Director DMPK
The company is dedicated to discovering and developing groundbreaking therapies to revolutionize cancer treatment. Our team, consisting of experienced leadership and a renowned scientific founder, focuses on translating innovative research into new therapeutic solutions. With a strong history in drug discovery and development, we have been instrumental in the creation of several clinical-stage compounds and an approved drug for the treatment of cancer and immune-mediated inflammatory diseases. Key Responsibilities: Lead DMPK efforts in support of drug discovery and early development for small molecules, working closely with the biology and chemistry teams. Report to the Executive Director of Preclinical R&D, collaborating with multifunctional teams across DMPK, biology, and chemistry to advance projects from discovery through early clinical development. Provide scientific expertise in DMPK assays and their application to solve broader project challenges, ensuring alignment with overall drug development goals. Represent DMPK on multiple cross-functional project teams, contributing to decision-making and project strategies. Mentor and train junior members of the DMPK team, fostering professional development and knowledge sharing. Manage in-vivo and in-vitro ADME/PK studies, ensuring timely and accurate data generation to support drug discovery efforts. Prepare and review the nonclinical sections of regulatory submissions, contributing to IND/CTA filings and other regulatory documentation. Oversee the contracting and management of CROs for nonclinical studies, ensuring high-quality deliverables. Demonstrate leadership in driving DMPK initiatives, maintaining strong organizational and reporting skills to meet project milestones. Qualifications: Significant experience in a leadership role within a multifunctional DMPK group at a pharmaceutical company. Proven ability to manage and oversee ADME/PK studies and provide technical leadership across multiple projects. Extensive knowledge of DMPK assays, with a strong understanding of their application to drug development challenges. Experience in writing and reviewing nonclinical regulatory submissions, with familiarity in managing CRO relationships for nonclinical studies. Highly motivated, with excellent organizational, communication, and mentoring skills.
US$200000 - US$230000 per year + Medical, Dental, Vision, 401K
California
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Mechanical Engineer
EPM Scientific is currently supporting a technology leader based in Switzerland in the search for a Japanese-speaking Mechanical Engineer on a 6-month contract basis Key Responsibilities: Serve as a translator to facilitate effective communication, including translating technical documents, designs, and discussions between English, and Japanese as needed Develop and review technical designs, ensuring alignment with project requirements and standards Utilize CAD software to create, modify, and analyze mechanical designs Prepare, manage, and maintain comprehensive project documentation, including technical reports, specifications, and manuals Troubleshoot and resolve technical issues across the two sites, ensuring timely project delivery Facilitate knowledge sharing and ensure consistency in engineering practices across locations Qualifications and Skills: Bachelor's or Master's degree in Mechanical Engineering or a related field Proficiency in CAD tools (e.g., SolidWorks, AutoCAD, or similar) Strong technical background with hands-on experience in mechanical design and analysis Demonstrated experience in creating and managing technical documentation Excellent communication and organizational skills to work effectively across international teams Familiarity with cross-cultural work environments, particularly in Swiss and Japanese contexts, is a plus Fluency in English; and Japanese Please use the link to apply **Note, only those with the right to work in Switzerland can apply. Permit or Visa sponsorship is not possible**
Negotiable
Switzerland
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Senior Scientist Formulation
Job Title: Senior Scientist, Formulation - Biologics Job Overview: We are seeking a highly skilled and motivated Senior Scientist to join our Formulation Development team, focused on the development of Biologics including mAbs, ADCs, and fusion proteins. The ideal candidate will hold a PhD in a relevant scientific discipline, with a minimum of 2 years of industry experience in Biologics formulation. In this role, the Senior Scientist will be responsible for the design, optimization, and scale-up of protein formulations, stability studies, and drug product development for Biologic therapeutics. Key Responsibilities: Lead formulation development efforts for biologics, including monoclonal antibodies (mAbs), ADCs, and fusion proteins, focusing on stability, solubility, and compatibility with various delivery systems. Design, execute, and analyze experiments to optimize protein formulations, including buffer selection, excipient compatibility, and process conditions. Conduct stability testing under accelerated, real-time, and stress conditions to assess formulation integrity, stability, and compatibility. Work closely with cross-functional teams, including Analytical Development, Process Development, and Quality Control, to ensure alignment and consistency of formulations through the product development lifecycle. Drive the development of scalable and robust formulations for clinical and commercial manufacturing, ensuring compatibility with large-scale production methods. Provide scientific leadership in the resolution of complex formulation challenges during early and late-stage development. Author technical documentation, including formulation protocols, study reports, and data analysis for internal and regulatory submissions. Stay current with scientific trends and industry developments related to biologics formulation, particularly in the areas of mAbs, ADCs, and fusion proteins. Mentor and guide junior scientists and associates in formulation development best practices. Qualifications: PhD in Biochemistry, Molecular Biology, Chemical Engineering, Pharmaceutical Sciences, or a related field. Minimum of 2 years of industry experience in biologics formulation, with expertise in monoclonal antibodies (mAbs), ADCs, fusion proteins, or other protein-based therapeutics. Strong understanding of protein chemistry, stability, and formulation strategies. Proficiency in analytical techniques used for protein characterization and stability assessment (e.g., HPLC, SEC, DSC, DLS, FTIR, UV-Vis, etc.). Experience in conducting stability studies and interpreting data to assess shelf life, degradation pathways, and formulation performance. Familiarity with biopharmaceutical manufacturing processes, scale-up, and cGMP requirements. Ability to troubleshoot complex formulation issues and collaborate with cross-functional teams. Excellent written and verbal communication skills, with the ability to present complex data to internal and external stakeholders. .
US$110000 - US$140000 per year
Pennsylvania
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Manufacturing Engineer
EPM Scientific is partnering with a global leader in the life sciences industry to find a skilled Manufacturing Engineer for a 6- to 12-month contract to support clean room improvements, equipment Q&V, and process optimization. This hands-on role is key to driving design transfer, line balancing, and continuous improvements for efficient, high-quality production Responsibilities Optimise manufacturing processes to improve efficiency, quality, and productivity Collaborate with cross-functional teams, including R&D, Quality, and Operations Implement process improvements and troubleshoot manufacturing issues Ensure production meets regulatory and safety standards Design and validate manufacturing processes and develop work instructions Manage equipment, tooling, and resources for efficient production Drive continuous improvement initiatives using lean manufacturing principles Facilitate design transfer and line balancing to ensure smooth integration of new products into production Qualifications: Bachelor's degree in Engineering or related field. 3+ years of experience in manufacturing engineering, preferably in life sciences. Strong technical background in plastics manufacturing (e.g., injection molding). Proficiency in CAD and process design Fluent in French & English *Please note, only those with the right to work in Switzerland will be considered
Negotiable
Switzerland
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Manufacturing Engineer
EPM Scientific is partnering with a global leader in the life sciences industry to find a skilled Manufacturing Engineer for a 6- to 12-month contract to support clean room improvements, equipment Q&V, and process optimization. This hands-on role is key to driving design transfer, line balancing, and continuous improvements for efficient, high-quality production Responsibilities Optimise manufacturing processes to improve efficiency, quality, and productivity Collaborate with cross-functional teams, including R&D, Quality, and Operations Implement process improvements and troubleshoot manufacturing issues Ensure production meets regulatory and safety standards Design and validate manufacturing processes and develop work instructions Manage equipment, tooling, and resources for efficient production Drive continuous improvement initiatives using lean manufacturing principles Facilitate design transfer and line balancing to ensure smooth integration of new products into production Qualifications: Bachelor's degree in Engineering or related field. 3+ years of experience in manufacturing engineering, preferably in life sciences. Strong technical background in plastics manufacturing (e.g., injection molding). Proficiency in CAD and process design Fluent in French & English *Please note, only those with the right to work in Switzerland will be considered
Negotiable
Schweizer-Reneke
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SRA/Associate Scientist, Downstream Process Development
Company: Our client is a clinical stage biopharmaceutical company focused on developing therapeutic antibodies. Function: Purification and Formulation Process Development and Manufacturing Level: Senior Research Associate/Associate Scientist Reporting Manager: Director, Downstream Process Development About the Opportunity: We are seeking a highly motivated Senior Research Associate/Associate Scientist to become an integral member of the Downstream Process Development group. The Downstream Process Development group is responsible for critical drug development functions such as: development of robust downstream processes, technology transfer and scale-up to contract manufacturing facilities, and technical support and overseeing of manufacturing at contract manufacturing facilities. The scope of the position and requirements are described below. Role and Responsibilities: Develop and scale-up robust multi-step purification processes Design and execute drug substance formulation studies Present experimental data in project and group meetings Author technical reports Implement new purification technologies to optimize and streamline processes Transfer and oversee purification process at CMO for GMP manufacturing Review executed batch records from CMO manufacturing Produce material for in-house development Education, Experience and Qualification Requirements: Bachelors or Masters degree in Chemistry, Biochemistry or related scientific field. 4+ years of relevant industry experience for MS and 6+ years for BS level candidates. Core Competencies, Knowledge and Skill Requirements: Experienced in protein purification techniques including column chromatography, standard membrane filtration and Ultrafiltration/Diafiltration Working knowledge of AKTA systems and Unicorn programming Ability to analyze and interpret complexed process data Work independently and proactively with minimal supervision Strong interpersonal skills and excellent oral and written communication skills Ability to travel and perform Person-in-Plant manufacturing oversight at a CMO is preferred Experience working with external manufacturing vendors and partners is preferred
US$88000 - US$118000 per year
San Mateo
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Field Automation Engineer
Location: Tokyo Full time Permanent Responsibilities: Technical Support: Provide support including repair, preventive maintenance, and hands-on assistance with systems automation. Onsite Activities: Install, validate (IQOQ, SAT), maintain, and troubleshoot the systems. Perform site activities as dictated by local managers or scheduling teams. Technical Authority: Act as the go-to person for automation within the service team and offer support at customer sites. Testing and Training: Conduct installation, training, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT). Resolve mechanical/software issues and perform IQOQ. Communication and Documentation: Communicate effectively, document actions, and provide technical information. Review and update service manuals and procedures. Customer Experience and Professional Development: Enhance customer experience, support factory testing, maintain technical knowledge, keep workplace tidy, and involve in professional development projects. Requirements: Bachelor's degree or higher in software, systems, electronics, or automation engineering, or a related field. At least 5 years' experience in automation within scientific, laboratory, or bioprocess settings. Required electronic and mechanical aptitude. Proficient with Siemens WinCC / Siemens S7, Wonderware / Intouch, Dreamreports, iFIX, Rockwell Studio 5000 / Allen Bradley Micrologix, GAMP5, Salesforce, and Microsoft Office / Power Automate. Excellent interpersonal, verbal, and written communication skills in both Japanese and English. Familiar with GAMP regulations, US FDA 21 CFR part 11 compliance, CSV requirements, and able to understand automation architecture, IO List, electrical schematics, SDS, HDS, and FDS documents. Detail-oriented, strong problem-solving and analytical skills, self-motivated, able to prioritize and work independently. If you are interested, please apply with your updated CV attached.
Negotiable
Tokyo
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Principal Scientist Analytical Development
Principal Scientist, Analytical Development Location: San Francisco, California Key Responsibilities: Spearhead and supervise analytical development initiatives for small molecules, (including method development, validation, and testing in support of OSD) Collaborate closely with interdisciplinary teams including R&D, Formulation Development, Regulatory Affairs, and Quality Assurance to bolster late-stage development programs and facilitate regulatory filings. Ensure steadfast adherence to regulatory guidelines, GLP, and GMP practices throughout the analytical development lifecycle. Offer technical proficiency and guidance on analytical challenges, troubleshooting, and resolution. Cultivate and mentor junior scientists within the Analytical Development team, nurturing a culture of ongoing learning and growth. Qualifications: Hold a Ph.D. in Analytical Development or a related discipline. Accumulate a minimum of 3-5 years of industry experience in analytical development, with a focus on small molecules. Demonstrate proficiency with solid-state characterization techniques like X-ray diffraction (XRD), differential scanning calorimetry (DSC), and microscopy. Exhibit a track record of successfully supporting late-stage development programs and regulatory filings (NDA). Possess a comprehensive understanding of GLP and GMP regulations and guidelines. Showcase exceptional communication, leadership, and project management capabilities. Thrive in a dynamic, fast-paced environment and adeptly manage multiple priorities. If you're looking to join a top Biopharmaceutical Company throughout the industry, apply in directly or email your resume !
US$130000 - US$160000 per year
San Francisco
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Analytical R&D Senior Scientist
SUMMARY This leading global pharmaceutical company is looking for a strong Analytical Scientist to join their R&D team in support of their ever growing portfolios of pharmaceutical drug products across a wide range of therapeutic areas. The ideal candidate will have a Ph.D. with at least 1-2 years of hands-on experience with solid orals/semi-solids for small molecules OR Masters +4-6 years. RESPONSIBILITIES Lead analytical development activities while providing supervision, training, & leadership to the jr. chemists. Identifies analytical test method goals to support the different product development stages and develops accurate and robust analytical test methods Performs complex analytical testing with accuracy and efficiency Provides a high level of experimental design and data interpretation Participate in cross functional meetings and provide input on strategy implementation for various projects where needed. Author & review relevant technical documents/SOP's & FDA submissions QUALIFICATIONS Ph.D. in Pharmaceutical Sciences (Or equivalent/relevant degree) with 1-2 years of small molecule analytical development experience in the pharma industry OR M.S. +4-6 years. Expertise in key analytical techniques such as HPLC, LC-MS, dissolution studies, XRPD, DSC, IR, etc. Strong communication skills (written & verbal) Experience with additional dosage forms (nasal, topical, injectable, liquid solutions, etc.) is a major plus!-Solid Orals are a MUST. Experience with NDA/ANDA/505(b2) is HIGHLY DESIRED!
US$90000 - US$120000 per year
New York
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