CrawlJobs Logo
Amgen Logo Amgen · IT - Administration

Process Development Principal Scientist

United States of America, Cambridge Employment contract 141836.95 - 191897.05 USD / Year · Job Posted July 02, 2026
Apply Position
Job Link Share

Job Description

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Job Responsibility

  • Lead all attribute and analytical aspects of a program in pivotal clinical process development while working cross-functionally within a Product development team
  • Define analytical control strategies and implement methodologies for development of late phase clinical programs including analytical method development and optimization
  • Lead method transfer and support cGMP manufacturing activities at internal manufacturing, and contract manufacturing and testing sites
  • Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities
  • Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
  • Provide expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development
  • Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department
  • Maintain current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities and apply this knowledge to the evaluation and development of new methodologies
  • Recognized as a scientific resource in area of expertise who can provide mentorship to junior staff

Requirements

  • Doctorate degree PhD OR PharmD OR MD and 3 years of experience
  • Master's degree and 6 years of Scientific experience
  • Bachelor's degree and 8 years of Scientific experience

Nice to have

  • PhD with 3+ plus years of industry experience
  • Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques with an emphasis toward separation science, Process Analytical Technologies (PAT) for process understanding and process control, structure elucidation and solid-state characterization
  • Knowledge of analytical method development and testing requirements toward solid oral dosage support (immediate and controlled release solid dosage forms, liquid formulation or lyophilized formulation), including dissolution method development
  • Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner
  • Hands on experience in development, validation, transfer and remediation of methods for in-process, release and stability testing
  • Knowledge of the major Pharmacopeia and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development
  • Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations
  • Ability to multitask managing deliverables on complex projects against timelines
  • Strong leadership, problem solving, decision making and communication skills with the ability to work cross-functionally and globally within CMC teams to deliver results
  • Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents

What we offer

  • 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
  • Award-winning time-off plans
  • Flexible work models where possible
Amgen - All Job Offers

Looking for more opportunities?

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

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Process Development Principal Scientist

8 matching positions

Process Development Principal Scientist

Location
Location
United States , Thousand Oaks
Salary
Salary:
148363.00 - 171657.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • PHD degree or (foreign equivalent) in analytical chemistry, chemistry, or related field & 3 years of experience in the job offered or in a process development-related occupation. Position requires 3 years of experience in the following: 1. Mass spectrometry knowledge in mechanism of different ionization techniques, configuration of mass spectrometry platforms by different vendors including Waters, Thermo Fisher, or Agilent, and gas-phase ion chemistry for structural elucidation
  • 2. Sample preparation including liquid-liquid extraction and solid phase microextraction for qualitative and quantitative analysis of both small molecules and large molecules
  • 3. Analytical techniques including FT-IR (Fourier-transform infrared spectroscopy), NMR (nuclear magnetic resonance), and UV (ultraviolet–visible spectroscopy)
  • 4. Chromatography and related separation techniques including RP-HPLC (reversed phase high-performance liquid chromatography) and GC (gas chromatography)
  • 5. High-throughput analysis in processing multidimensional mass spectrometry-based data and implementing statistical analysis and interpreting statistical results
  • and 6. Software applications including ChemDraw, Xcalibur, or ChemStation and programming language for data processing including Python or Matlab.
Job Responsibility
Job Responsibility
  • Lead analytical method development, validation and trouble-shooting for drug substances and drug products and in-process testing for synthetic small molecules and/or synthetic peptide testing and characterization
  • Define analytical control strategies and implement methodologies for development of late phase clinical programs
  • Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives
  • Lead and mentor a group of analysts in supporting process development
  • Provide career development guidance to the team members
  • Provide concise summary to cross-functional leadership for endorsement of key decisions
  • Oversee activities at contract manufacturing and testing sites
  • Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents
  • Address analytical and product quality inquiries from health authorities
  • Supervises direct reports
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 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 Applied Scientist and Principal Applied Scientist

The Core AI Speech Group brings together talents in the areas of signal processi...
Location
Location
United States , Redmond
Salary
Salary:
119800.00 USD / Year
https://www.microsoft.com/ Logo
Microsoft Corporation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree in Statistics, Econometrics, Computer Science, Electrical or Computer Engineering, or related field AND 4+ years related experience (e.g., statistics predictive analytics, research) OR Master's Degree in Statistics, Econometrics, Computer Science, Electrical or Computer Engineering, or related field AND 3+ years related experience (e.g., statistics, predictive analytics, research) OR Doctorate in Statistics, Econometrics, Computer Science, Electrical or Computer Engineering, or related field AND 1+ year(s) related experience (e.g., statistics, predictive analytics, research) OR equivalent experience
  • Ability to meet Microsoft, customer and/or government security screening requirements are required for this role. These requirements include but are not limited to the following specialized security screenings: Microsoft Cloud Background Check: This position will be required to pass the Microsoft Cloud background check upon hire/transfer and every two years thereafter
Job Responsibility
Job Responsibility
  • Developing novel speech algorithms to advance state-of-the-art speech technologies for real world user scenarios, especially in integrating speech with LLM for multimodal modeling
  • Helps address scalability problems by adjusting to stakeholder needs
  • Works with large-scale computing frameworks, data analysis systems, and modeling environments to improve models
  • Applies the model to real products, and then verifies effects through iterations
  • Experiments by putting multiple models in production and evaluating their performance. Continues to monitor how algorithm performs against expected behaviors and performance or accuracy guardrails
  • Fulltime
Read More
Arrow Right

Senior Applied Scientist and Principal Applied Scientist

Are you passionate about advancing Artificial Intelligence through innovative re...
Location
Location
United States , Redmond
Salary
Salary:
119800.00 - 234700.00 USD / Year
https://www.microsoft.com/ Logo
Microsoft Corporation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree in Statistics, Econometrics, Computer Science, Electrical or Computer Engineering, or related field AND 4+ years related experience (e.g., statistics predictive analytics, research)
  • OR Master's Degree in Statistics, Econometrics, Computer Science, Electrical or Computer Engineering, or related field AND 3+ years related experience
  • OR Doctorate in Statistics, Econometrics, Computer Science, Electrical or Computer Engineering, or related field AND 1+ year(s) related experience
  • OR equivalent experience
  • Ability to meet Microsoft, customer and/or government security screening requirements
  • Microsoft Cloud Background Check
  • Additional or Preferred Qualifications: Bachelor's Degree AND 6+ years related experience
  • OR Master's Degree AND 4+ years related experience
  • OR Doctorate AND 3+ years related experience
  • OR equivalent experience
Job Responsibility
Job Responsibility
  • Collaborate with AI researchers, engineers, and multidisciplinary teams within M365 Core to design, build, and deliver end-to-end machine learning solutions optimized for human-human and human-AI interactions across productivity and collaboration scenarios
  • Lead and contribute to research and development initiatives in language model training, evaluation, and quality assessment with a specific focus on advancing the foundational capabilities and enterprise solutions of M365 Core
  • Design, develop, and refine robust ML pipelines, including data cleaning, feature engineering, model training, evaluation, deployment, and optimization
  • Adapt, extend or enhance the capability of large language models (LLMs) using a combination of supervised finetuning, reinforcement learning, and apply advanced techniques such as chain of thought prompting, agent orchestration, and synthetic data generation to meet evolving business needs
  • Remain current with the latest advancements in ML, AI, digital signal processing, and responsible AI practices, contributing to intellectual property portfolios through publications, patents, and libraries
  • Develop and deploy live production systems as part of integrated product teams, supporting all phases of the product cycle from ideation to shipping, post-launch optimization, and ongoing improvements
  • Champion ethics, fairness, and privacy in AI system development, contributing to policy creation and ensuring responsible research and data collection practices
  • Document work in progress, experimentation results, and share findings to promote a culture of innovation and transparency
  • Mentor and develop early-in-career team members, establish best practices, and collaborate with academic communities to build a robust recruiting pipeline for research talent
  • Present research findings at conferences and industry events, shaping the dialogue around AI-powered solutions for enterprise and communication platforms
  • Fulltime
Read More
Arrow Right

Principal Scientist: PKDM-BA (Small molecule bioanalysis group lead)

At Amgen, our shared mission—to serve patients—drives all that we do. It is key ...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
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 and xx years of directly related experience
  • Master’s degree and xx years of directly related experience
  • Bachelor’s degree and xx years of directly related experience
Job Responsibility
Job Responsibility
  • Lead and mentor a team of scientists in the design, execution, and interpretation of bioanalytical studies
  • Develop, validate, and implement bioanalytical methods for quantitative measurement of drug candidates, metabolites, and biomarkers in biological matrices
  • Perform and supervise quantitative bioanalysis using LC-MS/MS and other advanced analytical platforms
  • Handle and process complex biological matrices (e.g., plasma, tissue homogenates, urine, bile) with robust extraction procedures to ensure accurate and reproducible results
  • Apply sound knowledge of extraction techniques (e.g., protein precipitation, liquid-liquid extraction, solid-phase extraction) to optimize bioanalytical workflows
  • Ensure compliance with regulatory guidelines and maintain high-quality documentation
  • Collaborate with PKDM project team representatives and BA scientists located at our US sites and ensure integration of bioanalytical data into project decision-making
  • Ensure data quality, integrity, reproducibility, and timely delivery of results while maintaining safety standards across all workflows
  • Mentor and develop team members, promoting a culture of scientific rigor and innovation
  • Contribute to strategic planning and allocation of bioanalytical resources
  • Fulltime
Read More
Arrow Right

Principal Scientist, Microbiologist

Provides microbiology/sterility assurance support to the R&D Sterile Manufacturi...
Location
Location
United States , King of Prussia; Upper Merion; Marietta
Salary
Salary:
Not provided
us.gsk.com Logo
GSK
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS (+5 years), MS (+3 years), PhD (+0 years) in Microbiology or a related field
  • Three or more year performing environmental monitoring to support non-sterile and sterile areas and operations personnel
  • Three or more years of experience performing routine bioburden testing on raw materials and finished product, e.g., microbial enumeration, sterility testing, selected species testing
  • Three or more years of experience performing bacterial endotoxin testing on pharmaceutical water system samples, raw materials and finished products
Job Responsibility
Job Responsibility
  • Oversee and develop improvements in training for sterility assurance of operators (aseptic practices, gowning, gloving)
  • Establish and maintain partnership interfaces with intra- and inter-departmental contacts (Manufacturing, Analytical Workstream Leads, Quality), Global Supply Chain, and Third parties to convey sterility assurance aspects of manufacturing
  • Recognize, communicate and lead investigation of aberrant microbiological test results or trends
  • Author microbiological methods and SOPs regarding sterility assurance
  • Author validation protocols and implement validation on instrumentation and test methodology
  • Investigate new technology in microbiological testing in line with GSK Microbiology Modernization initiatives
  • Actively prepare and support internal quality and external regulatory inspections
  • Perform, when appropriate, additional Quality Control activities, including: Environmental monitoring to support non-sterile and sterile areas and operations personnel
  • Routine bioburden testing on raw materials and finished product, e.g., microbial enumeration, sterility testing, selected species testing
  • Bacterial endotoxin testing on pharmaceutical water system samples, raw materials and finished products
What we offer
What we offer
  • Competitive base salary
  • Annual bonus based on company performance
  • Flexible working options available for most roles
  • Learning and career development
  • Access to healthcare & wellbeing programmes
  • Employee recognition programmes
  • Fulltime
Read More
Arrow Right

Associate Principal Scientist - Formulation (Complex Meds)

Exciting Opportunity: Associate Principal Scientist - Formulation - Complex Meds...
Location
Location
United Kingdom , Cheadle
Salary
Salary:
Not provided
srgtalent.com Logo
SRG
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • PhD with 3+ years' of recent experience or a Bachelor's degree with 6+ years' recent experience in formulation development
  • Expertise in oral and parenteral formulation development, including modified-release, nano-particulate, or liposomal systems - Specifically Complex Drug Products
  • Strong knowledge of material properties, drug delivery systems, and global CMC regulatory requirements
  • Recent experience progressing complex drug products from discovery through to launch
  • Recent formulation experience with Peptides, Proteins, Lipids is essential
  • A valid UK driving licence
Job Responsibility
Job Responsibility
  • Leading formulation and process design for oral and parenteral drug products across clinical phases in the Complex Meds space
  • Applying scientific and pragmatic thinking to deliver innovative product and technology solutions
  • Providing hands-on troubleshooting and laboratory support when needed
  • Collaborating with analytical scientists to ensure robust testing of formulations
  • Acting as project leader for pharmaceutical development programmes
  • Managing CRO activities and client communications
  • Supporting regulatory strategy and authoring CMC documentation
  • Introducing new formulation technologies and contributing to continuous improvement
  • Coaching and mentoring junior staff and contributing to team development
  • Representing the company at conferences and industry events
  • Fulltime
Read More
Arrow Right

Principal Scientist PKPD

CK Group are recruiting for a Principal Scientist PKPD to join a global pharmace...
Location
Location
United Kingdom , Slough
Salary
Salary:
35.20 - 47.92 GBP / Hour
ckgroup.co.uk Logo
CK Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience working in a matrix environment, to help design and set non-clinical PKPD study protocols, and analyze, interpret, and report PKPD results including GLP toxicokinetics studies
  • PhD/MSc/BSc relevant discipline (quantitative pharmacology
  • pharmacokinetics /pharmacodynamics
  • DMPK, etc.) with more than 5 years hands on experience in PKPD data analysis within a pharma company or CRO environment
  • Good understanding of pharmacology and pharmacologic processes related to disease and drug mechanisms
  • Hands-on experience in delivering high quality pre-clinical PKPD data analysis
  • Proficiency in the use of Phoenix- WinNonlin for PKPD analysis is essential
  • Good written and verbal communication skills, and ability to communicate study results and produce high standard reports that meet regulatory submission standards
  • It is essential that applicants hold entitlement to work in the UK
Job Responsibility
Job Responsibility
  • Participate in the development of non-clinical PKPD and GLP toxicokinetics studies
  • Lead the non-clinical PKPD strategy
  • Participate in protocol designs and writing by providing scientific support and input into regulatory study designs and protocols
  • Work collaboratively with the project teams representatives (e.g. Non-Clinical Safety, Bioanalysis, Clinical Pharmacology) and with the CROs, to ensure high quality data is generated
  • Deliver PKPD study reports and integrated summaries of the studies and participate in regulatory submission documents
  • Facilitate the advancement of drug candidates by building a thorough knowledge of the drug pharmacology and PKPD
  • Fulltime
Read More
Arrow Right