17,439 Process Development Scientist jobs in the United States
Process Development Scientist
84601 Orem, Utah
$100000 Annually
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Our client is seeking an innovative and experienced Process Development Scientist to join their cutting-edge research and development team in Provo, Utah, US . This role is crucial for developing and optimizing chemical processes for the synthesis and manufacturing of novel compounds. You will be responsible for designing and executing experiments, analyzing results, scaling up processes, and ensuring robust and reproducible chemical manufacturing. The ideal candidate possesses a strong background in organic chemistry or chemical engineering, with a passion for translating laboratory discoveries into viable industrial processes. This is a fully remote position, allowing you to contribute from anywhere.
Responsibilities:
Qualifications:
Responsibilities:
- Design, conduct, and interpret experiments to develop and optimize chemical synthesis routes.
- Scale up laboratory processes to pilot plant and commercial manufacturing levels, ensuring safety and efficiency.
- Characterize raw materials, intermediates, and final products using analytical techniques (HPLC, GC, NMR, Mass Spectrometry, etc.).
- Develop and validate analytical methods for process monitoring and quality control.
- Troubleshoot and resolve issues encountered during process development and scale-up.
- Prepare detailed technical reports, protocols, and presentations on experimental findings and process development.
- Collaborate closely with R&D chemists, engineers, and manufacturing teams to ensure successful technology transfer.
- Maintain a thorough understanding of current scientific literature and emerging technologies in process chemistry.
- Ensure all laboratory activities comply with safety regulations, environmental standards, and company policies.
- Contribute to intellectual property generation through patent applications and internal disclosures.
- Manage project timelines and resources effectively to meet development milestones.
Qualifications:
- Ph.D. or Master's degree in Organic Chemistry, Chemical Engineering, or a related field with a strong focus on process development.
- 5+ years of hands-on experience in process chemistry, organic synthesis, and scale-up.
- Proven track record in developing robust and scalable chemical processes.
- Extensive experience with various analytical instrumentation and techniques for chemical characterization.
- Strong understanding of reaction kinetics, thermodynamics, and chemical engineering principles.
- Familiarity with process safety assessments (e.g., HAZOP) and risk mitigation strategies.
- Excellent problem-solving, critical thinking, and experimental design skills.
- Strong written and verbal communication skills, with the ability to document complex technical information clearly.
- Ability to work independently and collaboratively in a remote team environment.
- Experience with DOE (Design of Experiments) methodologies is a plus.
- Knowledge of GMP principles is advantageous.
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0
Principal Process Development Scientist
19101 Philadelphia, Pennsylvania
$130000 Annually
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Our client is seeking a highly accomplished Principal Process Development Scientist to lead critical initiatives in their pharmaceutical research and development division, located in Philadelphia, Pennsylvania, US . This senior role will focus on the development, optimization, and scale-up of innovative pharmaceutical manufacturing processes. The ideal candidate will possess extensive experience in biopharmaceutical process development, a strong scientific background, and a proven ability to manage complex projects from laboratory to pilot scale and beyond. You will be instrumental in driving process improvements, ensuring product quality, and contributing to the successful commercialization of new drug candidates.
Key responsibilities include:
Candidates must possess a Ph.D. or Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related life science discipline. A minimum of 8 years of relevant industry experience in pharmaceutical or biopharmaceutical process development is required. Demonstrated expertise in upstream and/or downstream process development, scale-up, and technology transfer is essential. Strong understanding of GMP regulations and ICH guidelines is mandatory. Excellent leadership, communication, presentation, and interpersonal skills are critical. Proven ability to manage complex projects and mentor junior scientists is highly valued. This is an exceptional opportunity for a scientific leader to make a significant impact in a dynamic pharmaceutical environment.
Key responsibilities include:
- Leading the design, execution, and analysis of experiments for the development and optimization of biopharmaceutical manufacturing processes (e.g., cell culture, purification, formulation).
- Developing and validating robust, scalable, and cost-effective manufacturing processes that meet regulatory requirements.
- Performing in-depth data analysis and interpretation to troubleshoot process issues and identify areas for improvement.
- Managing multiple development projects concurrently, ensuring adherence to timelines and budgets.
- Collaborating closely with cross-functional teams, including analytical development, formulation, manufacturing operations, and regulatory affairs.
- Authoring and reviewing technical reports, protocols, and regulatory submission documents.
- Providing scientific and technical leadership to a team of scientists and engineers.
- Staying abreast of cutting-edge technologies and scientific advancements in biopharmaceutical process development.
- Troubleshooting manufacturing process deviations and implementing corrective and preventative actions (CAPAs).
- Contributing to the intellectual property portfolio through innovation and invention disclosures.
Candidates must possess a Ph.D. or Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related life science discipline. A minimum of 8 years of relevant industry experience in pharmaceutical or biopharmaceutical process development is required. Demonstrated expertise in upstream and/or downstream process development, scale-up, and technology transfer is essential. Strong understanding of GMP regulations and ICH guidelines is mandatory. Excellent leadership, communication, presentation, and interpersonal skills are critical. Proven ability to manage complex projects and mentor junior scientists is highly valued. This is an exceptional opportunity for a scientific leader to make a significant impact in a dynamic pharmaceutical environment.
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1
Senior Process Development Scientist
95814 Sacramento, California
$120000 Annually
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Posted 6 days ago
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Job Description
Our client is seeking an innovative and experienced Senior Process Development Scientist to join their world-class, fully remote R&D team. This role is critical in the advancement of novel chemical processes from laboratory scale to pilot and commercial production. You will leverage your deep expertise in chemical engineering principles and process optimization to design, develop, and scale-up robust and efficient manufacturing processes. The ideal candidate will possess a strong background in reaction engineering, separation technologies, and process safety, with a passion for translating scientific discoveries into viable industrial applications.
Responsibilities:
Responsibilities:
- Design and execute laboratory experiments to develop and optimize chemical synthesis routes and isolation procedures.
- Utilize process modeling and simulation tools to predict process performance and identify key scale-up parameters.
- Develop detailed process flow diagrams (PFDs) and piping and instrumentation diagrams (P&IDs).
- Conduct hazard and operability studies (HAZOP) and other process safety assessments.
- Manage pilot plant trials, troubleshoot process issues, and analyze results to refine process design.
- Develop robust analytical methods for in-process control and final product characterization.
- Author comprehensive technical reports, invention disclosures, and regulatory documentation.
- Collaborate effectively with cross-functional teams, including research chemists, analytical scientists, and manufacturing personnel.
- Stay current with advancements in chemical engineering, process intensification, and sustainable chemistry.
- Provide technical guidance and mentorship to junior scientists and engineers.
- Ph.D. or Master's degree in Chemical Engineering or a closely related field.
- Minimum of 7 years of experience in process development, scale-up, and manufacturing within the chemical or pharmaceutical industry.
- Proven expertise in organic synthesis, reaction kinetics, and thermodynamic principles.
- Hands-on experience with various separation techniques (e.g., distillation, crystallization, chromatography).
- Familiarity with process safety management (PSM) principles and risk assessment methodologies.
- Proficiency in process simulation software (e.g., Aspen Plus, HYSYS) and statistical analysis tools.
- Excellent problem-solving abilities and a data-driven approach to process design.
- Strong written and verbal communication skills, with the ability to present complex technical information clearly.
- Ability to manage multiple projects simultaneously in a remote, fast-paced environment.
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2
Principal Process Development Scientist
95811 Sacramento, California
$155000 Annually
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Posted 6 days ago
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Our client, a leading pharmaceutical company, is seeking a highly accomplished Principal Process Development Scientist to join their innovative team in **Sacramento, California**. This role offers a hybrid work arrangement, blending essential on-site laboratory work with remote capabilities for data analysis and reporting. The ideal candidate will have extensive experience in developing, optimizing, and scaling biopharmaceutical manufacturing processes. You will lead critical projects focused on creating robust and efficient upstream or downstream processes for biologics, ensuring compliance with regulatory standards and driving therapeutic advancements.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Leading the development and optimization of novel biopharmaceutical manufacturing processes, including cell culture, fermentation, or purification.
- Designing and executing experiments to characterize process parameters and identify critical process controls.
- Developing strategies for process scale-up and technology transfer to manufacturing sites.
- Troubleshooting and resolving complex process-related issues during development and manufacturing.
- Utilizing statistical methods and Design of Experiments (DoE) to optimize processes and improve yields.
- Authoring technical reports, protocols, and regulatory submission documents.
- Collaborating effectively with cross-functional teams, including R&D, manufacturing, quality control, and regulatory affairs.
- Staying current with industry trends, emerging technologies, and regulatory guidelines in biopharmaceutical process development.
- Mentoring and guiding junior scientists and engineers in the process development group.
- Presenting scientific findings and project updates to internal stakeholders and external partners.
Qualifications:
- Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related scientific discipline.
- Minimum of 8 years of hands-on experience in biopharmaceutical process development.
- Proven expertise in upstream (e.g., microbial fermentation, mammalian cell culture) or downstream (e.g., chromatography, filtration) process development.
- Strong understanding of GMP principles and regulatory requirements (e.g., FDA, EMA).
- Demonstrated experience with scale-up principles and technology transfer activities.
- Proficiency in statistical analysis software (e.g., JMP, R) and DoE methodologies.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to present complex data clearly.
- Experience with single-use technologies and continuous manufacturing is a plus.
- Ability to lead projects independently and work effectively in a collaborative, cross-functional team environment.
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3
Principal Process Development Scientist
49503 Grand Rapids, Michigan
$125000 Annually
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Posted 8 days ago
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Our client is seeking a highly accomplished Principal Process Development Scientist to join their dynamic pharmaceutical manufacturing team in Grand Rapids, Michigan, US . This senior role will be instrumental in optimizing and scaling up pharmaceutical manufacturing processes, ensuring efficiency, quality, and regulatory compliance. You will lead the design, development, and validation of robust manufacturing processes for both new drug entities and existing products. Key responsibilities include troubleshooting process deviations, implementing continuous improvement initiatives, and staying current with industry best practices and emerging technologies in pharmaceutical manufacturing. The ideal candidate will possess extensive experience in process chemistry, chemical engineering, or a closely related field, with a strong understanding of cGMP regulations. You will collaborate closely with R&D, Quality Assurance, and manufacturing operations teams to ensure seamless technology transfer and successful production. This role requires a strategic thinker with excellent analytical, problem-solving, and project management skills. You will be responsible for developing and executing experimental plans, analyzing process data, and authoring comprehensive technical reports and validation documents. The ability to mentor junior scientists and engineers, fostering a culture of innovation and continuous learning, is essential. A Ph.D. in Chemical Engineering, Chemistry, or a related discipline, with a minimum of 8 years of relevant industry experience in pharmaceutical process development, is required. Experience with lyophilization, sterile processing, or other specialized pharmaceutical manufacturing techniques is a significant asset. You will play a vital role in ensuring the efficient and reliable supply of high-quality pharmaceutical products to patients. This hybrid position offers a blend of in-lab work and remote data analysis and collaboration, providing flexibility while maintaining strong team cohesion.
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4
Lead Process Development Scientist
53201 Milwaukee, Wisconsin
$110000 Annually
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Posted 9 days ago
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Job Description
Our client, a renowned pharmaceutical innovator based in Milwaukee, Wisconsin, US , is seeking an exceptional Lead Process Development Scientist to drive forward groundbreaking drug development initiatives. This pivotal role requires a visionary leader with a deep understanding of chemical synthesis, process optimization, and scale-up for active pharmaceutical ingredients (APIs). You will be instrumental in designing, developing, and validating robust and scalable manufacturing processes that meet stringent quality and regulatory standards. Your expertise will span from early-stage chemical development through to late-stage process validation and technology transfer to manufacturing sites.
The Lead Process Development Scientist will oversee a team of talented scientists and engineers, providing technical guidance, mentorship, and strategic direction. Responsibilities include troubleshooting complex process issues, implementing innovative process technologies, and ensuring efficient and cost-effective production. A significant aspect of the role involves extensive collaboration with cross-functional teams, including analytical development, formulation, regulatory affairs, and manufacturing operations. You will author and review critical process documentation, including development reports, validation protocols, and regulatory submissions. A key focus will be on identifying and mitigating process-related risks, ensuring the highest levels of safety and compliance. The ideal candidate will possess a strong scientific foundation, combined with excellent leadership and project management skills. Experience with current Good Manufacturing Practices (cGMP) and regulatory agency guidelines (e.g., FDA, EMA) is essential. This is a unique opportunity to contribute to the advancement of life-changing medicines and to shape the future of pharmaceutical manufacturing. The role offers the chance to work on cutting-edge projects in a stimulating and collaborative environment, making a tangible difference in patient lives. We are looking for a proactive and results-driven individual who thrives in a fast-paced setting and is committed to scientific excellence and continuous improvement.
Qualifications:
The Lead Process Development Scientist will oversee a team of talented scientists and engineers, providing technical guidance, mentorship, and strategic direction. Responsibilities include troubleshooting complex process issues, implementing innovative process technologies, and ensuring efficient and cost-effective production. A significant aspect of the role involves extensive collaboration with cross-functional teams, including analytical development, formulation, regulatory affairs, and manufacturing operations. You will author and review critical process documentation, including development reports, validation protocols, and regulatory submissions. A key focus will be on identifying and mitigating process-related risks, ensuring the highest levels of safety and compliance. The ideal candidate will possess a strong scientific foundation, combined with excellent leadership and project management skills. Experience with current Good Manufacturing Practices (cGMP) and regulatory agency guidelines (e.g., FDA, EMA) is essential. This is a unique opportunity to contribute to the advancement of life-changing medicines and to shape the future of pharmaceutical manufacturing. The role offers the chance to work on cutting-edge projects in a stimulating and collaborative environment, making a tangible difference in patient lives. We are looking for a proactive and results-driven individual who thrives in a fast-paced setting and is committed to scientific excellence and continuous improvement.
Qualifications:
- Ph.D. in Organic Chemistry, Chemical Engineering, or a closely related field.
- Minimum of 10 years of experience in pharmaceutical process development, with at least 3 years in a leadership or supervisory role.
- Extensive experience in process chemistry, scale-up, and validation of API manufacturing processes.
- Deep understanding of cGMP, ICH guidelines, and regulatory submission requirements.
- Proven track record of successfully transferring processes from R&D to manufacturing.
- Excellent leadership, communication, and interpersonal skills.
- Strong problem-solving abilities and a data-driven approach to decision-making.
- Experience with PAT (Process Analytical Technology) and QbD (Quality by Design) principles is a plus.
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5
Senior Process Development Scientist
95814 Sacramento, California
$130000 Annually
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Posted 9 days ago
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Job Description
Our client is at the forefront of chemical innovation and is actively seeking a highly motivated and experienced Senior Process Development Scientist to join their fully remote R&D team. This position is critical for the design, optimization, and scale-up of novel chemical processes. The ideal candidate will possess a strong background in organic synthesis, reaction engineering, and process chemistry, with a proven ability to translate laboratory findings into robust, scalable manufacturing processes. You will be instrumental in developing safe, efficient, and cost-effective chemical manufacturing routes, meticulously documenting experimental procedures and results, and presenting findings to cross-functional teams. Responsibilities include conducting literature surveys, designing and executing experiments to optimize reaction conditions, troubleshoot process issues, and evaluate new technologies. You will also be responsible for performing process hazard analyses, developing analytical methods for in-process control, and contributing to the generation of regulatory documentation. Collaboration with engineering and manufacturing teams to ensure successful technology transfer from lab to pilot plant and ultimately to commercial production is a key aspect of this role. Excellent written and verbal communication skills are essential for this remote position, enabling clear and concise reporting of complex scientific information. The ability to work independently, manage multiple projects simultaneously, and adapt to evolving research priorities is crucial. A Ph.D. in Chemistry, Chemical Engineering, or a related field, coupled with at least 5 years of industrial experience in process development, is highly desirable. This is an exceptional opportunity for a talented scientist to contribute to groundbreaking chemical advancements from the comfort of their home office, driving innovation in a forward-thinking organization.
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6
Senior Process Development Scientist
94103, California
$135000 Annually
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Posted 9 days ago
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Job Description
Our client, a pioneering biopharmaceutical company, is seeking a highly accomplished Senior Process Development Scientist with expertise in chemical engineering and biotechnology. This role is critical for optimizing and scaling up manufacturing processes for novel therapeutic agents. You will be instrumental in designing, executing, and analyzing experiments to improve process efficiency, yield, and quality. The ideal candidate will possess a strong scientific background, extensive experience in process development, and a deep understanding of cGMP environments. Your work will directly contribute to bringing life-saving medicines to patients.
Responsibilities:
Qualifications:
This is an exciting opportunity to join a world-class organization at the forefront of pharmaceutical innovation. You will play a key role in advancing therapeutic programs from the lab to commercial production.
Location: This position requires a hybrid work arrangement, with some in-office presence in San Francisco, California, US and the ability to work remotely.
Responsibilities:
- Develop, optimize, and scale-up chemical and biological processes for the manufacturing of APIs and drug products.
- Design and conduct experiments to understand process parameters and their impact on product quality and yield.
- Utilize principles of chemical engineering, reaction kinetics, and mass transfer to solve complex process challenges.
- Develop and validate analytical methods for in-process control and product characterization.
- Troubleshoot manufacturing issues and implement corrective actions to ensure process robustness.
- Prepare comprehensive technical reports, protocols, and regulatory documentation.
- Collaborate with research, manufacturing, and quality assurance teams to ensure seamless technology transfer.
- Stay current with scientific literature and emerging technologies in process development and manufacturing.
- Mentor junior scientists and provide technical guidance.
- Ensure all activities comply with safety regulations and cGMP guidelines.
Qualifications:
- Ph.D. or Master's degree in Chemical Engineering, Chemistry, Biotechnology, or a related field.
- Minimum of 5 years of progressive experience in process development within the pharmaceutical or biotechnology industry.
- Proven expertise in process scale-up, optimization, and validation.
- Strong understanding of cGMP regulations and their application in manufacturing.
- Hands-on experience with laboratory and pilot-scale equipment relevant to chemical synthesis or bioprocessing.
- Proficiency in data analysis, statistical process control (SPC), and design of experiments (DoE).
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to present technical information effectively.
- Experience with process modeling and simulation software is a plus.
- Demonstrated ability to work independently and collaboratively in a fast-paced R&D environment.
This is an exciting opportunity to join a world-class organization at the forefront of pharmaceutical innovation. You will play a key role in advancing therapeutic programs from the lab to commercial production.
Location: This position requires a hybrid work arrangement, with some in-office presence in San Francisco, California, US and the ability to work remotely.
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7
Senior Process Development Scientist
19103 Philadelphia, Pennsylvania
$135000 Annually
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Posted 12 days ago
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Our client, a rapidly expanding pharmaceutical company renowned for its innovative research and development, is seeking a highly skilled and motivated Senior Process Development Scientist to join their team in Philadelphia, Pennsylvania, US . This critical role will focus on optimizing and scaling up biopharmaceutical manufacturing processes to ensure the efficient and high-quality production of life-saving therapies. The ideal candidate will possess a strong background in upstream or downstream process development, excellent analytical skills, and a passion for advancing pharmaceutical manufacturing.
Responsibilities:
Responsibilities:
- Lead the development, optimization, and scale-up of biopharmaceutical manufacturing processes, including cell culture, fermentation, or purification.
- Design and execute experimental studies to characterize process parameters and identify critical process controls (CPCs).
- Develop robust analytical methods to support process development and product characterization.
- Perform risk assessments and implement strategies to mitigate process-related risks.
- Troubleshoot and resolve complex technical issues encountered during process development and scale-up activities.
- Collaborate with manufacturing, quality assurance, and regulatory affairs teams to ensure smooth technology transfer and regulatory compliance.
- Author technical reports, protocols, and documentation for regulatory submissions (e.g., IND, BLA).
- Stay current with industry best practices, emerging technologies, and regulatory guidelines relevant to biopharmaceutical process development.
- Mentor junior scientists and provide technical guidance on experimental design and data analysis.
- Contribute to the strategic planning and execution of the process development roadmap.
- Manage external collaborations with contract manufacturing organizations (CMOs) or academic partners as needed.
- Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, Molecular Biology, or a related field.
- A minimum of 5 years of hands-on experience in process development for biologics, including upstream or downstream unit operations.
- Strong understanding of biopharmaceutical manufacturing principles, including GMP requirements.
- Proven experience with process scale-up from laboratory to pilot or manufacturing scale.
- Expertise in relevant analytical techniques (e.g., HPLC, ELISA, SDS-PAGE, mass spectrometry).
- Proficiency in statistical analysis and Design of Experiments (DoE).
- Excellent problem-solving, critical thinking, and decision-making skills.
- Strong written and verbal communication skills, with the ability to present complex scientific information effectively.
- Ability to work independently and collaboratively in a fast-paced, multidisciplinary team environment.
- Experience with single-use technologies and continuous manufacturing is a plus.
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8
Principal Process Development Scientist
20001 Washington, District Of Columbia
$140000 Annually
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Posted 12 days ago
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Job Description
Our client, a leading innovator in specialty chemicals, is looking for a highly motivated and experienced Principal Process Development Scientist to lead critical research and development initiatives. This fully remote position allows you to work from anywhere in the US, focusing on designing and optimizing novel chemical processes that will define the next generation of our products. You will play a pivotal role in translating laboratory discoveries into scalable, efficient, and commercially viable manufacturing processes. This role requires a profound understanding of chemical engineering principles, reaction kinetics, separation technologies, and process safety.
Responsibilities:
Responsibilities:
- Lead the conceptualization, design, and execution of process development projects for new and existing chemical products.
- Develop and optimize reaction pathways, purification methods, and unit operations to improve yield, purity, and cost-effectiveness.
- Utilize advanced modeling and simulation tools to predict process behavior and identify optimization opportunities.
- Scale-up processes from laboratory bench to pilot plant and ultimately to commercial manufacturing, ensuring robustness and reproducibility.
- Conduct thorough process hazard analyses (PHAs) and implement appropriate safety measures.
- Collaborate closely with R&D chemists, engineers, and manufacturing teams to ensure seamless technology transfer.
- Author detailed technical reports, present findings to stakeholders, and contribute to intellectual property generation.
- Stay current with cutting-edge advancements in chemical engineering, process intensification, and sustainable chemistry.
- Mentor and guide junior scientists and engineers within the process development team.
- Contribute to the strategic roadmap for process innovation and development.
- Ph.D. in Chemical Engineering or a closely related field from an accredited institution.
- Minimum of 8-10 years of progressive experience in process development, scale-up, and optimization within the chemical or pharmaceutical industry.
- Demonstrated expertise in catalysis, reaction engineering, crystallization, distillation, or other relevant separation techniques.
- Proficiency with process simulation software (e.g., Aspen Plus, HYSYS) and statistical analysis tools (e.g., JMP, Minitab).
- Strong knowledge of process safety principles and experience conducting HAZOPs or similar analyses.
- Excellent analytical, problem-solving, and critical-thinking abilities.
- Exceptional written and verbal communication skills, with the ability to clearly articulate complex technical concepts.
- Proven ability to manage multiple projects simultaneously in a fast-paced, remote environment.
- Experience with continuous manufacturing processes is a strong advantage.
- A track record of successful process implementation and commercialization.
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