Process Development Principal Scientist Job at Amgen (Thousand Oaks)

Senior Principal Scientist: Process Chemistry

Lead the chemistry behind tomorrow's medicines by driving world‑class drug subst...

Location

United States , Palo Alto

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

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

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

Senior Applied Scientist and Principal Applied Scientist

Are you passionate about advancing Artificial Intelligence through innovative re...

Location

United States , Redmond

Salary:

119800.00 - 234700.00 USD / Year

Microsoft Corporation

Expiration Date

Until further notice

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

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

New

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

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

Principal Scientist, Microbiologist

Provides microbiology/sterility assurance support to the R&D Sterile Manufacturi...

Location

United States , King of Prussia; Upper Merion; Marietta

Salary:

Not provided

GSK

Expiration Date

Until further notice

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

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

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

Associate Principal Scientist - Formulation (Complex Meds)

Exciting Opportunity: Associate Principal Scientist - Formulation - Complex Meds...

Location

United Kingdom , Cheadle

Salary:

Not provided

SRG

Expiration Date

Until further notice

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

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

Principal Scientist PKPD

CK Group are recruiting for a Principal Scientist PKPD to join a global pharmace...

Location

United Kingdom , Slough

Salary:

35.20 - 47.92 GBP / Hour

CK Group

Expiration Date

Until further notice

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

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

Principal Scientist

Join Enveda as an Principal Scientist, Medicinal Chemistry in Hyderabad, India, ...

Location

India , Hyderabad

Salary:

Not provided

Enveda

Expiration Date

Until further notice

Requirements

PhD in Organic Chemistry or Medicinal Chemistry
10–15 years of experience in medicinal chemistry or preclinical discovery (CRO/IDD setting preferred)
Strong expertise in synthetic organic chemistry, rational drug design, and SAR analysis
Demonstrated ability to evaluate novelty, make sound decisions, and deliver innovative solutions
Proven leadership experience managing a team of chemists
Excellent oral and written communication, presentation, and collaboration skills
Integrity, high ethical standards, and a passion for teamwork

Job Responsibility

Lead the design and synthesis of molecules for SAR development, analyze data, and decide next steps
Execute and oversee multi-step reactions, compound characterization, and synthetic route optimization
Apply medicinal chemistry principles to design structural modifications, improve properties, and address IP considerations
Coordinate with cross-functional teams and contribute innovative ideas to research projects
Mentor and manage a team of 5–10 chemists, driving productivity and scientific excellence
Maintain compliance with Enveda’s SOPs, notebook standards, and IP protection processes
Present progress and outcomes in team meetings

What we offer

Culture
Medical
Block Leaves
Work-Life Harmony

Fulltime

Principal Scientist – Synthetic Separations

Amgen is seeking a highly motivated Senior Principal Scientist for their Discove...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Ph.D. in Chemistry, Analytical Chemistry, or related field with 8+ years of relevant experience, or M.S. with 12+ years of relevant experience in analytical or discovery chemistry within the biopharmaceutical industry
PhD in Analytical Chemistry or a related discipline with 8+ years of relevant industry experience in chromatographic analysis and/or purification of small molecules within a pharmaceutical R&D environment
Minimum of 5 years in a leadership or people management role
Develop, optimize, and implement analytical methods (LC, LC/MS, GC, SFC, NMR, HRMS, and related techniques) for purity assessment, structural confirmation, quantitative analysis, and reaction monitoring of synthetic compounds
Develop, optimize, and implement analytical methods (LC, LC/MS, GC, SFC, NMR, etc.) for purity assessment, structural confirmation, and reaction monitoring of synthetic compounds
Design, qualify, and maintain high-throughput or automated analytical workflows to support medicinal chemistry cycles
Collaborate with cross-functionally digital and automation groups to enable data-driven analytics and AI-supported structure prediction
Drive continuous improvement in analytical workflows and laboratory efficiency through process automation and robotics
Excellent written and verbal communication skills
Prepare concise, high-quality reports and presentations for internal review and external disclosure

Job Responsibility

Lead analytical strategy and execution for drug discovery-stage projects, enabling medicinal chemistry and early candidate selection through deep expertise in analytical and separation sciences
Bridge synthetic and analytical chemistry, ensuring rapid, reliable characterization of novel compounds and intermediates that drive Amgen’s small molecule discovery pipeline
Lead and manage the Synthetic Separations group, providing strategic direction, technical leadership, and mentorship to staff while prioritizing workloads, optimizing team performance, and serving as both a people manager and subject matter expert in synthetic separations
Design and qualify automated workflows enabling rapid turnaround and consistent data quality for purification and analysis of diverse compound libraries
Utilization of a diverse set of instruments and technologies, such as (but not limited to) HPLC, SFC, MS, mass-directed purification, and preparative-scale SFC and LC is necessary
Lead library purification efforts across multiple scales, ranging from microgram-level purification of screening compounds to hundreds of milligrams for advanced characterization
Assist in research efforts directed at improving process efficiencies, expanding the range of assays and applications, building state-of-the-art analytical capabilities, and improving technologies and infrastructure

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Process Development Principal Scientist

Job Responsibility

Requirements

What we offer

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