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Senior Scientist Downstream Process Development Jobs in Delaware

Senior Scientist

Wilmington, DE · On-site

$88K - $121K/yr

... process from development, launch and through life cycle management -Experience working in one of the following disciplines: Analytical Science, Chemical Science, Formulation Science, Physical Science ...

... manufacturing, downstream processing, sterile biopharmaceutical product fill-finish, supply ... Sciences R&D, Manufacturing Production, Manufacturing Scale-Up, Process Improvements, Process Scale ...

... manufacturing, downstream processing, sterile biopharmaceutical product fill-finish, supply ... Sciences R&D, Manufacturing Production, Manufacturing Scale-Up, Process Improvements, Process Scale ...

Senior Scientist, Bioanalytics

Wilmington, DE · On-site

$88K - $121K/yr

... process issues, and recommend scientifically sound corrective actions. * Contribute to global product stewardship through method development, knowledge sharing, and transfer of analytical methods ...

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R&D Scientist

Newark, DE · On-site

$65K - $85K/yr

The R&D Scientist will explore and develop novel base materials for stationary phase in ... Collaborate with production team to improve production process and product quality and consistency.

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R&D Scientist

Newark, DE · On-site

$65K - $85K/yr

The R&D Scientist will explore and develop novel base materials for stationary phase in ... Collaborate with production team to improve production process and product quality and consistency.

Scientist 1 - JOB ID SIMNJP00038611 Location: Newark, DE 19702 Type: 11 Months Contract Potential ... Provides assistance in research, analysis, and experimentation for product and process development ...

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Senior Scientist Downstream Process Development information

What does a senior scientist in downstream process development do?

A Senior Scientist in Downstream Process Development focuses on developing, optimizing, and scaling up processes to purify biological products such as proteins or antibodies after cell culture (the 'downstream' part of biomanufacturing). They design experiments, analyze data, and work with cross-functional teams to ensure product quality and regulatory compliance. Their role is critical in moving biopharmaceutical products from research to commercial production by ensuring efficient and robust purification processes.

What are the key skills and qualifications needed to thrive as a senior scientist in downstream process development?

To thrive as a Senior Scientist in Downstream Process Development, you need advanced knowledge in bioprocess engineering, protein purification, and process scale-up, typically supported by a Ph.D. or Master’s degree in a relevant field. Expertise with chromatography systems (such as AKTA), analytical instrumentation, and familiarity with regulatory requirements like GMP are essential. Strong problem-solving abilities, leadership, and effective communication skills distinguish top performers in this role. These competencies are crucial for developing robust, scalable processes that meet quality standards and drive successful product development.

What are some common challenges faced by senior scientists in downstream process development, and how can they be addressed?

Senior Scientists in Downstream Process Development often encounter challenges such as optimizing purification processes for novel biologics, scaling up from lab to production scale, and ensuring product consistency and regulatory compliance. Addressing these challenges typically involves close collaboration with cross-functional teams, continuous process optimization, and staying current with industry advancements in chromatography and filtration technologies. Proactive problem-solving, effective communication, and leveraging data analytics are also key strategies for overcoming obstacles in this role.
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Infographic showing various Senior Scientist Downstream Process Development job openings in Delaware as of July 2026, with employment types broken down into 1% As Needed, 79% Full Time, 16% Part Time, and 4% Contract. Highlights an 91% Physical, 2% Hybrid, and 7% Remote job distribution.

Senior Scientist

US Tech Solutions

Wilmington, DE • On-site

$88K - $121K/yr

Contractor

Re-posted 20 days ago


Job description

Company Description

US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website www.ustechsolutions.com.

We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, sets the correct expectation and thus becomes an accelerator in the mutual growth of the individual and the organization as well.

Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset.

Job Description

The Senior Scientist role is responsible for aiding in the supply of strategic drug product technical expertise and support to a portfolio of established products. The products are manufactured either internally at an CLIENT'S manufacturing site or externally at a contractor. The technical expertise and support is used in problem solving as well as in continuous improvement activities.

This a great opportunity to learn about CLIENT'S's exciting and diverse established product portfolio and to gain experience working in a Global function and with external suppliers.

Responsibilities:

Support License to Operate activities:

-Provide technical expertise and problem solving support to the manufacturing sites.

-Provide technical expertise and support in creating regulatory documentation and responses to regulatory questions in a way that ensures maximum flexibility for Operations.

Support manufacturing and supply chain changes:

-Perform technical risk assessments for proposed changes, e.g. to excipients, packaging/device components, manufacturing processes and/or analytical testing methods.

-Propose experimental work to support changes

-Review generated data and make recommendations on whether to proceed with changes or not.

Maintain product knowledge:

-Write reports and memos to record technical investigations or recommendations, ensuring data integrity.

-Contribute to and/or coordinate Quality Risk Assessments and Technical Opportunity and Risk Assessments (TORAs) as required.

-Produce and maintain information in the Product Knowledge Management tool.

Coordinate, lead or support product improvement initiatives:

-As required, ensure delivery of product and process improvements that will deliver business benefits.

-Develop or support the manufacturing sites in developing business cases.

-Co-ordinate appropriate support teams if required

Maintain communication to product stakeholders:

-Work with Product Champions to receive work requests, perform priority assessments and agree level of effort on each activity

-Establish networks between sites who manufacture the same or similar products to ensure effective collaboration.

-Effectively communicate product performance and product issues to the manufacturing sites.

Build technical understanding and capability:

-Train manufacturing sites in, e.g. pharmaceutical technologies, formulation and packaging design, manufacturing and testing control strategies and analytical techniques as appropriate.

Minimum Requirements - Education and Experience (Required)

-BSc degree in a relevant discipline, e.g. analytical chemistry, chemical engineering or pharmaceutics

-Experience of pharmaceutical manufacturing/QC testing and/or research and development

-Knowledge of the overall drug development and commercialization process from development, launch and through life cycle management

-Experience working in one of the following disciplines: Analytical Science, Chemical Science, Formulation Science, Physical Science, Pharmaceutical Manufacturing and Supply Chain Management

-Knowledge of international GMP and SHE requirements and their applicability to pharmaceutical manufacturing, research and development

-Knowledge of Quality Management Systems and their applicability to pharmaceutical manufacturing


Qualifications

Minimum Requirements - Education and Experience (Desired)

-Masters Degree or PhD in a relevant discipline, e.g. analytical chemistry, chemical engineering or pharmaceutics

-Experience working in Global function and/or with external parties

-Experience working in more than one area of the overall drug development and commercialization process from development, launch and through life cycle management

-Experience working in two or more disciplines such as Analytical Science, Chemical Science, Formulation Science, Physical Science, Pharmaceutical Manufacturing and Supply Chain Management

-Extensive knowledge of international GMP and SHE requirements and their applicability to pharmaceutical manufacturing, research and development

-Extensive knowledge of Quality Management Systems and their applicability to pharmaceutical

Manufacturing

Additional Information

Sneha Shrivastava

Sr Technical Recruiter

sneha.s(at)ustechsolutionsinc.com

862 - 579 - 4236



US Tech Solutions logo

About US Tech Solutions

Sourced by ZipRecruiter

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.

Industry

It services

Company size

1,001 - 5,000 Employees

Headquarters location

Jersey City, NJ, US

Year founded

2000

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