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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Analytical Scientist II
Analytical Scientist II Location: South Carolina Salary: $90,000 - $100,000 + benefits + bonus A leading manufacturing organization for health and wellness products is looking for a strong scientist to join their Analytical team. They are known for their commitment to developing and manufacturing high quality dietary suppliments for both humans and pets. Its product range includes joint health supplements, probiotics, and other nutritional aids to enhance overall well-being. Responsibilities: Designing and developing robust analytical methods and work cross functionally with other departments such as the Quality and Drug product teams. Identifying and resolving issues related to analytical methods or instrumentation, ensuring disruption to project timelines. Usage of a variety of analytical instruments such as HPLC, GC, GC, LC-MS, GC-MS, ICP-MS, HPTLC, ICP, and FTIR. Performing Quality Control testing and data review to support the timely release of product. Developing and validating analytical methods to ensure analysis and prompt release of raw materials. Communicating effectively with other departments within the organization. Qualifications: Bachelor's in chemistry or related field with 10 years of industry experience in Analytical Development. OR MS in Chemistry or related field with 5 years of industry experience in Analytical development. Hands on experience in a cGMP/GMP setting Prior knowledge of using Empower Software and troubleshooting on HPLC/GC. Strong background in analytical techniques such as HPLC, GC, LC-MS, GC-MS, ICP-MS, HPTLC, ICP, FTIR. Any additional experience in laboratory techniques and fundamentals such as titration and gravimetric methods. Effective communication skills and comfortable working cross functionally with other R&D teams.
US$90000 - US$100000 per year
South Carolina
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Principal Scientist Formulation
SUMMARY This Industry leading Nutraceutical & Pharma Organization is looking for a scientific leader specializing in formulations of solid orals to support the rapid growth of their product portfolio. The ideal candidate will have experience in DoE, scale-up, and manufacturing of pharma/OTC/dietary products with the opportunity choose between management or operate as an Individual Contributor. RESPONSIBILITIES Design & execute experiments for formulations of pharmaceutical, veterinary, and consumer solid-dosage products, soft chews, powders, and liquids. Contribute to the sourcing of excipients or active ingredients for the formulations while collaborating with the product development team . Create trial batches and product prototypes in accordance with approved protocols. Execute tech transfers in collaboration with the operations team to convert new pilot-scale formula production into full-scale manufacturing. When necessary, collaborate with operations to enhance or optimize current products. Identify & analyze new ingredients for potential implementation into new products and start research to aid in the creation of prototypes, inquiries, and product assessment Create documentation recording all product development activities to assist with providing technical direction. QUALIFICATIONS Bachelor's Degree (Ideally in Chemistry, Pharma, Food Science, or related discipline) with 10 years' industry experience OR M.S. + 5-6 years OR Ph.D. +3-5 years Hands-on experience in solid dosage formulation, food, scale up and manufacturing trouble shooting of dietary supplements and/or pharmaceutical products (animal health a plus).
US$100000 - US$150000 per year
South Carolina
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Director of Downstream Process Development
Director of Downstream Process Development Job Summary: The Director of Downstream Process Development will lead the development and optimization of downstream processes for the production of novel biologics. This role is responsible for design, scale-up, and transfer purification processes from laboratory scale to manufacturing, ensuring compliance with regulatory guidelines and meeting project timelines. The ideal candidate will have extensive experience in chromatography, filtration, and process validation, as well as a strategic vision for developing innovative solutions in downstream processing. Key Responsibilities: Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement. Establish clear objectives, KPIs, and development plans for team members. Oversee the design, development, and optimization of downstream processes, including purification methods like chromatography (affinity, ion exchange, size exclusion, etc.), filtration, and ultrafiltration/diafiltration. Lead efforts in process scaling and technology transfer from R&D to GMP manufacturing, ensuring robust and reproducible results. Drive process characterization and validation in accordance with regulatory guidelines (FDA, EMA, ICH). Perform CMC risk assessment activities in a phase appropriate manner ensuring proper measures are in place in support of production and filing requirements. Lead or support the preparation of relevant sections for regulatory submissions (IND, BLA, etc.). Oversee the project lifecycle, from feasibility studies to full-scale production, ensuring timely delivery and alignment with project milestones. Identify opportunities for innovation and improvement in downstream processes, driving cost-effective and scalable solutions. 20-25% travel in support of manufacturing activities at the CDMOs. Collaborate with cross-functional teams, including upstream development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and process success. Qualifications & Requirements: Master's or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field with 8 - 10 years of experience in downstream process development; with at least 5 years in a leadership role within the biopharmaceutical industry. Strong expertise in the purification of biologics, including monoclonal antibodies, proteins, viral vectors, or similar biologics. Experience with scale-up and technology transfer to GMP manufacturing. Extensive knowledge of downstream purification techniques (e.g., chromatography, filtration) and associated analytical methods. Proven track record in process characterization, validation, and regulatory submissions. Familiarity with automated process development tools and high-throughput screening technologies. Experience working with CDMOs and external manufacturing partners.
US$200000 - US$230000 per year
Boston
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Director of Upstream Process Development
Director of Upstream Process Development Boston, MA Job Summary: The Director of Upstream Process Development will lead the design, optimization, and scale-up of upstream processes for biologics production, focusing on cell culture and fermentation technologies. The position will be pivotal in developing robust, scalable, and cost-efficient processes for the development of novel biologic therapeutic products. The ideal candidate will have extensive experience in bioreactor operations, cell line development, media optimization, and tech transfer. This is a hands-on leadership role with direct involvement in process development and close collaboration with downstream, analytical, and manufacturing teams. Key Responsibilities: Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement. Establish clear objectives, KPIs, and development plans for team members. Oversee the development and optimization of upstream processes, including cell culture, media development, bioreactor design, and process control strategies. Focus on high-yield, scalable processes using mammalian, microbial, or insect cell systems for biologic production. Implement robust experimental designs (DOE) to optimize parameters such as media composition, feed strategy, and culture conditions. Collaborate with cross-functional teams (e.g., downstream, analytical, QA/QC, regulatory, and clinical) to ensure seamless integration of upstream processes into the overall development pipeline. Lead efforts in scaling up upstream processes from bench-scale to pilot- and manufacturing-scale, ensuring process consistency and robustness. Coordinate and manage technology transfer to internal or external GMP manufacturing facilities (CMOs), ensuring the successful implementation of processes for clinical and commercial production. Troubleshoot and resolve scale-up challenges, ensuring alignment with quality and regulatory expectations. Lead or support the preparation of relevant sections for regulatory submissions (IND, BLA, etc.). Oversee the project lifecycle, from feasibility studies to full-scale production, ensuring timely delivery and alignment with project milestones. 20-25% travel in support of manufacturing activities at the CDMOs. Collaborate with cross-functional teams, including downstream development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and process success. Qualifications & Requirements: Master's or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field with 8 - 10 years of experience in upstream process development; with at least 5 years in a leadership role within the biopharmaceutical industry. Expertise in cell culture, fermentation, bioreactor operations (single-use and stainless steel), and process scale-up. Strong scientific background in cell line development, media optimization, and bioreactor operation. Hands-on experience with various cell culture platforms, such as CHO, HEK, microbial systems, and viral vector production. Proven track record in process characterization, validation, and regulatory submissions. Familiarity with automated process development tools and high-throughput screening technologies. Experience working with CDMOs and external manufacturing partners.
US$200000 - US$230000 per year
Boston
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Scientist II Upstream Process Development
SUMMARY This innovative biopharmaceutical company is looking for an R&D scientific leader with a strong background in Upstream Bioprocessing for cell & gene therapy to join their cross functional team as an individual contributor to facilitate IND, Phase I & II enabling activities advancing programs to BLA. RESPONSIBILITIES: Independently design, develop, and execute experiments for bioprocess development, optimization, and characterization. Execute adherent and suspension small-scale bioreactor-based cell culture processes for manufacturing of gene therapy vectors across multiple programs. Coordinate with internal & external partners for deliverables and timelines related to testing, optimizing, & advancing new cell therapy programs from early development through clinical trials. Cell therapy upstream process development and analytics, including product characterization, process parameter optimization, and singleโuse bioreactors Serve as the SME all bioprocessing activities that support clinical development and IND/BLA filing. Provide technical oversight, guidance, troubleshooting, and provide new approaches or experimental strategies for problem solving to ensure that clinical materials are delivered on schedule. Write and evaluate CMC sections & technical reports needed for regulatory submissions. QUALIFICATIONS: Master's or PhD in Chemical Engineering, Microbiology, Biochemistry, or related degree with 1 year min. of industry experience (PhD) or (MS +3-5 years) developing upstream processes. Prior hands-on experience with stirred tank bioreactors for adherent and suspension cell cultures Experience with iPSC, mesenchymal stem cell, T cell, or NK cell expansion using bioreactors. Track record of successfully executing Design of Engineering (DoE) approach. Prefer experience with multivariate data analysis, predictive analytics, and machine learning. Prefer multivariate or machine learning data analytics experience (JMP, python, R).
US$80000 - US$115000 per year
San Antonio
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Scientist II Upstream Process Development
SUMMARY This innovative biopharmaceutical company is looking for an R&D scientific leader with a strong background in Upstream Bioprocessing for cell & gene therapy to join their cross functional team as an individual contributor to facilitate IND, Phase I & II enabling activities advancing programs to BLA. RESPONSIBILITIES: Independently design, develop, and execute experiments for bioprocess development, optimization, and characterization. Execute adherent and suspension small-scale bioreactor-based cell culture processes for manufacturing of gene therapy vectors across multiple programs. Coordinate with internal & external partners for deliverables and timelines related to testing, optimizing, & advancing new cell therapy programs from early development through clinical trials. Cell therapy upstream process development and analytics, including product characterization, process parameter optimization, and singleโuse bioreactors Serve as the SME all bioprocessing activities that support clinical development and IND/BLA filing. Provide technical oversight, guidance, troubleshooting, and provide new approaches or experimental strategies for problem solving to ensure that clinical materials are delivered on schedule. Write and evaluate CMC sections & technical reports needed for regulatory submissions. QUALIFICATIONS: Master's or PhD in Chemical Engineering, Microbiology, Biochemistry, or related degree with 1 year min. of industry experience (PhD) or (MS +3-5 years) developing upstream processes. Prior hands-on experience with stirred tank bioreactors for adherent and suspension cell cultures Experience with iPSC, mesenchymal stem cell, T cell, or NK cell expansion using bioreactors. Track record of successfully executing Design of Engineering (DoE) approach. Prefer experience with multivariate data analysis, predictive analytics, and machine learning. Prefer multivariate or machine learning data analytics experience (JMP, python, R).
US$80000 - US$115000 per year
San Antonio
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Director of Upstream Process Development
Director of Upstream Process Development Job Summary: The Director of Upstream Process Development will lead the design, optimization, and scale-up of upstream processes for biologics production, focusing on cell culture and fermentation technologies. The position will be pivotal in developing robust, scalable, and cost-efficient processes for the development of novel biologic therapeutic products. The ideal candidate will have extensive experience in bioreactor operations, cell line development, media optimization, and tech transfer. This is a hands-on leadership role with direct involvement in process development and close collaboration with downstream, analytical, and manufacturing teams. Key Responsibilities: Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement. Establish clear objectives, KPIs, and development plans for team members. Oversee the development and optimization of upstream processes, including cell culture, media development, bioreactor design, and process control strategies. Focus on high-yield, scalable processes using mammalian, microbial, or insect cell systems for biologic production. Implement robust experimental designs (DOE) to optimize parameters such as media composition, feed strategy, and culture conditions. Collaborate with cross-functional teams (e.g., downstream, analytical, QA/QC, regulatory, and clinical) to ensure seamless integration of upstream processes into the overall development pipeline. Lead efforts in scaling up upstream processes from bench-scale to pilot- and manufacturing-scale, ensuring process consistency and robustness. Coordinate and manage technology transfer to internal or external GMP manufacturing facilities (CMOs), ensuring the successful implementation of processes for clinical and commercial production. Troubleshoot and resolve scale-up challenges, ensuring alignment with quality and regulatory expectations. Lead or support the preparation of relevant sections for regulatory submissions (IND, BLA, etc.). Oversee the project lifecycle, from feasibility studies to full-scale production, ensuring timely delivery and alignment with project milestones. 20-25% travel in support of manufacturing activities at the CDMOs. Collaborate with cross-functional teams, including downstream development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and process success. Qualifications & Requirements: Master's or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field with 8 - 10 years of experience in upstream process development; with at least 5 years in a leadership role within the biopharmaceutical industry. Expertise in cell culture, fermentation, bioreactor operations (single-use and stainless steel), and process scale-up. Strong scientific background in cell line development, media optimization, and bioreactor operation. Hands-on experience with various cell culture platforms, such as CHO, HEK, microbial systems, and viral vector production. Proven track record in process characterization, validation, and regulatory submissions. Familiarity with automated process development tools and high-throughput screening technologies. Experience working with CDMOs and external manufacturing partners.
US$200000 - US$230000 per year
Cambridge
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Director of Downstream Process Development
Director of Downstream Process Development Job Summary: The Director of Downstream Process Development will lead the development and optimization of downstream processes for the production of novel biologics. This role is responsible for design, scale-up, and transfer purification processes from laboratory scale to manufacturing, ensuring compliance with regulatory guidelines and meeting project timelines. The ideal candidate will have extensive experience in chromatography, filtration, and process validation, as well as a strategic vision for developing innovative solutions in downstream processing. Key Responsibilities: Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement. Establish clear objectives, KPIs, and development plans for team members. Oversee the design, development, and optimization of downstream processes, including purification methods like chromatography (affinity, ion exchange, size exclusion, etc.), filtration, and ultrafiltration/diafiltration. Lead efforts in process scaling and technology transfer from R&D to GMP manufacturing, ensuring robust and reproducible results. Drive process characterization and validation in accordance with regulatory guidelines (FDA, EMA, ICH). Perform CMC risk assessment activities in a phase appropriate manner ensuring proper measures are in place in support of production and filing requirements. Lead or support the preparation of relevant sections for regulatory submissions (IND, BLA, etc.). Oversee the project lifecycle, from feasibility studies to full-scale production, ensuring timely delivery and alignment with project milestones. Identify opportunities for innovation and improvement in downstream processes, driving cost-effective and scalable solutions. 20-25% travel in support of manufacturing activities at the CDMOs. Collaborate with cross-functional teams, including upstream development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and process success. Qualifications & Requirements: Master's or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field with 8 - 10 years of experience in downstream process development; with at least 5 years in a leadership role within the biopharmaceutical industry. Strong expertise in the purification of biologics, including monoclonal antibodies, proteins, viral vectors, or similar biologics. Experience with scale-up and technology transfer to GMP manufacturing. Extensive knowledge of downstream purification techniques (e.g., chromatography, filtration) and associated analytical methods. Proven track record in process characterization, validation, and regulatory submissions. Familiarity with automated process development tools and high-throughput screening technologies. Experience working with CDMOs and external manufacturing partners.
US$200000 - US$230000 per year
Boston
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Principal Scientist - Analytical Development Small Molecules
Principal Scientist, Analytical Development Location: LA, 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 well-known player in the Pharmaceutical industry, apply in directly or email your resume !
US$140000 - US$160000 per year
Los Angeles
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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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