Associate Scientist, Process Development (Process Validation & Business Strategy) Job at Amgen (Holly Springs)

New

Specialist IS Analyst

In this vital role, you will work as part of a Product Team focusing on the Elec...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's OR Master’s degree with 8–12 years of experience in Software Engineering, Data Science, or Machine Learning Engineering
Strong experience with enterprise application testing in GxP-regulated environments
Hands-on experience with CSV/CSA validation methodologies and documentation
Software engineering best practices: Git, CI/CD (Jenkins, Maven), automated testing
Experience supporting enterprise platforms with issue ticketing and customer-facing support models
Proven experience in Application Support & Maintenance (AMS) for regulated systems
Experience with cloud platforms (AWS, Azure, GCP)
Incident response experience, including P1/P2 production incidents
Experience with ServiceNow, ITIL processes, and change management workflows
Ability to translate vendor capabilities and constraints into business-aligned solutions

Job Responsibility

Work as part of a Product Team focusing on the Electronic Lab Notebook (ELN) and Instrument Data Acquisition Platform, accelerating Amgen’s product development and commercial manufacturing
Collaborate with a dynamic, globally distributed team of technical product owners, business analysts, test/validation engineers, project managers, and scrum masters on the design, development, validation, support, and continuous optimization of Amgen Operations’ ELN ecosystem
Possess strong software development skills and rapidly translate concepts into working, production-ready solutions
Conduct code reviews to ensure quality, security, performance, and adherence to enterprise standards
Create and maintain documentation for architecture, design, validation, deployment, disaster recovery, and operations
Identify, troubleshoot, and resolve complex technical challenges across integrated enterprise platforms
Stay current with emerging technologies, industry best practices, and regulated system development trends
Lead and contribute to enterprise application testing in GxP environments, ensuring compliance with FDA, EMA, and global regulatory requirements
Own and execute CSV/CSA activities, including risk assessments, test strategy, IQ/OQ/PQ (or equivalent), traceability, and validation documentation
Develop and maintain test plans, test scenarios, and test scripts for system enhancements, patches, upgrades, and vendor releases

Sterility Assurance Scientist

This technical role is responsible for developing and implementing the site’s st...

Location

United States , Concord

Salary:

35.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Demonstrated understanding and experience with scientific principles for manufacturing parenteral drug products under cGMP conditions, including operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance
2+ years (Senior) or 5+ years (Principal) pharmaceutical manufacturing experience in microbiology, sterility assurance, TSMS, or related departments
Technical expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, cleaning/sanitization strategies, and disinfectant efficacy
Knowledge of microbiological media, enumeration techniques, and microorganism isolation and identification (Principal level)
Strong interpersonal, organizational, oral, and written communication skills for cross-functional teamwork and technical documentation
Experience with data analysis, trending, and root cause investigations related to sterility assurance programs
Ability to wear appropriate PPE and gown into cleanroom attire as required for manufacturing or laboratory environments
Flexibility to support varying production schedules, including occasional extended or off-hour work and travel for training and implementation
Ability to perform tasks requiring repetitive motion, standing or walking for long periods

Job Responsibility

Develop and implement sterility assurance programs and contamination control strategies for the site
Provide technical guidance and oversight for environmental monitoring, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization activities, including disinfectant efficacy
Lead or support technical activities related to airflow pattern testing, environmental monitoring performance qualifications (EM PQ), aseptic processing techniques, and facility monitoring
Author, execute, review, and approve technical documents, protocols, and change controls related to sterility assurance programs
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvement
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls for potential microbial, endotoxin, and particulate contamination
Lead or support root cause investigations and corrective actions for sterility assurance issues
Participate in and provide technical support during internal and external audits
Mentor team members and collaborate with cross-functional teams to achieve business and quality objectives
Support the development and maintenance of cleanroom gowning and aseptic technique strategies/programs

What we offer

Competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
401k plan that includes a company match and is fully vested after you become eligible
Paid time off, sick time, and paid company holidays
Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Risk Manager

We are seeking a highly motivated Model Risk Manager for Amazon’s Payments Risk ...

Location

Colombia , Bogota

Salary:

Not provided

Amazon Pforzheim GmbH

Expiration Date

Until further notice

Requirements

3+ years of risk management experience, including building, testing, implementing, and validating models in financial services technology, payments, merchant/acquiring, audit/consulting, business software, retail, or online services companies (preferably AI/ML models)
Bachelor's degree in Financial Engineering, Financial Mathematics, Mathematics, Statistics, Computer Science, or related field, OR equivalent knowledge gained from relevant experience
Proven ability to manage difficult risk programs across multiple teams, with experience designing and implementing model risk management programs or processes from the ground up
Strong data analysis and technical skills, including knowledge of SQL and Big Data technologies like Hadoop or similar
Excellent written and spoken communication skills, with ability to transform complex risk concepts into clear documentation and influence business decisions across stakeholders
knowledge of data management fundamentals and data storage principles

Job Responsibility

Drive vision and execution of tactical elements of governance and compliance activities for AI and machine learning (ML) risk models
Assist in managing AI/ML risk management processes in alignment with regulatory requirements
Work with stakeholders and team members to ensure requisite activities associated with AI/ML regulatory guidance occur
Work with team members and leadership to prepare content and facilitate key stakeholder and working group meetings
Work with key stakeholders to ensure requisite activities within the enterprise AI/ML Risk Management Standard occur
Work with key stakeholders on identifying heightened risks, controls, and value of prospective Al/ML use cases
Work with Enterprise Architecture and data scientists to create and sustain a comprehensive Al/ML use intake process
Maintain the comprehensive inventory of Al/ML use cases, evidence of review and approval, and associated documentation
Partner with other functions (e.g., Legal, Compliance) on requisite review and effective challenge of new Al/ML use cases
Partner with subject-matter-experts and strategic leaders to ensure execution of requisite control activities as articulated in the enterprise Al/ML strategy

What we offer

Inclusive Team Culture
Mentorship & Career Growth
Work/Life Balance
flexibility as part of our working culture

Senior Associate, Product Management - Discovery Big Bets

This person will serve as an internal consultant/strategist, dedicated to explor...

Location

United States , New York; McLean; Richmond

Salary:

101100.00 - 138400.00 USD / Year

Capital One

Expiration Date

Until further notice

Requirements

Bachelor’s degree or military experience
At least 1 year of product management experience or at least 1 year of experience in product design, agile delivery, business analysis, data science, or software engineering

Job Responsibility

Proactively seek out and investigate new, large-scale opportunities that have the potential to drive significant future growth for Capital One Travel
Conduct market analysis, competitive landscape assessments, and customer research to fully understand the viability of new spaces
Balance business opportunities with deep customer needs, ensuring that new product concepts solve real problems for the user
Function as an internal consultant and gaining buy-in by effectively communicating the customer value and business potential to core product and delivery teams, who are responsible for the final execution
Take ownership of an idea and building the strategic and evidential case required to turn 'something out of nothing'
Collaborate with tech teams to build comprehensive acceptance criteria, identifying and elevating any need for additional research to define future feature design
Breakdown business epics into features and further into user stories, driving your team towards lowest effort or Minimal Viable Product (MVP) for a valid feature test
Effectively use hypothesis-driven assessment of data to ensure your product or feature delivers on real business needs
Own and prioritize feature development roadmaps, ensuring all necessary processes and procedures are followed to manage risk
Work autonomously in an agile environment, to conduct research and develop features that utilize new and evolving technology

What we offer

performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
comprehensive, competitive, and inclusive set of health, financial and other benefits that support your total well-being

Fulltime

Data Observability Consultant

We are looking for a data observability consultant who will help mature data qua...

Location

India

Salary:

Not provided

Lingaro

Expiration Date

Until further notice

Requirements

Bachelor’s degree in any quantitative discipline
7 to 10 years of experience in implementing off-the-shelf or be-spoke data observability solutions
Proven experience with data observability tools such as Acceldata, BigEye, Soda, Monte Carlo, Anomalo etc. Or experience implementing bespoke observability solutions using Grafana, Prometheus or cloud native services
Proven experience as a Data Quality Consultant, Data Quality Engineer or similar role
Proficiency in SQL and other programming languages such as Python or R
Ability to clearly articulate, influence, and thought partner with senior business leaders
Understanding of modern technology trends and data stacks in data management and governance
Experience in running customer workshops and other collaboration sessions to discover customer priorities, understand current state, and determine maturity/readiness to execute on enterprise Data Management & Governance vision
Familiarity with Azure, or GCP and associated DQ capabilities
Understanding of cloud-based data storage and data pipeline architecture

Job Responsibility

Data Observability Management: Define end-to-end data quality and observability solution including data quality operating model and framework using relevant Data Observability tools
Data Observability: Lead development and deployment of off-the-shelf or be-spoke solutions that monitor data pipelines and databases with help of automated checks and alerts
Data Quality Improvement: Develop and implement reactive, predictive, and preventive strategies to improve the quality of data in the data analytics products and platforms using various methods including data cleansing, data enrichment, data validation, data observability and AI/ML
Collaboration: Collaborate with data engineers, data scientists, and other stakeholders to ensure data quality across all stages of the data lifecycle
Innovation in Data Quality & Observability: Stay abreast of industry trends and emerging technologies. Propose innovative solutions to enhance data observability processes
Liaise with information security teams, and business data stewards, to define priorities and roadmaps for managing and mitigating risks related to data security and data privacy
Drive upskilling and adoption initiatives on data observability within customer organizations
Contribute to balanced score cards as well as data collection and reporting process for data governance councils for monitoring progress and tracking bottlenecks
Identify and define opportunities for automating data quality related processes
Collaborate with other Data Management consultants at Lingaro to identify and create repeatable methodologies and templates for effectively delivering data management and governance services

What we offer

Stable employment
“Office as an option” model
Flexibility regarding working hours and your preferred form of contract
Comprehensive online onboarding program with a “Buddy” from day 1
Cooperation with top-tier engineers and experts
Unlimited access to the Udemy learning platform from day 1
Certificate training programs
Upskilling support
Internal Gallup Certified Strengths Coach to support your growth
Grow as we grow as a company

New

Accounting Clerk

Check figures, postings, and documents for correct entry, mathematical accuracy,...

Location

Kenya , Nairobi

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

Bachelors degree in Accounting or related field
Minimum of 2 years of experience in a similar role (Income Audit experience is an added advantage)
Preferably in a hotel or luxury service environment (4- or 5-Star hotel is highly desirable)
CPA certification

Job Responsibility

Check figures, postings, and documents for correct entry, mathematical accuracy, and proper codes
Organize, secure, and maintain all files, records, cash and cash equivalents in accordance with policies and procedures
Record, store, access, and/or analyze computerized financial information
Maintain accurate electronic spreadsheets for financial and accounting data
Classify, code, and summarize numerical and financial data to compile and keep financial records, using journals, ledgers, and/or computers
Prepare, maintain, and distribute statistical, financial, accounting, auditing, or payroll reports and tables
Complete period-end closing procedures and reports as specified
Prepare, review, reconcile, and issue bills, invoices, and account statements according to company procedures
Follow all company policies and procedures
ensure uniform and personal appearance are clean and professional

What we offer

Training
development
recognition
a place where you can pursue your passions in a luxury environment with a focus on holistic well-being

Fulltime

New

Customer Success Specialist

As a Customer Success Specialist, you’ll play a key role in capturing the voice ...

Location

United Kingdom

Salary:

28000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Strong knowledge of the Auction proposition and/or training delivery experience
Passion for customer experience and continuous improvement
Excellent communication and relationship-building skills
Proactive, self-motivated and solutions-focused
Curious mindset with a drive to turn insight into action
Strong written and verbal English skills

Job Responsibility

Conduct ‘Voice of the Customer’ calls, capturing feedback and resolving dissatisfaction
Provide actionable insight to internal teams to improve Partner Agent engagement
Support growth of key partners through performance and sentiment reporting
Deliver live online training sessions to enhance product understanding
Develop and maintain learning content, case studies and testimonials
Track engagement metrics including NPS and CSAT, supporting monthly reporting
Support new product and feature launches through outbound partner engagement

What we offer

Private Counselling with a weekly confidential helpline available
SimplyHealth private healthcare plan
£150 Wellbeing Allowance per year
Working elsewhere policy (4 weeks per year)
Buy and sell annual leave scheme (upto 3 days per year)
Additional Day off for your Birthday

Fulltime

New

Scientist 2, Separations and Biophysical Characterization

The Analytical Sciences group, part of the Technical Development & Services depa...

Location

United States , Novato

Salary:

118400.00 - 162800.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

PhD degree in Biophysics, Biochemistry, Chemistry or related discipline and minimum 5 years of relevant post graduate experience in the industry
Master’s degree in biochemistry or chemistry or related discipline and minimum 7 years of relevant post graduate experience in the industry
In-depth understanding of biophysical methods for protein structure and function, protein chemistry, small molecule or oligo chemistry structure, and function
Subject matter expertise in biophysical methods using AUC, CD, DSC, DSF, DLS, ITC, SEC-FFF/MALS, and other areas such as subvisible particulate characterization, microscopy
Knowledge in standard liquid chromatography methods (e.g. SEC, IEX, RP-HPLC), capillary electrophoresis (CE, cIEF) and detectors: UV, FLD, CAD, and ELSD
Experience in phase appropriate analytical development supporting drug substance (DS), drug product (DP) assays and supporting formulation development across both early and late phases
Collaborative skills to work in a cross-functional environment
Excellent writing skills including experimental documentation
Proven data analysis, interpretation and communication, collaboration and scientific communication skills
Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment

Job Responsibility

Manage the development, optimization and implementation of biophysical characterization activities within Analytical Sciences for various protein-based therapeutics and other modalities
Design and conduct studies independently, including but not limited to assess protein structure, structure function relationship, protein-excipient compatibility, solubility, and binding kinetics and affinities
Use biophysical methods (AUC, CD, DSC, DSF, DLS, ITC, SEC-FFF/MALS) to analyze stability and solution properties for various therapeutics
Develop and qualify biophysical methods for products from early (pre-clinical) to commercial stages
Manage CDMO partnerships to implement analytical methods or troubleshoot if necessary
Troubleshoot and optimize methods
Provide quantitative analysis and interpretations
prepare protocols, reports, and maintain electronic records for inspections
Present data regularly to teams and leadership
Write technical reports summarizing study outcomes

What we offer

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off

Fulltime

Associate Scientist, Process Development (Process Validation & Business Strategy)

Amgen

Location:
United States , Holly Springs

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 08, 2026

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