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Internship Downstream Process Development Scientist information

What are the key skills and qualifications needed to thrive as an internship downstream process development scientist, and why are they important?

To thrive as an Internship Downstream Process Development Scientist, you need foundational knowledge in biochemistry, molecular biology, or chemical engineering, often supported by ongoing or recent enrollment in a relevant degree program. Familiarity with laboratory techniques such as chromatography, filtration, and analytical instruments, as well as experience with lab management software, is typically expected. Attention to detail, problem-solving abilities, and effective teamwork are standout soft skills in this role. These skills and qualifications are crucial for conducting reliable experiments, analyzing data, and contributing to the optimization of bioprocesses in a collaborative research environment.

What does an internship downstream process development scientist do?

An Internship Downstream Process Development Scientist works in the biopharmaceutical industry, assisting with the development and optimization of processes that purify biological products such as proteins, antibodies, or vaccines after they are produced by cells. Their role often involves supporting laboratory experiments, analyzing samples, and documenting results to improve the efficiency and scalability of downstream processes like filtration and chromatography. Interns in this position gain hands-on experience with cutting-edge technologies and learn about regulatory requirements and industry standards. This role helps prepare students or recent graduates for a career in process development or biomanufacturing.

What types of projects and responsibilities can an internship downstream process development scientist expect to work on?

As an Internship Downstream Process Development Scientist, you can expect to be involved in hands-on laboratory work focusing on the purification and characterization of biopharmaceutical products. Typical responsibilities include preparing buffer solutions, operating chromatography and filtration systems, analyzing samples using various analytical techniques, and documenting experimental results. Interns often collaborate with experienced scientists and engineers, contributing to process optimization and troubleshooting. The role provides valuable exposure to industry-standard procedures and the opportunity to develop technical skills in a team-oriented environment.

What are the most commonly searched types of Downstream Process Development Scientist jobs in Missouri?

The most popular types of Downstream Process Development Scientist jobs in Missouri are:

What are popular job titles related to Internship Downstream Process Development Scientist jobs in Missouri?

For Internship Downstream Process Development Scientist jobs in Missouri, the most frequently searched job titles are:

What job categories do people searching Internship Downstream Process Development Scientist jobs in Missouri look for?

The top searched job categories for Internship Downstream Process Development Scientist jobs in Missouri are:

What cities in Missouri are hiring for Internship Downstream Process Development Scientist jobs?

Cities in Missouri with the most Internship Downstream Process Development Scientist job openings:

Internship Downstream Process Development Scientist jobs near you
Infographic showing various Internship Downstream Process Development Scientist job openings in Missouri as of July 2026, with employment types broken down into 1% As Needed, 80% Full Time, 15% Part Time, and 4% Contract. Highlights an 90% Physical, 2% Hybrid, and 8% Remote job distribution.

Product Process Validation Manager

kindeva

Bridgeton, MO

Full-time

Re-posted 16 days ago

Kindeva rating

6.7

Company rating: 6.7 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The is an exciting opportunity as Product Process Validation Manager is a key member of the Manufacturing Science & Technology (MS&T) organization, responsible for leading process validation strategy and execution across the product lifecycle. This role oversees the design, authorship, and facilitation of technology transfer activities, Process Performance Qualification (PPQ) protocols and reports, and supporting ongoing Continued Process Verification (CPV). The manager partners closely with Process Development, Quality, Manufacturing, and Regulatory Affairs to ensure robust, compliant, and efficient validation programs. This position reports directly to the Director of MS&T.

Role Responsibilities

Process Validation & PPQ

  • Lead the development, authorship, and execution of process validation strategies in alignment with regulatory expectations (e.g., FDA, EMA, ICH Q8–Q11).
  • Write, review, and approve PPQ protocols, sampling plans, risk assessments, and final reports.
  • Facilitate cross-functional PPQ readiness, including coordinating activities with Manufacturing, Quality Control, and Quality Assurance.
  • Ensure validation deliverables meet internal standards and external regulatory requirements.

Technology Transfer

  • Serve as the MS&T lead for technology transfer of new products, processes, or scale-up activities into manufacturing.
  • Develop and maintain tech transfer plans, process descriptions, and knowledge transfer documentation.
  • Drive process fit-gap assessments, risk analyses, and mitigation strategies.
  • Support equipment and facility readiness, including URS development and process capability assessments.

Continued Process Verification (CPV)

  • Partner with data analytics and quality teams to monitor process performance, identify trends, and drive data-based decision-making.
  • Lead investigations and corrective actions related to process performance deviations or CPV signals.

Cross-Functional Leadership

  • Collaborate with Process Development to translate laboratory-scale processes into robust, scalable manufacturing processes.
  • Support Regulatory Affairs with process validation content for submissions, responses to regulatory queries, and inspections.
  • Provide technical leadership during audits and regulatory inspections.
  • Mentor and guide junior MS&T staff in validation and tech transfer best practices.

Documentation & Compliance

  • Ensure all validation and tech transfer documentation is accurate, complete, and audit-ready.
  • Maintain strong alignment with internal quality systems, change control, and document management processes.
  • Champion continuous improvement initiatives to enhance validation efficiency and process robustness.

Basic Qualifications

  • Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or related field.
  • 7+ years of experience in biopharmaceutical or pharmaceutical manufacturing, MS&T, process validation, or related technical functions.
  • Demonstrated expertise in PPQ, CPV, and technology transfer.
  • Strong understanding of cGMP regulations and global validation guidelines.
  • Excellent technical writing, communication, and project management skills.

Preferred

  • Experience with biologics, cell therapy, gene therapy, or aseptic manufacturing.
  • Familiarity with statistical tools (e.g., JMP, Minitab) for process analysis.
  • Prior leadership or team management experience.
  • Experience supporting regulatory inspections.

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