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Associate Downstream Process Development Scientist Jobs in Indiana

Genovice

Scientist

Indianapolis, IN · On-site

$80K - $150K/hr

Scientist / Senior Scientist - Radiopharmaceutical Drug Product Development (CMC) Location ... This individual will support CMC-driven initiatives including process development, technology ...

Merck Group

Process Engineer 2

Indianapolis, IN · On-site

$75.90K - $120.80K/yr

Our colleagues across the globe love innovating with science and technology to enrich people ... In this role you will be responsible for executing business unit driven process development ...

IQVIA

Associate Scientist/Scientist

Indianapolis, IN

$51.80K - $108K/yr

We are seeking a Scientist/Associate Scientist - ADME to join IQVIA Laboratories at Indianapolis ... drug development process * Strong attention to detail with the ability to produce accurate ...

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Associate Downstream Process Development Scientist information

What are the key skills and qualifications needed to thrive as an Associate Downstream Process Development Scientist, and why are they important?

To excel as an Associate Downstream Process Development Scientist, you need a solid understanding of biochemistry, chemical engineering, and downstream purification techniques, often supported by a bachelor's or master's degree in a life science or engineering discipline. Familiarity with chromatographic systems (such as AKTA), filtration equipment, and analytical tools, as well as knowledge of GMP/GLP regulations, is typically required. Strong problem-solving, attention to detail, and effective teamwork and communication skills help you navigate complex experiments and collaborate with cross-functional teams. These skills ensure efficient process optimization, compliance with regulatory standards, and successful development of biopharmaceutical products.

What are some typical challenges faced by an Associate Downstream Process Development Scientist, and how can they be addressed?

Associate Downstream Process Development Scientists often encounter challenges such as optimizing purification processes, troubleshooting equipment performance, and ensuring batch-to-batch consistency. These challenges can be addressed by maintaining meticulous documentation, collaborating closely with upstream and analytical teams, and staying current with best practices in chromatography and filtration. Proactively seeking feedback from experienced colleagues and participating in cross-functional meetings can also help in identifying solutions and improving process efficiency.

What is an Associate Downstream Process Development Scientist?

An Associate Downstream Process Development Scientist is a professional who works in the biotechnology or pharmaceutical industry, focusing on developing and optimizing processes that purify biological products, such as proteins or antibodies, after they have been produced by cells. Their work is crucial for ensuring the final product meets quality and safety standards before it is used in research or clinical applications. They typically perform laboratory experiments, analyze data, and collaborate with other scientists and engineers to improve yield and efficiency. This role is often entry-level or early-career, providing hands-on experience in process development and technical troubleshooting.

What is the difference between Associate Downstream Process Development Scientist vs Associate Upstream Process Development Scientist?

AspectAssociate Downstream Process Development ScientistAssociate Upstream Process Development Scientist
Primary FocusPurification and recovery of bioproductsCell culture and fermentation processes
Required SkillsProtein purification, chromatography, filtrationCell culture, bioreactor operation, media preparation
Work EnvironmentLaboratories, manufacturing facilitiesLaboratories, bioreactor labs
Common CertificationsBiotech or bioprocessing certificationsBiotech or bioprocessing certifications

Both roles are essential in biopharmaceutical development, focusing on different stages of the production process. The Associate Downstream Process Development Scientist specializes in purification techniques, while the Associate Upstream Process Development Scientist concentrates on cell growth and fermentation. Understanding these distinctions helps candidates target their skills and career paths effectively.

What are the most commonly searched types of Downstream Process Development Scientist jobs in Indiana? The most popular types of Downstream Process Development Scientist jobs in Indiana are:
What cities in Indiana are hiring for Associate Downstream Process Development Scientist jobs? Cities in Indiana with the most Associate Downstream Process Development Scientist job openings:
Associate Downstream Process Development Scientist jobs near you

Scientist

Genovice

Indianapolis, IN • On-site

$80K - $150K/hr

Full-time

Posted 16 days ago

Job description

Job Title: Scientist / Senior Scientist – Radiopharmaceutical Drug Product Development (CMC)
Location: Indianapolis, IN
Overview:
Our client is seeking a Scientist/Senior Scientist to support radiopharmaceutical drug product development activities across pre-clinical through late-stage programs. This individual will support CMC-driven initiatives including process development, technology transfer, scale-up activities, and commercialization efforts within a regulated environment. The ideal candidate will bring a strong radiopharmaceutical background with experience supporting drug product development programs and cross-functional collaboration.

Key Responsibilities:

  • Support radiopharmaceutical drug product development activities from early-stage through late-stage programs

  • Design, execute, and analyze laboratory experiments supporting process development and optimization

  • Support CMC activities related to drug product development, process characterization, and manufacturing readiness

  • Participate in technology transfer activities between development and manufacturing teams

  • Support preclinical, clinical, and/or commercial-stage development activities

  • Collaborate with cross-functional groups including Manufacturing, Quality, Regulatory, Analytical Development, and Technical Operations

  • Document experimental work and maintain compliant records following cGMP and GDP requirements

  • Assist with troubleshooting technical challenges and identifying process improvements

  • Support regulatory submission activities and/or commercialization efforts where applicable

Required Qualifications:

  • Bachelor's, Master's, or PhD in Chemistry, Radiochemistry, Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline

  • Experience ranging from Scientist to Senior Scientist level within radiopharmaceuticals, pharmaceuticals, biotechnology, or related industry

  • Experience supporting radiopharmaceutical or drug product development activities

  • Knowledge of CMC principles and regulated development environments

  • Understanding of cGMP documentation practices

  • Strong scientific problem-solving and communication skills

Preferred Qualifications:

  • Experience with radiopharmaceutical drug product development

  • Experience supporting technology transfers

  • Exposure to pre-clinical and/or late-stage development programs

  • Experience supporting commercialization activities or NDA-related programs

  • Experience with radioisotopes such as Ac-225, Lu-177, In-111, or similar therapeutic/diagnostic isotopes

  • Familiarity with analytical techniques such as HPLC, TLC, GC, or related methods

  • Validation experience is considered a plus but is not required

Additional Skills:

  • Ability to work independently and within cross-functional teams

  • Strong organizational and project management skills

  • Ability to manage multiple priorities in a fast-paced environment