluation of contract terms, claims eligibility validation, formulary verification, rebate adjudication and external customer management to ensure proper determination and payment of contracted rebates. Responsibilities: • Review executed paper contract, develop summary of contract terms and set up contract to accurately reflect the intent of the contract., • Maintain Managed Care rebate contracts including contract terms, membership and formulary status, • Review and validate submitted Managed Care rebate claims data and make decisions on claims eligibility based on plan formulary status and compliance. Calculate rebates on eligible claims, review for accuracy through the thorough analysis and resolution of discrepancies and make decision on final payment due to customer per contract terms., • Collaborate with Contract Operations team, as needed, to ensure that the intent of the contract is carried out in the rebate calculations and payments., • Provide analytical thinking and business acumen to identify and make decisions to resolve variances in claims data trends or expected rebate rates. Evaluate invoices for year-to-date rebate payment trends and provide explanations for variances vs. prior periods. Make decisions to escalate certain unexplained variances which may indicate potential compliance or performance issues to leadership for further action., • Prepare payment packages and process payments. Resolve outstanding issues to ensure payments are made within the contractual timeframe., • Monitor drug formulary compliance., • Serve as primary contact with external customers (payers) and Contract Operations team to address questions or to resolve issues. In the event of disputes, gather supporting facts and make recommendations for resolution for approval by management., • Apply process oriented and critical thinking to enhance organizational effectiveness of accurate and timely contract administration and rebate processing. Revise SOPs as required to reflect process improvements., • Maintain compliance with SOX and audit controls governing contract and rebate operations., • Assist in fulfilling requirements related to internal/external audits of systems and processes, legal requests and government agency inquiries. Qualifications: • 0-2 years of experience in one of the following: contract administration, rebate processing or business/financial analysis, • Experience with analytical techniques to determine reasonableness of data, trends and the root cause of issues, • Demonstrated strong organizational skills, • Proven ability to multitask and make rapid decisions when discrepancies or non-routine situations arise, • Acquired effective communication skills and has dealt with both internal and external customers while obtaining the know-how to prompt them for complete/accurate information, • Flexible, team player open to collaborating across team assignments and ad-hoc projects, • MS Office (Excel, Access), • Managed Care experience is preferred, • BA/BS degree is preferred Compensation Overview: Madison - Giralda - NJ - US: $69,120 - $83,760 Princeton - NJ - US: $69,120 - $83,760 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 https://careers.bms.com/life-at-bms/. 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: The 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 adastaffingsupport@bms.com. 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: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial

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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. The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. 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Ensure documentation by Safety Topic Review/Signal Report or other means of communication., • Approve safety labeling activities for assigned products., • Provide Safety Subject Matter Expertise for input to regulatory product labeling., • Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products., • Provide input to R&D publication strategy/ plan & ensure safety input to publications/ presentations. Clinical Development • Oversee the global safety strategy for assigned compounds in development. Support global submission document production. 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Actively drive benefit-risk strategies for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc. Postmarketing Support • Oversee the lifecycle safety strategy for assigned marketed compounds and support global postmarketing safety activities and submissions., • Provide medical safety, benefit-risk input and approve DSUR/PBRER, product renewal submissions, postmarketing study documents, and reports, responses to HA queries., • Provide medical safety oversight of and execution of risk management strategies and risk management plan (RMP) elements for assigned products., • Oversee safety signal evaluation & management. Review and Approve reports on safety signals (ie, Safety Topic Reviews/ Signal Reports) and ad hoc regulatory responses., • Provide postmarketing safety study guidance to other groups including epidemiology and medical affairs, including but not limited to investigator sponsored research/ trials (IST), epidemiology studies, and non-interventional research., • Ensure safety labeling adequately reflects emerging postmarketing safety profile. Department Activities • Drive change in the organization and adoption of new processes. Assist the MSA TA Head in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS., • Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates., • Assist the team and senior management in all forms of issue management and crisis management., • Liaise with all TA staff and maintain an effective and collaborative patient safety team., • Hire, Orient, Manage, Mentor, and Develop staff. Cross-Functional Activities • Identify data gaps and Prioritize data acquisition. Provide input to strategic plans for safety differentiation of BMS products., • Oversee and/or provide training to BMS employees on product safety profiles/issues., • Provide input to due diligence and potential in-licensing opportunities as requested., • Act as WWPS TA liaison for assigned products with BMS functions (Legal, BD, Operations, Marketing, etc.)., • Support manufacturing quality. Review integrated health hazard assessments., • Review communications of safety data & interpretation to BMS and external parties, globally. Leadership Behaviors • Communicate the company's vision, values, and strategies in a way that builds the understanding and commitment of others., • Facilitate skill development by coaching others and sharing expertise., • Effectively motivate and retain top talent, offer praise, and recognize contributions., • Provide team members with regular and constructive performance feedback, encourage sharing better practices and ideas., • Resolve conflict within the team so that performance and engagement are not impacted. Degree / Experience Requirements • MD/equivalent required. Postgraduate qualification or experience in internal medicine, immunology, oncology, or related specialty desirable., • 7+ years in pharmacovigilance (PV) or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred. Management experience is strongly preferred. Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience. Key Competency Requirements • Extensive understanding of the drug development process., • Expert knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product., • Skilled ability to direct (and leverage) range of available tools to investigate safety concerns, including the science of observational research., • In-depth understanding of regulatory requirements for safety assessment and action., • Expert scientific analytical reasoning skills., • Ability to manage (and work on) multiple complex projects in parallel., • Excellent attention to detail., • Behavioral competencies necessary to work and lead within a complex matrix environment., • Excellent verbal and written communication skills. Travel: Occasional travel within the US (eg, once every 2-3 months

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