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About Us Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands.We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. Purpose The Associate Director, QC, acts as senior leadership for the Quality Control operation at Evergreen Theragnostics. This position will oversee and lead the QC department at Evergreen. This role will be accountable for governing the department in terms of function and responsibility as well as providing technical guidance/decisions (when needed) for the operational levels to ensure an efficient and structured operation that can cater to internal as well as external needs within the organization to deliver quality radiopharmaceutical products. This role will be the primary accountable person for the success of the QC department operations at Evergreen Theragnostics in terms of efficiency, skill retention and compliance. They will ensures processes are designed and compliant per applicable cGMPs, Evergreen Theragnostics’ procedures, and that processes are defined consistently with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. Key Responsibilities/Essential Functions • Design, establish and maintain a standard QC operational structure with assigned roles and responsibilities that can be aligned with the needs of the organization., • Oversee the creation and maintenance of a QC training matrix and program to ensure consistency in execution and retention of capability & skill., • Define specific qualification standards for SMEs and the subsequent qualification processes., • Manage mid-management (supervisors, managers etc) direction to ensure alignment of objectives and completion of deliverables by the department., • Provide technical guidance and decisions to mid-management in order to be able to achieve the required objectives and deliverables., • Design, maintain and defend the internal departmental processes to ensure compliance to cGXP requirements., • Oversee and manage departmental efficiency and proficiency to enable a lean operation., • Review and approve department related protocols, procedures, test methods, and studies as appropriate. Responsible to create, maintain and harmonize key business processes with internal and external stakeholders., • Partner with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage., • Partner with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics’ business growth., • Partner with site operations to effectively deliver analytical services to meet product release timelines for future product supply. Partner with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized analytical process., • Leads, motivate, mentor, and develops team members to exceed and meet company goals., • Develop and maintain effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities., • Lead assigned operational personnel in owning Quality processes within the required responsibility of the department (i.e. Change controls, Investigations, CAPAs, Protocol & report writing), • Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders., • Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment., • Report and take initiative to correct safety and environmental hazards., • Actively demonstrate Evergreen Theragnostics’ values. Typical Minimum Skills and Experience and Education • Requirements include a B.S. in relevant scientific/technical disciplines, advanced degrees (e.g., MS) or technological certificates preferred but not required., • 2+ years of experience in the radiopharmaceutical industry preferred but not required, • Minimum 10+ years experience in a GMP Quality Control Environment., • Minimum 5+ years experience in people management and conflict resolution., • Minimum 3+ years experience in defending QC operations against FDA and EMEA regulatory inspections., • Previous experience with managing a microbiology department is preferred., • Previous experience working with sterile filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred. Other Requirements • Subject matter expert (SME) in various analytical test methods and analytical technology. Strong knowledge of global regulatory requirements related to the design and control of these processes., • Knowledge of SOPs, cGMPs, GCPs and GLPs and the ability to work and manage within a regulatory environment., • Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product analytical processes., • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing & testing., • Excellent organizational skills and the ability to successfully manage a multitude of technical projects., • Ability to work in a fast paced, complex and changing environment., • Excellent analytical, technical and experiences., • Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills., • Understanding of FDA and/or EMEA quality and regulatory processes. Prior experience with regulatory filings is highly desired., • Experience working with external partners is highly desirable., • Ability to work independently in decision-making and resolution of program obstacles and conflicts., • Keen insight, independent judgment and tactful discretion are required., • Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”., • Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Evergreen Theragnostics’ to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism., • Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Evergreen Theragnostics and CDMO locations.

About Us Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. Purpose The Associate Director, Technology Development and Transfer, acts as a technology development and transfer lead in the Tech Ops organization at Evergreen Theragnostics. This position will lead and manage the Manufacturing Science and Technology (MSAT) team at Evergreen. This role will be accountable for the technical work between internal and external stakeholders to ensure design, development, and transfer of robust manufacturing processes for new products and key lifecycle injectable pharmaceutical finished products. This role will be the principal expert and process owner for the end-to-end manufacturing process for injectable pharmaceutical finished products at Evergreen Theragnostics. Ensures processes are designed and validated per applicable cGMPs, Evergreen Theragnostics’ procedures, and that processes are defined consistent with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating /maintaining associated tech development transfer business processes. Key Responsibilities/Essential Functions • Leads technology development and transfer projects for key lifecycle injectable radiopharmaceutical products, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities., • Leads a team of engineers/scientists to execute the development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms., • Leads a team of engineers/scientists to Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies (PCS)., • Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental or authoring plans or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes with internal and external stakeholders., • Partners with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage., • Partners with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics’ business growth., • Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process., • Leads, motivates, mentors, and develops team members to exceed and meet company goals., • Develops and maintains effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities., • Leads a team of engineers/scientists to own QEs (i.e. Change controls, Investigations, CAPAs, Protocol & report writing), • Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders., • Requires approximately ~20% travel., • Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment., • Reports and takes initiative to correct safety and environmental hazards., • Actively demonstrates Evergreen Theragnostics’ values. Typical Minimum Skills and Experience and Education • Requirements include a B.S. or M.S. in relevant scientific/technical disciplines, advanced degrees (e.g., PhD) or technological certificates preferred but not required., • 5+ years of experience in the radiopharmaceutical industry, including 3+ years focused on technology development and tech transfer activities., • If no prior radiopharmaceutical experience, 10+ years of work experience within pharmaceutical or medical device industry, 5+ years of technology development and transfer experience, within a matrixed pharmaceutical, medical device, or biotechnology organization., • Previous experience working with aseptically filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred. Other Requirements • Subject matter expert (SME) in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology operations. Strong knowledge of global regulatory requirements related to the design and control of these processes., • Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment., • Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes., • Ability to work within and lead different technical teams., • Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing., • Excellent organizational skills and the ability to successfully manage a multitude of technical projects., • Ability to work in a prompt, complex and changing environment., • Excellent analytical, technical and experiences., • Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills., • Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired., • Experience working with external partners is highly desirable., • Ability to work independently in decision-making and resolution of program obstacles and conflicts., • Keen insight, independent judgment and tactful discretion are required., • Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”., • Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Evergreen Theragnostics’ to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism., • Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Evergreen Theragnostics and CDMO locations.

Company Overview: Do you enjoy making a difference in a child's life, transforming education, and evolving learning? Come join Teachstone, the interaction company! Teachstone® was founded in 2008 to deliver the Classroom Assessment Scoring System® (CLASS®) nationwide and around the globe. Developed through years of research, the CLASS observation tool measures the interactions between teachers and children, which have been shown to drive learning and lifelong achievement. Teachstone helps organizations conduct classroom observations and provides professional development so that teachers improve, and children learn more. Our online subscription service, myTeachstone, simplifies CLASS implementation by combining observation data with a robust library of CLASS resources and professional development. At Teachstone, everything we do is about improving the ways teachers interact with their students. We train coaches and observers, build and deliver online support programs, design professional development – all of it grounded in one proven fact: the interactions teachers have with students have a lasting impact on their academic and developmental success. By helping educators describe, measure and improve their interactions and relationships with students, Teachstone is transforming education nationwide, one interaction at a time. Role Overview: CLASS Specialists are charged with supporting, planning, and delivering a variety of CLASS-based professional development, coaching, and training services. The position will require 75% travel. Role Responsibilities: • Train and provide ongoing support to participants/clients as they deliver Teachstone’s programs., • Deliver and contribute to observer support programs/services (e.g., calibration, double coding)., • Collaborate with other CLASS Specialists to ensure quality implementation of services., • Guide and collaborate with clients on multi-layered contracts., • Support with planning out services implementation on large contracts, • Contribute to the development and revision of program materials to fit client needs., • Achieve certification and maintain reliability for all age levels CLASS tool assigned., • Other duties as needed to support Teachstone as the organization matures. Service Delivery responsibilities include but are not limited to: • Intro to CLASS, • Train the Trainer, • CLASS Primer, • Instructional Support Strategies, • Feedback, • Instructional Support Essentials for Teachers, • Coaching with MyTeachstone, • 1:1 Video Coaching (MTP), • Group Coaching (MMCI), • CLASS-Master Coaching (CMC), • Reliability Support, • Live Coding, • Video Coding, • Live Calibrations, • Recorded Calibrations, • Subject Matter Experts (SME), • Leader Consultations, • Conference Attendance, • Certification/Recertification, • Community Engagement, • Other services as assigned by the manager Role Qualifications: • Certified CLASS Observer, • Master’s degree (or higher) in education or related field., • 3+ years of professional experience in the field of education., • Experience providing professional development and support to education professionals., • Knowledge of current trends in early-childhood education research and practice., • Team player who shares problem-solving responsibilities and offers creative responses to new challenges., • Ability to translate research into practice., • Ability to provide feedback that is both directive and supportive., • Excellent oral and written communication skills., • Proven training and facilitation skills., • Adept use of technology., • Experience using Google Suites, Canvas, Zoom, Microsoft Teams, and other Microsoft Programs, • 75% travel based on professional development support workloads Role Preferred Qualifications: • Bilingual; Spanish and English, • Experience working on military bases What We Offer: • Fair, Competitive Pay: We ensure equal pay for equal work, using consistent salary bands based on market benchmarks, reviewed annually. Prior salaries, negotiation skills, or fear of conflict don’t influence your pay., • Salary Range: $62,100 - $73,000 determined by your experience, skills and internal equity., • Comprehensive benefits: Medical/dental, 401(k), PTO, insurance, development opportunities. Details provided at offer. Eligibility depends on your role and employment status. Ready to Make a Difference? At Teachstone, we believe that every interaction shapes a brighter future. If you're passionate about transforming education and want to be part of a team that's committed to meaningful impact, we want to hear from you. Apply today and help us create classrooms where every child thrives! At Teachstone, we encourage all individuals to apply and bring their unique perspectives to our team. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, age, or any other characteristic protected by law. We value the different experiences and ideas our team members bring and believe they are essential to solving complex challenges and driving our mission forward.

Lexeo Therapeutics is seeking a Contract Associate Scientist to join our CMC team in New York City. LEXEO is advancing a deep and diverse pipeline of AAV-based gene therapy candidates in rare cardiovascular diseases and APOE4-associated Alzheimer's disease and is led by pioneers and experts with dec

Job Description Who We Are TetraScience is the Scientific Data and AI Cloud 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 7+ years / Masters with 10+ 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 DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs), • Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity, • Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data, • Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents, • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports), • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC, • Demonstrated ability to lead others to complete complex projects, • Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines, • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment, • Organizational expert within the nonclinical subject area, • Excellent written/oral communication and strong time and project management skills, • Ability to attend regular team meetings, lead client meeting and CRMs, • Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars, • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)Requirements:, • BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control, • Knowledge of GLP, ICH guidelines, and applicable regulatory requirements, • 2+ years of pharmaceutical regulatory nonclinical writing experience, • Strong writing and analytical skills, • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred uuQhjdtYkG

Job Description Clinical Supplies Manager Paramus, NJ Clinical Supplies Manager Paramus, NJ Experience level: Mid-senior Experience required: 8 Years Education level: Bachelors degree Job function: Management Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No SUMMARY OF POSITION: Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies. Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents. Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product. Assist and support the management of clinical supply inventories using Interactive Response Technology. Expected to prepare data tables when needed for data interpretation. Assist with documentation and process internal and external change controls. Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc. Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking. Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global). Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits. Assist and support Clinical Operations on document reviews related to KEY RESPONSIBILITIES: Technical Management Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it. Prepare requests for proposals for activities in support of clinical supply projects. Review CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations. Assist and prepare CDMO Vendor Comparison slides and assist in the selection of an appropriate CDMO based on technical ability, cost, and ability to deliver on time. Provide technical support for vendors IRT/IWRS system in support of SK clinical studies. Utilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed. Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments. Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols. Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc. Assist and prepare Excel tables when needed. Assist in the maintenance of SOPs related to reflecting current clinical supply activities. Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors. Financial Management Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects. Prepare, maintain, and monitor project budgets for the CMC Team Review and process clinical supply CMO invoices for project activities. Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested. Participate in project budgeting and forecasting process for the CMC Teams annual project budget management activities. QUALIFICATIONS: Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background. Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports. Expert technical skills, good organization skills, ability to follow directions, and good communication skills. Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data. Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities. Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products Knowledge of GMP batch record development, review, and approval process Demonstrated understanding of the entire supply chain and associated cost drivers Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system. Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus. Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus. Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus. Ability to understand, maintain, and demonstrate troubleshooting on vendors IRT/IVRS system, a plus.

Job Description Who We Are TetraScience is the Scientific Data and AI Cloud 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’s values and ethos are the right fit for you. 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 daily. Requirements Who You Are TetraScience is hiring an elite engagement leader for key accounts in North America. The Engagement Director role concurrently drives activities for renewal numbers and drives overall success of implementation delivery and value realization. There is also a parallel effort to closely collaborate with Account Executives and Pre-sales TAMs to identify and land expansion opportunities. As we rapidly evolve our platform and open up new value creation paths with new SKUs and new personas, we require an uncompromising and results-driven engagement leader to help us deliver scientific and operational value as well as expand within our customer base. You are a customer centric and see-around-the-corner individual with a passion for delivering value while navigating customer hierarchy within the high-inertia Life Sciences industry. You will need to fundamentally embody the principles of extreme ownership and have a demonstrated history of building and leading high-performing delivery or engagement teams. You will have demonstrable experience in managing critical activities of your delivery teams and proof of consistently delivering complex data solutions in challenging scenarios. You are a top-tier communicator and able to tell compelling stories in difficult situations. You will be a forward-deployed captain to ensure customer success no matter the obstacles or friction the team encounters. For the avoidance of doubt, we remain in the category creation and evangelism phase and thus you are not coming in to follow a strict playbook or be a siloed people manager. It will require extreme self-discipline and determination as we forge a category that will fundamentally and forever change the life sciences industry. What You Have Done • 7+ years in delivery leadership roles within the Life Sciences software and data market with expertise in at least two of the following three areas: Discovery/Early-Stage Development, Late-Stage Development/CMC, Manufacturing/QC, • 3+ years in management consulting, • Worked in startup environments, • Led teams to successfully deploy solutions in the top 250 bio/pharma cohort (not biotech alone), • Delivered complex enterprise deals - $ hundreds of thousands to millions in ARR per deal, • Expanded customer land deals - $ hundreds of thousands to millions in ACV, • Evidenced strong program leadership skills while navigating difficult periods with your delivery team(s), • Delivered solutions within GxP-compliant areas, • Coached and mentored Engagement, Project, Program and/or Customer Success Managers who went on to do their best work due to your assistance, • Operated effectively in a fast-paced, team environment What You Will Do • Execute a comprehensive delivery motion to drive faster time-to-value with high customer satisfaction and meet annual renewal targets., • Lead key account delivery teams consisting of project managers, scientific data architects, scientific business analysts and data engineers, aligning on clear targets and objectives to ensure team success., • Collaborate with Sales leadership and Account Executives to pursue new business opportunities within existing accounts during implementation and in the absence of an active delivery motion., • Gain a deep and broad understanding of TetraScience’s Product, enabling you to evangelize and explain it to customer teams in a way each persona will comprehend., • Work closely with product teams to bring customer enhancement requests to fruition and deliver more value and maintain customer awareness of relevant Product roadmap details., • Collaborate with Account Executives to create and execute account-specific plans in order to meet expansion goals and support the renewal strategy., • Maintain ongoing relationships with existing customers, ensuring high levels of customer satisfaction and retention while expanding your network within the accounts., • Manage renewal forecasts and account health providing regular updates to leadership on progress toward targets of your accounts., • Lead by example and inspire your delivery teams to do the best work of their life., • Employ analytical and EQ skills to generate insights from customers’ data strategies and actions, respectively. Benefits • 100% employer-paid benefits for all eligible employees and immediate family members, • Unlimited paid time off (PTO), • 401K, • Remote role - work where you want to work, • Company paid Life Insurance, LTD/STD We are not currently providing visa sponsorship for this position

Job Description About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. Position Overview The Regulatory Affairs Specialist – CMC is responsible for supporting global regulatory submissions and lifecycle management activities related to the chemistry, manufacturing, and controls (CMC) components of drug development. This role ensures that all CMC documentation complies with applicable regulatory requirements and company standards, enabling timely approvals and continued product compliance. Essential Duties and Responsibilities • Prepares and/or coordinate activities for investigation and new product registrations, post approval changes, renewals, annual reports, and extension applications ensuring on-time and high-quality global submissions., • Interface with external Contract Manufacturing Organizations (CMO) and relevant functional teams in obtaining the necessary CMC documentation in support of a regulatory submission., • Execute preparation of timely responses to CMC regulatory questions in coordination with Subject Matter Experts (SME) as needed., • Reviews and assesses change control requests pertaining to CMC aspects and coordinates filing strategies with minimal assistance; attend change control meetings as regulatory-CMC representative., • Maintain submission information according to the document management system, track regulatory commitments & timelines for specific projects/products/markets with minimal supervision., • Maintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements., • Familiarity with global CMC regulations, including ICH requirements and US/EU regulatory guidances., • Experience in authoring technical documents, CTD M2 and M3 sections., • Experience with post-approval CMC changes and lifecycle management., • Strong oral and written communication skills with superior attention to detail., • Demonstrates initiative and is proactive; ability to work independently and within a team setting., • Minimum of a bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, Chemistry)., • 4 + years of experience in Regulatory Affairs specifically with Small Molecules focused on Regulatory CMC. 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 $70,000 to $120,000 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 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 $3000,000 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 Director/Sr. Director of Drug Product CMC Location: New York City, NY Company Overview: We are partnered with a dynamic clinical-stage biotechnology company focused on developing innovative therapies to address unmet medical needs. They are dedicated to advancing science and improving patient outcomes across several treatments and therapies. Their portfolio consists of assets across early and late stage development. Job Summary: The Director/Sr. Director of Drug Product CMC will lead and oversees drug product development, manufacturing, and regulatory activities to ensure high-quality products are delivered from early development through commercialization. This role involves cross-functional collaboration to support product lifecycle management, process optimization, and regulatory compliance for drug products, ensuring all CMC strategies align with company goals and regulatory standards. The Director/Sr. Director will provide technical and strategic leadership, working closely with internal teams and external partners to meet critical project milestones. Key Responsibilities: • Lead the development and implementation of CMC strategies for drug product development and manufacturing., • Oversee technology transfer to and from contract manufacturing organizations (CMOs) and provide technical oversight of drug product manufacturing., • Ensure compliance with cGMP regulations and manage quality assurance activities, including deviation management, batch record reviews, and lot disposition., • Develop and manage risk-based strategies for CMO oversight, considering product lifecycle, technical complexity, and CMO capabilities., • Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, Clinical Development, and Supply Chain, to ensure timely delivery of drug products., • Support regulatory submissions by providing CMC-related documentation and expertise., • Lead process optimization, validation, and continuous improvement initiatives., • Manage the drug product manufacturing budget and long-range planning., • Serve as a subject matter expert during regulatory inspections and audits. Qualifications: • Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field, with 10+ years of experience in CMC and drug product development (or equivalent industry experience for those with a Ph.D.)., • Strong knowledge of cGMP regulations, ICH guidelines, and CMC content of regulatory submissions., • Proven track record in CMC regulatory submissions (IND, IMPD, NDA), • Experience managing CMOs and overseeing technology transfer processes., • Excellent problem-solving, project management, and communication skills., • Ability to work collaboratively in a fast-paced, dynamic environment., • Familiarity with quality-by-design (QbD) principles, statistical analysis, and DOE., • Willingness to travel as needed (up to 10%). What We Offer: • Opportunity to lead in a dynamic, fast-growing company with a strong pipeline of innovative therapies., • Collaborative work environment with professional development and career growth opportunities.

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., • 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 Welcome! Ovid Therapeutics is a biopharmaceutical company developing medicines designed to conquer seizures with courageous science. We exist to serve and meaningfully improve the lives of people affected by epilepsies and brain disorders with seizure symptoms. It is with curiosity, courage, and tenacity that, together, we work for meaningful change in the lives of patients and their families. With this sense of purpose and urgency we challenge the conventional and embrace the wisdom and thought that comes from diverse backgrounds and perspectives. Importantly, we understand the commitment we make to our patients, our broad community and to each other is based on the humanity that we share. The Role On Our Team We are seeking an experienced formulation development and process development scientist in the New York City, Philadelphia, or Boston area for a new and uniquely broad role spanning from formulation discovery to pharmaceutical development, to deliver multiple drug product options for CMC manufacture. Working across functional groups, the Director will be responsible for providing leadership and decisions on small molecule drug products from drug discovery to clinical studies. As the lab functions are completely outsourced, strong communication and interpersonal skills are needed to direct work done in CROs and CDMOs in remote locations often in different time zones. Broad technical expertise and leadership in formulations, process development, and CMC will be critical to the success of the role. Reporting to the CSO, this is a highly visible and team-facing role. The role is a hybrid of office visits in NYC a few times a month, working from home, and meeting with other colleagues in local workshare locations. Job Responsibilities: • Serve as a senior member of the R&D Team responsible for developing and establishing small molecule strategies, • Provide leadership and direction for the area of formulations, process development, and clinical CMC for small molecule formulations including oral solid dosage forms and sterile injectables, • Provide leadership and hands-on technical, operational, and strategic guidance on a wide range of activities across all development stages from lead optimization of pre-clinical drug candidates, pre-formulation, formulation development, process scale-up, technology transfer, and process validation of clinical drug candidates, • Demonstrate a thorough understanding of the cGMP environment (internal and external cGMP manufacturing operations) and compliance requirements and provide technical support to internal and external cGMP manufacturing operations, • Ensure successful transfer of new products and technology to internal and external clinical and commercial manufacturing sites, including generation of knowledge and understanding to support product robustness targets, • Liaison with internal and external stakeholders to ensure there is accurate levels of finished goods material availability per demand management requirements to reduce obsolescence, minimize expired items and maximize inventory turns, • Provide guidance and strategic directions through interactions with each project team. Work across functional groups in Research, Regulatory and external partners identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise, • Minimum of BS in a related field with 10+ years of relevant process development, formulations, and CMC of pharmaceutical products and supporting CMC clinical programs, • Small molecule experience in drug discovery teams, • Demonstrated experience for leading early-stage pharmaceutical development functions Your Background and Experience - preferred qualifications • MS with 8+ years or PhD with 6+ years of relevant experience. Advanced degree in chemical engineering or chemistry or pharmaceutical development, • Experiences designing and optimizing drug formulations, conducting stability studies, analyzing data, preparing technical reports for regulatory submissions, and collaborating with cross-functional teams, • Have experience in the production of small molecules (API and drug product) from planning through procurement; technical transfers, qualification, validation, trouble shooting, NDA’s, FDA inspections, process scale-up, and commercial operations support, • Experience with managing contract manufacturing organizations and be familiar with supply chain architectures including vendor selection, qualification, and contracting, • Have outstanding written and verbal communication, including listening, presentation, and conveying technical information for a broad audience., • Bring a history of great collaboration and teamwork with the ability to motivate and influence others; have a reputation for successful partnering with internal and external stakeholders, • Have the ability and the drive to succeed in a small biotech organization. Interest to grow in the function to advance new technologies in new therapies. Must be self-motivated, proactive, work well under pressure and deadlines, and thrive in a small “all hands-on deck” environment, • Solution-oriented thinker who possesses a “can do” attitude with a strong sense of urgency, • Have strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best path forward in the face of competing points of view, • Create a balance of analytical and methodical problem solving with creative and flexible solutions We operates in a hybrid-work model. Candidates applying must be willing and able to be in the NYC office in coordination with their manager's expectations, as well as department and business needs. The base salary range for this position is $220,000 - $270,000. The actual salary offered within the range is dependent on a variety of factors including, but not limited to , relevant experience, qualifications, skills, level offered, and performance expectations. Powered by JazzHR hrLf0XvG9T

Job Description Clinical Supplies Manager needs Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background Clinical Supplies Manager requires: CDMO management, Master Batch Records (MBR), Master Packaging Work Orders (MPWO), Interactive Response Technology (IRT), Interactive Web Response System (IWRS), Excel, Microsoft Office, ARIBA, Clinical Trial Material (CTM) inventory forecasting, regulatory submissions (IND, Annual reports, amendments), SOP writing, SOP review, study protocols, pharmaceutical stability protocols, GMP batch record development/review/approval, GCP, cGMP, supply chain management, budget management, financial tracking, RFP preparationve, Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background. Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports. Expert technical skills, good organization skills, ability to follow directions, and good communication skills. Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data. Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities. Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products Knowledge of GMP batch record development, review, and approval process Demonstrated understanding of the entire supply chain and associated cost drivers Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system. Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus. Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus. Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus. Ability to understand, maintain, and demonstrate troubleshooting on vendors IRT/IVRS system, a plus. Clinical Supplies Manager duties o Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies. o Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents. o Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product. o Assist and support the management of clinical supply inventories using Interactive Response Technology. o Expected to prepare data tables when needed for data interpretation. o Assist with documentation and process internal and external change controls. o Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc. o Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking. o Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global). o Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits. o Assist and support Clinical Operations on document reviews related to o o Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it. o Prepare requests for proposals for activities in support of clinical supply projects. o Review CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations. o Assist and prepare CDMO Vendor Comparison slides and assist in the selection of an appropriate CDMO based on technical ability, cost, and ability to deliver on time. o Provide technical support for vendors IRT/IWRS system in support of SK clinical studies. o Utilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed. o Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments. o Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols. o Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc. o Assist and prepare Excel tables when needed. o Assist in the maintenance of SOPs related to reflecting current clinical supply activities. o Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors. o Financial Management o Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects. o Prepare, maintain, and monitor project budgets for the CMC Team o Review and process clinical supply CMO invoices for project activities. o Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested. o Participate in project budgeting and forecasting process for the CMC Teams annual project o

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