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EPM Scientific
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  • AD GHEOR (Philadelphia)  

    - Philadelphia County
    AD GHEOR
  • CTM/ Senior CTM (San Diego)  

    - San Diego County
    Clinical Trial Manager/ Senior Clinical Trial Manager San Diego Metrop... Read More
    Clinical Trial Manager/ Senior Clinical Trial Manager San Diego Metropolitan Area Salary: $150,000-$180,000 A clinical-stage cell therapy company based in San Diego is expanding its clinical operations team. Focused on developing treatments for autoimmune diseases and hematological cancers, the company uses a unique approach to cell therapy, harnessing Natural Killer (NK) cells that target B cells. The team has been a pioneer in cell therapies, with one of the first IND filings for Lupus using cell therapy. Now advancing several indications, the company is working to streamline manufacturing and distribution to improve access to novel treatments. Their CEO brings over 20 years of experience in biotech and venture capital, including leadership roles in notable life sciences companies, while the CMO has an extensive background in clinical research from leading pharmaceutical firms. This role offers the opportunity to contribute to the ongoing development of therapies at the intersection of cell therapy and auto-immunology. Primary Responsibilities Take the lead in reviewing work completed by members of the clinical development team. Lead or assist in revising study-related documents, such as informed consent forms, laboratory manuals, pharmacy manuals, case report forms (CRFs), and other tools essential for study execution. Provide assistance with site recruitment, initiation, payments, and close-out activities. Contribute to the training of new clinical site staff and offer additional training for protocol amendments. Coordinate with in-house teams to ensure timely collection of regulatory documents as required. Offer daily guidance to clinical sites, including interpretation of protocols and adherence to protocol safety standards. Lead or assist in training staff within the clinical development group. Work with the CPM to prepare and update trial progress reports for the Clinical Development team. Support the tracking and summarization of patient treatment, response, and survival data for ongoing studies. Perform other tasks as assigned. Qualifications Bachelor's degree with 7-10 years of experience in clinical research. Bachelors degree required experience in cell therpay and/or auto immune inidations is prefered Skills Read Less
  • Chief Scientific Officer (CSO) (San Francisco County)  

    - San Francisco County
    Chief Scientific Officer (CSO) Location: California (Onsite, Full-Time... Read More
    Chief Scientific Officer (CSO) Location: California (Onsite, Full-Time) Type: Permanent, Full-Time (Monday-Friday; occasional out-of-hours work expected) Travel: Some travel required This is a rare opportunity to join a global biopharmaceutical company at the C-Suite level who will be directly responsible for driving the scientific innovation and strategy across the company. As Chief Scientific Officer, you will work hand-in-hand with the CEO to define and execute strategies that drive the development of transformative therapies across a portfolio of complex, high-impact platforms. We are seeking a proven biotech leader with deep expertise in drug development-someone who thrives on solving scientific challenges and shaping programs that advance patient care. If you're ready to take the next bold step in your career and influence the trajectory of an organization and an entire field, this is your moment. Step into a role where your vision will accelerate progress, your leadership will set the standard for excellence, and your impact will be felt globally. Key Responsibilities Partner closely with the CEO and executive leadership to set and execute scientific strategy. Define and implement the organization's research priorities across preclinical and clinical programs. Lead global scientific teams to deliver R experience with peptides, polymers, and formulation development preferred. Familiarity with global regulatory frameworks (FDA, EMA, IND/NDA filings) and ICH Good Clinical Practice. Proven scientific credibility through publications and/or patents. Expertise in clinical trial design, monitoring, and statistical reporting. Ability to interpret and evaluate clinical data and prepare regulatory documentation. Exceptional leadership, organizational, and project management skills. Excellent communication and presentation skills for diverse audiences. Financial management experience related to R Read Less
  • Director GHEOR (Philadelphia)  

    - Philadelphia County
    Director of Global Health Economics and Outcomes Research Location: Ph... Read More
    Director of Global Health Economics and Outcomes Research Location: Philadelphia, PA OR Boston, MA (Hybrid- 3 days onsight/ week) EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics ability to work across time zones as needed. Requirements: Graduate degree in health economics, epidemiology, health services research, or a related field 12-15+ years of HEOR/ RWE/ Outcomes Research experience Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH) Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies. Deep knowledge of drug development process and payer landscape in the United States Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams. Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure. Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences. History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments. Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship. **Applicants who do not meet the above requirements will not be considered for this role. Desired Skills and Experience Graduate degree in health economics, epidemiology, health services research, or a related field 12-15+ years of HEOR/ RWE/ Outcomes Research experience Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH) Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies. Deep knowledge of drug development process and payer landscape in the United States Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams. Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure. Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences. History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments. Read Less
  • Procurement Specialist (Raw Materials) (Piscataway)  

    - Middlesex County
    EPM Scientific is partnering with a Consumer Goods client based in New... Read More
    EPM Scientific is partnering with a Consumer Goods client based in New Jersey on a very exciting opportunity! Our client is seeking a specialist in Procurement making sure contracts are uploaded in the Ariba contract repository by the responsible party Support Tactical and Strategic sourcing initiatives Prepare tactical specifications, issue bid requests and review quotations Build and Lead RFPs (Request for Proposals) and RFQs (Request for Quotes) Contract Details: - 9 month contract - Full Time - 4 days onsite in Middlesex County, remainder remote - W2 model If interested, please click the relevant links to apply! Looking forward to hearing from you. Read Less
  • Head of Analytical Development: NYC Position Overview We are seeking a... Read More
    Head of Analytical Development: NYC Position Overview We are seeking a Director or Senior Director of Analytical Development to lead and expand the analytical development function. This individual will play a pivotal role in supporting late-stage programs, ensuring robust analytical strategies for drug substance and drug product, and driving method development, validation, and transfer activities. This is a hands-on leadership role for someone who thrives in a dynamic environment, enjoys rolling up their sleeves, and is committed to building best-in-class analytical capabilities. The ideal candidate will be comfortable commuting to the New York site four days per week and collaborating cross-functionally with CMC, Quality, and external partners. Key Responsibilities Lead the Analytical Development team responsible for method development, qualification, validation, and transfer for drug substance and drug product. Develop and implement analytical strategies to support late-stage development, scale-up, and commercialization. Oversee characterization studies, stability programs, and specification setting in alignment with regulatory requirements. Partner closely with Process Development, Quality, and Regulatory teams to ensure seamless integration of analytical deliverables. Manage relationships with CDMOs and external testing labs, ensuring timelines and quality standards are met. Provide technical leadership and mentorship to a growing team, fostering a culture of scientific excellence and accountability. Contribute to regulatory submissions (IND, NDA) and represent Analytical Development in health authority interactions as needed. Qualifications Ph.D. or M.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline. 10+ years of experience in analytical development within the biotech or pharmaceutical industry, with a strong focus on small molecule late-stage development and commercialization. Proven track record of leadership in method development, validation, and transfer for complex modalities (biologics experience strongly preferred). Deep understanding of ICH guidelines, regulatory expectations, and CMC requirements for global filings. Excellent communication and collaboration skills; ability to work effectively in a fast-paced, matrixed environment. Willingness and ability to be onsite in New York 4 days per week . Why Join? Opportunity to shape analytical strategy for a late-stage pipeline with high-impact programs. Work in a well-funded biotech with strong pharma partnerships and a clear path to commercialization. Collaborative, science-driven culture where your contributions make a tangible difference. Read Less
  • Executive Director of Regulatory Ad/Promo (Bridgewater)  

    - Somerset County
    Title: Executive Director of Regulatory Affairs Ad/Promo Summary: A gl... Read More
    Title: Executive Director of Regulatory Affairs Ad/Promo Summary: A global health care company, dedicated to improving people's lives through innovative solutions specialized in pharmaceuticals, medical devices, and over-the-counter products is looking to bring on an Executive Director of Regulatory Affairs Ad/Promo to join their team! The Ad/Promo team is rapidly growing, and they are looking for someone to come in and provide their expertise, based out of their New Jersey office. This role will give you an amazing opportunity to contribute to the company's mission to enrich lives by delivering better health outcomes. The Executive Director will be responsible for Review Ad/Promo materials, new campaigns, and launch strategies for assigned products to ensure regulatory compliance. Ensure timely and accurate evaluation to meet deadlines and requirements Develop and implement regulatory strategies and solutions to ensure all ad/promo material comply with regulatory requirements and company policies Monitor FDA activities, including enforcement actions and guidance documents, to assess their impact on company products Ensure that promotional package inserts and important safety information are updated as necessary The Executive Director should have the following qualifications: Bachelor's degree is required in Life Science or related field; Advanced degree (MS, MD, PhD, PharmD) preferred Minimum of 15 years of industry experience; preferably some experience in GI People management experience Course training in ad/promo review Strong interpersonal skills, ability to work on a team, and communication skills Benefits: Medical, Dental and Vision insurance 401(k) matching Tuition reimbursement Commuter benefits Read Less
  • Sr. Validation Engineer (Cambridge)  

    - Middlesex County
    Title: Senior Validation Engineer Location: Boston, MA (on-site) About... Read More
    Title: Senior Validation Engineer Location: Boston, MA (on-site) About the Role: A growing biotech company working on regenerative medicine is looking for a Senior Validation Engineer to join their team. If you're experienced in GMP biotech environments and enjoy hands-on work with equipment, processes, and documentation, this could be a great fit. What You'll Be Doing: Handling IQ/OQ/PQ for equipment, facilities, cleaning, sterilization, and manufacturing processes. Writing and executing validation protocols, project plans, and final reports. Coordinating with different teams to keep projects on track. Updating and creating SOPs when needed. Leading technical tasks and helping hit project milestones. Supporting investigations, CAPAs, and equipment release. Pitching in with calibration and metrology work. Mentoring junior engineers and sharing your expertise. Jumping in on other quality-related tasks as needed. Requirements: Bachelor's in engineering or science with 6+ years of validation experience, or a Master's with 4+ years. Solid background in GMP validation-equipment, processes, utilities, or software. Experience with temperature chambers, sterilization, cleaning, and depyrogenation. Familiarity with GE Kaye Validator or Ellab systems. Must be authorized to work in the US without visa sponsorship Please apply directly in for more information! Read Less
  • Study Start Up Specialist (San Mateo)  

    - San Mateo County
    Study Start-Up Specialist Location: San Mateo, CA (Hybrid - 3 days ons... Read More
    Study Start-Up Specialist Location: San Mateo, CA (Hybrid - 3 days onsite) Type: Full-Time, Permanent Compensation: 75,000 - 90,000 annually + bonus + benefits Are you passionate about clinical research and want to play a key role in bringing innovative therapies to patients? We are partnered with a sponsor that is seeking a Study Start-Up Specialist to join our dynamic team and support the initiation of clinical trials across North America. Responsibilities: Identify and evaluate potential research sites through feasibility assessments. Engage with site staff to foster collaboration and ensure readiness for study initiation. Organize and support contract negotiations. Prepare and submit regulatory documents to IRBs and other authorities. Conduct Site Initiation Visits (SIVs) and train site staff on protocols and procedures. Coordinate study supplies and ensure timely delivery. Track and report progress to ensure timely start-up of studies. Communicate effectively with internal teams, vendors, and research sites. Assist with audits, process improvements, and other clinical operations tasks. Qualifications: Bachelor's degree in Biological Sciences, Nursing, Pharmacy, or related field. Minimum 1 year of experience as a Clinical Research Assistant or similar role. Working knowledge of ICH GCP guidelines. Strong organizational and communication skills. Ability to manage multiple priorities and work in a fast-paced environment. Travel: 20 - 30% travel Read Less
  • Sr CQV Engineer / Sr Validation Engineer (Holly Springs)  

    - Wake County
    Senior Validation Engineer / CQV Specialist Location: Greenville, NC /... Read More
    Senior Validation Engineer / CQV Specialist Location: Greenville, NC / Holly Springs, NC Employment Type: Full-Time, On-Site Salary Range: $70,000-$120,000/year Position Summary A leading pharmaceutical manufacturing organization is seeking a few Senior Validation Engineers / CQV Specialists to support commissioning, qualification, and validation activities for critical systems and processes. These roles ensure compliance with regulatory standards and drives continuous improvement in a GMP-regulated environment. Key Responsibilities Develop and execute validation documentation for equipment and processes Support sterility assurance and related validation activities Maintain project timelines and coordinate with cross-functional teams Review technical documents and provide compliance input Assist with troubleshooting and process improvements Ensure adherence to cGMP and regulatory requirements Qualifications Bachelor's degree in engineering, life sciences, or related field 5+ years of experience in pharmaceutical or biotech validation Hands-on experience with commissioning, qualification, and validation protocols Familiarity with GMP regulations and FDA compliance standards Strong technical writing and problem-solving skills Ability to work onsite in Greenville, NC or Holly Springs, NC Physical Read Less

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