Associate Engineer, Process Development - Downstream Job at Amgen (Holly Springs)

Purification Development Associate

The purification development team is seeking a highly motivated associate to joi...

Location

United States , Philadelphia

Salary:

Not provided

Revel IT

Expiration Date

Until further notice

Requirements

Master/Bachelor in biochemistry, chemistry, chemical engineering, bioengineering, or related area with 0-4 years of relevant industry experience
Knowledge of downstream process development of the biologics, such as viral vectors, monoclonal antibodies, vaccines, and therapeutic recombinant proteins in the biopharma industry
Strong organizational skills and detailed documentation abilities are required
Perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Excellent writing and verbal communication skills are required

Job Responsibility

Execute lab experiments according to predefined experimental design and protocols
Support the maintenance of essential equipment and critical raw materials to ensure smooth laboratory operations
Maintain accurate documentation with a high level of detail. Close out experiments in a timely manner
Collaborate with team members to ensure the DSP laboratories are maintained in a professional and organized working environment

Specialist Manufacturing: NPI, Process Owner

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of biotechnology operations experience
Associate’s degree & 8 years of biotechnology operations experience
Bachelor’s degree and 4 years of biotechnology operations experience
Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
Doctorate degree
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Downstream GMP manufacturing operations
Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.

Job Responsibility

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of downstream unit operations
Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs
Support CAPA development to prevent error recurrence
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
Responds to regulatory questions and/or audit findings
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior/Research Associate, Drug Product Development

We are seeking a skilled and motivated Senior/Research Associate to join our Del...

Location

United States , South San Francisco

Salary:

75000.00 - 100000.00 USD / Year

NewLimit

Expiration Date

Until further notice

Requirements

MS in Biomedical Engineering, Chemical Biology, Pharmaceutical Sciences, or a related discipline with 2+ years of industry experience or equivalent experience
Experience formulating LNPs with diverse lipid components for nucleic acid delivery
Experience with purification techniques, including dialysis, Tangential Flow Filtration (TFF), ultracentrifugation, and sterile filtration
Proficiency in LNP analysis using DLS, LC-UV, LC-CAD, CGE, fragment analyzers, Osmolality, MALS, ELISA, and fluorescence-based 96-well plate assays

Job Responsibility

Formulate, downstream process, and characterize LNPs for nucleic acid delivery across diverse model systems, including pre-clinical models
Partner with the Epigenetic Editing and Product teams (Immunology, Metabolism, Vascular) to meet LNP requirements for reprogramming interventions at both small and large scales
Develop and optimize LNP compositions, downstream processing and analytical methods to establish robust production protocols
Map future formulation needs, manage material procurement, and ensure the lab is equipped for upcoming programs
Interpret complex experimental data to drive decision-making within Delivery Science and Preclinical Development workstreams
Maintain rigorous and detailed records of experimental protocols and results in an Electronic Laboratory Notebook (ELN)

What we offer

Health, dental, and vision insurance
401(k) with company match
Paid parental leave
Industry-leading paid time off (PTO) — 20 days/year for all employees + holidays
Meals and snacks on-site

Fulltime

Associate Director, Manufacturing Science and Technology

We are seeking a dynamic and experienced MSAT Associate Director to support late...

Location

United States

Salary:

175000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience
7+ years of biologics development and manufacturing experience
Experience with late phase development and commercialization of monoclonal antibodies within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.)
Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and validation/PPQ, including person in plant and pre-approval inspection support
Experience with process and economic modeling of DS manufacturing processes
Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain
Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
Ability to multi-task and keep pace with a fast-moving organization
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Job Responsibility

Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment
Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners
Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations
Analyze process and manufacturing data to understand and optimize process performance
Develop process characterization and PPQ strategies and documentation
Support regulatory activities including submissions and site inspections from preparation through execution
Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness
Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements
Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

New

Applications Development Technical Lead Analyst

Citibank, N.A. seeks an Applications Development Technical Lead Analyst for its ...

Location

United States , Tampa

Salary:

153381.00 - 171200.00 USD / Year

Citi

Expiration Date

March 26, 2026

Requirements

Master’s degree, or foreign equivalent, in Computer Applications, Applied Computer Science, or related field and 3 years of experience as an Application Development Senior Programmer Analyst, Programmer Analyst, Associate, Senior Associate, or related position involving developing and modifying software systems, unit and integration testing, and production roll out
Alternatively, employer will accept a Bachelor’s degree in the stated fields and 5 years of the specified progressive post-baccalaureate experience
3 years of experience must include: Developing applications using core Java, J2EE and Frameworks Spring MVC, Spring JPA, Hibernate, and IDEs including IntelliJ, Eclipse and NetBeans
Implementing and following SDLC processes, performing system design, coding, debugging, testing, code reviews, artifacts packaging, storing, and deployment
Version control and configuration management tools GIT, SVN and Maven
Jenkins, LightSpeed, OpenShift to design CI/CD pipelines
Designing and developing Service-Oriented architecture REST and SOAP, APIs using Spring, JAX-RS, JAX-WS and Microservices
Message Brokers including Oracle JMS, TIBCO, and IBM MQ
Working with SQL/NoSQL databases using Oracle, Cassandra, or Ignite for financial systems and integrating Java services
Front-End application development using Angular, React, Java Script, HTML, XML, XSLT and CSS

Job Responsibility

Research, design, and develop computer and network software and specialized utility programs
Design, develop and validate unit and integration testing with upstream and downstream system before every software release in production to avoid adverse regulatory impact
Analyze user needs and develop software solutions, applying principles and techniques of computer science, engineering, and mathematical analysis to determine feasibility of design within time and cost constraints
Use programming and integration technologies and tools to build the platform
Collaborate with various teams in different time zones to deploy the changes to the production environment
Create monitoring and alerting dashboards for regulatory application and systems, and define automated repairing steps to minimize downtime
Monitor time sensitive batches and application to ensure proper operation
Evaluate and recommend new technologies and update versions of existing ones to avoid risks and security breaches
Use BlackDuck, GEM, Sonar, Checkmarx scans to avoid risks and security breaches
Store, retrieve and cleanup the margin data for analysis, and maintain the application and system activities as per regulatory guidelines

What we offer

medical, dental & vision coverage
401(k)
life, accident, and disability insurance
wellness programs
paid time off packages, including planned time off (vacation), unplanned time off (sick leave), and paid holidays

Fulltime

Associate Manager of Lifecycle Marketing

We’re seeking a strategic and data-driven Associate Manager of Lifecycle Marketi...

Location

United States , Santa Monica

Salary:

64300.00 - 86200.00 USD / Year

Disney

Expiration Date

Until further notice

Requirements

3+ years in Lifecycle marketing, or related field
Experience with marketing automation platforms (e.g., Braze, Iterable, Salesforce Marketing Cloud)
Knowledge of email and push best practices for deliverability and downstream impact
Superior project management skills and attention to detail with experience in managing Airtable workflows
Ability to provide strategic recommendations motivated by data
Ability to independently develop presentations and communicate clearly to marketers, data analysts, data engineers, and product
Ability to anticipate needs, innovate, and flourish in a fast-paced environment
A positive attitude, ability to work with a team to drive projects to completion, and penchant for solving problems
Extensive project launch experience and understanding of QA processes
Bachelor’s degree or equivalent work experience

Job Responsibility

Partner within the Lifecycle Marketing teams, agencies, data teams, and external partners to bring high priority marketing initiatives to life
Plan, schedule, execute, and test email and push notification journeys, including end-to-end QA documentation and performance measurement
Partner with content teams to identify opportunities for increasing engagement in existing and new journeys
Hyper-target subscribers with relevant content to ensure a positive experience for users engaging with Hulu's products
Optimize current email and push programs through continual testing of creative, copy, timing, offers, targeting, and more
Coordinate work activities with internal and external partners to launch campaigns in a timely and consistent manner
Find opportunities to improve the effectiveness of email and push marketing programs

What we offer

A bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits

Fulltime

Avionics Radiation Hardness Assurance Engineer

Are you passionate about human space exploration, understanding the origins of t...

Location

United States , Houston

Salary:

Not provided

Amentum

Expiration Date

Until further notice

Requirements

Typically requires a bachelor's degree in Engineering and a minimum of 1 year of experience in the field or in a related area
Be familiar with the subject matter expertise (SME) and/or specialty engineering field in radiation effects in microelectronics for NASA spaceflight (or similar complexity)
Work directly with technicians, engineers, managers, and other stakeholders on a wide variety of Projects
Possess technical knowledge of radiation effects in microelectronics and avionics systems, may include: basic mechanisms for single-event effects and total dose, test strategies, mitigation techniques, and analysis of circuits, systems, and data links
Be familiar with the suite of activities known as Radiation Hardness Assurance (RHA) for avionics (analog, digital, power, etc.): determining Mission, Environment, Application, and Lifetime (MEAL) factors, developing and interpreting requirements, bill-of-materials requirement gap analysis, radiation testing, environment definition, radiation transport, shielding analysis, dose-depth curves, Single-Event Effects Criticality Analysis (SEECA), derating, Safe Operating Area (SOA), Radiation Design Margin (RDM), etc.
Assess EEE parts, circuits, functions, components, subsystems, and systems to evaluate risks, effectiveness of mitigation strategies, and the ability to meet functional, performance, and reliability requirements during and after exposure to the mission ionizing radiation environment
Lead or support screening and characterization test efforts for heavy ion, proton, and pulsed-laser Single-Event Effects (SEE), Total Ionizing Dose (TID), Enhanced Low-Dose Rate Sensitivity (ELDRS), Total Non-Ionizing Dose (TNID), Displacement Damage Dose (DDD), etc.
Create detailed radiation assessments, presentations, test plans, analyses, and reports
Design, troubleshoot, and repair new and existing radiation test setups, may include: cables, laboratory test equipment, printed circuit boards, software, firmware, hardware description languages, etc.
Test Engineer / Lab Scientist with at least 1 year experience

Job Responsibility

Report directly to the Electronics and Electrical Section Manager as part of group of over 45 other Electronics and Electrical Engineers
Be familiar with systems engineering and integration (S&EI) and/or specialty engineering for NASA spaceflight (or similar complexity)
Support new projects and sustaining efforts throughout product life cycle, including: standards adjudications, system requirements reviews, preliminary design reviews, critical design reviews, manufacturing readiness reviews, flight readiness reviews, and failure investigations, as well as testing, analysis, inspection, sustaining support efforts
Drive critical decision-making processes for performing radiation testing, deriving part performance classification and taxonomy, and improving vehicle and subsystem level radiation reliability and survivability
Tailor Radiation Hardness Assurance (RHA) requirements based upon mission, environment, application, and lifetime (MEAL) factors as well as program/project risk posture
Bound stochastic and deterministic electronics failure modes induced by natural space radiation environment
Write verification test plans, test procedures, and test reports against product requirement
Ability to read and understand schematics for circuit and system diagrams to evaluate upstream and downstream impacts for transient analysis
Collaborate with design engineers, project personnel, and other stakeholders to evaluate performance of electronic hardware and assess need to address impacts to functional, performance, reliability, and availability metrics
Support program activities on behalf of subject matter experts (SMEs) by assessing relevance information with technical discussions to determine need to request SME consideration, and then accurately conveying SME assessments back to program and project stakeholders

What we offer

Excellent personal and professional career growth
9/80 work schedule (every other Friday off), when applicable
Onsite cafeteria (breakfast & lunch)

Fulltime

Neural Nexus – AI Data Enablement (AuRA), Associate Director

In this vital role of Neural Nexus – AI Data Enablement (AuRA), Associate Direct...

Location

United States , Thousand Oaks

Salary:

176811.00 - 203390.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of data enablement, project management in Life Sciences, analytics, or related fields
Master’s degree and 5 years of data enablement, project management in Life Sciences, analytics, or related fields
Bachelor’s degree and 7 years of data enablement, project management in Life Sciences, analytics, or related fields
Associate’s degree and 12 years of data enablement, project management in Life Sciences, analytics, or related fields
In-depth experience working directly with Commercial and/or Analytics functions, translating business needs into scalable data enablement solutions
Demonstrated strength in project & program management and data stewardship principles including data ownership, quality accountability, and lifecycle management, leading complex, cross-functional initiatives end to end
Proven ability to manage multiple concurrent workstreams with interdependencies
Experience acting as a delivery owner, not just a contributor
Strong understanding of AI/ML and GenAI data requirements, including feature engineering and data pipelines
Proven ability to operationalize data governance without slowing delivery

Job Responsibility

Own and deliver the workstreams for AI-enabled data foundations that power Neural Nexus across Amgen’s commercial and analytics ecosystem
Focus on the full execution lifecycle of the workstreams under AuRA (design, development, implementation, rollout, and training)
Ensure solutions are deployed on time, on scope, and with measurable business value
Accountable for data stewardship across Neural Nexus AI Data Enablement, ensuring that data assets adhere to FAIR principles and align to Amgen’s Clean Core and enterprise data strategy
Establish clear data ownership, stewardship practices, and quality standards
Accountable for the end-to-end planning, execution, and implementation of all AI Data Enablement workstreams under AuRA
Partner closely with Commercial Analytics, CD&A, AI&D, Tech and Engineering teams
Complete delivery plans for AI Data Enablement initiatives and AuRA workstreams
Support business and platform teams by translating commercial requirements into clear delivery objectives and executable working plans
Supply tactical input to broader program planning by identifying risks, blockers, and dependencies

Fulltime

Associate Engineer, Process Development - Downstream

Amgen

Location:
United States , Holly Springs

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 13, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Associate Engineer, Process Development - Downstream

Purification Development Associate

Specialist Manufacturing: NPI, Process Owner

Senior/Research Associate, Drug Product Development

Associate Director, Manufacturing Science and Technology

Applications Development Technical Lead Analyst

Associate Manager of Lifecycle Marketing

Avionics Radiation Hardness Assurance Engineer

Neural Nexus – AI Data Enablement (AuRA), Associate Director

Associate Engineer, Process Development - Downstream

Amgen

Location:United States , Holly Springs

Category:Manufacturing

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:January 13, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Associate Engineer, Process Development - Downstream

Purification Development Associate

Specialist Manufacturing: NPI, Process Owner

Senior/Research Associate, Drug Product Development

Associate Director, Manufacturing Science and Technology

Applications Development Technical Lead Analyst

Associate Manager of Lifecycle Marketing

Avionics Radiation Hardness Assurance Engineer

Neural Nexus – AI Data Enablement (AuRA), Associate Director

Location:
United States , Holly Springs

Category:
Manufacturing

Contract Type:
Not provided

Job Posted:
January 13, 2026