Associate Director/Director Analytical Sciences & Technology
Our client is a research organisation that develops vaccines and biologics. They are currently looking for a leader for their Analytical Sciences & Technology team to drive the development and implementation of analytical controls activities. Responsibilities: Develop and manage strategies for the entire lifecycle of analytical methods, ensuring compliance with regulatory standards. Provide strategic leadership for AS&T and QC systems, overseeing processes, programs, and procedures. Collaborate with various departments to support scientific analysis and manage external laboratory activities. Ensure QC laboratory operations comply with GMP standards, and review and approve all analytical documents. Monitor AS&T and QC program performance, address laboratory issues, and drive continuous improvement. Lead and mentor the AS&T team, contributing to strategic planning and quality standards as part of the Quality Leadership Team (QLT). Requirements: Bachelors in Science, Engineering or related technical field. Masters or PhD preferred. At least 10 years of experience in CMC, Analytical Sciences, Quality Control or related Familiar with regulatory requirements Strong GMP knowledge and experience Strong leadership experience Strong and effective communication skills If you are interested, please apply with your CV attached.
Negotiable
Singapore
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Scientist II Analytical Development
SUMMARY This leading global pharmaceutical company is looking for a strong Analytical Scientist to join their R&D team in support of one of the fastest growing portfolios of pharmaceutical drug products across a wide range of therapeutic areas. The ideal candidate will have a Ph.D. with at least 2-3 years of hands-on experience with solid orals/semi-solids for small molecules OR Masters +8-10 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 2-3 years of small molecule analytical development experience in the pharma industry OR M.S. +8-10 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.
US$90000 - US$130000 per year
California
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Formulation Sciences Associate Director/Director
Our client is a research organisation that develops vaccines and biologics. They are currently looking for a leader for their Formulation Sciences team to drive the product development strategies of their pipeline products. Responsibilities: Spearhead the development of pipeline products, including vaccines, monoclonal antibodies, and recombinant proteins. Manage the DP manufacturing team and ensure production equipment and processes are qualified. Oversee the introduction of new pipeline candidates into manufacturing, including production changeovers and equipment commissioning. Lead GMP-driven projects, address CAPA, investigate deviations, and enhance manufacturing technologies. Ensure the team adapts to evolving business needs and maintain high team engagement and performance. Work with various departments, implement innovative solutions, and drive continuous improvement in drug product development. Requirements: Bachelors in Chemistry, Biology, Pharmacy, Engineering or related Pharmaceutical Sciences. Masters or PhD preferred. At least 10 years of industry experience with 5 years of leadership experience Experienced in CMC biopharmaceutical development Knowledge in Good Manufacturing Practices (cGMP); Great communication skills If you are interested, please apply with your CV attached.
Negotiable
Singapore
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Director of Process Development
Job Title: Director of Process Development Location: Bay Area, CA Reports to: Vice President of R&D About our Client: Our client is an innovative, mid-sized cell therapy company dedicated to developing cutting-edge therapies that address unmet medical needs. Position Overview: We are seeking a dynamic and results-driven Director of Process Development to lead and oversee the development and optimization of manufacturing processes for our biopharmaceutical products. This role will be critical in ensuring the scalability, reproducibility, and regulatory compliance of our processes as we advance our pipeline into clinical trials and commercial production. The ideal candidate will have deep expertise in process development, strong leadership skills, and a passion for driving innovation within a fast-paced and growing biotech environment. Key Responsibilities: Oversee and manage the design, optimization, and scale-up of processes for the production of biologic drugs, including cell culture, purification, and formulation development. Ensure processes are robust, reproducible, and meet the regulatory standards for clinical and commercial manufacturing. Manage and mentor a cross-functional team of scientists, engineers, and technicians focused on process development activities. Foster a culture of collaboration, continuous learning, and excellence within the team. Work closely with R&D, analytical development, quality control, and manufacturing teams to ensure seamless transition from development to clinical manufacturing. Provide process insights and troubleshooting support to manufacturing operations. Lead the development of process characterization and validation strategies to ensure processes are scalable and meet GMP requirements. Manage the design and execution of process qualification, stability studies, and process performance qualification. Ensure that all process development activities comply with regulatory requirements (e.g., FDA, EMA, ICH guidelines) and internal quality standards. Prepare regulatory filings and documentation related to process development activities. Drive continuous process improvement initiatives through the implementation of new technologies, data analytics, and lean methodologies to reduce cost, improve efficiency, and enhance product quality. Oversee the process development budget, manage resource allocation, and ensure timely execution of process development milestones. Regularly update executive leadership and stakeholders on progress, milestones, risks, and opportunities related to process development. Qualifications: Ph.D. in Biochemistry, Chemical Engineering, Molecular Biology, or a related field. Alternatively, M.S. with significant experience (10+ years) in process development for biologics. Minimum of 8-10 years of experience in process development within the biotech or biopharmaceutical industry, with at least 3 years in a leadership role. Strong hands-on experience with upstream and downstream bioprocessing (e.g., cell culture, protein purification, chromatography). In-depth knowledge of GMP manufacturing, process validation, and regulatory requirements. Experience with biologic modalities (e.g., monoclonal antibodies, gene therapies, recombinant proteins). Proven ability to lead, mentor, and build high-performing teams in a fast-paced environment. Strong communication, interpersonal, and project management skills. Strong understanding of process scale-up and technology transfer. Expertise in the design and implementation of process characterization and process development strategies. Familiarity with data-driven approaches, process analytics, and continuous process improvement methodologies (e.g., DoE, Lean, Six Sigma). Ability to tackle complex technical challenges and provide creative solutions in a resource-constrained environment. Compensation $220,000-$255,000 base salary dependent on experience. Discretionary bonus and LTIs.
US$220000 - US$255000 per year
San Francisco
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Formulation Sciences Associate Director/Director
Our client is a research organisation that develops vaccines and biologics. They are currently looking for a leader for their Formulation Sciences team to drive the product development strategies of their pipeline products. Responsibilities: Spearhead the development of pipeline products, including vaccines, monoclonal antibodies, and recombinant proteins. Manage the DP manufacturing team and ensure production equipment and processes are qualified. Oversee the introduction of new pipeline candidates into manufacturing, including production changeovers and equipment commissioning. Lead GMP-driven projects, address CAPA, investigate deviations, and enhance manufacturing technologies. Ensure the team adapts to evolving business needs and maintain high team engagement and performance. Work with various departments, implement innovative solutions, and drive continuous improvement in drug product development. Requirements: Bachelors in Chemistry, Biology, Pharmacy, Engineering or related Pharmaceutical Sciences. Masters or PhD preferred. At least 10 years of industry experience with 5 years of leadership experience Experienced in CMC biopharmaceutical development Knowledge in Good Manufacturing Practices (cGMP); Great communication skills If you are interested, please apply with your CV attached.
Negotiable
Singapore
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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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