CrawlJobs Logo

Process Development Senior Scientist

United States, Cambridge 139595.00 - 170664.00 USD / Year · Job Posted February 04, 2026
Apply Position
Job Link Share

Job Description

Join Amgen’s Mission of Serving Patients. In this vital role you will design and analyze clinical trials, using statistical methods to support drug development and regulatory submissions.

Job Responsibility

  • Design and analyze clinical trials, using statistical methods to support drug development and regulatory submissions
  • Provide statistical contributions, statistical review, and quality control of Key Design Elements, protocols, randomization specifications, Statistical Analysis Plans, Table, Listing and Graph shells, Submission Data File specifications, other key study related documentation, protocol deviations, Flash Memos, Clinical Study Reports, clinical publications, and other communications
  • Completing statistical analysis of individual studies/projects
  • Publish applied research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
  • Being familiar with statistical policy and strategies
  • Stay abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field
  • Communicate the role of the Global Biostatistics department, and contribute to statistical training within Global Biostatistics
  • Assist in the review of Amgen Policies, SOPs, and other controlled documents
  • Assist with study and systems audits conducted by Amgen internally and external bodies
  • Use SAS and R to produce comprehensive tables and graphs to collect any summarize outcomes.

Requirements

  • Master’s degree or foreign equivalent in Statistics, Biostatistics or related field & completion of a university-level course, research project, internship, thesis, or one year of experience in the job offered or experience in any occupation in which the required experience was gained: Designing experiments or clinical trials to meet project requirements, regulatory standards, or scientific objectives, including development of protocols and Statistical Analysis Plans (SAPs)
  • Utilizing SAS, R or other statistical software to analyze clinical study data or observational study data
  • Assessing, implementing or developing new statistical methods to improve efficiency and validity of clinical trials
  • Utilizing R or other statistical software to perform simulations to evaluate operating characteristics of analytic methods or design options
  • Utilizing programming software to develop tools to evaluate methods or statistical designs including creation of software packages or interactive tools
  • Performing causal inference analyses on clinical trial or observational datasets to address potential biases and confounding factors
  • Employ trial design strategies to mitigate challenges such as high dropout, skewed distributions, missing data, and confounding, including the use of robust regression and imputation.

What we offer

  • Stock
  • Retirement
  • Medical
  • Life and disability insurance
  • Eligibility for an annual bonus
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models, including remote and hybrid work arrangements, where possible

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Process Development Senior Scientist

8 matching positions

Process Development Senior Scientist

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...
Location
Location
United States , Cambridge
Salary
Salary:
123777.00 - 167463.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree PhD OR PharmD OR MD and relevant post-doc where applicable completed by August 2026
  • OR Master's degree and 3 years of Scientific experience
  • OR Bachelor's degree and 5 years of Scientific experience
Job Responsibility
Job Responsibility
  • Design and develop synthetic routes and scalable chemical processes for the manufacture of synthetic and hybrid drug substances
  • Develop safe, robust, efficient, and cost-effective manufacturing processes suitable for clinical and commercial production
  • Advance enabling technologies that accelerate pharmaceutical development and improve sustainability, efficiency, and process robustness
  • Support cGMP manufacturing activities and assist with technology transfer efforts to internal manufacturing sites and external contract manufacturing organizations (CMOs)
  • Build process understanding through experimentation, process characterization, modeling, and data analysis to ensure consistent process performance
  • Contribute to cross-functional drug substance development teams by providing technical expertise, experimental data, scientific recommendations, and clear documentation
  • Collaborate across disciplines to support regulatory filings and author technical sections of regulatory documentation
  • Stay current with advances in synthetic organic chemistry, process chemistry, and related technologies, and apply new scientific insights to ongoing programs
  • Effectively collaborate within multidisciplinary teams that include chemists, engineers, analytical scientists, and other technical experts
  • Independently manage project activities and deliver high-quality results within established timelines
What we offer
What we offer
  • Health and welfare plans for staff and eligible dependents
  • Financial plans with opportunities to save towards retirement or other goals
  • Work/life balance
  • Career development opportunities
  • Retirement and Savings Plan with generous company contributions
  • Group medical, dental and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Fulltime
Read More
Arrow Right

Process Development Senior Scientist - Drug Product Technologies

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...
Location
Location
United States , Thousand Oaks
Salary
Salary:
126066.05 - 170559.95 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
  • OR Master’s degree and 3 years of Scientific experience
  • OR Bachelor’s degree and 5 years of Scientific experience
Job Responsibility
Job Responsibility
  • Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership
  • Plan and execute formulation and fill/finish process studies for early-stage programs
  • Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab-scale sterile filling
  • Build process understanding across unit operations to support scalable drug product development
  • Evaluate in-use compatibility and drug product stability under clinical conditions
  • Investigate ADC- and biologics-relevant CQAs (e.g., aggregation, fragmentation, drug-to-antibody ratio, free payload, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions
  • Leverage high-throughput tools for formulation screening and processability assessments
  • Identify and address technology gaps impacting ADC stability, linker-payload integrity, protein-excipient interactions, and process-related stress responses
  • Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making
  • Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Process Development Senior Scientist - Synthetic Peptides, Oligonucleotides, ADCs

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...
Location
Location
United States , Thousand Oaks
Salary
Salary:
126066.05 - 170559.95 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
  • OR Master’s degree and 3 years of Scientific experience
  • OR Bachelor’s degree and 5 years of Scientific experience
Job Responsibility
Job Responsibility
  • Work effectively with a diverse team of synthetic chemists, chemical engineers and analytical chemists to invent synthetic routes and develop safe, robust, sustainable and cost-effective processes for antibody drug conjugate, peptide antibody conjugates, synthetic peptides and/or oligonucleotide manufacturing
  • Drive technology innovation in the synthesis, purification, and characterization of bioconjugates, oligonucleotides, and/or synthetic peptides
  • Support cGMP manufacturing and technology transfer to our internal manufacturing facilities and external contract manufacturers
  • Advance enabling technologies to accelerate pharmaceutical development and to improve sustainability and process efficiency
  • Ensure process performance through process understanding, modeling and characterization
  • Contribute to drug substance development teams by providing experimental results, technical updates, documentation, data interpretation, recommendations, etc
  • Work cross-functionally to deliver regulatory documents and support regulatory filings
  • Serve as a technical expert and keep current in the field of bioconjugation, antibody drug conjugate, oligonucleotide, peptide, and process chemistry and manufacturing
  • Work independently in advancing projects and studies within required deadlines
What we offer
What we offer
  • Health and welfare plans for staff and eligible dependents
  • Financial plans with opportunities to save towards retirement or other goals
  • Work/life balance
  • Career development opportunities
  • Retirement and Savings Plan with generous company contributions
  • Group medical, dental and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Fulltime
Read More
Arrow Right

Process Development Senior Associate

At Amgen, if you feel like you’re part of something bigger, it’s because you are...
Location
Location
United States , Cambridge
Salary
Salary:
85306.00 - 103484.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree or (foreign equivalent) in Chemical Engineering, Bioengineering, Analytical Chemistry, Biochemistry or a related field & completion of a university-level course, research project, internship, thesis, or one year of experience in the following: 1. Analytical chemistry experience for small molecules, and completion of project deliverables including: designing and conducting targeted metabolomics experiments, extracting and analyzing results via dedicated software: ChemStation, MassHunter, or MassAnalyzer
  • 2. Analytical method development (chromatography and mass spectrometry), related technologies and instrumentation including: U/HPLC, GC, or LC-MS
  • 3. Method qualification and transfer for analytical instruments, along with data analysis and statistical evaluation of experimental results
  • 4. Application analytical instrument troubleshooting across different platforms: Waters, Agilent, or Sciex, and problem solving of such technologies
  • 5. Implementing Standard Operating Procedures in a laboratory environment in accordance with GLP standards
  • and 6. Maintaining a laboratory notebook.
Job Responsibility
Job Responsibility
  • Conduct experiments, analyze results, and implement process improvements to enhance efficiency and product quality
  • Design, develop, and optimize manufacturing processes
  • Collaborate closely with a team of analysts and scientists
  • Responsible for the technical aspects of developing analytical tools to gain understanding of quality attributes in product and process for late phase synthetic small molecule, synthetic peptide, and siRNA programs
  • Utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application
  • Develop, optimize, and execute analytical methods for synthetic small molecules, synthetic peptide, and SiRNA release testing and process characterization
  • Collaborate closely with drug substance process development team to achieve project objectives and provide analytical data to support drug substance product development.
What we offer
What we offer
  • stock
  • retirement
  • medical
  • life and disability insurance
  • eligibility for an annual bonus
  • Retirement and Savings Plan with generous company contributions
  • group medical, dental and vision coverage
  • life and disability insurance
  • flexible spending accounts
  • discretionary annual bonus program
  • Fulltime
Read More
Arrow Right

Senior Scientist- Process Chemistry

10x is looking for an outstanding Senior Scientist to join the Process Developme...
Location
Location
United States , Pleasanton
Salary
Salary:
158400.00 - 214400.00 USD / Year
10xgenomics.com Logo
10x Genomics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Ph.D. in Chemical Engineering, Organic Chemistry, Polymer Chemistry, Surface Chemistry, and 4+ years of industry experience
  • Ability to integrate a broad range of scientific and engineering disciplines
  • Ability to design meaningful experiments and in-depth analysis of results
  • Experience using statistical tools for process control
  • Good documentation skills and ability to communicate experimental design, results and plans through presentations and reports
  • Understanding of physical chemical principles to scale up chemical manufacturing processes
  • Ability to develop, validate and transfer processes to manufacturing or OEM vendors
  • Strong collaboration and communication skills
  • Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
Job Responsibility
Job Responsibility
  • Act as a technical lead to develop, optimize and support a broad range of chemistry-based production processes through use of custom equipment, optical imaging, and analytical testing
  • Develop a deep understanding of the interplay between chemistry, microfluidics, production processes, and molecular biology to identify the root cause of product deviations, troubleshoot them, and identify and implement solutions
  • Plan and execute experiments, maintain an accurate record of experimental details, in-depth data analysis, and clear communication of these results through documentation and presentations
  • Write protocols, develop procedures, and maintain accurate records
  • Communicate and present results clearly and contribute data for making critical design decisions
  • Job may require 10% international travel
What we offer
What we offer
  • Equity grants
  • Comprehensive health and retirement benefit programs
  • Annual bonus program or sales incentive program
  • Competitive and comprehensive health benefits package
  • Easy-to-use benefits that promote wellbeing
  • Family friendly policies like parental leave
  • Generous time off
  • Fulltime
Read More
Arrow Right

Senior Principal Scientist: Process Chemistry

Lead the chemistry behind tomorrow's medicines by driving world‑class drug subst...
Location
Location
United States , Palo Alto
Salary
Salary:
Not provided
proclinical.com Logo
Proclinical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Ph.D. in Organic Chemistry with 8+ years of relevant industry experience in process chemistry
  • Strong expertise in synthetic chemistry, scale-up, and cGMP manufacturing
  • Working knowledge of QbD principles, PAT, risk management, and regulatory expectations
  • Proven experience managing CDMOs and CROs
  • Demonstrated ability to operate independently and influence cross-functional teams in a fast-paced development environment
  • Excellent problem-solving, communication, and project management skills
  • Up to ~20% travel, primarily to CDMO sites
Job Responsibility
Job Responsibility
  • Serve as the technical point of accountability for drug substance programs, ensuring alignment across CMC, Quality, Regulatory, and external partners
  • Lead route selection, process development, optimization, and impurity control strategies
  • Lead and manage CDMOs from proposal evaluation and selection through GMP manufacturing, release, and delivery
  • Characterize drug substance properties and support form selection activities
  • Review and approve batch records and oversee external manufacturing quality and compliance
  • Troubleshoot process issues and drive continuous improvement initiatives with internal and external teams
  • Prepare comprehensive tech transfer packages and support analytical method development
  • Guide chemical development strategy from early-stage programs through commercialization
  • Author and review technical sections for IND, IMPD, and other global regulatory submissions
  • Partner with Project Management and Finance to support cost, timeline, and risk management for drug substance programs
Read More
Arrow Right

Senior Scientist, Diagnostic Assay Development

10x Genomics is establishing a diagnostics effort to translate our leading singl...
Location
Location
United States , Pleasanton
Salary
Salary:
158400.00 - 214400.00 USD / Year
10xgenomics.com Logo
10x Genomics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Ph.D. in Molecular Biology, Genetics, Biochemistry, or a related field, or M.S. with equivalent industry experience
  • 3+ years (Ph.D.), 5+ years (M.S.) of hands-on industry experience in molecular diagnostics or genomics assay development
  • Extensive, direct hands-on experience with 10x Genomics single-cell and/or spatial technologies, including troubleshooting and optimization
  • Demonstrated ability to independently adapt and refine published molecular biology protocols
  • Strong background in NGS workflows, including nucleic acid extraction, PCR/qPCR, and library preparation
  • Experience working with complex or low-input clinical samples (e.g., FFPE tissue, primary tumor material)
  • Experience with cell culture methods
Job Responsibility
Job Responsibility
  • Assay Development & Execution: Independently execute complex single-cell and spatial genomics workflows
  • Serve as a hands-on technical expert for 10x Genomics platforms
  • Systematically troubleshoot and optimize assay workflows
  • Adapt, refine, and extend published protocols
  • Design and execute feasibility studies
  • Process diverse and challenging clinical sample types
  • Analytical Validation & Documentation: Design and execute experiments supporting analytical validation
  • Generate, review, and maintain high-quality laboratory documentation
  • Analyze assay performance metrics and quality control data
  • Clearly present experimental data and scientific conclusions
What we offer
What we offer
  • Equity grants
  • Comprehensive health and retirement benefit programs
  • Annual bonus program or sales incentive program
  • Generous time off
  • Competitive and comprehensive health benefits package
  • Family friendly policies like parental leave
  • Fulltime
Read More
Arrow Right

Scientist / Senior Scientist, Multimodal AI

Altos Labs is building a world-class AI ecosystem to solve the most complex prob...
Location
Location
United States , San Francisco Bay Area, CA; San Diego, CA
Salary
Salary:
188600.00 - 330000.00 USD / Year
altoslabs.com Logo
Altos Labs
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • PhD in Computer Science, AI/ML, Biomedical Engineering, or a related quantitative field
  • Deep experience building and deploying modern Computer Vision architectures (Vision Transformers, U-Nets, Self-Supervised Learning)
  • Proven experience training and fine-tuning large models at scale using frameworks like PyTorch Distributed, DeepSpeed, or Jax
  • Expert-level Python skills, with a focus on building production-ready machine learning code and large-scale data management systems
  • A track record of technical contributions via high-impact publications (CVPR, ICCV, NeurIPS, etc.) or significant contributions to open-source ML frameworks
Job Responsibility
Job Responsibility
  • Model Development: Design, code, and train large-scale foundation models (e.g., Vision Transformers, Multimodal LLMs) that can embed spatial data and integrate multiple modalities
  • Hands-on Data Fusion: Implement innovative cross-domain mapping and fusion strategies to synchronize heterogeneous biological datasets
  • Scaling & Training: Build and manage high-performance ML pipelines capable of processing petabyte-scale image repositories and multi-omics streams in a cloud environment
  • Technical Collaboration: Work directly in the trenches with experimental scientists and software engineers to translate biological complexity into performant code and reliable distributed systems
  • Fulltime
Read More
Arrow Right