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

Associate Manufacturing – Downstream - Days

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

Location

United States , Holly Springs

Salary:

75618.00 - 89473.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School/GED + 2 years manufacturing and/or other regulated environment experience
Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
Bachelor’s Degree

Job Responsibility

Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Assure proper gowning and aseptic techniques are always followed
Perform hands-on downstream bio-tech operations (Column Chromatography, Tangential Flow Filtration among others) including set-up, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations
Identify and escalate issues and concerns regarding daily routine functions related to process and tasks
may engage with team on potential solutions
Perform documentation for assigned functions (i.e., equipment logs, EBRs)

What we offer

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

Fulltime

Senior Associate Manufacturing - Downstream - Nights

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

Location

United States , Holly Springs

Salary:

92002.00 - 108605.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
Associate’s Degree + 2 years manufacturing and/or other regulated environment experience
Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience
Master's Degree
Completion of NC BioWorks Certification Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
Excellent verbal and written communication (technical) skills
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

Job Responsibility

Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Initiate quality non-conformance (NC) reports
Interact with regulatory agencies as needed and guided
Assure proper gowning and aseptic techniques are always followed
Perform hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations
Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions

What we offer

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

Fulltime

Associate Manufacturing – Downstream - Nights

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

Location

United States , Holly Springs

Salary:

75618.00 - 89473.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School/GED + 2 years manufacturing and/or other regulated environment experience
Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
Bachelor’s Degree
Completion of NC BioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical
Basic understanding and process experience in a cGMP manufacturing facility
Excellent verbal and written communication
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Job Responsibility

Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Assure proper gowning and aseptic techniques are always followed
Perform hands-on downstream bio-tech operations (Column Chromatography, Tangential Flow Filtration among others) including set-up, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Initiate and own manufacturing related process deviations
Identify and escalate issues and concerns regarding daily routine functions related to process and tasks
may engage with team on potential solutions
Perform documentation for assigned functions (i.e., equipment logs, EBRs)

What we offer

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

Fulltime

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 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

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