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Job Description Clinical Trial Recruiter RCT 101/100 Job Type: Full Time and Part Time positions available Seeking individuals for Clinical Trials Recruiter position in our Fairfield, NJ facility. CPTC provides testing and consultation services to the pharmaceutical, cosmetic, personal care, medical device and household product industries. Job Type: Full Time/Part Time: Base Hours vary MINIMUM QUALIFICATION REQUIREMENTS To perform this job, an individual must be able to perform each essential duty satisfactorily, and meet the educational and experience requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES • Review database for panelists with matching inclusion/exclusion criteria to upcoming clinical trial protocols., • Contact potential subjects and discuss clinical trial requirements and availability to participate, • Ensure compliance with protocols, and standard operating procedures, • Data entry of subject data into database · High School diploma / GED required · General Office Equipment Skills · 2 years clerical experience preferred COMMUNICATION SKILLS • Computer skills: MS Word and Excel required, • Organizational, analytic, and problem-solving skills, • Attention to detail; ability to maintain confidentiality PHYSICAL REQUIREMENTS On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch; talk, hear, and smell. Specific vision requirements including reading of written documents, visual inspection of documents and use of computer monitor screen frequently. This position entails repetitive motion with keyboard and mouse. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Job DescriptionQuality Control Analytical Associate IIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Under the direction of the Manager, QC Analytical Associate II, responsibilities include: • Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations, • Performs maintenance, monitoring, and troubleshooting of pertinent equipment, • Performs and assists in the training of other Quality Control technicians, • Maintains training records and coordinates records retention with Document Control and Training groups, • Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines, • Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable, • Participates in managing QC materials and supplies, • Performs and assists in equipment and method qualification/validation activities as needed, • Performs reagent and media preparation, • Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment, • Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results, • Initiates, investigates, and prepares deviation reports with input from assigned supervisor, • Brainstorms and implements corrective and preventive actions, as and when applicable, • Documents training and execution of shipping test samples to contract laboratories for testing, • Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP), • Communicates effectively with other co-workers, departments, management and clients, • Eventually serves as a lead and/or co-lead for client projects, • Additional tasks as assignedREQUIREMENTS, • BA/BS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferred, • Prior industrial experience in cell count methodologies preferred, • Prior academic and/or industrial cell therapeutic experience preferred, • Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry, • Proficient with computer software such as: Microsoft Office, Visio, • Strong written and oral communication skills, • Strong presentational skills preferred, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities.Other Information, • While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens., • Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays, and as required by the company, • Must be able to handle the standard/moderate noise of the manufacturing facility, • The QC Analytical Associate II must be able to work in a laboratory environment for an extended period., • Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hearPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. QC Analytical Associate I is available as well.

Job DescriptionJob Title: QC Microbiology Compliance Investigator Job Description As a QC Microbiology Compliance Investigator, you will play a pivotal role in determining the causes and preventative actions of Deviations, Non-Conformances, Out of Specifications (OOS), Out of Trends (OOT), and environmental excursion investigations. You will drive investigations to their true root cause using appropriate tools, benchmark industry standards, and implement investigative and impact assessment toolsets. Your work will define and implement effective preventative actions to prevent recurrence while managing multiple investigations efficiently. Responsibilities • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approaches., • Develop materials to train personnel on writing problem statements and using root cause analysis tools., • Manage CAPA plans and their implementation., • Communicate plans for ongoing deviations and CAPAs effectively., • Oversee the timely completion of deviations, CAPAs, and Change Controls., • Expertise in laboratory processes, CAPA, Bioburden, and Aseptic techniques., • Experience in investigations and analysis, including life-cycle investigations of deviations and non-conformances., • GMP Training, Quality Systems Training, and Safety Training., • Experience with QC Micro deviations and compliance in microbiology., • Bachelor of Science in a Quality/Process-related field or equivalent experience., • 3-5 years of experience in quality control or assurance within the bio-pharma, biologics, or pharmaceutical industry., • Experience leading event investigations, Root Cause Analysis (RCA), and CAPA., • Technical experience in writing and assessing deviations, investigations, and OOS., • Strong IT skills, including proficiency with Visio, Microsoft Project, and Excel. You will work in a GMP Commercial Facility with a schedule of Monday to Friday on the 1st shift. Flexibility is essential. The work environment offers a great atmosphere, opportunities for growth, and the chance to be part of a new project taking a client's product commercial. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. This position is urgently hiring - If interested, please submit your updated resume along with your availability for a 5-minute call to kvespia @astoncarter.com Pay and Benefits The pay range for this position is $45.55 - $45.55/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Oct 20, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description Warehouse Operator – Pharmaceutical Distribution Location: Pearl River, NY Shift: 1st Shift | Monday–Friday | 7:00 AM – 3:30 PM Type: On-site | Contract Pay Range: $25/hour Insight Global is hiring a Warehouse Operator to support a large pharmaceutical manufacturing and distribution facility in Pearl River, NY. This role is ideal for someone with hands-on warehouse experience and a strong commitment to safety and teamwork. Key Responsibilities: • Operate forklifts and other warehouse equipment safely and efficiently, • Pick, receive, store, and distribute pharmaceutical products, • Maintain accurate inventory records and follow GMP protocols, • Collaborate with team members to ensure smooth daily operations Required Skills & Experience: • 3+ years of experience in a warehouse environment, • Forklift operation experience (certification preferred), • Ability to work effectively in a team setting, • High school diploma or equivalent

Title: Validation SME Duration: 5+ months contract (candidates who are willing to be converted to FTE/Perm upon completion of contract will be moved to stop of the list) Location: Hybrid onsite 3 days in Long Island City, NY (11101) Must Have: • Extensive experience within medical, pharmaceutical, or regulatory compliance environments, • Strong Computer Software Assurance (CSA) expertise; able to serve as the subject matter expert, • Excellent communication, leadership, and collaboration skills; positive and approachable demeanor, • Agile methodology knowledge/experience strongly preferred Responsibilities: • Provide subject matter expertise on validation project risk and complexity, • Ensure adherence to validation best practices and compliance standards, • Gather project information and requirements from system stakeholders, • Collaborate frequently with Business Analysts and cross-functional teams, • Maintain compliance with Good Documentation Practices (GDP), • Support authoring and reviewing of validation reports and documentation, • Collect and integrate feedback from system stakeholders on deliverables, • Draft and execute GxP Assessments, Risk Assessments, Validation Plans, Test Plans, and Validation Summary Reports as needed, • Review, draft, and execute additional validation documentation when required Qualifications: • Bachelor’s degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or a related field, • 7–10+ years of progressive experience in Computer System Validation (CSV) and Computer Software Assurance (CSA), • Solid knowledge of GAMP 5 and 21 CFR Part 11 standards, • Prior experience in GxP or life sciences industries required, • Strong understanding of FDA regulations and compliance requirements, • Proven experience creating, reviewing, and resolving CAPAs, • Ability to work independently while meeting project deadlines, • Practical knowledge of Data Integrity and ALCOA+ principles is a plus Competencies: • Technical Competency: Able to translate business requirements into CSV documentation and supporting materials, • Time Management: Manages strict deadlines and competing priorities effectively, • Analytical Skills: Applies logical reasoning to identify, research, and communicate critical information, • Agility: Adapts to shifting priorities and timelines while maintaining high-quality deliverables, • Commitment to Quality: Demonstrates strong understanding of CSA, prioritizing customer safety, data integrity, and product quality Note: This opportunity is not open to C2C arrangements.

About the Company Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world. About the Role The Manager, Institutional Contracts plays a crucial role at Breckenridge by overseeing the management of contacts, negotiations and legal agreements. This position requires expertise in contract administration, compliance and strong knowledge of pharmaceutical industry specifically with in the Institutional space. The Manager, Institutional Contracts collaborates with cross-functional teams and external stakeholders to ensure effective management and mitigate legal risks. Responsibilities: Contract Administration & Maintenance • Oversee the full lifecycle of Bids and Contracts functions, including contract administration., • Ensure timely submission of bids and RFPs via email or online portals., • Maintain accurate and updated contract data including product lists, prices, annual renewals, and customer compliance documentation., • Administer customer pricing and maintain master customer data using internal systems and processes., • Track and follow up on project bids and agreement deadlines to ensure timely execution. Contract Development & Negotiation • Draft, develop, prepare, and review contract documents in collaboration with Legal to minimize exposure and maximize value., • Partner with Commercial counterpart to ensure harmonization of contract language across both Commercial and Institutional business., • Lead contract negotiation processes by partnering with internal departments and providing strategic guidance on terms., • Communicate contract requirements and the intent of terms and conditions clearly to internal and external stakeholders., • Identify contractual pricing risks and escalate issues to Senior Leadership and relevant management levels., • Proactively govern and lead expiring contracts and extension activities. Cross-functional Collaboration & Compliance • Collaborate with Sales, Finance, Strategic Alliances, and Supply Chain to drive contract and price strategy from opportunity discovery to execution., • Work cross-functionally to ensure alignment and understanding of current contract terms (e.g., admin fees, rebates, failure to supply)., • Create and monitor customer offer letters and ensure adherence to customer compliance requirements. Qualifications: • Bachelor’s degree in business related field. Required Skills • 5+ years proven experience in contract management within the institutional space of the pharmaceuticals industry, preferably in generics., • In-depth knowledge of the pharmaceutical industry, market dynamics and commercial environment., • Proficiency in contract administration, including contract drafting, review and analysis., • Exceptional communication and interpersonal skills, with the ability to influence and collaborate effectively across all levels of the organization., • High proficiency with iContracts and SAP., • Strong knowledge of Microsoft Word, Excel and PowerPoint preferred., • Detail oriented and capable of managing multiple projects simultaneously., • Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities. Pay range and compensation package At Breckenridge Pharmaceutical, Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location: • Flexible approach to how we work, • Health benefits and time-off programs, • Competitive compensation packages including a yearly bonus opportunity, • The anticipated annual salary for this role is $130,000 – 150,000. Equal Opportunity Statement Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Job Description Summary The Commercial Counsel - Customer Contracts provides timely legal counsel on commercial matters including contract management matters for the U.S. Sterile Injectable and Generics business unit. This Attorney will strategically and efficiently lead, coordinate, facilitate and manage contract requests across these two business segments, which shall include the preparation and negotiation of commercial agreements including numerous customer agreements. The role will manage adherence to the Endo contract management process, including utilization of the Legal Department’s contract management tool. In addition to providing contract support, the position will provide commercial and regulatory counsel and support on commercial initiatives and promotional labeling through the MARC review process. All incumbents are responsible for following applicable Division & Company policies and procedures. Job Description Accountability Responsibilities % of Time Contract Management • Independently consult, advise, and represent the Company on a variety of highly complex contractual legal matters, particularly customer agreements, for the sterile injectable and generics and business units., • Act as advisor of commercial contract management processes, with strong project management skills, legal analysis, quality standards, and strong understanding of contract terms based on client need and business objectives., • Provide legal advice and counsel to business colleagues to assist the Company in managing risk with respect to contract-related matters Business Unit Counsel • Provides legal advice and counsel to business colleagues in the Sterile Injectables and Generics Business Unit to assist the Company in managing risk with respect to regulatory compliance of commercial initiatives and promotional labeling through the Company’s MARC review process for the sterile injectable and generics business units. Special Projects • Assist with development and or creation of policies, standards, and procedures for contract management., • Assist with other special projects as assigned, • Juris Doctor degree from an accredited law school required., • Bar admission in New Jersey and Pennsylvania preferred., • Minimum eight years senior level experience with customer contracting at law firms, corporate legal departments, or other service providers required., • Previous attorney position at law firm, corporate legal department or other relevant service provider., • A deep understanding of pharmaceutical contracting across various commercial business segments, including generics, government and hospital-based contracts as well as corporate support areas (e.g., Finance, IT, etc.)., • Understanding of laws and regulations applicable to pharmaceutical marketing and commercialization for the sterile injectable and generics business units., • Understanding of contracts management programs and requirements., • Demonstrated success in the management of multiple projects ranging in size and scope, with an emphasis on larger more complicated matters., • Ability to operate independently while providing legal counsel and guidance in fast paced fluctuating environment., • Good research skills with an ability to analyze and interpret complex information., • Strong written and negotiation skills., • Effective verbal and written communication skills supporting interaction with various levels of employees and management (e.g. diplomacy, advocacy and “active” listening skills)., • Excellent client relationship skills, which include the ability to proactively manage client expectations., • Excellent judgment and ability to make concrete recommendations., • Leadership abilities coupled with strong personal accountability and initiative., • Ability to multitask under pressure., • Excellent organizational, planning, prioritization and problem-solving skills., • Customer service demeanor; approachable, respectful and polite., • Ability to build and maintain effective working relationships, both within the Company and with outside suppliers., • Superior technical communication skills., • Flexibility in unanticipated situations., • Ability to own tasks from start to finish with limited supervision., • Expert level PC user with deep familiarity utilizing Microsoft Office Suite. EEO Statement: We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

QC Manager – Fairfield, NJ Summary: The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for training and personnel development. This is a hands- on position. In addition to managerial responsibilities, this position will be performing analytical testing including wet chemistry, GC, HPLC, etc. as needed Responsibilities: • Lead, coach and manage a team of analysts to ensure data integrity and performance to meet business objectives, • Train and develop analysts, • Formulate, document, and maintain quality control standards and on-going quality control objectives, • Schedule workload to meet release objectives and deadlines, • Review, interpret, analyze and report HPLC/GC/UV/FTIR data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines, • Author analytical methods and SOPs, • Clean, maintain, and troubleshoot HPLC/GC/UV/FTIR instruments, • Develop specifications and analytical methods as required, • Develop analytical methods to support product development projects, • Prepare analytical method validation protocols and reports, • Perform Laboratory Investigations, root cause analysis, CAPA, Change Controls, Validations, Stability Programs, APRs, statistical analysis, environmental monitoring of air, water, and surfaces, as needed., • Manage the outsourcing process of testing to contract laboratories, • Ensure lab safety and manage chemical inventory, • Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations, • Perform duties of QC Analyst as needed including HPLC sample preparation and testing and any other testing requirements, • Audit the work of QC Analysts, • Other duties assigned by Management Education: • Bachelor’s degree in a scientific discipline (Chemistry preferred) with a minimum of 5 years’ experience in laboratory management OR Master’s degree in a scientific discipline (Chemistry preferred) with a minimum of 3 years’ experience in laboratory management Experience Requirements: • Experience with Empower 3, • Experience working in an FDA regulated environment, • Experience with GC sample preparation and testing, • Knowledge of USP Monograph testing, analytical method development & validation, • Knowledge of CFR & ICH Regulatory Guidelines, • Knowledge of cGMP processes, lab safety and GDP. Computer Skills: • Proficiency in Microsoft Word, • Proficiency in Microsoft excel, • Proficiency in Empower 3 Other requirements: • Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory., • Able to perform complex mathematical problems, • In depth knowledge of all laboratory equipment, practices, and procedures, • Demonstrated managerial abilities, • Problem analysis, solving and resolution skills, • Has excellent oral and written skills, • Has excellent interpersonal skills, • Is self motivated, • Has a very high attention to detail, • Has a positive attitude, • Must speak, read, and write in English, • Able to lift 25 pounds, • Able to stand for extended periods Hours: • Standard: 8:30 AM to 5:00 PM, Monday through Friday, • Occasionally: Extended hours and/or Saturday and Sunday may be required as necessary to support manufacturing.

Job DescriptionJob Title: Investigation and Deviation Writer Job Description We are seeking a dedicated Investigation and Deviation Writer responsible for writing and completing investigations and deviations from a compliance and operations perspective. This role involves conducting root cause analyses and managing the full lifecycle of investigations, from initiation to closure, to ensure manufacturing and GMP compliance. Responsibilities • Determine the causes and preventative actions of Deviations, Non-Conformances, Out-of-Specification (OOS), Out-of-Trend (OOT), field complaints, and environmental excursion investigations., • Drive investigations to uncover true root causes using appropriate tools and benchmark industry standards., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track Corrective and Preventative Action (CAPA) plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Utilize change management approaches effectively., • Develop training materials to educate personnel on writing problem statements and using root cause analysis tools., • Champion CAPA plans and implementation., • Provide ongoing communication plans for deviations and CAPAs., • Oversee timely completion of deviations, CAPAs, and Change Controls., • Ensure adherence to quality standards.Essential Skills, • 2-3 years of experience writing and reviewing deviations and investigations within a pharmaceutical company., • Experience working with quality assurance teams to ensure accurate tracking and documentation of investigations., • Proficiency in root cause analysis, CAPA, and biologics., • Experience with GMP operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma., • Familiarity with e-Quality Management Systems.Additional Skills & Qualifications, • Bachelor's degree in a related scientific field., • Experience in technical writing., • Experience with cell and gene therapies or biologics., • Relevant IT skills, including proficiency with Visio, Microsoft Project, and Excel.Work Environment You will work closely with a team of QA/QC professionals in a collaborative environment, engaging cross-functionally with the manufacturing team. The role involves working at two sites located close to each other. The team consists of five other investigators, and you will work the first shift from Monday through Friday, starting between 8 AM and 9 AM. The company offers a supportive work culture with opportunities for growth and expansion, as well as the satisfaction of contributing to saving patients' lives. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. Pay and Benefits The pay range for this position is $40.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Oct 20, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Eurofins Transplant Genomics Inc. (“ETG”) is a molecular diagnostics company committed to improving organ transplant outcomes with non-invasive serial monitoring guided by biomarkers. ETG’s product portfolio of both individual and combined whole blood gene expression and donor derived cell-free DNA testing is capable of reliably ruling out subclinical kidney rejection and acute rejection in kidney transplant patients. In addition to kidney transplantation testing, our newest product for liver transplant patients is a blood-based biomarker assay designed to rule out rejection as immunosuppression therapy is optimized. Basic Function and Scope of Responsibility: The Territory Manager – (TM) is the account “lead” and is primarily responsible for; 1) generating account demand for ETG product offerings with new customers, 2) coordinating and facilitating product adoption and growth, 3) onboarding and educating on ordering process and sample collection, and 4) ultimately assuring a positive customer experience by demonstrating and delivering the Value Proposition(s) of the ETG product portfolio through our clinical, provider, patient, and practice management support systems and resources. The Territory Manager will support the financial objectives of the assigned territory by effectively implementing Transplant Genomics’ sales and marketing strategies to grow product portfolio volume and revenue. The Territory Manager is expected to be in-field client facing personnel supporting all commercial company endeavors. Qualifications • Bachelor’s degree required, preferably in a science or business-related field of study., • At least 5 years of successful direct sales and business development experience in the academic hospital setting responsible for all aspects of the sales process, with a strong preference for previous solid organ transplant, hepatology, dialysis, or laboratory experience required, • Ability to travel up to 50%, • Customer service focused and professional attitude, • Self-starter who takes control of all account sales processes and solves problems, prioritizes tasks, and mobilizes resources to achieve sales objectives, • Goal oriented with excellent time management, prioritization, and organizational skills and disciplines., • Excellent interpersonal skills with ability to interact effectively and work efficiently with people at all levels in an organization, • Excellent verbal & written communication skills, • Keenly attentive to detail, • Ability to keep sensitive information confidential Additional Information Schedule: • Excellent full time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job Description Faro Health aims to improve lives by helping life sciences companies answer complex clinical questions, simply, efficiently and effectively. Our software platform is used to orchestrate complex clinical development with a single source of truth. It brings words, data and teams together, empowering researchers to design more intelligent trials, master complexity and reach milestones faster. The Clinical Strategy and Solutions Specialist will support all aspects of study modeling within the Faro Study Designer to ensure quality of studies modeled supporting the success of our users and supports the enhancement of data-driven features on the Faro Health Platform. In this role, you will utilize your expertise in Clinical Operations to understand and reflect clinical protocols in the Faro Health Platform across a variety of Therapeutic Areas and Study Designs. This role will also support the development of training materials and other tasks that may require clinical expertise. This position is 100% remote and only open to candidates who currently reside in one of the following states: California, Wisconsin, North Carolina, Massachusetts or New York only. Requirements Duties and Responsibilities • Conduct modeling of publicly available studies in the Faro Study Designer for customers, sales demos and continuous buildout of the public study library, • Conduct clinical QC of public study library modeled studies, • Conduct QC of Clinical Data Management gap assessments of public studies for customer, sales demo, and public study library modeled studies, • Work with the Product Experience (PX) team to support the development of training materials that may require clinical expertise, • Support other tasks as needed, • Ability to work 30-40 hours per week, • Ability to work during the hours of 9am to 3pm Pacific Time Qualifications • Bachelor’s degree required, preferably in physical or life science or statistics discipline, • 5+ years of Clinical Operations work experience in pharmaceutical clinical trials, • Experience as a Clinical Research Associate, • Oncology experience or complex clinical trial experience, • Experience with Phase I and Phase II studies, • Strong knowledge of clinical trials and drug development processes, • Ability to read and comprehend complex clinical trial protocols and designs, • Familiarity with and experience using clinical trial technologies (e.g., EDC, IRT, CTMS, ePRO, eCOA, eConsent, TMF), • Knowledge of regulatory requirements and information governance frameworks (e.g. ICH, GCP, HIPAA, GDPR), • Excellent team player with demonstrated track record of success in a cross-functional team environment; consistent commitment to delivering on team goals with a sense of shared urgency Skills and Competencies • Strong organizational, motivational, and leadership skills, promoting a team-based approach, • Strong attention to detail skills and ability to triage and aid in resolution of escalations, • Ability to work independently or in a group setting; ability to adjust to changing priorities, • Strong emotional intelligence, interpersonal and communication skills, both verbal and written, • Strong organizational and leadership skills, • Strong problem solving skills, • Goal-oriented, • Ability to project and maintain a professional and positive attitude Salary • This is a 5 month contract with possibility for extension, • Hourly range for this position is $50 to $60 per hour. Individual hourly pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training., • Open to candidates who currently reside in California, Wisconsin, North Carolina, Massachusetts or New York only.

Job DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: Compass is seeking a highly motivated and experienced Director, Regulatory Project Management to lead the end-to-end project management of a New Drug Application (NDA) submission. This individual will ensure that all activities are strategically planned, efficiently executed, and delivered on time, within scope, and to the highest quality standards. Location: Hybrid in our New York City office or remote on the East Coast, USA. Reports to: Senior Vice President, Regulatory Affairs. Duration: 12 months contract. Roles and responsibilities (Include but are not limited to): Submission Leadership • Develop, implement, and maintain a comprehensive NDA submission project plan, including detailed timelines, workstreams, milestones, and dependencies, • Drive the overall project plan for NDA preparation and submission, ensuring all components are planned, tracked, and delivered on schedule, • Define the critical path activities and proactively adjust plans in response to evolving requirements or risks, • Align submission activities with overall development program strategy and corporate objectives, • Partner with Regulatory Strategy and Operations leads to translate high-level regulatory strategy into detailed, executable submission plans Governance & Oversight • Establish appropriate submission governance forums (e.g., core team, functional sub-teams, steering committee, etc.), • Define decision-making process and escalation pathways to ensure effective risk and issue management, • Facilitate effective cross-functional working sessions to maintain alignment and momentum, • Provide regular status updates, metrics, and dashboards to cross-functional teams, management and executive leadership Execution & Deliverable Management • Drive collaboration across Clinical, CMC, Nonclinical, Clinical Pharmacology, Safety, Statistics, and Medical Writing, to ensure alignment of deliverables, • Track document authoring, review, and finalization cycles, providing clear visibility of status across teams, to ensure CTD content is delivered on schedule, • Partner with regulatory operations to oversee dossier compilation, QC, and submission readiness, • Serve as the central point of contact for submission progress and status inquiries Risk, Issue & Change Management • Proactively identify risks to submission timelines and establish mitigation and contingency plans, • Maintain a risk register and ensure issues are tracked, escalated, and resolved in a timely manner, • Manage changes in priorities or scope while preserving overall submission objectives Operational Excellence • Develop and maintain detailed timelines, trackers, and dashboards to drive execution against critical path activities, • Support Regulatory Operations efforts in publishing, document management, and inspection readiness with internal teams and external vendors, • Ensure adherence to SOPs while introducing pragmatic process improvements where gaps exist, • Develop, maintain, and monitor detailed submission project plans, including critical path analyses and contingency planning, • Ensure adherence to company standard operating procedures (SOPs), templates, and regulatory publishing requirements, • Support inspection readiness and documentation of submission-related activities Health Authority Engagement • Develop and oversee project plans and timelines for FDA interactions related to the NDA submission, including briefing packages, meeting logistics, and response management, • Ensure all submission components meet regulatory agency requirements and withstand internal/external audit scrutiny Post-Submission Transition • Establish mechanisms to track submission-related milestones, commitments, and queries from FDA (e.g., Labeling, REMS, IRs, etc.), • Develop and oversee response authoring timelines for FDA submission-related queries, • Transition governance from submission execution to lifecycle management and post-approval commitments Candidate profile: • Bachelor's degree in life sciences, pharmacy, or related discipline required; advanced degree (MS, PharmD, PhD, or MBA) preferred, • 10+ years of experience in the pharmaceutical/biotech industry, with significant experience in regulatory project management, • Demonstrated leadership in managing at least one NDA or BLA submission from initiation through completion; experience managing rolling and/or expedited reviews is a plus, • Deep knowledge of FDA regulations, ICH guidelines, and CTD/eCTD structure, • Proven ability to manage complex, multi-disciplinary projects under tight timelines, • Proficiency with project management methodologies and tools (e.g., MS Project, Smartsheet, Veeva Vault RIM, or equivalent), • Strong organizational, analytical, and facilitation skills, with an ability to influence across functions and levels 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$225,000—$275,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Job Description One of the nation’s largest independent testing facilities seeks a Stability and Study Coordinator with a minimum of 2 years stability systems experience in a GMP environment. The perfect candidate will also have previous experience as an Analytical Chemist with a minimum 2 years experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Must have the technical ability to understand client requirements, technical documentation, and be able to prepare testing protocols. Responsibilities include, but are not limited to the following: • Communicates with clients regarding studies to ensure timely processing and submission to the laboratories., • Entry of stability studies and all associated information into company software system and communicates the stability testing schedules to department management., • Performs time point pulls within the acceptable guidelines and documents details as per SOPs, customer and regulatory requirements., • Submission of the stability samples to the appropriate departments., • Develops and generates stability study protocols according to customer requirements and timelines, internal SOPs and regulatory requirements., • Compilation of time point raw data and verification of results entry into stability system as well as generation of interim and summary time point data and reports., • Prepares the generation of shelf life summary reports for products based on compiled data., • Coordinates with department management regarding stability workload and schedules to ensure timelines are met., • Preparation of sample shipments and paperwork for returned samples., • Entry of routine, development and validation studies and all associated information into company software system and communicates the study details to department management., • Documents work clearly and accurately., • Perform technical writing and peer review as needed, • Capable of working in a fast paced environment. Education and Experience • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of stability systems experience in a GMP laboratory., • Minimum 2 years of product testing experience in a GMP laboratory., • ISO 17025 experience a plus., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Candidates must be local and work hybrid out of: Lake County, IL; San Francisco, CA; Irvine, CA; Florham Park, NJ The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients. Responsibilities: • Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for evidence generation)., • Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects., • Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately., • Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff., • Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures., • Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics department., • (Clinical Statistics) Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements. Qualifications • MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field., • High degree of technical competence and excellent communication skills, both oral and written, • Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others, • Able to manage project timeline and quality of deliverables, • Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo, • Have strong leadership skills and experience in working/managing cross-cultural or oversea teams, • Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Description Position Summary: Oncology Avyxa Pharma, a leading manufacturer of 505(b)(2) oncology products, is seeking an experienced and driven Director of Sales to lead our sales efforts in the eastern and western United States. These individuals will be responsible for managing a team of sales professionals, driving business growth, and developing strategic relationships with key stakeholders in the oncology space while maintaining a competitive and positive work culture. The ideal candidate will have pharmaceutical sales experience, with a strong background in oncology and 505(b)(2) drug commercialization. This role requires up to 70% travel and reports to the Vice President of Sales & Corporate Accounts. Key Responsibilities: · Following company strategic goals and philosophy, the Director of Sales will provide sales leadership and guide strategic direction for direct reports in assigned territory. · Lead and mentor a team of sales professionals, setting performance objectives and ensuring successful execution as evidenced by quarterly goal attainment for all qualified Avyxa products. · Will work independently and with direct reports to identify and develop new business opportunities to drive market penetration and revenue growth endeavoring to maintain strong customer relationships over an extended period. • Team Management & Development:, • Recruit, train, and develop a high-performing sales team that will have responsibility for selling Avyxa’s products including but not limited to Docivyx®, Frindovyx™, Posfrea™ and Axtle™., • Conduct regular performance reviews, provide coaching, and support career development., • Foster a collaborative, results-driven culture within the sales organization., • Customer Engagement & Relationship Management:, • Build and maintain strong relationships with customers, including but not limited to oncologists, pharmacists, nurses, key business personnel, aggregator and group purchasing organizations (GPOs) sales representatives., • Work closely with direct reports to ensure customer needs are met and growth opportunities are maximized by maintaining close relationships with customers, providing Avyxa product contract updates, Avyxa support materials, and ensuring productive collaboration between customers and other internal Avyxa resources (market access, field reimbursement, payer team, operations) • Represent Avyxa Pharma at industry conferences, advisory boards, and networking events. Data-Driven Decision Making: • Utilize Tableau, Excel, and other analytics tools to track sales performance and market trends., • Prepare and present sales reports, forecasts, and business reviews for senior leadership., • Communicate and leverage market intelligence to adjust strategies and optimize sales efforts., • Cross-Functional Collaboration:, • Partner with Avyxa Strategic Account Directors, Data and Analytics, Field Reimbursement Team, Operations Team, and Medical Affairs to ensure effective product positioning and messaging., • Provide customer insights to support product development and commercialization efforts., • Ensure compliance with pharmaceutical regulations and corporate policies. Qualifications & Experience: • 8+years of pharmaceutical sales experience, with at least 3 years in oncology. Managerial experience preferred. Candidates with similar experience and exceptional track record of success will be considered., • Strong understanding of the 505(b)(2) regulatory pathway and drug commercialization in community oncology and hospital/IDN setting preferred., • Proven leadership experience with a track record of managing and developing sales teams., • Excellent verbal and written communication skills., • High proficiency in PowerPoint, Excel, Tableau, and other sales analytics tools., • Ability to travel up to 70% across the designated region. Preferred Qualifications: • Experience working with community oncology practices, hospitals, and integrated delivery networks (IDNs)., • Sales management · Understanding of the buy-and-bill oncology reimbursement methodology, GPO and aggregator relationships. • Prior experience launching 505(b)(2) oncology drugs. Location: Remote (Must reside within the designated region) Compensation & Benefits: Competitive salary, performance-based bonus, comprehensive benefits package, and travel reimbursement. Company DescriptionAvyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system. Our core values are grounded in providing access to meaningful products that improve patient care.Avyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system.\r\n\r\nOur core values are grounded in providing access to meaningful products that improve patient care.

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. About the Role The Senior Manager, Validation, situated within the Quality Assurance department, will provide quality support on validation activities for internal and external (i.e., contract organizations) GxP computer systems and data integrity processes. This position will be responsible for ensuring equipment and systems are in an operational state of compliance associated with cGMP manufacturing environments, GxP requirements, and internal policies. They will ensure consistent application and maintenance of Validation procedures This position will collaborate cross-functionally for on-going activities in support of validation activities occurring both internally and at Tonix contracted organizations including support of risk assessments, deviations, CAPAs, and change controls. The Senior Manager, Validation, will lead, direct, and advise continuous improvement of the department’s area of control, and assist in any other area as needed or directed by management. Essential Duties • Ensure the validated status of GxP computer systems used to support GxP activities, is established in accordance with internal procedures, regulatory requirements and industry guidance / standards., • Define computer system validation policies and overall strategies and ensure compliance and consistency with regulatory requirements and best industry practices., • Responsible for maintaining the CQV and CSV programs in a state of compliance., • Establish and provide quality and technical input on the development of policies, procedures, standards and templates, • Review and approve technical documents throughout the equipment/system lifecycle from commissioning, qualification and/or validation through decommissioning, including validation plans, risk assessments, test protocols and reports., • Develop validation and testing strategies based on system risk, complexity, and other relevant factors and ensure all validated systems and documentation comply with applicable regulatory requirements., • Assist with the development of system requirements and specifications to ensure requirements are testable and 21 CFR Part 11 requirements are met. Implement and ensure effective data integrity controls and practices., • Evaluate proposed changes to validated computer systems and recommend the level of validation activities required., • Manage and perform all Quality System functions for the department including impact assessments, deviations, CAPAs, change controls, SOP revisions, and audit responses., • Participate in regulatory inspection, internal audits, supplier audits (as needed), and audit response activities., • Must comply with all applicable rules and regulations of Emergent and Pharmaceutical/Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations, and company regulations. Will maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation., • Define and communicate metrics used to track performance relevant to the operations qualification programs’ activities / responsibilities and ensure commitment to key stakeholders and company goals are met., • Proficiency with Quality system applications (e.g., eDMS, QMS), • Dedicated team player who is able to withstand the high demands of a fast-paced environment., • Results driven, problem solver, and collaborator Excellent written and verbal communication skills, • Excellent planning and time management skills and the ability to handle several tasks simultaneously., • Comfortable working independently with minimal supervision, • Ability for travel up to 20% of the time, • Must be able to provide clear direction while motivating teams., • 10+ years of experience in the biotech industry and 2+ years of management experience., • Demonstrated knowledge of cGMPs for biotechnology, validation-related topics, and key industry validation approaches (e.g., validation lifecycle approach, ASME BPE, PIC/S ISPE Baseline Guides ASTM E2500, GAMP 5, V-model, etc.). Complementary knowledge of biopharmaceutical and process engineering principles and practices., • Demonstrated experience in IT System/Software Development Life Cycle (SDLC), change controls, validation needs, and activities., • Demonstrated expertise in Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and knowledge of applicable Codes of Federal Regulations as they apply to computerized systems, e.g., GxP, validation, 21 CFR Part 11, CSA, etc., • Strong understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory guidance is critical., • Experience with personnel management and development., • Strong project management skills., • Working knowledge in Facility, Utility & Equipment Qualification, Process Validation, and Quality System Management. Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $100,000 to $170,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

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

Job DescriptionCompany Description • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices., • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Responsibilities: • Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)., • Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets., • Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements., • Provides input in the design and development of case report forms and clinical databases., • Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs., • Programs for quality checks for clinical study raw data and report the findings to Data Management., • Provides input in the design and development of case report forms and clinical study databases., • MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years., • Experience in providing statistical programming support to early and late phase clinical trials., • Excellent skills in SAS programming and statistical reporting., • Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements., • Familiarity with FDA and ICH regulations and guidelines., • Excellent problem-solving skills., • Good written and verbal communication skills and organizational and documentation skills., • Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc., • Ability to prioritize and multi-task effectively., • Demonstrated positive attitude and the ability to work well with others.Additional Information All your information will be kept confidential according to EEO guidelines.

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

Job Description Director/Sr. Director of Drug Product CMC Location: New York City, NY Company Overview: We are partnered with a dynamic clinical-stage biotechnology company focused on developing innovative therapies to address unmet medical needs. They are dedicated to advancing science and improving patient outcomes across several treatments and therapies. Their portfolio consists of assets across early and late stage development. Job Summary: The Director/Sr. Director of Drug Product CMC will lead and oversees drug product development, manufacturing, and regulatory activities to ensure high-quality products are delivered from early development through commercialization. This role involves cross-functional collaboration to support product lifecycle management, process optimization, and regulatory compliance for drug products, ensuring all CMC strategies align with company goals and regulatory standards. The Director/Sr. Director will provide technical and strategic leadership, working closely with internal teams and external partners to meet critical project milestones. Key Responsibilities: • Lead the development and implementation of CMC strategies for drug product development and manufacturing., • Oversee technology transfer to and from contract manufacturing organizations (CMOs) and provide technical oversight of drug product manufacturing., • Ensure compliance with cGMP regulations and manage quality assurance activities, including deviation management, batch record reviews, and lot disposition., • Develop and manage risk-based strategies for CMO oversight, considering product lifecycle, technical complexity, and CMO capabilities., • Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, Clinical Development, and Supply Chain, to ensure timely delivery of drug products., • Support regulatory submissions by providing CMC-related documentation and expertise., • Lead process optimization, validation, and continuous improvement initiatives., • Manage the drug product manufacturing budget and long-range planning., • Serve as a subject matter expert during regulatory inspections and audits. Qualifications: • Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field, with 10+ years of experience in CMC and drug product development (or equivalent industry experience for those with a Ph.D.)., • Strong knowledge of cGMP regulations, ICH guidelines, and CMC content of regulatory submissions., • Proven track record in CMC regulatory submissions (IND, IMPD, NDA), • Experience managing CMOs and overseeing technology transfer processes., • Excellent problem-solving, project management, and communication skills., • Ability to work collaboratively in a fast-paced, dynamic environment., • Familiarity with quality-by-design (QbD) principles, statistical analysis, and DOE., • Willingness to travel as needed (up to 10%). What We Offer: • Opportunity to lead in a dynamic, fast-growing company with a strong pipeline of innovative therapies., • Collaborative work environment with professional development and career growth opportunities.

Job DescriptionWe are looking for a skilled Procurement Specialist to join our team in New York, New York, on a long-term contract basis. This role is ideal for professionals with a passion for managing procurement operations and building strong vendor relationships. You will play a key part in ensuring timely and compliant purchasing processes while contributing to continuous improvement initiatives. Responsibilities: • Manage the full lifecycle of procurement activities, from sourcing to delivery., • Create, execute, and monitor purchase orders and change orders, ensuring proper documentation and adherence to deadlines., • Collaborate closely with internal teams, such as R& D and Finance, to align procurement strategies with project goals and budgets., • Maintain and oversee vendor records and procurement documentation within systems like NetSuite and Zip., • Ensure strict compliance with internal policies, procedures, and regulatory standards., • Identify opportunities to improve procurement workflows and implement process enhancements., • Conduct supplier evaluations and maintain qualification documentation as needed., • Support contract negotiations to secure favorable terms and conditions., • Provide timely reports and analysis on procurement activities to stakeholders.• 2–4 years of experience in procurement or purchasing, ideally within the biotech, pharmaceutical, or life sciences industries., • Solid understanding of procurement workflows and systems such as NetSuite, Oracle, or similar platforms., • Strong communication skills with the ability to foster productive vendor and stakeholder relationships., • Exceptional attention to detail and proficiency in organizational and analytical tasks., • Familiarity with supplier qualification procedures and documentation standards., • Certification in procurement or supply chain management is a plus., • Experience working with early-stage or growth-stage biotech companies is preferred.

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Electrical Factory Inspector (Remote/Travel) responsibilities include, but are not limited to, the following: • Support department objectives and company goals, • Be a team player, • Sustain a positive, enthusiastic and professional attitude at all times, • Accommodate requests with a smile and “let me see what I can do” attitude, • Adhere to manager directives, • Maintain a professional appearance and demeanor, • Arrive on time, properly dressed and prepared to work, • Perform all duties in a timely, accurate, honest and professional manner, • Communicate with customers professionally and in accordance with customer service standards, • Surveillance inspections of factories to assure products remain in compliance with conditions of granted certification., • Other duties assigned by management.Qualifications Basic Minimum Education Qualifications: • Knowledge of electronics, • Certification in Electronics, • Willing to travel - This position requires 90% - 100% travel, • Add requirement to be able to rent a car (Minimum age of 25), • Willing to work overtime and remote, • Cannot be on any no fly list, • Clean driver record, • Ability to maintain confidentially, • Needs to be receptive to and accepting guidance from others, • Ability to deal with difficult people and problems, • Able to work well in a team environment, • Able to work in a diverse group of people, • Attention to detail, • Ability to multi-task and prioritize assignments, • Able to sit or stand for long periods of time, • Able to lift up to 30 pounds Additional Information Position is full-time travel & hybrid, working Monday - Friday 8:00 am to 5:00 pm, with overtime as needed. • Compensation: $50,000 - $70,000, • Excellent full time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job Description About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. Position Overview The Sr Manager, Commercial Finance will be responsible for driving financial performance and strategic decision-making across the commercial functions of the pharmaceutical business. This role involves leading financial planning, gross-to-net (GTN) analysis, inventory management, budgeting processes, and new system implementation. The successful candidate will work closely with cross-functional teams, including Sales, Marketing, Supply Chain, and Operations, to ensure financial health and sustainable growth. Essential Duties • Commercial Finance Leadership, • Provide financial leadership to commercial teams, ensuring alignment with business objectives., • Develop and implement financial strategies to support revenue growth, profitability, and cost efficiency., • Partner with commercial teams to analyze business performance, pricing strategies, and margin improvements., • Gross-to-Net (GTN) Analysis & Revenue Management, • Oversee GTN calculations, ensuring accurate revenue recognition and reporting., • Monitor and evaluate rebate programs, discounts, and other commercial deductions., • Provide insights into pricing and contract strategies to optimize net revenue., • Develop robust GTN forecasting models to improve accuracy and decision-making., • Inventory Management & Supply Chain Finance, • Oversee inventory valuation, ensuring compliance with financial reporting standards., • Optimize inventory levels to balance demand, working capital, and cost efficiency., • Work closely with Supply Chain and Operations to drive efficiency in inventory turnover., • Implement controls to mitigate inventory risks, obsolescence, and write-offs., • Financial Planning, Budgeting & Forecasting, • Lead annual budgeting and periodic forecasting processes for commercial functions., • Develop financial models to assess business scenarios, risks, and opportunities., • Track performance against budgets and forecasts, providing variance analysis and recommendations., • Collaborate with business leaders to ensure financial targets are met., • New System Implementation, • Lead the implementation of new financial and operational systems to enhance efficiency and reporting capabilities., • Work with IT and business stakeholders to ensure smooth transition and integration of new systems., • Provide training and support to commercial finance teams on new tools and processes., • Ensure data integrity and compliance throughout the implementation process., • Business Partnering & Stakeholder Management, • Act as a key financial advisor to the executive leadership team., • Work closely with Sales and Marketing teams to assess market opportunities and profitability., • Collaborate with external auditors, tax advisors, and regulatory bodies as required., • Strong understanding of GTN, inventory management, budgeting, and financial planning in a pharma setting., • Experience leading financial system implementations and process improvements., • Expertise in financial modeling, data analytics, and strategic financial planning., • Strong leadership skills with experience managing teams and cross-functional partnerships., • Excellent communication, stakeholder management, and problem-solving abilities., • Bachelor's degree in Finance, Accounting, Economics, or a related field (MBA or CPA preferred)., • CPA preferred, • 8+ years of experience in finance with a focus on commercial finance in the pharmaceutical industry Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $120,000 to $170,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

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

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert (SME) and Project Manager in the execution of Cresilon’s Preclinical Research Operations, including but not limited to in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy. This will include the development and execution of strategies for preclinical evidence necessary to competitively position a project’s product for domestic and international regulatory and clinical acceptance. This position as a hybrid role, with work off-site at CRO in NY/NJ area, work from home and on-site at Brooklyn NY. Job Responsibilities: The Preclinical Research Scientist will: • Lead, staff, and manage Cresilon’s Preclinical Research activities., • Provide preclinical scientific input and leadership on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life cycle., • Plan, direct, coordinate and execute activities related to the design, initiation and follow-up of studies to support approval of Class I-III medical devices., • Develop, write, and/or review study protocols and reports. Act as technical mentor for the development of study experimental designs, protocols, and reports of junior associates., • Administrate and manage Cresilon preclinical regulatory strategy and communication., • Work with Contract Research Organizations (CROs) to execute both Biocompatibility / Safety and Efficacy/Functionality research, including negotiating, drafting, and managing research contracts and agreements with pre-clinical trial sites., • Ensure that company operates within the scope of regulatory compliance including Quality System Regulations (ISO 13485), health and safety, environmental protection regulations, and the core values of Cresilon., • Be a Subject Matter Expert (SME) for preclinical research department growth strategy. Actively interact with the internal and external scientific community to maintain state of the art knowledge., • Oversee the development of and modifications to preclinical models to address project needs., • Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines., • Surveys the literature to identify and compare competitive product performance and safety risks., • Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP's, company policies, etc), • Work cross functionally with Regulatory and Quality to assess project risks, product safety and efficacy on NPD projects, including ensuring external facilities meet Cresilon standards for animal use and generating contracts and CRO audits, if necessary., • Manage budgetary requirements for all research projects to support efficacy and safety programs., • Lead the effort to publish surgical research in peer-reviewed journals., • Regularly interface with management to ensure research operations reflect overall corporate vision/strategy., • DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field is required., • Minimum 6+ years’ experience in preclinical medical device research is required, preference given to veterinary surgical or human surgical experience., • 4+ years of people management experience preferred., • Extensive knowledge of surgery, anatomy, toxicology, and pathology is required., • Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred., • Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred., • Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations., • Experience with surgical publication submission strategy is strongly preferred., • Strong communication skills (both written and verbal) is required with the ability to extract key facts from complex information and present concise summaries to management., • Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required., • Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred., • Excellent problem solving, conflict resolution, and analytical skills is required., • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment is required., • Prior experience and ability to work well with external CROs and collaborators with professionalism and discretion is required., • Requires strong leadership and organizational skills including attention to detail and multi-tasking skills., • Able to understand and execute to project details but keep overall “big picture” view of projects, priorities, and strategies is required., • Medical Device product development experience, including knowledge of medical device regulations, regulatory/notified body requirements is preferred., • Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP), • Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is preferred., • Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred., • Legal authorization to work in the United States., • This position is located in Brooklyn, NY and may require up to 30% travel (to monitor and execute out-sourced studies) Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $130,000 - $210,000, depending upon job level and qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job Description Reporting directly to the CEO, the Marketing Manager is responsible for all marketing and partnership development activities to support the strategic direction of Manhattan Restorative Health Sciences (MRHS). They will be responsible for supporting a patient-centric work environment, in alignment with MRHS’ core values: Inspiration, Purpose, Professionalism, Collaboration, and Innovation. Responsibilities: Marketing: • Develop an annual marketing plan for MRHS with clearly defined goals and a plan for execution, • Collaborate with leadership to identify and execute strategic initiatives utilizing the standard business cases and project charters, • Oversee the overall branding and public relations function for MRHS, • Maintain a Brand Center for MRHS and audit collateral to ensure compliance for branding and messaging (print and electronic media), • Maintain editorial calendars, • Lead patient experience initiatives and report to the CEO and or other stakeholders as required, • Support a culture of service excellence by triaging high priority patient concerns while investigating the causes and providing an immediate solution(s), • With input from the leadership team, develop a quarterly business development plan, • Identify and prospect potential business development/partnerships opportunities, • Evaluate business deals to include projected value, prepare presentations and briefing books, • Collaborate with key stakeholders to structure the negotiations and contracts, • Maintain and monitor the business development pipeline, • Collaborate with other department leads to implement and track “new patients referral seen”, • Represent MRHS at events to explore new business development e.g., Trade Shows, Conferences, Corporate Events, Membership Associations, etc., • Maintain relationships with key vendors and pharmaceutical representatives, • Administrative oversight for the Marketing function and all its direct reports, • Participate in the hiring and onboarding of staff as needed across the organization, • Conduct training and performance appraisals for direct reports, • 4 - 8 years of experience in the marketing field, including leading the execution of an end to end marketing program, • Undergraduate degree in a related field, • Graduate degree preferred; but not required All qualified applicants will receive consideration for employment without regard to age, sex, sexual orientation, gender identity, national origin, race, color, religion, disability, or protected veteran status, or any other legally protected basis, following applicable laws. For more information, visit MRHSclinics.com Company DescriptionOur team of world class, award-winning physicians and specialists are driven to develop innovative 'body and mind' treatment plans for our patients, and to advance impactful medical research for all.Our team of world class, award-winning physicians and specialists are driven to develop innovative 'body and mind' treatment plans for our patients, and to advance impactful medical research for all.

Job Description One of the nation’s largest independent testing facilities seeks an Analytical Chemist with a minimum 2 years' experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Responsible for performing physical, chemical and instrumental techniques on APIs, raw materials and finished products according to schedule. Must have the technical ability to understand client requirements and assist in the preparation of testing protocols. • Run instrumentation such as, but not limited to: ICP-MS, HPLC, GC,UV, IR, AA, DSC, KF on products according to compendial, client and internal methodologies., • Prepare standards and samples for analysis., • Perform physical, chemical and instrumental techniques on APIs, raw materials and finished products., • Execute method transfer and validation protocols., • Document work clearly and accurately., • Perform technical writing and peer review as needed., • Operates and maintains laboratory equipment and instrumentation required for cGMP analysis of samples., • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of product testing experience in a GMP laboratory., • ICP-MS/OES experience required., • Previous data acquisition software (Totalchrome, Empower, etc.) experience required., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs.Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global pharmaceutical manufacturing client in San Diego CA and Parsippany NJ This is a Hybrid role see details below. This role will be onsite/hybrid and available to candidates local to the San Diego CA and Parsippany NJ area. We are interested in every qualified candidate who is eligible to work in the United States. Unfortunately, we are not able to sponsor visas or employ corp-to-corp. Title: IT Project Manager – SAP S/4HANA ERP Implementation Location: San Diego CA and Parsippany NJ Hybrid: (Mon-Fri, 40 hours) NOTE Hybrid Role, 5 days a week, with a minimum of 3 days per week onsite between both NJ and SD (La Jolla, CA) locations Contract Duration: 12 - 15 months, with likely extension Pay Rate: Up to $142.85 per hour (w2) DOE must meet all the requirements Project Overview: We are seeking an experienced IT Project Manager (Consultant Contractor) to lead a 12–15-month SAP S/4HANA ERP implementation project, with a focus on Finance, Supply Chain Management, and enterprise system integrations. This role will drive execution from planning through go-live, ensuring the solution meets both technical and business requirements. Key Responsibilities: ERP Program Leadership • Lead the full project lifecycle of the SAP S/4HANA implementation, focusing on core functional areas including Finance and Supply Chain Management., • Manage project scope, schedules, and budgets across business and IT stakeholders., • Coordinate internal teams, external SAP consultants, and integration partners to ensure alignment and timely delivery. Integration Management • Drive the planning, design, and implementation of integrations between SAP S/4HANA and surrounding systems (e.g., CRM, MES, WMS, legacy platforms)., • Collaborate with architects and technical teams to define integration requirements, data flows, and performance standards., • Oversee integration testing, issue resolution, and cutover readiness., • Execution & Oversight, • Maintain comprehensive project documentation, including project plans, risk logs, decision registers, and status reports., • Facilitate resolution of cross-functional issues and escalate project risks as necessary., • Ensure functional and technical deliverables support end-to-end business processes across Finance and Supply Chain. Change & Communication • Support change management, stakeholder engagement, and training efforts., • Lead communication plans to keep executives and key users informed throughout the implementation lifecycle., • Oversee cutover planning, go-live support, and transition to operational support teams. Required Qualifications: • 6+ years of IT project management experience, including at least 2–3 full lifecycle SAP ERP Private Cloud implementations., • Hands-on experience managing SAP implementations specifically covering:, • Finance modules and related business processes, • Supply Chain Management, including procurement, inventory, production planning, and order fulfillment, • System integrations between SAP and enterprise applications, • Proven ability to lead cross-functional teams in high-complexity enterprise environments., • Strong knowledge of SAP Activate or equivalent implementation methodology., • Excellent stakeholder communication, vendor coordination, and executive reporting skills., • Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet). Preferred Qualifications: • PMP, PRINCE2, or Agile/Scrum certification., • SAP S/4HANA certifications or demonstrated expertise in SAP FI, MM, SD, or PP modules., • Experience with integration platforms such as SAP Business Technology Platform (BTP), SAP CPI, or Informatica., • Prior experience in regulated or manufacturing industries (e.g., life sciences, pharma). Questionnaire • How many SAP S/4HANA ERP Private Cloud (RISE) implementations have you managed?, • Have you implemented SAP ERP for a mid-sized life-sciences pharma firm(s)?, • Do you have experience managing external vendor ERP System Implementation (SI) teams?, • Are you willing to work onsite 3+ days per week, either in our La Jolla CA or Parsippany NJ locations, or both?

For over a decade, this organization has collaborated with stakeholders in sectors such as specialty pharmacies, manufacturers, prescribers, and payers to design solutions for the high-touch specialty pharmaceutical service model.Through integrated programs, innovative technology platforms, contract

For over a decade, this organization has collaborated with stakeholders in sectors such as specialty pharmacies, manufacturers, prescribers, and payers to design solutions for the high-touch specialty pharmaceutical service model.Through integrated programs, innovative technology platforms, contract

Job DescriptionJob Title: QA InvestigatorJob Description We are seeking a dedicated QA Investigator to join our team. The role involves writing and completing investigations and deviations, ensuring compliance from both compliance and operations perspectives. The ideal candidate will conduct root cause analysis and manage the entire lifecycle of investigations independently, communicating effectively with vendors and manufacturing teams. Responsibilities • Determine the causes and preventative actions of Deviations, Non-Conformances, Out of Specification (OOS), Out of Trend (OOT), field complaints, and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools and benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track Corrective and Preventive Action (CAPA) plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approaches., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy, and deviation processes., • Champion CAPA plans and implementation., • Provide communication plans for ongoing deviations and CAPAs., • Create and communicate CAPA plans effectively to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • 2-3 years of experience writing and reviewing deviations and investigations., • Experience within a pharma company supporting manufacturing., • Previous experience within a quality assurance team., • Bachelors degree within a related scientific field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operations., • Experience using e-Quality Management Systems., • Experience with CAPA and GMP., • Knowledge of biopharma/biotech and biologics., • Technical writing skills. The QA Investigator will work closely with quality assurance and a team of QA/QC professionals on a daily basis, collaborating cross-functionally with the manufacturing team. The role is based at two sites located a block apart, and the team currently includes five other investigators. The position operates on a first-shift schedule from Monday through Friday, with start times at either 8 am or 9 am. The company offers a supportive work culture with opportunities for growth and expansion, focused on saving patients' lives. Job Type & Location This is a Contract to Hire position based out of Allendale, New Jersey. Pay and Benefits The pay range for this position is $40.00 - $46.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Oct 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

The Commercial Counsel - Customer Contracts provides timely legal counsel on commercial matters including contract management matters for the U. A deep understanding of pharmaceutical contracting across various commercial business segments, including generics, government and hospital-based contracts

Job Description Job Title: Coating Operator II Department/Division: Manufacturing/Coating Reports to: Manager, Coating About LTS: LTS Lohmann Therapy Systems is a premier, global Contract Development and Manufacturing Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes. We Care. We Create. We Deliver. Job Summary Lohman Therapy Systems North America is seeking a highly motivated and experienced Machine Operator with a strong focus on coating processes to join our growing team. In this role, you will play a crucial part in the successful production of high-quality products by operating and maintaining various coating equipment, ensuring optimal performance, and maintaining a safe and clean work environment. This is a full-time onsite position located in West Caldwell, NJ • Control and align multiple web paths during manufacturing with tension drive units, pressure rollers, and an edge guiding system., • Perform machine setups and correct machine functions., • Handle raw stock materials with a pallet jack., • Splice materials with a utility knife, tape gun, and splicing table., • Ensure proper disposal of hazardous waste, cleaning solutions, and adhesive compounds., • High school diploma or equivalent., • 4–5 years of machine operator experience, with at least 3 years of GMP manufacturing experience, preferably in the pharmaceutical field., • Experience with coating is preferred., • A strong mechanical aptitude and familiarity with equipment operation., • Strong math skills are a must., • Good reading, writing, and verbal skills., • Good computer skills to navigate systems and fill out necessary forms and documents., • Knowledge of laminating pressures for various types of films, fabrics, and foams., • Knowledge of Corona Treatment. LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job DescriptionSalary: Founded in 1919, Holt Construction is celebrating over 100 years in business with our 3rd generation of Holt family leadership. Holt thrives on its reputation as a quality construction company that maintains its core values and family atmosphere while providing the best services to our clients. Our teams experience, training and backgrounds have allowed us to work within the most sensitive markets, including data centers, Class A secure buildings, airports as well as the healthcare and pharmaceutical industries for over 80 years. Many of Holts employees have been with the company for over 25 years which is a true indication of our particular core values and business approach. Our extensive project portfolio and repeat clientele are testament to our quality of work and ability to develop and maintain long-term client relationships. Holts management philosophy is to be managers of the construction process, not just overseers and recorders of the process. We pride ourselves in working with owners and all team members in a collaborative process to provide cost-effective solutions to the numerous roadblocks that may be encountered during design and construction to ensure successful project execution. Job Summary The Superintendent is responsible to plan/manage/build construction projects and oversee progress from start to completion in a timely and cost-effective manner. Provide overall leadership for on-site field administration/supervision and technical management for all construction operations, including direct supervision of foreman, subcontractors, and other construction related personnel. Key responsibilities include planning, coordinating, and executing work on time, within budget, attaining or exceeding profit goals, adhering to safety standards (company and regional) and promoting and enhancing client relationships. Essential Duties and Responsibilities • Maintain a thorough understanding of contract documents, project plans and specifications to be able to plan ahead and anticipate potential problems before they arise., • Attend and participate in project meetings, including subcontractor meetings., • Plan, coordinate, and manage jobsite logistics, in coordination with Project Manager., • Coordinate project mobilization, demobilization and equipment needs with accounting., • Attend and Participate in Project Walk-throughs with Design team to address specific issues and communicate discussion/ resolution to PM for record., • Prepare and submit Superintendents Daily Reports, toolbox talks and distribute appropriately., • Manage schedules, including preparation of two-week look ahead and any other applicable schedules. Ensure all activities take place on or ahead of scheduled dates. Review weekly with PM / noting deliveries, long lead items, critical work, inspections, and any impacts affecting progress., • Oversee Holt labor and track project requirements for needed workforce, coordinating with PM for proper phase codes and available funds., • Forecast deficiencies and schedule impacts; record and address subcontractors missing milestone date deliverables and scheduled path work. Communicate schedule status, updates and changes to Project Team and Trade Contractors., • Coordinate third party site testing, and inspections with required entities to facilitate schedule progress. Maintain inspection records., • Enforce site safety plans while adhering to laws, and OSHA operating industry standards, as well as regional best practices., • Maintain a clean, safe site, with all required OSHA/ regulatory documents on hand for reference., • Conduct site safety orientation for all subcontractors and visitors., • Communicate quality standards to each subcontractor and vendor regarding contract requirements and general industry best practices., • Communicate with owners and architects/engineers in connection with field issues. Investigate and resolve issues as they arise. Escalate issues, if necessary, for prompt resolution., • Review and understand all subcontractor scopes of work and corresponding milestones for reference, coordination, and adherence. Advise PM of concerns for missing scope., • Identify Possible Changes in work requested in field and/or inconsistencies with documentation that may generate RFI and/or changes in cost of work to PM for address of RFI/ change order procedures., • Review approved submittals, RFI responses and sketches to ensure all materials and work are done in accordance with issued documents. Coordinate work / revisions with on-site trades., • Ensure all proper documentation is maintained in the project specific folders for easy reference and record keeping., • Create or ensure a photo journal is updated throughout a project. Photos must be taken starting with existing conditions for the space and all areas to be traveled or utilized during project (prior to the start of any work), as well as daily photos taken throughout the project duration., • Coordinate Close Out Documentation with PM to ensure Punchlist, Inspections/ Approvals, Trainings, Attic Stock, As-builts, etc. are addressed as designated per Contract and the Holt Closeout Checklist, • Maintain daily reports and documentation using BuildSpace and/or Procore., • Other duties as assigned. Supervisory responsibilities • Ensure all individuals on-site follow and adhere to the site safety plan., • Direct day-to-day on-site supervision of field labor force, Holt, and Subcontractor., • Communicate effectively and in a professional manner with Holt internal team, customer/project representatives, AOR/EOR or any other agency or jurisdiction to ensure the efficient operation of the assigned project., • Mentor supporting staff to assist in their progress and ability to expand their role., • Attend all corporate required trainings and classes, for new procedures or policies. Qualifications • Minimum of 5 years of field knowledge/related work experience, • Proven working experience in construction field, • Experience in Out of Ground, Site, Civil Construction, • Knowledge of building products, construction details and relevant rules, regulations, and quality standards, • Knowledge of Microsoft Office Suite (Word, Excel, and PowerPoint), • Familiarity with construction management software packages such as Microsoft Project, Primavera and/or Procore, preferred., • Ability to read and understand prints, manuals, contract requirements, and general industry best practices, • Competent in conflict and crisis management. Leadership skills, • OSHA 30 Certification, • First Aid/CPR/AED Certification, • ASHE Certification Holt Construction Corp. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status, such as race, religion, color, national origin, sex, age.

Job Description Human Resources Administrator- rx2go rx2go is seeking a dynamic Human Resources administrator to join our team and drive both administrative excellence and strategic talent acquisition. This role will be instrumental in recruiting top talent, creating seamless onboarding experiences, while maintaining strict compliance with all regulatory requirements. The ideal candidate is a detail-oriented professional with strong strategic planning capabilities and a passion for building exceptional employee experiences. Key Responsibilities Talent Acquisition & Recruitment • Lead full-cycle recruiting process, conducting interviews to assess candidates' experience, technical skills, and cultural fit, • Maintain and update job descriptions and requirements to reflect evolving business needs, • Conduct thorough reference checks and coordinate background screenings in accordance with company policies, • Design and facilitate comprehensive new employee orientation and onboarding programs, • Guide new hires through benefits enrollment, compensation structures, and company policies, • Coordinate training programs to support employee growth and development, • Ensure full compliance with all federal, state, and local HR regulations and employment laws, • Maintain accurate and confidential employee records and documentation, • Advise leadership on benefits strategy and evaluate vendor contract proposals, • Participate in or lead committees focused on wellness, training, safety, culture, and internal communications, • Support organizational planning and development initiatives, • Bachelor's degree in Human Resources, Business Administration, or related field, OR minimum 2 years of hands-on human resources experience, • Fluent Russian language skills (speaking, reading, writing) - Required, • Exceptional written and verbal communication skills with strong presentation abilities, • Proven track record in building positive interpersonal relationships and coaching employees, • Advanced proficiency with HRIS systems, Microsoft Excel, and database management, • Highly organized with strong attention to detail and ability to manage multiple priorities, • Specialized training or certification in employment law, compensation, organizational development, employee relations, safety protocols, or labor relations, • Experience in healthcare or pharmaceutical industry

Job DescriptionExperienced Chemical Ingredients Sales Professional based in Central NJ Our client is an established chemical distributor with significant success in several markets. It is seeking an experienced sales person selling chemical intermediates for the pharmaceutical industry. The client is a profitable, family owned distributor/manufacturer of a number of ingredients used in the pharmaceutical, nutraceutical, food, nutrition and petrochemical industries. This position is for the pharmaceutical market. Experience selling to Contract Manufactuers making formulations for pharmaceutical companies would be ideal. The company requires a science degree in chemistry, biochemistry or other related sciences and at least two years of sales to the pharma related industries. There is a base in the low six figures and an incentive program of ten percent on the gross profit of all sales for as long at the product is being consumed by the customer. There are also travel allowances plus an auto allowance and health care. The company is in central NJ and requires the salesperson to be in the office twice a week. This is an immediate opening. Candidates must be authorized to work in the US and be local to central New Jersey.

Job DescriptionCompany Description EVERSANA has partnered with Mitsubishi Tanabe Pharma America, Inc. for this Direct Hire opportunity. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson’s (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology. MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare disease treatments including RADICAVA® (edaravone) injectables in 2017 and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness. Job Description Direct Hire Opportunity! The Senior Director, Trade & Distribution, will build, lead, and manage the team while focusing on developing strategies to support the launch and lifecycle management of our leading Parkinson's and ALS therapies, as well as future products in the United States. The primary responsibility of the Senior Director Trade & Distribution is to develop and implement the distribution strategies across the specialty businesses. This includes specialty pharmacies, distributors and all channels that would support any present or future MTPA products. This person will have an intimate knowledge of the distribution systems from all aspects including durable medical equipment. The ideal candidate will possess strong leadership experience in managing teams that work both directly and indirectly with specialty vendors, coupled with exceptional analytical skills to identify operational gaps and implement effective solutions. Cross-functional collaboration with supply chain, marketing, sales, and customer-facing teams will be key to success in this role. Responsibilities • Provides overall leadership and direction for Trade Market Access strategy for Mitsubishi Tanabe Pharma US’ lead Parkinson and ALS products, • Evolve and innovate distribution network by aligning it with business needs, identifying growth opportunities, and addressing operational gaps to overcome challenges and drive access. Serves as the Distribution and Trade Strategy Team Leader, representing, • trade across all teams and driving key success factors to support long-term distribution strategies. Lead the development and execution in Federal Markets, including VA and Department of Defense to drive product access, distribution, and growth. Act as subject, • matter expert from a Market Access perspective for 340B program and other government programs., • Informs senior and corporate executives informed about changes and emerging issues in the broad, trade customer environments and subsequent implications for Mitsubishi Tanabe Pharma US, • Develops awareness of market and government policy changes in collaboration with legal and compliance and implications across key stakeholders to help inform/update commercial strategies, • Assists market access marketing agency (and other vendor relationships) to develop promotional programs, tactics and materials aligned with our distribution process, • Develops/maintains thorough understanding of dynamics driving various market access segments and channels and how distribution impacts each function, • Effectively manages budgets and project timelines including contract management, • Oversight in the negotiation, execution, and adherence to the Distribution Service Agreements (DSAs), Product Purchase Agreements, and other contract offerings as appropriate, • Develop account metrics against strategic, financial, and product access KPI’s, • Develops and monitors KPIs, continually assessing impact and execution of access services & offerings including feedback from service users and internal stakeholders, • Attends professional, provider programs, and patient conferences, and keeps up to date on innovation and recommends ways to improve business., • This is a home office based position. The expectation is to be in the office 3 days a week. #LI-CG1 Qualifications • Bachelor’s Degree Required, Masters preferred, • Must have 15 plus years within the pharmaceutical industry and 10 years’ experience in Distribution, Account Management or Aligned Market Access functions., • Experience with distribution for early-stage pipeline programs, • Experience in Federal Markets including VA, Department of Defense and 340B Program preferred., • Device/Drug combination strongly preferred, • Minimum 5 years of people management experience required, • Track record of closing complex negotiations within the specialty pharmacy arena, • Preferred experience includes:, • All aspects of distribution, • Launch and life cycle management for the distribution process, • Experience in Market Access marketing, • History of successful negotiations, • Broad based knowledge of the Pharma/Biotech industry, healthcare finance, and all forms of product distribution: DME, Orals, and Solutions, • Firm grasp of legal, regulatory and compliance issues in the healthcare space, • Analytical/strategic thinker with proven ability to:, • conduct situation analysis of the external distribution environment; synthesize relevant information to develop strategic plans, • understand the best pathway for distribution based on the product and its attributes, • conduct strategic gap analysis and implement metric-based solutions, • Strong interpersonal and internal/external relationship-building skills in order to drive change and innovation and succeed in a highly specialized distribution environment, • Excellent oral/written communication skills, coupled with exceptional presentation skills, including ability to present to large audiences, • Ability to prioritize and manage complex projects, with multiple stakeholders, and drive high-quality results within allotted budget, • Highly proficient in MS Office; advanced Excel skills, • Must be able to travel domestically and internationally (approximately 40%) Additional Information Mitsubishi Tanabe Pharma America Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits. MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date. The salary range for this position is $210,000 - $280,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

Job DescriptionSalary: Founded in 1919, Holt Construction is celebrating over 100 years in business with our 3rd generation of Holt family leadership. Holt thrives on its reputation as a quality construction company that maintains its core values and family atmosphere while providing the best services to our clients. Our teams experience, training and backgrounds have allowed us to work within the most sensitive markets, including data centers, Class A secure buildings, airports as well as the healthcare and pharmaceutical industries for over 80 years. Many of Holts employees have been with the company for over 25 years which is a true indication of our particular core values and business approach. Our extensive project portfolio and repeat clientele are testament to our quality of work and ability to develop and maintain long-term client relationships. Holt s management philosophy is to be managers of the construction process, not just overseers and recorders of the process. We pride ourselves in working with owners and all team members in a collaborative process to provide cost-effective solutions to the numerous roadblocks that may be encountered during design and construction to ensure successful project execution. Job Overview The Senior Project Accountant serves a vital function in the financial reporting system of the company. Key responsibilities of this role are to assist and support the project team by reconciling and maintaining complete and accurate project accounting records. This position is highly depended upon to guide and assist junior project accountants as well as to provide timely and accurate financial information to project stakeholders including clients, subcontractors, vendors, the project team, and management. Essential Duties and Responsibilities • Attend project kick-off meeting. Review client contract for all pertinent financial information and note items, as required, • Attend monthly accounting staff meetings. Complete all duties in compliance with the month-end schedule, • Work on site with project management team (conditions permitting), • Prepare monthly requisition for Project Managers review. This includes all costs for the month, subcontractor invoices, insurance, and all applicable taxes, • Obtain the contract SOV and budget for review with Estimating and Project Management to properly assign phase codes and enter original budget into the accounting system, • Set up appropriate billing template for client billings, use the industry standard AIA format or client specific format when warranted, • Review monthly and reconcile as required:, • Owner change order requests, as prepared by project management. Update, and post as required, • Subcontracts and subcontractor change orders and submissions. Verify established billing rates for all subs, • Confirm receipt of all invoices by reviewing statements and inquire with subcontractors for any missing invoices, prior to months close, • Check invoicing forms and subcontractor progress for payment of all invoices. Follow up with client regarding project billings and payment status. Document delinquent receivable statuses weekly, • Make sure all insurance, sales and use tax rates are current and accurately reflected on all invoices for client, subcontractors, and vendors, • Compare cost and billings to date to ensure job is billed timely and properly. Identify and report any other variances to project management and accounting teams, • Work closely with Project Management to assist with the following:, • Update and balance all cost reports for financial projection and status reports monthly, • Review budget adjustments before posting, • Track budget and allowance expenditures, • Close-out procedures. Ensure that all costs have been received, processed, and included in the final billing, • Review all, • Alert Project Management and Accounting Teams as follows:, • Any instances that impede project billings, • Any unaddressed, unresolved change orders both subcontractor and client related, • Any instances that prevent close out documentation from being obtained, • Any issues that may hinder the close-out process, • Follow up with client regarding project billings and payment status. Document delinquent receivable statuses weekly, • Respond to project vendors requesting payment status, • Mentor, train and manage the day-to-day activities of Junior Project Accountants, • Interface with Owner/Owners Representative and be able to answer questions about submitted Payment Applications, • Set up the Project Specific Accounting Calendar and assist the team in maintaining deadlines, • Stay current on industry standards for project accounting, • Other duties as assigned Qualifications • Experienced with Accounting software. Viewpoint/Vista, Procore or Textura a plus, • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), • Excellent verbal and written communication skills, • Excellent organizational and time management skills, • Strong interpersonal skills to communicate with multiple participants, at all levels, involved with a construction project (i.e., clients, subcontractors, project team), • Ability to work independently and in a team environment, • Ability to supervise, direct and mentor junior employees. Supervisory experience a plus, • Ability to work on several projects simultaneously, meet critical deadlines, and prioritize assignments accordingly Holt Construction Corp. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status, such as race, religion, color, national origin, sex, age.

Job DescriptionSalary: Founded in 1919, Holt Construction is celebrating over 100 years in business with our 3rd generation of Holt family leadership. Holt thrives on its reputation as a quality construction company that maintains its core values and family atmosphere while providing the best services to our clients. Our teams experience, training and backgrounds have allowed us to work within the most sensitive markets, including data centers, Class A secure buildings, airports as well as the healthcare and pharmaceutical industries for over 80 years. Many of Holts employees have been with the company for over 25 years which is a true indication of our core values and business approach. Our extensive project portfolio and repeat clientele are testament to our quality of work and ability to develop and maintain long-term client relationships. Holt s management philosophy is to be managers of the construction process, not just overseers and recorders of the process. We pride ourselves in working with owners and all team members in a collaborative process to provide cost-effective solutions to the numerous roadblocks that may be encountered during design and construction to ensure successful project execution. Job Summary The Project Manager is responsible for the efficient and successful management of one or more projects from conception to completion. Although a member of the Operations Team, the role requires collaboration from multiple internal departments as well as direct interface with the customer, subcontractors, and design teams. The Project Manager is expected to maintain and advance the Holt brand and reputation while ensuring all team members adherence to the Holt Core Values and established Policies and Procedures. Essential Duties and Responsibilities • Ensure document control is adhered to on all aspects of the project., • Create project plans that include schedules, logistics, manpower, and task delegation at the onset of each project and evaluate regularly throughout., • Assist with the preparation and submission of permitting documentation as required., • Support and participate in the procurement of buying out projects, including pre-qualification of subcontractors for Project Executive review and execution., • Track and provide progress reports on all aspects of the projects including financials, adherence to schedule, legal issues, cost matters, or client concerns., • Plan regular site visits including but not limited to weekly OAC meetings., • Ensure quality construction standards and the use of proper construction techniques., • Review 2-week look ahead and adjust schedule accordingly prior to scheduled OAC meetings., • Review RFI and Submittal logs as well as Architect returned RFIs and Submittals, prior to scheduled OAC meeting, for accuracy and potential impact to project or sub-contract., • Prepare change orders including any cost or schedule impact for review by the Project Executive prior to issuance., • Review any 3rd party testing reports to confirm compliance., • Review owners contract to ensure project execution in accordance with the agreement., • Work regularly with project Accountant to ensure all billings, change orders, back charges, are being tracked, reported, and submitted appropriately., • Prepare monthly project financial report for review by Project Executive. This report will include the presentation of CM expenditures, contingency use, and budget allocations., • Manage the close out process including all financial, contractual, and delivery of required documentation., • Understand and adhere to contract documents including the Master Subcontractors Agreement, Subcontractor Specific Contract, Purchase, • Orders, and other relevant contractual obligations and procedures., • Other duties as assigned. Supervisory Responsibilities • 5+ years of supervisory experience, • Manage all team members and delegate tasks with clear and concise expectations of deliverable and timelines to ensure the success of the project. Monitor progress and compliance of each team member, • Ensure team is aware of, and adhering to, all Holt safety guidelines, procedures, and reporting requirements, both internal and external, • Manage and develop assigned staff toward maximum job performance and career potential, • Work closely with the Pre-Construction and Estimating teams to assist Business Units with the growth and maintenance of the subcontractor base including following proper procedures for pre-qualification. Qualifications • Bachelors Degree Construction Management, Engineering or related field, • 4-7 years construction management or project management experience including cost, scheduling, estimating, and purchasing, • Minimum of 3 years experience as an APM or similar position, • Proficient with computer applications, including Microsoft Office Suite (Word, Excel, PowerPoint), • Working knowledge of Microsoft Project, Primavera and/or Procore, • Skilled at reading, understanding and interpreting contract documents, drawings, specifications, scopes of work, and project schedules, • Excellent and effective written and verbal communication skills, • Must have advanced presentation skills, • Demonstrated leadership and interpersonal skills, • Up to 25% travel may be required Holt Construction Corp. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status, such as race, religion, color, national origin, sex, age.

Job Description Position Summary: Avyxa Pharma, a leading manufacturer of 505(b)(2) oncology products, is seeking an experienced and driven Director of Sales to lead our sales efforts in the eastern and western United States. These individuals will be responsible for managing a team of sales professionals, driving business growth, and developing strategic relationships with key stakeholders in the oncology space while maintaining a competitive and positive work culture. The ideal candidate will have pharmaceutical sales experience, with a strong background in oncology and 505(b)(2) drug commercialization. This role requires up to 70% travel and reports to the Vice President of Sales & Corporate Accounts. Key Responsibilities: · Following company strategic goals and philosophy, the Director of Sales will provide sales leadership and guide strategic direction for direct reports in assigned territory. · Lead and mentor a team of sales professionals, setting performance objectives and ensuring successful execution as evidenced by quarterly goal attainment for all qualified Avyxa products. · Will work independently and with direct reports to identify and develop new business opportunities to drive market penetration and revenue growth, endeavoring to maintain strong customer relationships over an extended period. • Team Management & Development:, • Recruit, train, and develop a high-performing sales team that will have responsibility for selling Avyxa’s products, including but not limited to Docivyx®, Frindovyx™, Posfrea™, and Axtle™., • Conduct regular performance reviews, provide coaching, and support career development., • Foster a collaborative, results-driven culture within the sales organization., • Customer Engagement & Relationship Management:, • Build and maintain strong relationships with customers including but not limited to oncologists, pharmacists, nurses, key business personnel, aggregator and group purchasing organizations (GPOs) sales representatives., • Work closely with direct reports to ensure customer needs are met and growth opportunities are maximized by maintaining close relationships with customers, providing Avyxa product contract updates, Avyxa support materials, and ensuring productive collaboration between customers and other internal Avyxa resources, (market access, field reimbursement, payer team, operations) • Represent Avyxa Pharma at industry conferences, advisory boards, and networking events. Data-Driven Decision Making: • Utilize Tableau, Excel, and other analytics tools to track sales performance and market trends., • Prepare and present sales reports, forecasts, and business reviews for senior leadership., • Communicate and leverage market intelligence to adjust strategies and optimize sales efforts., • Cross-Functional Collaboration:, • Partner with Avyxa Strategic Account Directors, Data and Analytics, Field Reimbursement Team, Operations Team and Medical Affairs to ensure effective product positioning and messaging., • Provide customer insights to support product development and commercialization efforts., • Ensure compliance with pharmaceutical regulations and corporate policies. Qualifications & Experience: • 8+years of pharmaceutical sales experience, with at least 3 years in oncology. Managerial experience preferred. Candidates with similar experience and exceptional track record of success will be considered., • Strong understanding of the 505(b)(2) regulatory pathway and drug commercialization in community oncology and hospital/IDN setting preferred., • Proven leadership experience, with a track record of managing and developing sales teams., • Excellent verbal and written communication skills., • High proficiency in PowerPoint, Excel, Tableau, and other sales analytics tools., • Ability to travel up to 70% across the designated region. Preferred Qualifications: • Experience working with community oncology practices, hospitals, and integrated delivery networks (IDNs)., • Sales management · Understanding of the buy-and-bill oncology reimbursement methodology, GPO and aggregator relationships. • Prior experience launching 505(b)(2) oncology drugs. Location: Remote (Must reside within the designated region) Compensation & Benefits: Competitive salary, performance-based bonus, comprehensive benefits package, and travel reimbursement. Company DescriptionAvyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system. Our core values are grounded in providing access to meaningful products that improve patient care.Avyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system.\r\n\r\nOur core values are grounded in providing access to meaningful products that improve patient care.