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Territory: Madison, WI - Psychiatry Target city for territory is Madison - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Madison, Janesville, Beloit, LaCrosse, Eau Claire. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university, • 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience, • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually, • Self-starter, with a strong work ethic and outstanding communication skills, • Must be computer literate with proficiency in Microsoft Office software, • Must live within 40 miles of territory boundaries, • Driving is an essential duty of this job; must have a valid driver’s license with a safe driving record that meets company requirements, • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Previous experience within a specialty product sales force., • Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder, • Documented successful sales performance, • Ownership and accountability for the development and execution of fully integrated account plans, • Strong analytical background, and experience using sales data reporting tools to identify trends, • Experience in product launches, • Previous experience working with alliance partners (i.e., co-promotions), • Strong leadership through participation in committees, job rotations, panels and related activities TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $120,000 - $140,000 and eligibility for a sales incentive target of $39,000. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our ___. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the ___. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the ___. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in ___.

Come expand and grow your potential leadership and skills at Fortrea as an (onsite) Physician Assistant (PA) based in our Phase I Madison, Wisconsin location supporting clinical trials. The Physician Assistant reports to onsite Medical Director and one of the major functions of the role is communication and interaction with participants, regulatory bodies, and clinical teams along with other departments within Clinical Pharmacology. Job Summary: This role will provide an information service and knowledge base on the clinical aspects of clinical trials in Clinical Pharmacology. In addition, incumbent may act as a sub-investigator. Key Responsibilities: Perform physical examinations/medical histories, and other participant assessments as delegated by the Medical Director. Interact with regulatory bodies as are relevant to the operations department. Assume responsibility as technical advisor to the clinical teams and other departments within Clinical Pharmacology. Maintain and further develop facilities and processes relevant to operations. May perform clinical feasibility review of new proposals. Oversee and direct the development/implementation of quality systems to ensure good clinical practices are maintained. Ensure compliance with FDA/GCP/ICH regulations. Perform routine study activities as needed. May assist operations and client managers with Sponsor visits and interactions as appropriate. Ensure safe working practices/environment is employed and maintained. Recommend changes as necessary and justify them in accordance with company policy. Attend investigator meetings as appropriate. Serves as an educational resource and instructor/trainer for staff. And all other duties assigned. Required Education / Licensures / Certifications: Graduate of an accredited Physician Assistant Program Successfully completed the National Certification Requirements for Physician Assistant (NCCPA) and is currently certified to practice (PA-C) Experience: Three to five years hands on clinical care experience Research experience a plus Work Environment: Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment. Occasional drives to site locations, occasional domestic travel. Exposure to biological fluids. Personal protective equipment required such as protective eyewear, garments and gloves. Physical Requirements: Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. Benefits: All job offers will bebased on a candidate's skills and prior relevant experience, applicabledegrees/certifications,as well as internal equity and market data.Regular,full-timeor part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable #LI-SE1 Learn more about our EEO & Accommodations request here.

Description The Ammonia Refrigeration Technician coordinates and executes all aspects of operational activities related to ammonia refrigeration, steam generation, and all other utility systems. The Ammonia Refrigeration Technician is responsible for the maintenance, troubleshooting, repair, and installation of all ammonia related machinery. They are also required to respond to any breakdown or outage, and maybe called upon to conduct emergency repairs. While Ammonia Refrigeration Technicians usually work indoors, they may be exposed to chemicals and extreme temperatures when servicing equipment. Ammonia Refrigeration Technicians must be able to perform physical tasks such as climbing ladders, working on elevated platforms, and moving around refrigeration equipment. The list of duties and responsibilities is not all-inclusive and may be expanded to include other duties and responsibilities as management deem necessary. • Work in conjunction with the Refrigeration Coach to operate the ammonia refrigeration systems at the Division Street and Manufacturer Drive facilities in an efficient and safe manner., • Follow ammonia refrigeration operational procedures in order to safely service and maintain all ammonia refrigeration equipment and components., • Assist in maintaining the Process Safety Management (PSM) documentation and ensure compliance with all regulations within the scope of Process Safety Management (PSM) and EPA requirements (RMP)., • Work weekends to accommodate ammonia equipment service while preserving the production schedule., • Experienced with ammonia refrigeration best practices regarding policies, procedures, and processes established by OSHA, EPA, IIAR, and other regulatory entities., • Minimum of 3-7 years of industrial maintenance, with 2-5 years of hands on experience with ammonia refrigeration equipment maintenance., • Pump out, disassemble, repair, and reassemble all types of refrigeration equipment while adhering to all mandated safety procedures, • Troubleshoot and repair ammonia compressors, • Monitor condenser operation and chemistry, then perform service as needed, • Conduct refrigeration pump troubleshooting and service, • Perform evaporator troubleshooting, defrost, and repair including, scrap surface, flooded, and direct expansion style evaporators., • Service plate and frame chillers, • Record daily rounds on all refrigeration and utility systems, • Coordinate and oversee the activities of outside contractors in general repairs and capital projects., • Maintain compliance with all regulatory standards, including GMP, OSHA, FDA, WDATCP and USDA., • Minimum of 3-7 years of industrial maintenance, with 2-5 years of hands on experience with ammonia refrigeration equipment maintenance., • 401(k), • 401(k) matching, • Dental Insurance, • Employee assistance program, • Employee discount, • Flexible spending account, • Health insurance, • Health savings account, • Free Life insurance, • Paid time off, • Referral program, • Retirement plan, • Vision insurance, • SIGN ON BONUS

Purpose: • Supervision of Maintenance Crew and to make sure all equipment and tools are kept up., • Upkeep and maintenance of production building to include all electrical, air conditioning and mechanical equipment., • Upkeep and maintenance of warehouse building to include all electrical and mechanical equipment., • Maintain an ongoing inventory of parts for all production (manufacturing) machines., • Appropriate storage and display of equipment, tools, machine parts, and kitchen tools—utensils., • Conduct and document monthly safety meetings., • Set up of all equipment is satisfactory., • Responsible for reporting any food safety and quality problems to the proper corrective action supervisor., • Member of the HACCP, SQF Food Safety, Regulatory Team. Qualifications • Skills: Direction, leadership, supervision, planning., • Degrees: Not required., • Abilities: Work in teams, perform maintenance activities, mechanical knowledge, guide and manage personnel activities, planning and supervision of operations.

Job Title: Associate Director QARA Department: Quality Reports to: Employment Type: Non-exempt About NeuWave NeuWave Medical develops image guided microwave ablation tools and software that enables physicians to treat tumors in a minimally invasive procedure.This technology allows patients to be treated in outpatient settings, reducing procedural complexity and recovery times. Our organization is excited to be embarking on numerous new development projects to further improve patient care, and we are looking for new teammates to help us on this inspired journey. You’ll join an interdisciplinary group of engineers who work closely with manufacturing, quality, regulatory, clinical, and strategic marketing professionals. This team highly values rapid experimentation and close collaboration with clinicians. Our culture blends friendly competition with genuine camaraderie—we move quickly, celebrate wins, and build lasting relationships while shaping the future of the business. As part of NeuWave, you’ll have access to a comprehensive offering of competitive benefits. If you’re motivated by clinically meaningful problems, evidence driven development and building solutions at scale, NeuWave offers the chance to perform career defining work--with freedom to develop yourself within a progressive and growing healthcare company. Position Summary NeuWave is seeking a dynamic Associate Director of Quality Assurance & Regulatory Affairs (QA/RA) to lead and scale our quality and regulatory functions during a critical phase of transition and innovation. This role is responsible for establishing and maintaining compliant quality systems (ISO 13485, 21 CFR 820), overseeing regulatory approvals, leading audits, ensuring product safety, and partnering cross-functionally with R&D and Operations. The Associate Director will drive a strong quality culture while overseeing full-time and contract staff across New Product Development & Lifecycle Quality, Quality Systems, Production & Service Quality, Supplier Quality, and Post-Market Surveillance. A key focus will be leading major transition initiatives, including standing up a new Quality System, implementing a new eQMS, and executing the 2025 functional business plan. Key Accountabilities • Lead and maintain a compliant Quality Management System (QMS) aligned with FDA, ISO 13485, EU MDR, and global regulatory standards; drive achievement of key quality metrics, including CAPA effectiveness., • Oversee major transition initiatives, including implementation of a new QMS, eQMS deployment and validation, and migration of legacy quality systems., • Serve as primary liaison to regulatory authorities (FDA, EU Notified Bodies); lead regulatory submissions, registrations, labeling compliance, and responses to inquiries., • Ensure audit readiness and lead internal, third-party, and regulatory audits, including TÜV surveillance audits., • Oversee product and lifecycle quality, including risk management, design controls, production quality, and post-market surveillance., • Partner with R&D and Operations to support successful new product introductions and define regulatory pathways., • Strengthening supplier quality and manufacturing performance, driving operational efficiency and Cost of Goods (COGs) improvements., • Education: Bachelor’s degree in Engineering, Science, or related field required; advanced degree preferred., • Experience: 5+ years in QA/RA within regulated industries, including leadership experience., • Regulatory Expertise: Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and global submission processes (510(k), PMA, EU MDR). This position will be based in Madison, Wi. Relocation assistance may be available for the preferred candidate. Equal Opportunity Employer NeuWave Medical is an equal opportunity employer. We are committed to creating an inclusive environment and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status.

Senior Director, Quality-100% onsite in Madison, WI This is an exciting executive leadership position responsible for overseeing strategic Quality operations within a best-in-class Global Contract Manufacturing Organization (CMO). You will be member of the site leadership team and is expected to lead in a manner that promotes and drives a Patient First culture throughout the organization. • Defining, developing and overseeing company Quality functions and roadmaps including Quality Strategy & Implementation, Compliance and Risk Management Strategy, Client & Regulatory Agencies Relationships Management, and Resources & Quality Innovation Management., • Responsibility for ensuring the site Quality teams (100-200HC) is staffed with high caliber Quality leaders and professionals, driving strong and effective performance culture at all levels across the sites, and creating a strong succession pipeline for key leadership roles., • Overseeing and managing the Quality organization's budget, ensuring all budgets meet company targets., • Communicating, deploying and executing the company's Quality roadmap across the organization., • Ensuring the adherence to the company Compliance Risk Management program which manages risks associated with deviations from regulatory requirements., • Providing input on issues, opportunities, risks, and risk management to clients., • Supporting Regulatory submissions and inspections across sites, advising on best regulatory path to accelerate approval., • Leading, developing, and executing quality and regulatory initiatives in compliance with company procedures and ethics., • Supporting Innovation strategies in line with quality processes, including reporting of Performance of a Lean culture., • Ensuring necessary resources are available to support the execution of quality, regulatory, and compliance objectives. Desired Skills & Experience: • BS, or Master's Degree in Biology, Biochemistry, Chemistry, Molecular Biology, or related Scientific/Engineering field is required., • Extensive experience (10+ yrs) in biologics is a requirement., • Experience with drug substance manufacturing is required. Experience with drug product manufacturing is preferred., • Exceptional strategic team leadership and functional Quality organizational leadership experience., • Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies., • Experience leading multiple Quality operations, organizational strategies, roadmaps and functions for large organizations., • Expertise leading Compliance initiatives within a large-scale organization., • In depth understanding of life science operations and business practices, throughout product life cycles, for the development of large molecule drugs and therapeutics.

Senior Director, Manufacturing-Madison, WI- 100% on-site This is an exciting Executive leadership position responsible for overseeing strategic Manufacturing operations within a major US Biologics CDMO. You will be responsible for providing key leadership, direction, organization, management, monitoring, and cGMP compliance of the roles, activities, and proceedings of Manufacturing to ensure the successful, cost effective, timely, and safe processing of client projects. You will be charged with overseeing the following activities: • Leading a 200+ person manufacturing organization comprised of upstream cell culture and downstream purification manufacturing operations teams including Manufacturing Directors, Managers and Supervisors., • Develop the vision and direction of the Manufacturing operational strategy in conjunction with the Manufacturing vision set forth by the Head of Manufacturing., • Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to lead tech transfers, process validation, process change control, deviation investigation and process characterization activities. *Develops the manufacturing strategy and deploys initiatives to align with site strategy. • Driving programs and initiatives for operational excellence, root cause analysis, continuous improvement and lean manufacturing., • Interacting with executive leadership to optimize strategies and maximize efficiencies in manufacturing operations., • Interfacing and engaging with global BioPharma clients and partners throughout Business Development, Product Lifecycle and Technology Transfer projects., • Ensuring all plant safety policies and procedures are met in compliance with internal and external regulatory standards. Preferred Candidate Background and Expertise: • BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field., • 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience., • Strong team leadership overseeing large Upstream and Downstream Manufacturing organizations and teams. *Working knowledge of end-to-end supply chain preferred including experience with S&OP, Inventory Management, and other associated Supply Chain disciplines. • Thorough experience with clinical and commercial manufacturing., • Experience leading projects relating to process validation, manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes within cGMP, FDA and EMA compliance., • Active participation in regulatory inspections and up to date on compliance requirements. *will offer full relocation

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Sr Specialist, Stability QC is responsible for managing and enabling Arrowhead's Quality Control stability program. Key responsibilities of this position include Reference Material Management and Sample Stability Testing and Management. The Sr Specialist, Stability QC is also responsible for maintaining study documentation, ensuring that study reports are complete and accurate, as well as performing stability testing. This position will communicate with contract vendors to coordinate analytical testing and sample storage and is responsible for the reconciliation and disposition of stability samples upon completion of studies. Responsibilities: • Manage stability programs for various projects in commercial, preclinical and clinical development internally or at external parties., • Author, review, and approve stability protocols; responsible for planning, execution, data management, data analysis, and data trending to support in-process, drug substance and drug product retest period/shelf-life determination., • Create, implement, and manage stability databases, perform data trending and statistical analysis, study and test forecasting and reporting of metrics and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations., • Manage Reference material program., • Review raw data to support release testing, stability testing, and reference materials qualification., • Escalate trends and support associated investigations, including temperature excursion assessment, client and regulatory requests., • Summarize stability results by applying analytical testing expertise to ensure scientific and technical excellence. Utilize statistical software like JMP to perform statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards., • Manages Quality Systems records for QC Stability-creates, assesses, reviews Deviations, Change Controls, CAPA's and other applicable stability-related investigations and events., • Assist in the coordination and management of contract labs and storage sites for the preparation and initiation of stability studies., • Assist in the management of internal and external retain and reserve samples., • Produce impactful PowerPoint presentations to effectively communicate stability data to diverse project team members. Support the attainment of project milestones by facilitating stability monitoring and determining expiration dates for clinical and in-process materials., • Work cross-functionally to provide oversight of stability processes and improvements., • Bachelor's degree in Life Sciences with 8 years' relevant industry experience in the pharmaceuticals or biotechnology industry required., • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, degradation pathways, accelerated stability testing, shelf-life determination, expiry dating, and analytical method qualification/validation., • Proficient with ICH, cGLP and cGMP requirements for analytical techniques that include but are not limited to LC, GC, KF, UV-Vis, FT-IR, NMR, LCMS, compendial and microbiology methods., • Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/ shelf-life proposals., • Extensive technical writing experience., • Experience with MS programs including Excel, Word, and PowerPoint., • Strong verbal and written communication skills and ability to work in a cross-functional environment. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The purpose of this position is to provide Quality Assurance support for Arrowhead Pharmaceuticals' raw materials program. As a member of the Supplier Quality team, this role supports raw material supplier qualification, material risk assessment, specification development, and change control activities to ensure compliance with GMP and applicable regulatory requirements. The position also assists with the collection, analysis, and generation of supplier performance metrics to support ongoing monitoring and continuous improvement. This role requires regular interaction with internal cross-functional stakeholders as well as external organizations to support pre-clinical, clinical, and commercial manufacturing programs Responsibilities • Assist with raw material lifecycle management including, but not limited to, drafting, editing, reviewing, and approving raw material specifications, reviewing raw material qualification protocols and reports, and ensuring compliance with periodic requalification cycles, in collaboration with internal functional teams, • Perform risk assessments for raw materials (e.g., impact to product quality, patient safety, and regulatory compliance)., • Advise Supplier Quality Audits team with supplier qualification and requalification as needed, • Support maintenance of the ASL by providing and entering qualification information into the eQMS, • Collaborate with raw material suppliers to resolve quality issues, documentation discrepancies, and non-conformances per internal procedures., • Review Supplier Change Notifications and assess impact on product quality., • Initiate and manage change controls related to raw materials, • Manage Supplier Corrective Action Requests (SCARs) per internal procedures and applicable quality agreements., • Support deviation investigations, CAPAs, and root cause analyses involving material issues., • Provide quality oversight during material onboarding and lifecycle management, • Request and review supporting documentation for raw material qualifications from suppliers including, but not limited to, production records, certificates of analysis (CoA), certificates of conformance (CoC), BSE/TSE statements, etc., • Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval., • Assist with the preparation, update, review, and routing of Arrowhead procedural documents., • Track and trend raw material-related quality metrics, • BS/BA in Chemistry, Biology, Biochemistry, or related scientific field is preferred., • Minimum of 5+ years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment, with an emphasis on raw material release, Supplier Quality, and/or material qualification activities., • Prior experience with use of an Electronic Document Management System (EDMS) in a regulated environment., • Prior experience with use of an Enterprise Resource Planning (ERP) software in a regulated environment., • Working knowledge of ICH Q3, Q8, Q9, Q10, and Q11., • Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office applications, and SmartSheet., • Excellent interpersonal, verbal, and written communication skills., • Ability to consistently communicate with external parties in a professional manner., • Ability to follow company procedures, work instructions, and policies., • Excellent attention to detail and organizational skills. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Serve as a key contributor to the Quality Management System (QMS) by supporting the management and execution of comprehensive internal and external audit programs. This position requires expertise in quality management systems and regulatory compliance to ensure audit activities are executed in accordance with global GxP regulations, company policies, and industry standards. This role plays an integral part in upholding Arrowhead Pharmaceutical's commitment to patient safety, product quality, and regulatory compliance by partnering with cross-functional teams, external collaborators, and regulatory authorities to drive continuous improvement and maintain a culture of compliance and quality. Responsibilities: • Develop, implement, and maintain a comprehensive internal audit program covering applicable company objectives and global GxP requirements including GMP (FDA, EMA, ICH, MHRA, etc.), ICH guidelines, and ISO standards across Arrowhead facilities and operations., • Create risk-based audit plans and schedules and maintain oversight of planning, coordination, and execution per the established audit plans., • Prepare and issue comprehensive audit reports that clearly identify compliance gaps, systemic risks, and areas for improvement., • Coordinate and support regulatory inspections by FDA, EMA, and other health authorities, ensuring inspection readiness and effective responses to regulatory queries., • Conduct inspection readiness assessments and mock inspections to prepare facilities and teams for regulatory scrutiny., • Communicate audit findings to applicable quality leadership and facilitate timely escalation and resolution., • Coordinate audit response activities and maintain oversight to ensure regulatory compliance and effective follow-up through to closure., • Coordinate with cross-functional teams to implement process improvements and preventive measures based on audit observations., • Oversee corrective and preventive actions (CAPAs) CAPA activities resulting from internal audits and external inspections to ensure timely and effective closure., • Track audit findings, trends, and metrics to identify systematic issues and opportunities for improvements initiatives., • Mentor and train other team members on audit methodologies and best practices., • Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Biology, or related discipline., • 5 years in Quality Assurance or GxP-regulated operations (pharmaceutical, biotechnology, or related industry)., • Strong knowledge of GxP regulations and global compliance expectations., • Deep expertise and understanding of quality management systems, auditing principles, and risk identification and mitigation., • Excellent interpersonal and communication skills, with the ability to influence and work within a matrixed environment, • Strong critical thinking, problem-solving, and conflict resolution capabilities. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Arrowhead is seeking a motivated process development scientist to join our Chemistry Manufacturing and Controls group focusing on formulation and drug product. The successful candidate will be tasked with managing external drug product manufacturing and developing drug product formulations. Responsibilities • Provide technical direction to Contract Development and Manufacturing Organizations (CDMO) for external Drug Product operations, • Develop formulations of oligonucleotide and oligonucleotide-conjugate drug products appropriate for the phase of pharmaceutical development, • Characterize drug product formulations to support clinical dosing and regulatory filings, • Review and approve batch records for use at CDMOs, • Author and execute formulation characterization protocols and author technical reports, • Draft and review technical documentation and leverage expertise to support regulatory filings, • Present data and technical information to intra- and inter-departmental colleagues and management, • Maintain a well-documented laboratory notebook., • Track project deliverables and provide updates on progress to team members, management, and cross-functional teams., • M.S. with at least 5+ years or B.S. with at least 7+ years of relevant industrial academic experience, • Experience with formulation development or drug product manufacturing., • Excellent analytical, critical thinking, and communication skills, • Proactive, solutions-oriented mindset to anticipate challenges and devise solutions, • Understanding of the drug development process and governing regulations., • Direct experience overseeing CDMOs and external partners, • Formulation development experience, • Experience authoring regulatory CMC sections for regulatory filings All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Maintenance Service Technician I Job Description: Job Title: Maintenance Service Technician I Job Type: Contract to hire (6 months) Job Location: Madison,WI Work Schedule: Monday to Friday 7 am - 4pm PT with rotating Saturday shifts. There will be some overtime, you should be comfortable working overtime as needed. The schedule may change later, we require someone who can be flexible if the schedule changes. Pay Rate: $30, Based on experience Description: We are looking for an experienced Maintenance Service Technician I to provide service and maintenance for the Proton Beam Therapy (PBT) System, which is used for treating cancer at The University of Wisconsin Hospitals and Clinics, in Madison, and the associated support systems as assigned. The Maintenance Service Technician I will be responsible for preventative and corrective maintenances as well as troubleshooting. Maintenance Service Technician I will work as part of the team to ensure compliance of technical and mechanical programs such as; worker safety, spare parts program, tool management, equipment tagging, facility procedure compliance, administrative procedure compliance, office equipment and systems by following all necessary procedures, protocols and guidelines. Responsibilities • Monitor and positively affect operational performance of PBT system and patient experience., • Respond to calls for service support within a reasonable amount of time, • Interface with customers to ensure maximum customer satisfaction, • Perform all Preventative/Corrective maintenance tasks and corresponding paperwork (PM, CM and Work order) in detailed and organized fashion., • Work with team members to schedule preventive maintenances work to minimize part costs and maximize effectiveness, • Troubleshooting and problem solving complex PBT system issue to maximize system up-time under the Managers, Engineers, and Sr. Maintenance Service Technician direction., • Pack and unpack large cardboard boxes and/or wooden crates, perform inspect and test Incoming/outgoing materials and participate in shipment preparations., • Transport packages, wooden crates, gas cylinders to and from the loading dock and warehouse, • Documentation for inventory control of the necessary supplies and parts., • Work in compliance with all regulatory standards including but not limited to HIPPA, EH&S, FDA, OSHA Radiation Safety, applicable laws, and internal policies and interpretations of the above as required, • Safely work in areas with high voltage and utilize proper LOTO (lock-out, Tag-out) safety practices., • Write site specific procedures for preventive and corrective maintenance., • Create and maintain 6S practices (Safety, Sort, Store, Shine, Standardize, Sustain), • Complete and submit all timecards and service reports in a timely fashion and includes all relevant details., • Self-motivated and have a strong sense of responsibility. Qualifications: • Minimum of 1 years of experience working or education as a Technician or Field Service Engineer is required., • At least 1 year of experience for PBT system and/or Medical device environment is preferred., • Technically skilled with proven ability to troubleshoot problems, solve abstract issues, and interpret policies and procedures, • Ability to read and correctly interpret various engineering documents (schematics, wiring, piping diagrams, etc.), • Use standard electrical test and measurement instruments (Oscilloscope, etc.), • Safely work in regions of mechanical, electrical, high voltage and radiation., • Safely lift up to 50 pounds repeatedly, • Work on elevated area with safety harnesses, • Work as part of a cross-functional team, • Maintain focus and work with precision over extended periods, • Proficiency in Microsoft Office (especially Excel & Word), • Develop and improve procedures, • Flexibility to cover rotating shifts and availability to work overtime as needed., • Continue to be interested in new knowledge and have the consciousness to learn and grow on our own., • Must demonstrate ability to work well with various personnel demonstrating a good attitude and ability to work successfully as a member of the team. About Maxonic: Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients. Interested in Applying? Please apply with your most current resume. Feel free to contact Waseem Sheikh (/ (408) 400-2322) for more details. Company DescriptionSince 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award-winning, dedicated team of recruiting professionals specialized in technology, are great listeners and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 5,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award-winning, dedicated team of recruiting professionals specialized in technology, are great listeners and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 5,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.

Job Description About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL. Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI. Position Summary cGMP Consulting is seeking an experienced and driven individual to lead and manage cleaning validation activities, prepare and execute protocols, and act as SME regarding cleaning development and validation. This senior-level role offers significant autonomy, leadership responsibility, and the opportunity to influence operations in a fast-paced, GMP-compliant manufacturing environment. The ideal candidate will have a proven ability to lead cross-functional initiatives, navigate complex troubleshooting challenges, drive change management efforts, and ensure timely and thorough completion of protocols. This candidate has deep experience in current Good Manufacturing Practices (cGMP), along with a solid understanding of FDA regulations, and international compliance standards. Responsibilities The essential functions include, but are not limited to the following: • Design and develop cleaning procedures for new product and manufacturing equipment., • Provide technical support to cleaning activities associated with the manufacturing process., • Lead the cleaning validation program and activities., • Knowledge of cleaning agents and establishment of sound cleaning practices within new or refurbished manufacturing rooms and sampling suite areas., • Design and support implementation of cleaning strategies for product transfer projects and product development projects., • Investigate and conduct troubleshooting or root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under developed cleaning procedures., • Lead enhancement of cleaning practices and review and approve work instructions., • Support the periodic review of cleaning validation studies., • Perform successful resolution of incidents and deviations related to cleaning activities., • Minimum Bachelors’ degree in Engineering, Science, or a related field of study., • 4+ years’ experience in a GMP manufacturing environment, including cleaning validation. Must be familiar with regulatory (FDA) requirements., • Expertise in multiple areas: cleaning validation, continuous process improvement, and/or qualification of aseptic filling or formulation equipment/processes., • Advanced critical thinking and technical writing skills., • Expected pay range per year: $140,000-$200,000 USD The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable. Powered by JazzHR sobiWU2IZT

Job Description Job Title: Director of Operations Location: Madison, WI Company: Oakhouse Bakery – Granola Manufacturer for Private Label & Brand Products About Us: Oakhouse Bakery is a premier manufacturer of high-quality granola, producing a wide variety of products for private label brands. Our commitment to excellence, innovation, and sustainability has earned us a reputation as a trusted supplier in the granola industry. We are currently seeking an experienced Director of Operations to join our dynamic team and lead our operations at our Madison, WI facility. Position Overview: The Director of Operations oversees all daily operations within the manufacturing, supply chain, and logistics functions to ensure consistent delivery of safe, high-quality food products. This leader is responsible for driving efficiency, maintaining compliance with food safety and regulatory standards (e.g., SQF, FDA), optimizing plant performance, and developing a high-performing operations team that supports the company’s strategic and financial goals. Key Responsibilities: Operational Leadership • Lead all quality, production, maintenance, engineering, and logistics activities to ensure daily operational excellence and efficiency., • Develop, implement, and monitor KPIs related to production output, yield, quality, downtime, and cost., • Partner with Finance and the COO on capital planning, budgeting, and continuous improvement investments., • Ensure full compliance with SQF, FDA, OSHA, and other relevant food safety and occupational safety regulations., • Support the Quality Manager in maintaining and improving the Food Safety Management System (FSMS)., • Drive a culture of safety, accountability, and continuous improvement throughout the plant., • Ensure all employees are trained and competent in Good Manufacturing Practices (GMPs) and site procedures. Strategic Planning & Continuous Improvement • Develop and execute operational strategies aligned with company growth, cost reduction, and margin improvement objectives., • Champion Lean Manufacturing and 5S practices across all departments., • Identify and implement automation, process improvement, and cost-saving initiatives., • Build, lead, and mentor a strong operations management team (Production, Maintenance, Supply Chain, Quality)., • Establish clear performance expectations and accountability frameworks for all direct reports., • Partner with HR to foster employee engagement, recognition, and professional development., • Oversee procurement, materials management, and inventory control processes., • Optimize scheduling, planning, and logistics to ensure on-time production and fulfillment., • Manage capital request and approval processes for all operational investments., • Oversee plant expansion, construction, and equipment installation projects in coordination with engineering and external contractors. Education & Experience • Bachelor’s degree or equivalent experience in food or beverage manufacturing., • 10+ years of progressive leadership experience in food or beverage manufacturing operations., • Proven experience leading multi-shift manufacturing environments with SQF or GFSI certification., • Deep knowledge of food safety and regulatory compliance., • Financial acumen with experience in budgeting, cost control, and capital project justification., • Excellent leadership, communication, and organizational skills., • Strong problem-solving, analytical, and decision-making abilities., • Ability to thrive in a fast-paced, growth-oriented manufacturing environment.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Provide strategic leadership for the design, implementation, and continuous improvement of the company's data integrity program across GxP operations supporting clinical and commercial pharmaceutical and combination products. Define and oversee company-wide governance frameworks, policies, and requirements to ensure alignment with global data integrity regulations and ALCOA++ principles. Serve as a cross-functional leader and subject matter expert, partnering across the organization to embed data integrity principles and compliance into systems, processes, and culture. Responsibilities • Lead the development, implementation, and continuous improvement of data integrity policies, procedures, and program elements in alignment with global regulatory requirements., • Establish and oversee data integrity governance programs, partnering cross-functionally to drive strategic initiatives and foster a culture of data integrity., • Develop and maintain systems for data integrity impact assessments, risk evaluations, and remediation plans, ensuring timely completion of commitments., • Evaluate data management, documentation, and record control practices across systems and formats to ensure compliance with data integrity requirements., • Implement and maintain processes to assess computerized systems, software, and equipment for compliance with 21 CFR Part 11, Annex 11, and related guidance., • Lead and oversee comprehensive data integrity audits and assessments to identify risks, gaps, or discrepancies, and lead mitigation and remediation activities., • Drive corrective and preventive actions and process improvement initiatives to strengthen data integrity controls and system reliability., • Develop, analyze, and report data integrity metrics and key performance indicators to senior leadership., • Design and deliver training programs to promote data integrity awareness and ensure consistent understanding across the organization., • Provide subject matter expertise and support during regulatory inspections and partner audits, articulating data integrity program elements and strategy., • Monitor global regulations, emerging guidance, and best practices through active engagement with relevant professional organizations (e.g., ISPE, PDA)., • Bachelor's degree in science, engineering, information technology, computer science, data management, or a related technical discipline., • Minimum of ten (10) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry, including at least five (5) years in a leadership role with increasing responsibility., • Comprehensive knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards., • Demonstrated expertise with ALCOA++ principles, data lifecycle management, and data governance frameworks., • Proven experience applying 21 CFR Part 11, Annex 11, and other relevant regulations and guidance governing data integrity and information security., • Strong understanding of information technology and data management systems, including system validation, security, and enterprise data governance., • Proven ability to lead complex, cross-functional projects and build effective partnerships to advance data integrity and compliance objectives, demonstrating strong organizational, planning, and prioritization skills., • Strategic thinker with demonstrated success in driving continuous improvement, innovation, and proactive risk management., • Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels., • Advanced degree preferred., • Certification or formal training in quality management, data integrity, data governance, or regulatory compliance (e.g., ASQ, ISPE, PDA, or equivalent). Wisconsin pay range $180,000—$210,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Bring your expertise to Parexel and lead critical translational insights that accelerate our clients' pipelines and advance patient-focused innovation. Parexel is a global leader in clinical research, advancing the development of novel therapies. The Director / Senior Director, Translational Medicine will serve as a subject matter expert in biomarker strategy and translational medicine, with strong passion to our mission of translating science and expertise into meaningful long-lasting benefit for patient. In this role, the individual will provide scientific leadership, drug development guidance, and consulting support to clients, contributing directly to new business growth. They will also play a key role in shaping and executing precision medicine clinical studies across multiple therapeutic areas through close collaboration with cross-functional teams and external clients/partners. The ideal candidate brings deep scientific expertise and extensive hands-on experience in biomarker development and application (e.g., genomics, immunoassays, flow cytometry, CDx). They should possess strong knowledge of clinical development, global regulatory requirements for biomarker use in clinical trials, and the strategic integration of biomarker plans to enhance clinical trial design, execution, and overall program success. Knowledge and Skills : * Advanced scientific expertise in broad therapeutic areas (e.g., oncology, immunology, metabolic diseases, CNS, rare diseases), biomarker development, and translational medicine. * Ability to develop, articulate, and present complex biomarker strategies or consultative recommendations to cross-functional teams and external clients * Broad understanding of clinical drug development, clinical trial design, evolving regulatory landscape, and the broader business context of clinical research * Strong working knowledge of international and local regulatory guidelines (e.g., FDA GCP, ICH, IVD/IVDR) * Excellent interpersonal team-oriented, and client-facing skills, with the ability to work creatively and effectively in a fast-paced environment. * Motivational and leadership capabilities to support business development and operational teams in meeting organizational goals (e.g. business KPIs, sales targets) * Strategic and agile thinking with the ability to anticipate and adapt to emerging trends in biomarker development, validation, and application * Exceptional written and verbal communication skills, with the ability to clearly present complex strategies or proposals to diverse internal and external audiences. * Demonstrated learning agility, adaptability, collaborative skills, strong influencing skills to ensure successful delivery of project objectives * Recognized as an expert internally and/or externally in the Translational Medicine arena (preferred) Education : #LI-LB1 #LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Client Enablement Specialist Company: Norstella Location: Remote, United States Date Posted: Mar 21, 2026 Employment Type: Full Time Job ID: R-1818 Description About Norstella: Norstella is a premier and critical global life sciences data and AI solutions provider dedicated to improving patient access to life-saving therapies. Norstella supports pharmaceutical and biotech companies across the full drug development lifecycle - from pipeline to patient. Our mission is simple: to help our clients bring therapies to market faster and more efficiently, ultimately impacting patient lives. Norstella unites market-leading brands - Citeline, Evaluate, MMIT, Panalgo, Skipta and The Dedham Group and delivers must-have answers and insights, leveraging AI, for critical strategic, clinical, and commercial decision-making. We help our clients: * Accelerate the drug development cycle * Assess competition and bring the right drugs to market * Make data driven commercial and financial decisions * Match and recruit patients for clinical trials * Identify and address barriers to therapies Norstella serves most pharmaceutical and biotech companies around the world, along with regulators like the FDA, and payers. By providing critical proprietary data supporting AI-driven workflows, Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient, innovative, and responsive to patient needs. About the Role: We are seeking a knowledgeable and engaging Client Enablement Specialist to deliver training programs that empower users to maximize their use of Citeline and Evaluate platforms. The ideal candidate will combine deep product expertise with strong instructional skills to support onboarding, adoption, and ongoing proficiency across our client base. Key Responsibilities: * Conduct onboarding training for new clients, ensuring a smooth transition onto the platforms, including but not limited to Evaluate Pharma, Biomedtracker, Trialtrove, Pharmaprojects, Sitetrove, Trialtrove, Scrip, Pink Sheet * Conduct refresher trainings for current clients, focusing on their specific use cases and personas * Design & develop training sessions (eg. "How to market size for forecasting using our platforms") on Citeline and Evaluate products * Create and maintain training materials such as user guides, quick reference cards, e-learning modules, and video tutorials * Assess user training needs through usage data, personas, and use cases to tailor training programs accordingly * Collaborate with product, sales, and customer success teams to stay current on platform updates, new features, and upcoming releases * Maintain a training calendar and manage scheduling for sessions across multiple time zones * Provide post-training support and follow-up resources to reinforce learning * Track and report on training completion, engagement, and outcomes using an LMS and/or Salesforce * Gather user feedback to continuously improve training content and delivery methods * Other duties, as assigned Required Qualifications: * Bachelor's degree or equivalent * 3+ years of experience in a training, learning & development, or customer education role * Some familiarity with Citeline and/or Evaluate platforms (e.g., Trialtrove, Biomedtracker, Scrip) * Strong understanding of the pharmaceutical, biotech, or life sciences industry * Experience developing multi-format training content (e-learning, video, job aids, instructor-led) * Excellent presentation, communication, and facilitation skills * Ability to translate complex data and platform functionality into clear, user-friendly instruction * Highly self-motivated with a strong ability to independently learn, adapt, and drive progress Preferred Qualifications: * Experience with e-learning authoring tools * Familiarity with LMS platforms * Experience working with clinical trial data, drug pipeline analysis, or regulatory submissions * Experience with CRM tools such as Salesforce for tracking client interactions and training activity * Proficiency with webinar and virtual training platforms such as Zoom, Teams * Demonstrated experience using AI tools (e.g., ChatGPT, Copilot, or similar) to enhance training content creation, personalization, or delivery efficiency Work Environment: * Remote position, east coast preferred * Some travel may be required for on-site client training sessions or internal team meetings Please Note - All candidates must be authorized to work in the United States. We do not provide visa sponsorship or transfers. We are not currently accepting candidates who are on an OPT visa. The expected base salary for this position ranges from $62,000 to $72,000. It is not typical for offers to be made at or near the top of the range. Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, licensure or certifications obtained. Market and organizational factors are also considered. In addition to base salary and a competitive benefits package, successful candidates are eligible to receive a discretionary bonus. Norstella is an equal opportunity employer. All job applicants will receive equal treatment regardless of race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, physical or mental disability or handicap, medical condition, sex (including pregnancy and pregnancy-related conditions), marital or domestic partner status, military or veteran status, gender, gender identity or expression, sexual orientation, genetic information, reproductive health decision making, or any other protected characteristic as established by federal, state, or local law. All legitimate roles with Norstella will be posted on Norstella's job board which is located at norstella.com/careers. If a role is not posted on this job board, a candidate should assume the role is not a legitimate role with Norstella. Norstella is not responsible for an application that may be submitted by or through a third-party and candidates should proceed with extreme caution if a third-party approaches them about an open role with Norstella. Norstella will never ask for anything of value or any type of payment during or as part of any recruitment, interview, or pre-hire onboarding process. If you are aware of or have reason to believe a job posting purportedly for a role with Norstella is fraudulent or otherwise not authorized by Norstella, please contact the Company using the following email address: [email protected] Norstella is an equal opportunity employer. All job applicants will receive equal treatment regardless of race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, physical or mental disability or handicap, medical condition, sex (including pregnancy and pregnancy-related conditions), marital or domestic partner status, military or veteran status, gender, gender identity or expression, sexual orientation, genetic information, reproductive health decision making, or any other protected characteristic as established by federal, state, or local law.

Quality Manager Needed For Leading Manufacturing Company This Jobot Job is hosted by: Kevin Finlay Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $100,000 - $130,000 per year A bit about us: My client is a leading manufacturing company who is actively growing! They are looking to add a Quality Manager to their team to lead our quality assurance initiatives and enhance our operational standards. Why join us? Benefits: • Competitive salary with performance-based bonuses and salary reviews., • Comprehensive health, dental, and vision insurance plans., • Generous retirement plan options, including company matching contributions., • Paid time off and flexible work arrangements to help maintain a healthy work-life balance., • Opportunities for professional growth, training programs, and conferences. Job Details Key Responsibilities: • Formulate, document, and execute comprehensive quality assurance policies and procedures tailored to meet industry-specific standards., • Design and lead quality improvement programs that focus on reducing defects and enhancing product reliability, collaborating with cross-functional teams to align quality goals with business objectives., • Lead, mentor, and manage a diverse team of quality assurance specialists, fostering an environment of continuous learning and improvement., • Conduct regular workshops and training sessions on emerging QA methodologies, tools, and compliance regulations to ensure the team remains proficient in current practices., • Oversee the creation and implementation of rigorous testing plans and protocols, ensuring they are executed effectively to validate product performance and safety., • Conduct regular audits of production processes, employing statistical process control to pinpoint inefficiencies and facilitate corrective actions., • Analyze quality metrics and performance data, generating detailed reports that provide insights into trends, root causes of issues, and areas for improvement., • Utilize advanced data analysis software to create dashboards and visual representations of quality data for executive presentations., • Ensure that all QA activities and documentation comply with industry regulations such as ISO 9001, FDA, or other relevant standards., • Bachelor’s degree in Engineering, Quality Assurance, or a related field; a Master’s degree is highly desirable., • A minimum of 7 years of experience in quality assurance management,, • Comprehensive knowledge of quality management systems (QMS), methodologies, and relevant regulatory requirements (e.g., ISO standards, Good Manufacturing Practices)., • Proficient in data analysis tools, statistical methods, and quality improvement techniques such as Six Sigma or Lean Manufacturing. Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

JOB DESCRIPTION Position Summary The Water Specialist ensures all product contact water (city water and plant generated potable water) used in the facility meets regulatory FDA Grade 'A' Pasteurized Milk Ordinance (PMO) requirements and internal food safety and quality standards.This role oversees

JOB DESCRIPTION Position Summary The Water Specialist ensures all product contact water (city water and plant generated potable water) used in the facility meets regulatory FDA Grade 'A' Pasteurized Milk Ordinance (PMO) requirements and internal food safety and quality standards.This role oversees

JOB DESCRIPTION Position Summary The Water Specialist ensures all product contact water (city water and plant generated potable water) used in the facility meets regulatory FDA Grade 'A' Pasteurized Milk Ordinance (PMO) requirements and internal food safety and quality standards.This role oversees

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Senior Manager GxP Systems & Validation provides strategic and operational leadership for GxP-regulated computerized systems across their full lifecycle. This role is accountable for governance, validation strategy, inspection readiness, and compliant system administration, ensuring alignment with global regulatory requirements (FDA, EMA, MHRA, ICH) and evolving industry standards (GAMP 5, CSA). This leader serves as a key partner to Manufacturing, Quality, CMC, CSA and Compliance, GLP Operations, and external vendors, driving scalable compliance frameworks while enabling business agility. The role combines system ownership and administration, validation project management, and organizational oversight to ensure enterprise-wide data integrity and computerized system compliance. Responsibilities Strategic Leadership & Governance • Maintain governance frameworks for GxP computerized systems, • Define validation strategies aligned with GAMP 5 and CSA principles, • Support modernization initiatives (e.g., SaaS adoption, cloud validation, CSA transition), • Serve as system owner and system administrator for critical GxP platforms, • Maintain validation and system lifecycle policies and standards, • Participates in continuous improvement of validation methodologies, templates, and risk-based approaches, • Oversee administration and compliant operation of GxP systems (Laboratory systems, LIMS, MES, EDMS, enterprise SaaS platforms), • Ensure systems remain validated, secure, and audit-ready throughout implementation, upgrades, and decommissioning, • Approve system configurations, changes, and access governance frameworks, • Ensure robust data integrity controls in accordance with ALCOA+ principles, • Lead enterprise validation initiatives across multiple concurrent projects, • Oversee development and approval of validation deliverables (URS, Risk Assessments, IQ/OQ/PQ, Traceability, Summary Reports), • Ensure appropriate application of risk-based validation and CSA methodologies, • Manage validation master planning and resource allocation, • Provide oversight of regression testing and revalidation strategies, • Ensure validation documentation supports global inspection readiness, • Act as SME during regulatory inspections and internal audits, • Oversee remediation efforts related to audit findings, deviations, and CAPAs, • Lead cross-functional teams across CMC, Quality, IS&I, Manufacturing, Engineering, GLP Operations, and external partners, • Oversee third-party vendors and validation consultants, • Manage budgets, timelines, risks, and resource planning for validation programs, • Drive issue resolution and escalation management, • Lead, mentor, and develop validation and system administration staff, • Establish performance expectations and competency development plans, • Bachelor's degree in Life Sciences, Engineering, IT, or related discipline (advanced degree preferred), • 8+ years of experience in GxP computerized systems and validation, • 3+ years in a leadership or program management role, • Deep expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, and global data integrity requirements, • Demonstrated experience leading complex, enterprise-level system implementations, • Strong understanding of change control, deviation management, CAPA, and quality systems, • PMP or equivalent project management certification, • GAMP, ITIL, or related compliance certification, • Experience leading CSA transformation initiatives, • Extensive experience related to administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson), • Pharmaceutical or CRO experience, • Prior regulatory inspection leadership experience, • Risk-based decision making, • Continuous improvement mindset Wisconsin pay range $145,000—$165,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Supplier Quality is responsible for ensuring that suppliers and contract manufacturers meet quality, regulatory, and compliance requirements. This role supports all aspects of qualification, monitoring, and continuous improvement of suppliers, contract manufacturers (CMOs), contract testing laboratories, and material suppliers supporting pharmaceutical development and commercialization. The candidate will be expected to interact with multiple internal departments and external vendors. Responsibilities • Manage the SCARs and Supplier Change Notification Programs and ensure effective and timely assessment and resolution of the proposed changes., • Guide and coach key stakeholders on SCAR and SCN processes to promote consistency and drive quality culture., • Support the performance of cross-functional assessments of SCARs and SCNs, evaluating impact and ensuring appropriate action plans and effectiveness checks are established, as needed., • Perform quality agreement lifecycle management, including but not limited to, drafting, editing, reviewing, approving, and ensuring compliance with periodic review cycles., • Assist in establishing and implementing Supplier KPIs (key performance indicators) and actively contribute to the internal Quality Management Review and external Business Review meetings., • Maintain knowledge of current compliance expectations and regulations pertaining to drug development., • Write, review, update, approve, issue, and organize applicable Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms, )., • Support regulatory inspections by serving as a subject matter expert., • Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements., • Bachelor's degree in science field., • Minimum of 8 years of experience in pharmaceutical or biotechnology quality, with 4+ years in supplier quality., • Strong working knowledge of FDA, EMA, ICH, GxP, and GDP regulations., • Excellent communication skills and ability to work with diverse, • Prior experience with use of an electronic document management system in a regulated environment., • Prior experience working in Supplier Quality Management, • Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, DocuSign, and SmartSheet., • Excellent interpersonal, verbal, and written communication skills., • Ability to consistently communicate with external parties in a professional manner., • Ability to follow company procedures, work instructions, and policies., • Excellent attention to detail and organizational skills. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position We are seeking a highly skilled and motivated Process Validation Engineer with a strong background in Good Manufacturing Practices (GMP) to join our team. This individual will be responsible for drafting, reviewing, and overseeing the execution of process and cleaning validation documentation. The ideal candidate will have a minimum of 8 years of experience in GMP validation or related fields, with at least 3 years of GMP manufacturing experience preferred. Responsibilities • Draft and review process validation and cleaning validation protocols and reports, ensuring compliance with GMP regulations., • Oversee and manage the execution of manufacturing validation activities, ensuring timelines and quality standards are met., • Collaborate with cross-functional teams to ensure validation strategies align with production requirements and regulatory guidelines., • Provide technical support to manufacturing during validation and qualification activities., • Identify and assess risks, proposing corrective actions and improvements to enhance validation processes., • Ensure compliance with all applicable regulatory requirements, including FDA, EMA, and ICH guidelines., • Review and approve validation data and documentation to ensure accuracy and regulatory compliance., • Participate in audits and inspections, providing validation documentation and responding to inquiries from regulatory agencies., • BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry., • 8 years of experience in GMP validation or a related field., • Knowledge of process and cleaning validation activities, including test methods, execution, and data analysis., • Excellent technical writing skills with high attention to detail., • Excellent problem-solving skills and attention to detail., • Strong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies., • Experience with regulatory submissions and/or inspections., • Ability to work across teams., • Experience in drafting and reviewing validation protocols and reports., • Strong understanding of GMP regulations, validation principles, and industry best practices., • 3 years of GMP manufacturing experience, • Six Sigma or Lean certifications Wisconsin pay range $90,000—$120,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The purpose of this position is to provide quality assurance support for the Supplier Quality Management program. This person supports the qualification, monitoring, and ongoing oversight of suppliers, contract manufacturers, and service providers to ensure compliance with company quality standards and applicable global GxP regulations. This role plays a key part in maintaining supplier compliance and managing quality events related to externally sourced materials and services used in pharmaceutical development and commercialization. This person will be expected to interact with internal departments as well as multiple contract organizations to support ongoing pre-clinical and clinical development as well as commercial programs at Arrowhead Pharmaceuticals, Inc. Responsibilities • Support supplier qualification, requalification, and ongoing monitoring activities for raw material suppliers, CMOs, contract laboratories, packaging vendors, and service providers., • Assist with supplier risk assessments and ensure documentation is current and compliant., • Collaborate with stakeholders and suppliers, as needed, on quality events and non-conformances and issue supplier corrective action requests, as outlined in the applicable quality agreements, • Assist with maintenance of approved supplier lists and supplier quality records., • Review and assess supplier change notifications for quality and regulatory impact., • Ensure timely and accurate documentation within the Quality Management System (QMS)., • Track and trend supplier performance metrics (e.g., deviations, on-time CAPA closure, audit findings)., • Identify recurring issues and support continuous improvement initiatives., • Assist with preparation, update, review, and routing of Arrowhead procedural documents., • BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred, • 3 years of quality assurance experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization with an emphasis on Supplier Quality., • Prior experience with use of an electronic document management system in a regulated environment., • Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, and Smartsheet., • Excellent interpersonal, verbal, and written communication skills., • Ability to consistently communicate with external parties in a professional manner., • Ability to follow company procedures, work instructions, and policies., • Excellent attention to detail and organizational skills. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job DescriptionAbout eGenesiseGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. POSITION SUMMARY The Research Veterinarian maintains clinical oversight of the research grade pig population and surrogate herd for the eGenesis site. Additionally, this individual will manage personnel of the veterinary team. The Research Veterinarian will oversee internal in vivo studies conducted at the site and advise on regulatory compliance related to animal activities. PRIMARY RESPONSIBILITIES • Manage veterinary staff, • Provide personnel management including goal setting, performance reviews, conflict resolution, scheduling and training documentation oversight, • Participate in all surgery activities and advanced reproductive procedures such as embryo transfers and c-sections, • Evaluate neonate piglets daily and work with neonatal care team to implement treatment plans for any health concerns that arise, • Perform necropsies and submit diagnostic samples for relevant research and clinical cases to ensure health of donor and surrogate herds or provide findings to development team, • Perform ultrasound examinations according to study designs or for clinical assessments – intermediate skill level for abdominal imaging with plan to develop echocardiography skill, • Clinical support for surrogate herd including routine medical cases, ultrasound diagnostics, • Manage and participate on-call vet support during weekends to the staff, • May need to train for backup support for assisted reproductive technology procedures, • Develop a veterinary science department with expansion according to research needs in support of eGenesis xenotransplantation platform, • Collaborate with veterinarians and leadership across other eGenesis sites to manage veterinary care and population health programs, • Facilitate staff development in area of laboratory animal science, • Oversight of Wisconsin barns to meet IACUC standards and USDA regulations, • Participate in IACUC activities including inspections, advising of team members, interpretation of regulatory requirements, and serving as alternate veterinarian on committee, • Draft, review, and revise SOPs relevant to the neonatal, veterinary, and general animal care activities, • Participate in scientific and management meetings with Cambridge and Indiana sites, including donor animal allocation, preclinical development, and regulatory, • Serve ad hoc on internal eGenesis Publication Committee for review, collaboration, or preparation of manuscripts, • Develop and provide an annual training program to the Animal care, Neonatal and Vet tech team to assure compliance with animal welfare regulations and animal treatment plans, • Ensure compliance with company biosecurity practices to safeguard health of all animals produced by eGenesis, • Work in collaboration with veterinarians to identify potential biosecurity and husbandry process improvements in the neonatal area, • Promote and adhere to safety in the workplace: Report unsafe acts and conditions and ensure equipment is maintained correctly and report all accidents/incidents. Inspect work area and take remedial action to minimize or eliminate hazards: complete required training assignments, forms, and other paperwork, • Promote and adhere to the eGenesis animal welfare policies, • Follow all applicable regulatory requirements (USDA, FDA, OLAW) regarding animal welfare and ensure humane care according to the Guide for the care and use of Laboratory Animals and the Animal Welfare Act, • Perform other duties and assume additional responsibilities as assigned, • Tasks are completed during regular business hours Monday-Friday, • As essential personnel, occasional animal work outside of normal business hours or availability for emergency response may be required but very limited, • Support from leadership to enroll in continued education opportunities to maintain certifications, attend seminars and career developmentMINIMUM QUALIFICATIONS, • DVM or VMD from AVMA-accredited institution; may substitute completion of ECFVG program for graduates of non-AVMA schools., • License to practice veterinary medicine in at least one state; must attain Wisconsin licensure within 6 months of hire., • DEA Registration for maintenance of controlled drugs on site., • USDA Accreditation Category II, • Minimum of 5 years of experience working with animals in a research environment, • Excellent time management skills and the ability to prioritize work, • Attention to detail and problem-solving skills, • Excellent verbal and written communication skills, • Strong organizational skills with the ability to multi-task, • Interpersonal skills necessary to manage othersPREFERRED QUALIFICATIONS, • ACLAM board certification or residency training in laboratory animal medicine with eligibility to take ACLAM board exam, • Background in either swine management/research or experience in breeding/neonate management of any species

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Project Manager, supporting Quality Control is accountable for the planning, coordination, and successful execution of QC activities across clinical and commercial programs. This role provides indirect leadership of QC project teams and ensures high‑quality, timely, and compliant release and stability testing for internal and external programs. They will serve as the primary liaison between Arrowhead and external partners, including contract manufacturing organizations (CMOs) and contract research organizations (CROs), overseeing analytical method transfers, method validation, release testing, stability studies, and related QC deliverables. This position drives cross‑functional alignment by facilitating collaboration across technical, quality, regulatory, supply chain, clinical, legal, and finance teams. The Project Manager identifies risks and opportunities, establishes project priorities, and ensures accurate tracking of milestones, budgets, KPIs, and vendor performance. Responsibilities include managing vendor onboarding, contracts, proposals, and ongoing relationships; maintaining project documentation and dashboards; leading project meetings; and supporting operational readiness for QC activities. This is a non‑laboratory role requiring strong communication, organizational, and leadership skills to effectively support the operational excellence and strategic objectives of the QC organization. Responsibilities • Act as primary point of contact for projects, facilitating communication between internal and external team members for Quality control activities such as method transfers, method validation, in-process control sample timelines, release and stability planning/testing., • Communicate project status and vendor activities to Arrowhead management and stakeholders, • Manage budget, timeline, quality and deliverables for each project and vendor, • Collect and report on performance metrics for each project, • Generate and maintain project tracking tools using Smartsheet, Excel, Power Bi and other databases., • Partner with the cross functional project team (Process development, analytical development, QA, regulatory, manufacturing, supply chain) to deliver quality product on time., • Work with technical, legal and finance groups to draft RFPs, track, manage and negotiate new contracts, supply agreements, confidentiality agreements, purchase orders, etc. for new and existing vendors., • Track and review vendor invoices; collaborate with finance department to process payments., • Develop and maintain performance metrics for projects and external partners., • Lead project meetings, vendor visits and conference calls., • Oversee shipments and storage of GLP, GMP, and clinical materials in accordance with Arrowhead SOPs., • Collaborate with clinical and/or commercial supply chain to ensure materials are ready for current and up-coming developmental and/or commercial programs., • Manage internal and external inventory of intermediates, API, investigational product, retains, samples, and clinical and/or commercial supplies., • Bachelor's degree in Life Sciences with 3 years' relevant industry experience in the pharmaceuticals or biotechnology industry required., • 2 years in a project management or project coordination role, • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia for pharmaceutical manufacturing and testing., • Strong MS Office skills (Outlook, Excel, PowerPoint, and Word)., • Highly motivated team player willing to contribute to a growing biotech organization., • A detail oriented, organized, self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead., • Strong verbal and written communication skills and ability to work in a cross-functional environment, • Previous experience in pharmaceutical manufacturing, clinical supply, or project management roles., • Experience with Project Management Software such as Smart Sheet or MS Project., • Experience with an ERP system such as Microsoft Dynamics (D365) or SAP. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

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