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Job Purpose: The Associate will support a Senior Analyst in the Healthcare sector, focused on Biotechnology, with an emphasis on companies where applied chemistry, process development, formulation, and manufacturability (CMC) are key drivers of value. The Associate will conduct primary research and fundamental analysis, build and maintain financial models, and help author differentiated research that translates scientific/technical insights into clear investment conclusions. The ideal candidate is a self-starter with strong analytical rigor, excellent writing skills, and a Master’s-level foundation in Chemical Engineering and applied chemistry. Duties & Responsibilities: Research, Diligence & Technical Analysis • Perform deep diligence on biotech platforms and products where chemistry and process matter, including (as applicable): ADCs, oligonucleotides/siRNA, peptides, radiopharmaceuticals, LNP/delivery systems, biologics formulation, and chemistry-enabled tools., • Evaluate CMC and scale-up risk across development stages (preclinical through commercial), including:, • Synthetic route/process complexity, yield/throughput considerations, impurity profiles, stability and degradation pathways, • Formulation constraints, cold-chain/logistics considerations, and analytical characterization/assay robustness, • CDMO/manufacturing capacity, tech transfer risk, and timeline sensitivities impacting commercial readiness., • Conduct primary research through KOL outreach, expert calls, surveys/polling, and other proprietary data collection to support thesis formation and ongoing monitoring., • Build and maintain company financial models (forecasting, scenario analysis, valuation work) for use in updates, investment recommendations, and client discussions., • Assist in drafting and publishing research: initiations, earnings notes, catalyst previews/recaps, thematic reports, and breaking-news updates., • Help maintain and grow relationships with company management teams, industry/academic contacts, internal Sales & Trading partners, and institutional investors., • Master’s degree in chemical engineering preferred with demonstrated strength in applied chemistry (e.g., reaction engineering, separations/purification, formulation, analytical characterization, process development/scale-up)., • Demonstrated interest in Biotechnology and life sciences investing; ability to connect scientific/engineering details to business and valuation outcomes., • Strong financial aptitude and willingness to build expertise in modeling, forecasting, and valuation (advanced Excel required)., • Excellent written and verbal communication skills; ability to explain complex technical concepts clearly to non-technical audiences., • Highly organized, detail-oriented, and able to thrive in a fast-paced, deadline-driven environment., • Strong work ethic, resourcefulness, and critical/creative thinking. Additional Skills: • 1–3 years of experience in equity research, investment banking, consulting, or biopharma industry roles (process development, analytical development, manufacturing/CMC, QA/QC, or related)., • Familiarity with biopharma development and regulatory context as it relates to CMC (e.g., comparability, stability programs, method validation concepts)., • Experience with scientific literature review and interpreting preclinical/clinical datasets in conjunction with chemistry/manufacturing constraints., • SIE, Series 63, 86 & 87 preferred (not required upon hiring). Important Notes: • Must be authorized to work full time in the U.S., BTIG does not offer sponsorship for work visas of any type BTIG is a global financial services firm specializing in institutional trading, investment banking, research and related brokerage services. With an extensive global footprint and more than 700 employees, BTIG, LLC and its affiliates operate out of 20 cities throughout the U.S., and in Europe, Asia and Australia. BTIG offers execution, expertise and insights for equities, equity derivatives, ETFs and fixed income, currency and commodities. The firm’s core capabilities include global execution, portfolio, electronic and outsource trading, investment banking, prime brokerage, capital introduction, corporate access, research and strategy, commission management and more. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. BTIG is an equal opportunity employer Minorities/Females/People with Disabilities/Protected Veterans/Sexual Orientation/Gender Identity. Compensation: • BTIG offers a competitive compensation and benefits package. Salary range is based on a variety of factors including, but not limited to, location, years of applicable experience, skills, qualifications, licensure and certifications, and other business and organization needs.

Reporting into Chief Executive Officer, the selected individual will be responsible for oversight of all CMC related strategic & operational activities for drug substance and drug product from preclinical development stage through manufacturing. Lead the drug substance and drug product process devel

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

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Principal Scientist, Regulatory CMC will report to the Director, Regulatory CMC and be responsible for participating in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format. The Principal Scientist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs). Key responsibilities will include contributing to the development of submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc. Essential Functions • Prepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards, • Contribute to the development of global CMC regulatory strategies, • Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation, • Provide expert opinion on CMC topics planned or performed, • Contribute to the design of CMC protocols, • Interact with other groups when needed to address CMC related matters, • Assist with the preparation of responses to Health Authority comments and questions pertaining to CMC issues, • Train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate, • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years relevant progressive experience required, • Experience in the preparation of the submission of CMC modules in eCTD format required, • Familiarity with organizing responses to Health Authority requests required, • Familiarity with regulatory submissions outside of the US desired Knowledge, Skills, & Abilities • Knowledge of Health Authority procedures and guidance regarding document management and electronic submission, • Knowledge of Health Authority CMC guidance documents and requirements, • Proficient in Electronic Document Management Systems, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail, • Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred Working Environment / Physical Environment • This position works on-site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves the close study of scientific and regulatory documents. $170,000 (entry-level qualifications) to $187,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Manager, Veeva RIM will provide strategic and strategic leadership and oversight for Veeva RIM. The manager will manage the day-to-day management and operations of Veeva RIM, ensuring accurate, timely, and compliant uploads and maintenance of regulatory submissions and related documentation across US and ex-US regions. This role parents closely with Clinical, Nonclinical, and CMC regulatory teams to support all regulatory activities. This position will assist and direct staff in the use of Veeva RIM software to ensure that all regulatory content, submissions, and processes are managed efficiently, accurately, and in full compliance with global regulations. Essential Functions • Lead the Regulatory Affairs Veeva RIM Team by delegating projects, establishing and meeting timelines, and ensuring high quality work products., • Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees, and monitoring performance., • Manage dossier archiving and ensure regulatory data integrity, version control, and audit readiness., • Use Veeva RIM to upload and manage all regulatory submissions (e.g., BLA, IND, CTA), registrations, and archival of documents for both US and ex-US., • Upload, track, and maintain all correspondence with health authorities as well as ethic committees., • Partner with IT, Quality, and clinical on system support activities as needed., • Partner with IT, Quality, and clinical on system validation, upgrades, and testing, ensuring compliance with GxP and regulatory standards., • Ensure all regulatory questions, requests, and responses are accurately uploaded and linked properly in Veeva RIM., • Upload and maintain all Word and source documents in the Veeva Vault to enable version control, collaboration, and document updates., • Manage documents received but not limited to via regulatory gateways, emails, secure links., • Establish and maintain RIM-related SOPs, work instructions, and best practices., • Lead or support migration of regulatory and submission documents from legacy systems to Veeva., • Maintain full lifecycle document management: authoring, reviewing, approval, version control, metadata, retention., • Track regulatory submission, • Ensure all regulatory questions, requests, and responses are accurately uploaded and linked properly in Veeva RIM., • Upload and maintain all Word and source documents in the Veeva Vault to enable version control, collaboration, and document updates., • Manage documents received but not limited to via regulatory gateways, emails, secure links., • Establish and maintain RIM-related SOPs, work instructions, and best practices., • Lead or support migration of regulatory and submission documents from legacy systems to Veeva., • Maintain full lifecycle document management: authoring, reviewing, approval, version control, metadata, retention., • Track regulatory submission renewals, post-approval changes, and ensure timelines are met., • Monitor regulatory guidance and changes, perform impact assessment; communicate changes to cross-functional teams., • Ensure compliance with relevant regulatory requirements (FDA, EMA, ICH, local authorities), • Ensure that all working files and archives are organized and maintained in accordance with SOPs and Health Authority requirements, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications., • Provide user support/training for Veeva workflows; act as tool superuser., • Train and support cross-functional uses on Veeva RIM processes and document standards., • Prepare for internal/external audits, inspections, and data integrity assessments, address findings promptly., • Act as a point of contact for troubleshooting Veeva RIM issues and coordinating with system administrators., • Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 7+ years of regulatory operation experience in the biotech or pharmaceutical industry required; or, • High School diploma with 11+ years of regulatory operation experience in the biotech or pharmaceutical industry required., • Familiarity with global regulatory submissions (US and ex-US)., • 2 years of experience managing regulatory documentation using Veeva RIM required., • 2+ years of experience managing staff in support of Regulatory Affairs operations is preferred. Knowledge, Skills, & Abilities • Leadership skills with the ability to direct and develop professional staff, • Strong knowledge of Health Authority guidance documents and requirements., • Strong knowledge of Health Authority procedures and guidance regarding document management and electronic submission., • Strong knowledge of the use of Veeva RIM in document management., • Strong attention to detail and document management skills., • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities., • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $165,000 (entry-level qualifications) to $181,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Associate Director, Regulatory CMC will report to the Senior Director, Regulatory CMC and assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format. The Associate Director will have one or more direct reports, will work closely with cross-functional teams on CMC regulatory strategy and regional regulatory requirements, and will consult with CMC subject matter experts (SMEs). Key responsibilities will include the development of Health Authority submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc. Essential Functions • Provide expert opinion on CMC topics planned or performed, • Manage the preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards, • Assist with the development of global CMC regulatory strategies, • Prepare or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation, • Provide expert opinion on CMC topics planned or performed, • Assist with the design of CMC protocols, • Collaborate with other groups when needed to address CMC related matters, • Prepare responses to Health Authority comments and questions pertaining to CMC issues, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance, • Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required., • Experience in the management and preparation of the submission of CMC modules in eCTD format required, • Experience with organizing responses to Health Authority requests required, • Experience with regulatory submissions outside of the US preferred, • Experience managing staff preferred Knowledge, Skills, & Abilities • Strong knowledge of Health Authority CMC guidance documents and requirements, • Good leadership skills with the ability to direct and develop professional staff, • Expert knowledge of Chemistry, Manufacturing and Controls of a medical product and related regulatory requirements and guidelines, • Expert knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred, • Ability to manage work and staff with firm deadlines and adapt quickly to changing requirements and priorities, • Excellent organizational skills, written and oral communication skills, and attention to detail Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves the close study of scientific and regulatory documents., • This position will work closely with scientific colleagues throughout the day, often on a project team basis., • This position may also need to travel to meet with Regulatory Agencies, attend conferences, or visit manufacturing sites. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $200,000 (entry-level qualifications) to $220,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Support regulatory submission/publishing activities for eCTD global submission dossiers according to Agency and ICH Guidance requirements for major filings, (IND, NDA, sNDA, Amendments, DMFs, etc.) and regulatory maintenance activities. Support global submission timelines and coordination of publishing activities of work-related experience required for this position. Solid knowledge of submission requirements for regional markets may be required to ensure the overall submission and quality of the dossier meets regulatory compliance. Essential Functions Submission Management & Publishing Tasks: Manage assigned regulatory activity projects and closely collaborates with Senior Managers from GSM, Regulatory Affairs and other functional areas for the planning and publishing of regulatory submissions, monitoring submission forecast and ensuring timely high quality of regulatory submissions are submitted to health authority within required submission timelines. Publishing regulatory submissions (bookmarks, hypertext links, QC) scheduled to be submitted to regulatory agencies (e.g., FDA, EMA and Health Canada). Publishing Tasks: Assists with hands-on daily submission compilation and publishing activities associated with preparation of various dossier types Submission Specialist Tasks: • Responsible for publishing, review, submission compilation and archive for routine regulatory activities (e.g. Amendments) and complex eCTD submissions (e.g. IND, NDA)., • Uses internal and industry best practices in order to ensure quality submission deliverables., • Provide operational oversight to ensure timely, high quality regulatory submissions, • Participates in the development of optimal business processes (internal guides, SOPs, etc.) and practices within the department to ensure high levels of customer support and to achieve high quality submissions. Identifies and advises management with regards to opportunities for efficiencies, business process improvements, and cost reductions., • Position accountability/scope includes supervision of certain projects and assistance with priority setting required. Receives project assignments from manager, but has the responsibility for independently managing and executing own projects. Reviews project progress with manager on a regular basis with direction provided on follow-up., • Identifies opportunities and advises management for process improvements or cost savings. May participate on internal project teams in order to guide and update business processes., • Supports various document management assignments, including file transfer, archiving, tracking, and archival of Regulatory submission documentation (including SPL, FDA correspondence and submission)., • Demonstrates team leadership skills and ability to positively influence and work with others. Builds and maintains positive relationships internally and externally., • Participates in other key projects and activities as assigned by management to support the Regulatory Operations function including submission authoring and Regulatory Systems implementation projects. Publishing Tasks: Assist with hands-on daily submission compilation and publishing activities associated with preparation of various regulatory submission types. Applies good judgment and demonstrates initiative to resolve issues. • Expert understanding of Project Management tools and techniques., • Ensures publishing activities are processed in accordance with established SOPs., • Collaborate timeline with the regulatory affairs representatives, maintains the submission timelines, obtain status updates from the Publishing Manager and subteam members, RA Leads and reports submission status and activities to various stakeholders., • Update the regulatory submission calendar, and reports on key submission milestones to stakeholders, as applicable. Business Process Development & Problem Solving: • Participate and contribute to new and updated process and procedures. Review regulatory documents to ensure compliance with submission guidelines to drive efficient future state process including gaining buy in for key stakeholder and drive to standardization of processes., • Identifies risks and opportunities and addresses as needed with a focus on regulatory compliance requirements by supporting best practices, Working Procedures and SOPs., • Support process updates due to changing regulations that impact submission strategies and technologies, SEND, CDISC, Validator Software, etc. This includes not limited to identifying the validation checks needed to ensure compliance with eCTD Specifications for world-wide regulatory agencies., • May participate on internal project teams in order to guide and update business processes, as applicable. Regulatory Information Applications & Technology: • Support technology activities to ensure that regulatory information applications and systems are implemented, validated, and maintained in accordance with regulatory requirements compliance including but not limited to performing UAT scripts)., • Support Global System development and process development on a basic level, and process redesign., • Technical knowledge of the US and global regulatory requirements for electronic submissions Regulatory Training: Support and coordinate training to global submission management, regulatory publishing and other functional areas. Regulatory Submission Intelligence: Perform and collect regulatory information applicable to global electronic submissions guidance, publishing tasks, data standards, and technology and marketing trends in regulatory space. Ability to gather data, analyze research material information and communicate to management potential impact on regulatory operations strategies, and/or identify hot topic issues. Responsible for staying abreast of US, Harmonized (ICH) eCTD and Global guidances, and provide updates as required Requirements • Bachelor's Degree required, preferably in science or health related discipline, • Minimum 3-5 years pharma experience, including at least 1-2 years submission experience, • Experience regulatory professional that understands regulatory submission/ePublishing requirements for filing original applications, amendments, complex supplements/variations and line extensions, as well as routine submissions., • Excellent communication skills required to interact effectively with regulatory affairs members and regulatory colleagues in gathering the necessary information required for submissions, and to proactively address sensitive issues with diplomacy and tact., • Applies good judgment and demonstrates initiative to resolve issues., • Advance understanding of Submission Project Management tools and techniques., • Ensures submissions are processed in accordance with established SOPs., • Excellent analytical and problem solving skills: facilitating team(s) to identify issues and propose solutions with respect to regulatory eCTD submission issue, • Strong Communication Skills: Excellent verbal and written communication skills with demonstrated ability to present and articulate requirements with regulatory affairs members and regulatory colleagues proactively. Ability to foster and maintain relationships with strategic global regulatory organization and other functional partners to ensure understanding of current processes., • Project Management Skills: Strong project management skills with attention to detail, ability to work in a fast-paced environment while successfully prioritizing and working on multiple tasks while utilizing organizational skills., • Knowledge of Drug Development: Experience in regulatory operations or regulatory affairs with advanced knowledge of pharmaceutical development (e.g. CMC, Nonclinical, Clinical), • Technology & Software Skills: Advanced working knowledge of global eCTD publishing and Electronic Document Management technology, ISI Toolbox, Regulatory Tracking Systems (RTS) and related technology applications. Advanced user skill in MS Word, MS Sharepoint, Adobe Acrobat Professional, eCTD content templates and experience., • Teamwork Skills: Experience in working on teams and to establish effective relationships with team members., • Critical Thinking and Problem Solving Skills: Ability to track regulatory eCTD submission changes (e.g. regional DTD upgrade or system upgrades) and interpret potential implications for regulatory activities, training and/or timelines. Ability to identify the root cause of problems as well as the implications associated with potential solutions and communicate to management. Eisai Salary Transparency Language: The annual base salary range for the Senior Associate, Global Submission Management is from :$82,500-$108,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Job Locations US-NJ-Paramus ID 2026-1944 Category Regulatory Affairs Type Regular Full-Time A Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) Strategy is a leadership role within Regulatory Affairs responsible for the global regulatory strategy and execution related to the pharmaceutical quality and manufacturing of drug products. Strategic Leadership:Develop and execute global CMC regulatory strategies for products ranging from early-stage clinical development to post-approval lifecycle management. • Regulatory Submissions:Oversee the preparation and high-quality review of CMC components for major filings, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval supplements. Ensure CMC components in regulatory filings are scientifically sound, compliant, and aligned with ICH, FDA, EMA, and other global guidelines., • Health Authority Interactions:Serve as the primary point of contact for CMC-related negotiations with regulatory agencies, including leading formal meetings and responding to deficiency letters., • Cross-Functional Collaboration: Partner with Quality Assurance, CMC and Clinical Supply, R&D to ensure compliance with cGMP (current Good Manufacturing Practices) and assess the regulatory impact of CMC development plans and manufacturing changes., • Intelligence & Compliance:Monitor the evolving global regulatory landscape and communicate the impact of new guidelines (e.g., ICH guidelines) to senior leadership., • May be required to mentor and provide guidance to junior team members., • A bachelor's degree in a scientific field (Chemistry, Pharmacy, Biology, or Engineering) is required; an advanced degree (MS, PhD, or PharmD) is highly preferred., • Requires 10-15+ yearsin the pharmaceutical industry, with at least 8-10 years specifically focused on CMC regulatory affairs, • Deep expertise in eCTDsubmission formats, global regulatory requirements (US, EU, and Canada), and a proven track record of successful marketing application approvals., • Strong negotiation, conflict management, and the ability to influence cross-functional teams without direct authority., • Expertise with multiple dosage forms for small molecule drugs is preferred, • Experience with biologics is a plus., • Ability to travel up to 20% of the time domestically and internationally, • Experience working with Veeva

Job Locations US ID 2026-1934 Category Medical Affairs Type Regular Full-Time Working closely with the Early Development Lead, the Senior/Executive Director of Clinical Development Oncology will lead clinical execution of targeted protein degradation (TPD) projects for SK Life Science Labs (SKLSL) with a dotted line into its sister company, SK Life Science Inc. (SKLSI). This role will provide strategic leadership across both preclinical and clinical development, ensuring seamless translation of discovery and preclinical findings into early- and late-stage clinical programs, with a particular focus on oncology. The incumbent will provide therapeutic and translational expertise to the development of the current TPD asset(s), while also contributing to portfolio and pipeline strategy. The role includes close partnership with discovery, preclinical, translational, CMC, regulatory, and clinical operations teams to enable efficient progression from IND-enabling activities through clinical proof-of-concept. The position reports to the Chief Scientific Officer of SK Life Science Labs with a dotted line to the Chief Medical Officer of SK Life Science Inc. Preclinical and Translational Development Provide clinical and translational leadership to preclinical oncology programs • Partner closely with discovery and preclinical teams to ensure alignment between biological rationale, nonclinical data packages, and clinical development plans, • Contribute to the design, interpretation, and integration of:, • In vitro and in vivo efficacy models, • PK/PD and biomarker strategies, • Translational endpoints to support dose selection and first-in-human studies, • Provide medical and scientific input into IND-enabling studies, including toxicology, safety pharmacology, and reproductive toxicology, • Support development of translational and biomarker strategies to enable early signal detection and patient selection in oncology trials, • Participate in the development of integrated product development plans and clinical trial strategies informed by preclinical and translational data, • Lead the design and conduct of clinical trials and, as a member of the internal SK Life Science Inc. Clinical Development/Medical Affairs team, provide operational oversight by collaborating with internal and external operations personnel, • Provide medical expertise regarding product development or other scientific issues for drug discovery, development, and senior management decision-making, • Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials, • Participate in pharmacovigilance activities, including SAE evaluation, safety signal assessment, and ongoing analysis of safety data, • Participate in preparation and review of protocols, Investigator Brochures, clinical study reports, safety reports, and clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOPs, pediatric investigation plans, as well as abstracts and manuscripts, • Interface with regulatory agencies for clinical development programs and regulatory submissions as needed, • Oversee scientific interactions with medical consultants, advisors, and clinical investigators, • Training in and adherence to Good Clinical Practices (GCP); working knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) as they relate to preclinical and clinical development, • Knowledge of relevant global regulatory guidance impacting preclinical, translational, and clinical development, • Experience interacting with FDA and other global health authorities preferred, • Evidence of ability to work with opinion leaders, • Must be able to work effectively in a team setting, • Communication skills necessary to:, • Represent the Company externally in scientific presentations, conferences and industry groups;, • Present to internal stakeholders; Interact with industry, • M.D. degree with specialized training in oncology preferred, • Practice experience preferable but not required, • Minimum of 10 years of experience in clinical development in the pharmaceutical industry, preferably with oncology compounds or relevant academic research experience, • Ability to multitask, • Adapts to change, • Maintain composure under pressure, • Ability to follow verbal or written instructions and use of effective verbal communications, • Adapts change, adjust change and grasps information quickly, • Examine and observe details

• Job Type: Officer of Administration, • Bargaining Unit:, • Regular/Temporary: Regular, • End Date if Temporary:, • Hours Per Week: 35, • Standard Work Schedule:, • Building: Reporting to the Executive Director, the Senior Associate Director, Career Education and Advising designs and delivers career education programs, liaises with academic Centers & Programs, and provides one-on-one and small-group career advising and executive coaching. The role is responsible for supporting the career and professional development of Columbia Business School's graduate business students and alumni. The ideal candidate will demonstrate strong relationship-building skills with students, employers, and internal partners, along with excellent presentation, written, and interpersonal communication skills. About Columbia Business School For over a century, Columbia Business School has helped develop leaders and builders of enterprises who drive value for their stakeholders and society at large through our MBA, MS, PhD, and Executive Education programs. We are equally committed to cultivating new scholars and teachers and to creating and disseminating pathbreaking knowledge, concepts, and tools that advance the understanding and practice of management through our faculty research and PhD programs. Our vision is simple: to develop ideas and leaders that transform the world - from the very center of business. Our ever-evolving curriculum - featuring pioneering courses, STEM certification, and immersive experiential learning - prepares students to excel in key areas such as digital transformation, entrepreneurship, AI and innovation, twenty-first-century finance, the intersection of business and society, and climate and sustainability. The CBS administration enables CBS' educational and scholarly mission through strategic and operational guidance and support, optimizing School resources through well-designed, transparent processes with a culture of respect for all. Responsibilities Program Management, Development and Delivery * Partners with colleagues across CMC and the Business School to plan, develop, and deliver career education and professional development programs, including individual presentations, speaker series, panels, company visits, and other market-facing networking & educational events. Utilizes a variety of delivery formats such as webinars, live workshops, and short-form videos. * Leads the planning and execution of large-scale industry and networking events in collaboration with the School and employer partners, ensuring strong representation and managing event logistics. * Supports School-wide events, including career fairs, career action groups, on-campus recruiting, and other programs as assigned Coaching and Advising * Provides one-on-one and small group executive coaching and career advising on topics related to internship and full-time searches, self-assessment, self-marketing, networking, interviewing, and industry-specific job strategies. * Advises students on broader professional development topics such as executive presence, relationship management, and key workplace success factors. Data, Marketing, and Communications * Tracks job-seeking outcomes and identifies trends and patterns of candidates seeking a job change. * Conducts analysis of the data sets and presents findings regarding employment change trends to various business school stakeholders. * Manages and supports projects such as resume book production, on-campus recruiting qualification processes, and updates to online resources used by students in their job search. Also conducts one-on-one resume reviews. * In partnership with colleagues, develops key messages for periodic newsletters to students and alumni, highlighting upcoming programs, job opportunities, career research, and best practices. Engagement and Relationship Management * Independently cultivates relationships with alumni, current students, and recruiters to source panelists for industry sessions and company visits while leveraging engagement for employer referrals. Accompanies student groups to company visits after regular business hours, when needed. * Builds strong working relationships with the broader Career Management Center team, Office of Student Affairs, Admissions, Dean's Office, and other relevant Business School departments to facilitate seamless integration of CBS resources for student and alumni stakeholders served by the CMC. * Partners with colleagues on CMC Marketing & Communications and Strategic Partnerships teams to maintain contact databases and execute email marketing programs for employer outreach. * Participates in ongoing professional development activities to enhance skills related to career advising and program design. * Other related duties as assigned. Minimum Qualifications • Bachelor's degree is required, and a minimum of 4-6 years of related experience is required., • MBA or master's degree in counseling or higher education fields preferred., • Strong program and project management skills with demonstrated experience in relationship development., • Ability to excel in a fast-paced, high-volume environment., • Proficiency in Microsoft Office Suite, including Excel, PowerPoint, and Outlook, and/or Google Slides, Google Sheets, and Google Docs., • Strong professional demeanor, customer service orientation, and ability to engage with diverse stakeholders. Ability to manage difficult situations with firmness and diplomacy., • Ability to balance independent work with a collaborative approach., • Proactive, self-starter with strong problem-solving skills and the ability to navigate complex situations with tact and professionalism., • Excellent written and oral communication skills, including presentation abilities., • Experience in higher education and corporate settings, and experience working with executive-level professionals strongly preferred., • International experience or experience working with a diverse, global student population. Columbia University is committed to the hiring of qualified local residents.

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

Physical Therapist and Experience in Acute Care. All of which are provided by a highly trained staff comprised of physiatrists; internists; physician assistants; nurse practitioners; rehabilitation nurses; physical, occupational, and recreational therapists; speech-language pathologists; social work

Required hours are: 11:00AM-7:00PM, one weekday including every other weekend.

Atlantic Health System offers a competitive and comprehensive Total Rewards package. At Atlantic Health System, our promise to our communities is; Anyone who enters one of our facilities, will receive the highest quality care delivered at the right time, at the right place, and at the right cost. He

Top Places to work in Healthcare - Becker's Healthcare. Patients from Chilton Medical Center, Hackettstown Medical Center, Newton Medical Center, and Overlook Medical Center are seamlessly connected to Morristown when advanced cardiovascular care is necessary thanks to an infrastructure that include

Full-Time Environmental Aide I (Housekeeping).Full-Time Environmental Aide I (Housekeeping).Environmental Services Department at Chilton Medical Center.Essential Function/Responsibilities:.Utilizes appropriate cleaning equipment in cleaning all nursing units, patients' rooms and all other designated

The Associate Director, Drug Product, will provide strategic and hands-on operational leadership for all CMC activities related to drug product development and manufacturing, with a primary focus on sterile injectables (lyophilized and liquid) at all stages of development (IND-enabling to commercial

Under the supervision of the Phlebotomy Supervisor, the Phlebotomist ensures accurate specimen collection, labeling, and handling. Minimum two (2) years previous job experience as a phlebotomist preferred.

This position is ideal for students interested in careers in pharmaceutical development, manufacturing sciences, or technical operations. Chemistry or related engineering/science discipline.

This position is ideal for students interested in careers in pharmaceutical development, manufacturing sciences, or technical operations. Chemistry or related engineering/science discipline.

Job DescriptionBenefits: • 401(k), • 401(k) matching, • Bonus based on performance, • Dental insurance, • Health insurance, • Vision insurance Position Summary: The Inside Sales & Support Representative role will be responsible for supporting our field sales team, management, retention, and growth of existing house account base and lead generation. This position reports to the President. The role requires the individual to enter contacts, samples, quotes and opportunities in Dynamics CRM system. Sales Job Responsibilities 1. Coordinate and lead monthly/quarterly business reviews on house accounts. Monitor sales performance. Contact customer service/client to identify shortfalls in sales and correct as necessary, 2. Proactive communication and support with assigned accounts to increase maintain/increase sales, drive email blasts, 3. Review customer purchasing histories to gain insight and opportunities for penetration and growth. Monitor Power BI based performance metrics and sales scorecards, 4. Utilize Dynamics CRM system to document, track and manage all account related activities including quotes, sample and notes/correspondence, 5. Perform lead follow up and verification (UL prospector), 6. Work with customer service to maintain key procurement personnel., 7. Align with sales team and management on initiatives to target and develop key house accounts (mailers, emails blasts, webinars), 8. Manage 3rd party sample distribution company (CMC warehouse) Qualifications • BA/BS from accredited institution, • 2-5 years experience in sales, inside sales/support, • Ability to handle /maintain/retain large amounts of information on accounts, • Highly organized, • Experience in chemicals major plus, • Experience in Dynamics or related CRM systems (required), • MUST be comfortable with TALKING to customers/TEAMS interactions, • Computer expertise (typing, grammar etc.,) Position Type/Expected Work Hours Chemspire is normally open from 8;30-5pm Monday to Friday. You will be assigned a work schedule and you will be expected to begin and end work according to the schedule. You will be required to work in our Boonton offices full time. Flexible work from home will only be agreed on after satisfactory completion of 90 evaluation period

Job DescriptionJob Title: Certified Medical Coder – Outpatient & Emergency Department (ED) Location: Bronx, NY (Remote after training) Duration: 13 weeks (Contract) Shift: 8:00 AM – 4:00 PM Position Summary A healthcare organization is seeking an experienced Certified Medical Coder with strong expertise in outpatient and emergency department (ED) coding. This role begins with short-term onsite training and transitions to a remote work arrangement. The ideal candidate will be able to work independently with minimal supervision. Key Responsibilities • Perform medical coding for outpatient and emergency department services, • Assign accurate codes using ICD-10, CPT, and applicable coding systems, • Ensure compliance with coding, payer, and federal billing guidelines, • Review clinical documentation for accuracy and completeness, • Utilize coding tools and software (e.g., EPIC, 3M encoder systems), • Research and resolve coding-related issues, • Maintain accurate records and meet productivity/quality standardsRequirements, • High School Diploma or GED required, • Certification required: CCS or CCP (through AHIMA) or RHIA/RHIT, • Minimum 3+ years of coding experience (4+ years preferred), • Strong experience in outpatient and ED coding (required), • Knowledge of ICD-10, CPT, and coding guidelines, • Experience with EPIC and 3M coding systems (required), • Understanding of anatomy, physiology, and disease processes, • Strong computer skills (MS Word, Excel, coding software), • Ability to work independently with minimal trainingWork Arrangement, • Initial 1–2 weeks onsite for training (flexible) About Navitas Healthcare, LLC: It is a certified WBENC and one of the fastest-growing healthcare staffing firms in the US providing Medical, Clinical and Non-Clinical services to numerous hospitals. We offer the most competitive pay for every position we cater. We understand this is a partnership. You will not be blindsided and your salary will be discussed upfront.

Job Description Role Summary Lexeo is at an inflection point where AI and advanced analytics can materially accelerate decision-making across discovery, development, and operational execution. This Sr. Director will set direction and deliver applied AI/ML solutions across internal workflows and externally facing outputs, ranging from R&D insights to partner-ready analyses, while partnering closely with scientific teams and, when needed, external vendors/partners to solve real problems. This role is intentionally hands-on and outcome-driven: a leader who can build, validate, and operationalize models using real-world biopharma data to raise the signal-to-noise ratio in small or unstructured datasets (including synthetic control arm approaches where appropriate). Key Responsibilities AI/ML Strategy + Delivery * Define and execute Lexeo’s applied AI/ML roadmap across discovery and development, prioritizing use cases that improve speed, quality, and decision confidence. * Deliver solutions that are internal-only (e.g., scientific decision support, operational forecasting) and those that are generated internally but external-facing (e.g., partner-ready analyses (regulatory dossiers, briefing books, protocols etc.), validated dashboards, and decision materials). * Establish best practices for model lifecycle management (validation, documentation, monitoring, retraining), especially where outputs influence scientific decisions or regulated workflows. Advanced Analytics + Predictive Modeling * Lead development and selection of appropriate ML approaches (e.g., XGBoost, Random Forest, SVMs, and other advanced models) based on problem framing, data constraints, interpretability needs, and deployment context. * Build and oversee predictive analytics using real-world data, including robust evaluation design, bias/variance trade-offs, and performance monitoring. Small Data Excellence + Synthetic Controls * Apply techniques to amplify signal-to-noise in smaller datasets (e.g., regularization, Bayesian methods, hierarchical modeling, augmentation, multimodal integration, careful feature engineering, uncertainty quantification). * Guide strategy for synthetic control arms and comparable approaches (as appropriate), ensuring methodological rigor, transparency, and fit-for-purpose use in decision-making. Drug Discovery / Translational Partnership * Translate drug discovery and translational questions into testable analytical hypotheses; partner with bench scientists to design data capture that enables strong modeling. * Serve as a bridge between scientific teams and data/engineering, ensuring solutions are scientifically credible and operationally adoptable. Cross-functional Enablement + Platform Integration * Partner with stakeholders across R&D, CMC, Clinical, Safety, and IT/Security to implement scalable data pipelines and AI-enabled workflows. * Contribute leadership to current and emerging initiatives such as AI workflow automation/database buildouts and analytics agents that leverage enterprise platforms (examples already in motion include CMC AI automation, MaxisAI clinical database/AI efforts, and AI work to ingest historical data into Dataverse/Fabric for agent-based analysis; integration work such as a Benchling AI API initiative may also be in scope depending on priorities). External Partner/Vendor Leadership * Liaise with external partners to evaluate tools, define statements of work, and deliver solutions—while ensuring knowledge transfer and sustainable internal ownership. Operational Excellence * Improve internal processes through automation and analytics, focusing on measurable impact (cycle time, error reduction, throughput, decision latency). * Establish practical governance for data quality, documentation, and fit-for-use standards aligned with the realities of biopharma environments (including where regulated practices apply). What Success Looks like (First 6-12 Months) * A prioritized AI/analytics roadmap tied to measurable R&D outcomes; clear ownership and delivery cadence. * 2–4 production-grade analytics solutions adopted by teams (internal and/or external-facing outputs as needed). * A repeatable approach for small datasets and high-noise signals; documented modeling standards and review practices. * Strong partner engagement model: vendors/partners used strategically, with internal capability building and durable outcomes. Required Qualifications * Advanced degree in a quantitative or scientific discipline (PhD strongly preferred; MS with exceptional experience considered). * 10+ years of relevant experience across applied data science/ML in life sciences/biopharma (or adjacent domain with direct drug discovery translation), including 5+ years leading teams and influencing senior stakeholders. * Deep familiarity with advanced ML methods (including XGBoost, Random Forest, SVMs) and the judgment to select and justify the right tool for the job. * Demonstrated experience building predictive models with real-world, imperfect datasets and delivering them into production or decision workflows. * Proven ability to improve processes and operationalize analytics—moving beyond prototypes to adoption. * Strong cross-functional communication: can partner with scientists, engineers, and executives; can explain model performance and limitations clearly. Preferred Qualifications * Direct experience in drug discovery, translational research, and/or R&D decision support (target ID/validation, MoA, biomarker strategy, preclinical data integration). * Experience with small data strategies, causality-aware thinking, and synthetic control arms or closely related methodologies. * Experience operating in regulated/quality-sensitive environments and building documentation practices that scale (particularly relevant where validation and traceability are required) * Familiarity with enterprise data platforms and modern analytics stacks (lakehouse/warehouse patterns, feature stores, MLOps, model monitoring). Compensation is dependent on qualifications and experienceAbout Lexeo Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact. Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home. Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix is looking for a full-time Senior Director of Program and Portfolio Management (PPM) to effectively shape and implement PPM strategies decision making for a complex portfolio of drug development programs and execution of decisions. The Senior Director of PPM will be a responsible for implementing portfolio management best practices, drafting strategic and operational plans, mentoring project managers (PM) and operational staff, and supporting effective communications across multiple departments at Tonix. The individual in this position will also be responsible for building out the team of PMs which would report into this role. This is a fast-paced, challenging position offering a competitive compensation and benefits package. This position will report directly to the Company’s Chief Operating Officer that will ideally be based at the Tonix Chatham, NJ office. Essential Duties • Lead and manage cross-functional teams interacting with clinical, nonclinical, regulatory, CMC, discovery, and others to set priorities, work toward goals and monitor progress of programs, • Develop portfolio tools and materials to support portfolio decision-making, • Create, implement, and refine PPM practices to support leadership, PPM staff, and delivery of program goals, • Lead regular portfolio operations committee meetings and portfolio strategy sessions, • Coordinate and manage due diligence teams and decision making on in licensing activities for the portfolio, • Help to buildout and lead PMs responsible for developing cross-functional program plans, timelines, and budgets in collaboration with functional area leads, • Facilitate effective, science-based business decisions including development of scenarios and strategic impact of decisions, • Ensure all decisions are assessed as to their risks and impacts as well as accountable for communication to team and stakeholders in a transparent and timely manner, • Function as an integrator within the project team and across the Company to ensure alignment, • Develop and coordinate resource and budget planning activities across functions to ensure adequate resources are applied to the programs and decisions are assessed for portfolio impact, • Provide leadership to teams and functional areas to proactively anticipate and identify project issues which pose a challenge to achieving strategic goals; propose and implement plans to resolve such issues, and execute corrective actions, • Effectively execute change management to implement strategies for effecting, controlling, and helping teams adapt to change, • Provide updated project information for the Board as well as for regular budget and portfolio reviews, • Enable high-performing teams by ensuring good team dynamics within the project team, • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s), • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork, • Recruits, interviews, hires, and trains new team members, • Oversees the daily workflow of the department, • Provides constructive and timely performance evaluations, • If necessary, handles discipline and termination of employees in accordance with company policy, • Bachelor’s degree and fifteen (15) years of relevant project / program / portfolio management experience within the pharmaceutical / biotechnology industry; or a PhD in a scientific field or a PharmD, DVM or MD degree with ten (10) years of relevant experience preferred, • Scientific background and/or MBA preferred, • Ten (10) years of leading cross-functional program or portfolio management activities within the pharmaceutical industry with a deep understanding of practices and standards of pharmaceutical program and portfolio management preferred, • Experience managing PM professionals in the drug development industry, • Strong leadership presence with the ability to translate strategy into action, • Excellent analytical skills with an ability to summarize and present complex information in a clear and concise manner to support decision-making, • Ability to create an inclusive environment and lead empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration, • Outstanding verbal and written communications skills with the ability to effectively interact with and influence all levels within the company, • Ability for minimal travel, • Dedicated team player who is able to withstand the high demands of a fast-paced environment Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $200,000 to $300,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

Job Description Who We Are TetraScience is the Scientific Data and AI company. We are catalyzing the Scientific AI revolution by designing and industrializing AI-native scientific data sets, which we bring to life in a growing suite of next gen lab data management solutions, scientific use cases, and AI-enabled outcomes. TetraScience is the category leader in this vital new market, generating more revenue than all other companies in the aggregate. In the last year alone, the world’s dominant players in compute, cloud, data, and AI infrastructure have converged on TetraScience as the de facto standard, entering into co-innovation and go-to-market partnerships: Latest News and Announcements | TetraScience Newsroom: In connection with your candidacy, you will be asked to carefully review the Tetra Way letter, authored directly by Patrick Grady, our co-founder and CEO. This letter is designed to assist you in better understanding whether TetraScience is the right fit for you from a values and ethos perspective. It is impossible to overstate the importance of this document and you are encouraged to take it literally and reflect on whether you are aligned with our unique approach to company and team building. If you join us, you will be expected to embody its contents each day. Who You Are You are a product-minded, outcome-obsessed driver of technical scientific solutions. You a high velocity self-starter. You refuse to let uncertainty obstruct your path to designing and building solutions. You roll up your sleeves, try things out, and get things done. You do not hesitate to prototype, demo, and build in order to accelerate delivery of products for your end users. You thrive in environments where you can collaborate with scientists, product managers, and engineers to transform complex scientific data into actionable outcomes. Your ability to engage with scientists and business leaders alike makes you a key player in maximizing the value of scientific data. With rich experience applying cutting edge data methodologies to the biopharma R&D domain, you bridge understanding between present-day pain points and generalizable solutions. You are an insatiable learner, with a track record of deeply learning new tools, methods, and domains. You fundamentally embody the principles of extreme ownership and have a demonstrated history of building extensible data models and applications for Biopharma end users to maximize value from their data via analysis and integration with AI/ML. This role will require extreme self-discipline and determination as we forge a category that will fundamentally and forever change the life science industry. What You Have Done • PhD with +4 years or Masters with +8 years of industry experience in life sciences with extensive domain knowledge in drug discovery (target ID through lead optimization), preclinical development, CMC (all drug modalities), or product quality testing., • Proven track record of defining, designing, prototyping, and implementing productized AI/ML-driven use cases in cloud environments, • Collaborated with cross-functional teams, including product managers, software engineers, and scientific stakeholders., • Performed extensive exploratory data analysis and workflow optimization to enable scientific outcomes not previously possible., • Engaged diverse audiences, from scientists to executive stakeholders using your excellent communication and storytelling abilities., • You will be a critical team member in a unique partnership to industrialize Scientific AI. As such, you will engage directly with customers onsite a few times a week in the New York Region, building strong relationships, deeply understanding their scientific data challenges and requirements, and accelerating solutions., • Design and implement extensible, reusable data models that efficiently capture and organize scientific data for scientific use cases, ensuring scalability and future adaptability., • Translate scientific data workflows into robust solutions leveraging the Tetra Data Platform., • Own, scope, prototype, and implement solutions including:, • Data model design (tabular & JSON), • Python-based parser development., • Lab software (e.g., ELN/LIMS) integration via APIs., • Data visualization and app development in Python (using app frameworks like Streamlit and plotting tools like holoviews and Plotly), • Collaborate with Scientific Business Analysts (SBAs), customer scientists and applied AI engineers to develop and deploy models (ML, AI, mechanistic, statistical, hybrid), • Programmatically interrogating proprietary instrument output files., • Dynamically iterate with scientific end users and technical stakeholders to rapidly drive solution development and adoption through regular demos and meetings, • Proactively communicate implementation progress and deliver demos to customer stakeholders., • Collaborate with the product team to build and prioritize our roadmap by understanding customers’ pain points within and outside Tetra Data Platform., • 100% employer-paid benefits for all eligible employees and immediate family members, • Unlimited paid time off (PTO), • 401K, • Company paid Life Insurance, LTD/STD, • Remote Work, when not visiting customers onsite We are not currently providing visa sponsorship for this position.

Job Description Primary Responsibilities · Lead Clinical Pharmacology strategy across early and late stage development, integrating PK, PD, exposure–response, and biomarker data to inform dose selection, regimen, and overall study design. · Own model informed drug development (MIDD) plans (e.g., population PK, PBPK, and quantitative systems approaches) to optimize trial designs and decision points from first in human through pivotal phases. · Author and review CP deliverables for protocols, clinical development plans, IBs, SAPs, and regulatory documents (IND/IMPD/NDA/BLA/MAA), ensuring clarity, traceability, and compliance. · Drive analysis & reporting of PK/PD and exposure–response results (internal and CRO executed), ensuring scientific integrity, reproducibility, and timely insights for program teams and governance. · Establish bioanalytical strategy and standards (method selection/validation, sample handling, and data QC) in partnership with Translational Medicine and external labs/CROs. · Lead Health Authority interactions for CP topics; prepare briefing materials, address IRs, and represent the function in meetings with FDA, EMA, and other agencies. · Provide cross functional leadership with Clinical, Biostatistics, Data Science, CMC, and Regulatory to integrate quantitative evidence into go/no go decisions and portfolio prioritization. · Vendor selection and management for CP related CROs; define scopes, oversee execution, and ensure deliverables meet quality and timeline commitments. · Advance standards & governance (CDISC/ADaM for PK datasets, data pipelines, analysis reproducibility), championing best practices and inspection readiness for a GxP environment. · People collaborations (please note this is an individual contributor role): Must roll up sleeves and be a doer who wants to be into the details themselves. Mentor staff cross functionally and foster an inclusive, high-performance culture consistent with Immuneering values. Qualifications Education · Education: PhD or PharmD (or MS with significant industry experience) in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related quantitative field required. · Experience: Minimum of 5+ years in biotech/pharma Clinical Pharmacology required, more years of experience is a plus, including end-to-end ownership of CP strategy, MIDD, and regulatory submissions across Phase 1–3. · Technical depth: • Population PK/PD modeling (NONMEM, Monolix), PBPK (Simcyp, GastroPlus), and exposure–response methods., • Bioanalytical method development/validation oversight and data integrity in GxP contexts. Soft skills: Strong experience working as an individual contributor. This is a single employee function expected to collaborate with internal functions for success. Exceptional scientific communication, cross functional influence, vendor management, and decision making in fast paced settings. Must embody Immuneering’s core values of: Data Rules, Humble, All In, Care and Own It (accountability). Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job Overview: We are looking for our first Technical Subject Matter Expert in Drug Product to join our team and contribute to our innovative projects and commercial production. You'll provide strategic technical input, manage manufacturing partnerships, contribute to CMC regulatory submissions, and drive product/process improvements. If you're an experienced pharmaceutical professional eager to drive innovation in drug development and ensure robust compliance, this role offers a compelling challenge. Location: Hybrid in our New York City office or Remote in the United States. Reports to: Technical Director, Manufacturing and Supply. Roles and responsibilities (Include but are not limited to): • Technical Subject Matter Expert for all aspects of Compass' Drug Products (DP) in the US in particular, and also aspects of Compass Drug Substances (DS) where appropriate, • To manage, track, and report progress on DP projects and commercial production programs, and to provide strategic and technical input to these projects/programs, • Ensure effective relationships with Compass' Manufacturing partners (CMOs/CDMOs and key suppliers) as required, meeting business objectives and timelines, • To contribute to the writing of relevant dossier sections for CMC regulatory submissions, and ensure technical compliance with recognised regulations and standards, • Identify opportunities for product and process improvements during development and scale up, • To support the Manufacturing & Supply team in any section-related activities as required and as appropriate, • To support compliance and efficiency related projects, • Identify risks, implement mitigation & controls, monitor & report status Candidate Profile: • Education level, • Minimum of Bachelor's degree in science, or equivalent, • Experience, • Demonstrated relevant experience within the pharmaceutical industry; must have DP experience across a variety of formulations and dosage forms, • Experience working with, or for, contract manufacturing organisations (CMOs/CDMOs), • Experience of contributing to CMC Regulatory content., • Experience in technology transfer, process validation and process monitoring, • Technical experience supporting manufacturing within a Quality Management System, • Ability to prioritise tasks and objectives to ensure business goals are achieved, • Specific skills, • Excellent interpersonal communication and strong Stakeholder management skills, • Knowledge and expertise in formulation of DP and dosage forms, • Project Planning & Risk Management, • Ability to react to changing priorities Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$127,500—$172,500 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description At The Senior Company, we are committed to providing exceptional care and support to seniors and their families. We value compassion, integrity, and teamwork, and we are looking for individuals who share our passion for serving the aging population. We are seeking an experienced Social Worker/Geriatric Care Manager to join our team. You will play a crucial role in coordinating comprehensive care for our clients. This position requires a proactive and empathetic professional who can navigate the complexities of geriatric care, advocate for clients, and foster meaningful connections with families and healthcare providers. This position is a field position and requires regular travel to client homes and communities. Key Responsibilities: • Conduct thorough assessments to evaluate clients' physical, emotional, and social needs., • Collaborate with clients, families, and interdisciplinary teams to create and implement individualized care plans that prioritize client goals and preferences., • Manage all aspects of client care, including scheduling appointments, coordinating services, and following up on progress., • Help clients and families access community resources, including financial assistance, transportation services, and home care options., • Act as an advocate for clients in medical settings, ensuring clear communication between clients and healthcare providers., • Provide education to clients and families about aging-related issues, care options, and available resources., • Maintain accurate and up-to-date records of client interactions, care plans, and progress notes in accordance with agency policies and regulations., • Experienced social worker with a background in senior care. Experience in skilled nursing facilities (SNF) or assisted living/independent living facilities (ALF/ILF) is a plus., • Must have active NJ LSW or LCSW license, • Certification as a Geriatric Care Manager (CCM, CMC, or equivalent) is highly desirable., • Valid driver’s license and reliable vehicle, • Health and Wellness Insurance plans such as medical, dental, vision and more, • 401k Retirement Savings Plan, • Flexible PTO, • Paid Major Holidays, • Travel and Entertainment Member Deals Powered by JazzHR NouLFa4LNR

Job Description Part-Time Optometrist (Mobile Care) Location: Williamstown • Vineland • Surrounding NJ Areas Start Date: February 2026 Compensation: $900 Per Day (Guaranteed) About Us Comprehensive Mobile Care (CMC) is a family-owned healthcare organization with 25+ years of experience and a flawless ethical and legal track record. Our mission is simple and powerful: bring high-quality healthcare directly to geriatric and underserved populations who need it most. We provide portable dentistry, podiatry, audiology, and optometry services across 20+ states, partnering with Senior Centers, Skilled Nursing Facilities, Assisted Living Facilities, and Veteran Homes. Our team handles all logistics, equipment, scheduling, and billing, allowing providers to focus entirely on patient care. Position Summary CMC is seeking a compassionate, reliable Part-Time Optometrist to serve facilities in the Williamstown/Vineland region and nearby communities. This is an excellent opportunity for an OD looking to supplement their current schedule, enjoy flexible, low-volume work, and make a meaningful impact in long-term care settings. This is an independent contractor role with full administrative support—no overhead, no staffing, no insurance headaches. Key Responsibilities • Perform routine eye exams, refractions, and vision screenings, • Diagnose and manage ocular diseases common in geriatric populations, • Prescribe corrective lenses and coordinate with optical labs, • Doctor of Optometry (OD) degree, • Active New Jersey optometry license, • Minimum 1 year of clinical experience (geriatric or mobile care experience preferred), • 2–3 visits per month, • Weekdays only (Monday–Friday), • No weekends or holidays, • Typical hours: 8:30 AM – 4:30 PM 👓 Ready to make a difference while keeping your flexibility? Apply today and help bring compassionate, high-quality care directly to the communities that need it most.

Job DescriptionRole Summary The Translational Science and Clinical Biomarker (TSCB) team is comprised of drug development scientists representing pharmacology, toxicology, non-clinical bioanalytics and clinical biomarker development and operational support. The Manager/Sr. Manager, Non-Clinical Operations position will support operational oversight and conduct of outsourced small and large animal non-clinical studies at contract research organizations (CROs) related to AAV-based gene therapy for cardiac disorders. Key functions of the position include direct interactions with preclinical CROs, qualification of vendors, oversight and coordination of study logistics (e.g., contracts, test articles, study records, etc.), and monitoring of non-clinical studies at specific milestones. Importantly, this position will interface with Medical Writing and liaise with contractors to manage authoring and review of non-clinical study reports and non-clinical sections/modules of regulatory documents such as pre-INDs and INDs. Primary Responsibilities • Lead work plans (SOWs) by working with department leaders, key stakeholders and CROs following the principles of Good Laboratory Practices (GLPs/21 CFR 58), where applicable, and company Standard Operating Procedures (SOPs), • Coordinate meetings with vendors to ensure agendas are appropriate for the discussion, ensure meeting minutes are documented, follow-up on action items, and provide status updates to the internal teams, • Liaise with bioanalytical leads to ensure bioanalysis is well coordinated with in-life study phases, and that samples are appropriately tracked throughout the lifetime of the study and any agreed storage period, • Monitor the study plan, timelines, and progress of study deliverables against forecasted timelines and budget and escalate issues that impact the study plan or budget in an effective and transparent manner, • Work closely with quality assurance to ensure compliance is checked as appropriate, • Summarize key findings of data as well as relevant scientific publications in presentations for internal review, • Work closely with Medical Writing and contractors to manage authoring and review of non-clinical study reports and non-clinical sections/modules of regulatory documents such as pre-INDs and INDs, • Coordinate with other internal and external stakeholders, including Clinical, CMC, Regulatory Affairs, and Finance and Accounting teamsRequired Skills & Qualifications, • BS with 10+ years, MS with 8+ years or Ph.D. with 4+ years in life sciences, pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences or equivalent, • Experience in AAV gene therapy products for minimum of 2 years, • Working knowledge of GLP and ICH guidelines, • Experience managing studies and authoring non-clinical sections of regulatory documents, particularly pre-INDs and INDs, • Cross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity, • Results oriented, has a bias for action. Strong initiative, accountability, and willingness to take ownership and drive projects to completion, • Accustomed to “roll up their sleeves” and execute the tasks needed in a small company environment, • A demonstrated sense of urgency and ability to work independently and under tight deadlines is required

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters. Responsibilities • Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information., • Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions, • Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies, • Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings., • Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests., • Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions, • Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization, • Develops, implements, and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC., • Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company., • Trains, develops and mentors individuals; may include formal supervisory responsibilitiesQualifications, • Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject., • Preferred Education: Relevant advanced degree preferred. Certification a plus., • Required Experience: 8 years pharmaceutical with at least 3 years of demonstrated leadership, • Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing., • Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority., • Experience working in a complex and matrix environment., • Strong oral and written communication skills., • Note: Higher education may compensate for years of experience Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Description Director, Clinical Project Management (Remote) Position Summary The Director of Project Management will oversee and drive the execution of global clinical trials in oncology. This leadership role is responsible for ensuring the successful planning, implementation, and completion of complex clinical programs, collaborating with cross-functional teams and external partners worldwide. Key Responsibilities • Lead the strategic planning and operational execution of global oncology clinical trials, ensuring projects are delivered on time, within scope, and budget., • Work with cross-functional project teams, including Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Data Management, and external vendors., • Develop and maintain detailed project plans, timelines, and risk management strategies for all assigned studies., • Monitor trial progress, proactively identify issues, and implement solutions to ensure quality and regulatory compliance., • Contribute to process improvement initiatives and best practices in global project management., • Work closely with other professional project managers who work in our early stage development programs. Education & Qualifications • Bachelor’s degree in life sciences, healthcare, or related field; advanced degree (MS, PhD, MBA) preferred., • Minimum of 8 years’ experience managing global clinical trials in oncology, with demonstrated leadership in complex, multi-center studies and global regulatory submissions., • Proven track record in project management within the biopharmaceutical industry., • Strong understanding of regulatory requirements (FDA, EMA, ICH-GCP) for global clinical development., • Ability to travel domestically and internationally as required. Technical / Soft Skills • Exceptional communication, organizational, and leadership skills., • Must be a strong champion of our Values: All in, Data Rules, Care, Humble, Own It (Accountable) Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

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We're currently looking for individuals across the country to take part in remote paid research, including remote focus groups, product trials, and consumer studies.Earn up to $750 a week in your free time by providing feedback on everyday products and services.If you're comfortable sharing your opi

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