Senior Scientist, Analytical Development and Quality Control Job at Kailera Therapeutics (Waltham)

Senior Scientist I, Quality Control

This position is within the Quality Control structure, under the Quality Organiz...

Location

United States , Verona

Salary:

90000.00 - 108000.00 USD / Year

Arrowhead Pharmaceuticals, Inc

Expiration Date

Until further notice

Requirements

M.S. in Chemistry (or related field) with 7+ years relevant laboratory experience
B.S. in Chemistry (or related field) with 9+ years of relevant laboratory experience
Fully knowledgeable of cGMP and ICH laboratory requirements and operations
Proficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practices

Job Responsibility

Fully knowledgeable of cGMP requirements and ICH guidelines
Works independently to meet project timelines and deliverables with minimal supervision to no supervision
Collaborates routinely with Analytical Development on procedural method transfers and may participate in the execution of method validation protocols
Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and stability samples using established test methods and procedures
Proficient with various analytical instrumentation theory and practice
Executes training requirements for assigned SOPs and participates in department specific training modules
Independently completes complex instrumentation for testing according to written test methods and procedural documents to analyze samples
Demonstrates proficiency with a variety of instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, Endotoxin plate readers, and/or Raman spectroscopy) and will assist in training on instrumentation
Is a subject matter expert in technical aspects of both instrumentation and workflow management and prioritization
Performs analyses in a timely and efficient manner to support ongoing prioritized studies

What we offer

competitive salaries and an excellent benefit package

Fulltime

Process Development Senior Scientist

Join Amgen’s Mission of Serving Patients. In this vital role you will design and...

Location

United States , Cambridge

Salary:

139595.00 - 170664.00 USD / Year

Amgen

Expiration Date

Until further notice

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.

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.

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

Fulltime

Senior Scientist, Diagnostic Assay Development

10x Genomics is establishing a diagnostics effort to translate our leading singl...

Location

United States , Pleasanton

Salary:

158400.00 - 214400.00 USD / Year

10x Genomics

Expiration Date

Until further notice

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

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

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

Senior Scientist, Reagents Sustaining and Applications

We are seeking a Senior Scientist to join the Reagent Sustaining and Application...

Location

United States , Pleasanton

Salary:

158400.00 - 214400.00 USD / Year

10x Genomics

Expiration Date

Until further notice

Requirements

BS, MS or PhD in molecular biology, biochemistry, genetics, microbiology, analytical chemistry, or related fields
12+ years (BS), 10+ years (MS) or 5+ years (PhD) of relevant experience in reagent or assay development and optimization, preferably in the Biotechnology industry
Experience analyzing large-scale single-cell or spatial transcriptomics datasets to derive biologically meaningful insights and/or diagnostic biomarkers
Ability to design and execute experiments to measure the impact of process improvements and/or formulation changes
Experience with a broad variety of molecular biology and analytical techniques including qPCR, nucleic acid isolation, use of plate readers, Bioanalyzers, gel imagers, real-time PCR instruments, etc.
Experience with single cell assays including cell handling, library preparation and downstream analysis
Experience investigating, identifying, documenting, communicating, and resolving quality control issues in a controlled manufacturing environment
Experience defining, documenting, communicating, and transferring new manufacturing workflows into controlled manufacturing environments
Meticulous attention to detail and a conscientious work ethic

Job Responsibility

Lead efforts in testing new materials, tools, and workflows to improve 10x’s state-of-the-art products
Collaborate with key internal and external partners to troubleshoot and mitigate any issues that may arise in 10x’s Chromium product line
Design and execute experiments to assess the impact of protocol, reagent, or process changes on 10x’s Assays
Design, test, and implement process improvements in 10x’s Chromium product line
Perform statistical analyses on key assay and QC metrics
Update manufacturing documents and present results

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

Senior Scientist, LNP Sciences

Beam is seeking a scientist with expertise in formulation and ligand conjugation...

Location

United States , Cambridge

Salary:

145000.00 - 180000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Bioengineering or related field with drug product and CMC development experience (PhD 4+ years or MS 12+ years)
Deep understanding of sterile product development
Prior industry research experience, especially in nucleic acids and drug delivery, is required
Experience with development of antibody-drug conjugates and/or biologics is preferred
Knowledge of statistical techniques and concepts (regression, properties of distributions, statistical tests, and proper usage, etc.)
Ability to adapt to increasing scope and complexity of work brought on by growth/change and help others manage through change
Excellent computational, written, and verbal communication skills, strong organizational abilities, and an ability to work with a diverse group of scientists and engineers
Ability to work in a hybrid environment with sufficient on-site presence

Job Responsibility

Responsible for formulation design, development, characterization, and technology transfer to enable development of Beam sterile drug products
Accountable as an individual contributor to support formulation development as well as providing necessary guidance and support of drug product control strategy for drug candidates across all stages of development
Independently design, execute, analyze, and document experiments to optimize LNP potency, tolerability, biodistribution, and ligand conjugation
Design and execute experiments to enable a robust and reproducible process for manufacture of ligand conjugated LNPs at-scale
Interface closely with Analytical Development and Biotherapeutics teams to characterize different unit operations for the manufacturing of DP to understand process robustness
Provide support with tech transfer activities for manufacturing of drug products
Generate high quality documentation as per Beam SOPs and in support of regulatory filings
Communicate scientifically rigorous findings via verbal and written communications, and presentations both internally and externally

Fulltime

Senior Data Scientist, AI & Model Risk

It all started with an idea at Block in 2013. Initially built to take the pain o...

Location

United States , Bay Area

Salary:

139000.00 - 225000.00 USD / Year

Cash App

Expiration Date

Until further notice

Requirements

A minimum of 5 years of related experience with a Bachelor’s degree in a quantitative field
or 3 years and a Master’s degree
or a PhD without experience
or equivalent work experience in risk management, model risk management, or AI risk management
Proficiency in Python or similar languages for evaluating AI system behavior, writing test scripts, or analyzing model outputs
Strong understanding of generative AI architectures
Including LLMs, transformer models, RAG systems, and agentic AI, plus hands-on experience interacting with and critically evaluating these systems, sufficient to assess design decisions, output quality, and limitations
Understanding of interagency model risk management principles, including SR 26-2
Knowledge of AI testing methodologies, ex. functional testing, bias testing, adversarial testing, and performance monitoring plus familiarity with data privacy and security principles (encryption, access controls, data classification)
Excellent written and verbal communication and the ability to translate complex technical AI concepts for non-technical stakeholders, senior management, and regulators

Job Responsibility

Lead end-to-end AI Risk Assessments for generative AI and LLM use cases across the Bank
Embedding in Block's enterprise-wide GenAI review process, coordinating cross-functional SMEs (Legal, Compliance, InfoSec, Data Governance, MRM, ERM, BRC, TPRM, Financial Crimes), and managing timelines to ensure reviews are completed within SLA
Review AI system design and documentation
Including retrieval sources, assumptions, limitations, fallback plans, guardrail configurations, and change management procedures — across banking use cases such as fraud detection, BSA/AML compliance, credit decisioning, and customer-facing applications, ensuring governance controls are commensurate with each use case's risk profile
Assess pre-deployment testing for adequacy inclusive of output integrity, hallucination detection, boundary and edge case testing, ethical and safety guardrails, bias testing, A/B testing, volume testing, and UAT — designing and conducting independent testing as needed
Evaluate ongoing monitoring plans for comprehensiveness - including accuracy, hallucination rates, drift detection, sensitive data controls, reliability metrics, CSAT, acceptable performance ranges, and documented remediation procedures
Develop and maintain templates, tools, and procedures to support the effectiveness and scalability of the AI Risk Governance Program
Monitor the evolving regulatory landscape for AI in banking — including FFIEC IT Examination Handbook standards, FDIC Financial Institution Letters, interagency statements, and the anticipated RFI on AI model risk management referenced in SR 26-2 — and incorporate emerging guidance into the AI risk governance program
support SFS's response to regulatory inquiries as needed

What we offer

Remote work
medical insurance
flexible time off
retirement savings plans
modern family planning

Fulltime

Senior Applied Scientist - Computer Vision for Quantum

Join Microsoft Quantum to help build the foundation for scalable quantum computi...

Location

Denmark , Copenhagen

Salary:

715600.00 - 1201100.00 DKK / Year

Microsoft Corporation

Expiration Date

Until further notice

Requirements

Master's or Doctorate degree in Computer Science, Physics, Electrical Engineering, Applied Mathematics, Statistics, Data Science, or a related field OR equivalent experience
Programming experience in Python, including scientific computing and development of production-quality code (testing, packaging, version control, and code review)
Experience with image processing, computer vision, or imaging-based analysis workflows
Demonstrated expertise in statistical analysis and uncertainty estimation in measurement or experimental systems

Job Responsibility

Develop and maintain scalable analysis pipelines and agentic workflows for experimental microscopy imaging and characterization data, enabling consistent and reliable interpretation of the data
Design and implement algorithms for image analysis, registration, feature extraction, and quantitative metrics, ensuring robustness, correctness, and reproducibility in production environments
Build and operationalize machine learning and AI models for feature extraction, classification, regression, or anomaly detection, ensuring interpretability, validation, and long-term reliability
Partner with physicists, hardware engineers, materials scientists, and data engineering teams to translate experimental data into actionable insights that improve product quality and yield
Design and maintain clear, interpretable data models and datasets, including handling of missing, invalid, and unprocessed data states to ensure reproducibility
Own the quality, reliability, and documentation of analytical workflows, including debugging, testing, performance tuning, and continuous improvement of production systems
Embody our culture and values

What we offer

Find additional benefits and pay information here: https://careers.microsoft.com/v2/global/en/corporate-pay/denmark-corporate-pay.html

Fulltime

Senior Data Scientist, AI & Model Risk

It all started with an idea at Block in 2013. Initially built to take the pain o...

Location

United States , New York

Salary:

139000.00 - 225000.00 USD / Year

Cash App

Expiration Date

Until further notice

Requirements

A minimum of 5 years of related experience with a Bachelor’s degree in a quantitative field
or 3 years and a Master’s degree
or a PhD without experience
or equivalent work experience in risk management, model risk management, or AI risk management
Proficiency in Python or similar languages for evaluating AI system behavior, writing test scripts, or analyzing model outputs
Strong understanding of generative AI architectures
Including LLMs, transformer models, RAG systems, and agentic AI, plus hands-on experience interacting with and critically evaluating these systems, sufficient to assess design decisions, output quality, and limitations
Understanding of interagency model risk management principles, including SR 26-2
Knowledge of AI testing methodologies, ex. functional testing, bias testing, adversarial testing, and performance monitoring plus familiarity with data privacy and security principles (encryption, access controls, data classification)
Excellent written and verbal communication and the ability to translate complex technical AI concepts for non-technical stakeholders, senior management, and regulators

Job Responsibility

Lead end-to-end AI Risk Assessments for generative AI and LLM use cases across the Bank
Embedding in Block's enterprise-wide GenAI review process, coordinating cross-functional SMEs (Legal, Compliance, InfoSec, Data Governance, MRM, ERM, BRC, TPRM, Financial Crimes), and managing timelines to ensure reviews are completed within SLA
Review AI system design and documentation
Including retrieval sources, assumptions, limitations, fallback plans, guardrail configurations, and change management procedures — across banking use cases such as fraud detection, BSA/AML compliance, credit decisioning, and customer-facing applications, ensuring governance controls are commensurate with each use case's risk profile
Assess pre-deployment testing for adequacy inclusive of output integrity, hallucination detection, boundary and edge case testing, ethical and safety guardrails, bias testing, A/B testing, volume testing, and UAT — designing and conducting independent testing as needed
Evaluate ongoing monitoring plans for comprehensiveness - including accuracy, hallucination rates, drift detection, sensitive data controls, reliability metrics, CSAT, acceptable performance ranges, and documented remediation procedures
Develop and maintain templates, tools, and procedures to support the effectiveness and scalability of the AI Risk Governance Program
Monitor the evolving regulatory landscape for AI in banking — including FFIEC IT Examination Handbook standards, FDIC Financial Institution Letters, interagency statements, and the anticipated RFI on AI model risk management referenced in SR 26-2 — and incorporate emerging guidance into the AI risk governance program
support SFS's response to regulatory inquiries as needed

What we offer

Remote work
medical insurance
flexible time off
retirement savings plans
modern family planning

Fulltime

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Senior Scientist, Analytical Development and Quality Control

Job Description

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Requirements

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