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Analytical Development Biotech Jobs in Indiana (NOW HIRING)

Astrix Inc

R&D Formulation Scientist

Columbus, IN · On-site

$27 - $30/hr

Write, review, and execute analytical and microbiological test methods. * Lead and support method ... Experience in regulated environments such as pharmaceutical, biotech, personal care, cosmetics ...

Elanco

Head of Business Development

Indianapolis, IN · Hybrid

... biotech industries, including executive leadership and high-value deal execution. * Strategic ... Effective problem-solving and analytical skills to resolvehighly complexbusiness challenges and ...

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Analytical Development Biotech information

What are some typical challenges faced by Analytical Development professionals in the biotech industry?

Analytical Development professionals in biotech often encounter challenges such as developing robust methods for novel biologics, ensuring regulatory compliance, and adapting to rapid technological changes. They frequently work within cross-functional teams, collaborating closely with research, manufacturing, and quality assurance groups to optimize assay performance and troubleshoot issues. Staying current with evolving regulatory standards and balancing project timelines with method validation requirements are also common aspects of the role.

What is the difference between Analytical Development Biotech vs Quality Control Analyst?

AspectAnalytical Development BiotechQuality Control Analyst
CredentialsBachelor's/Master's in Life Sciences, Chemistry, or related fieldsBachelor's in Chemistry, Biology, or related fields; often requires GMP training
Work EnvironmentResearch labs, development departments, collaborative teamsQuality labs, manufacturing facilities, compliance-focused settings
Industry UsageDeveloping and optimizing analytical methods for biotech productsTesting and ensuring product quality and compliance with standards

Analytical Development Biotech focuses on creating and refining analytical methods during product development, while Quality Control Analysts primarily test products to ensure they meet quality standards. Both roles require similar educational backgrounds and work in laboratory settings, but their core responsibilities differ in the product lifecycle.

What is Analytical Development in biotech?

Analytical Development in biotech refers to the process of designing, developing, and validating methods to analyze biological products, such as proteins, antibodies, or cell therapies, during various stages of drug development and manufacturing. These methods are essential for ensuring the safety, quality, potency, and purity of biotechnological products. Professionals in this field work closely with research, production, and regulatory teams to ensure that analytical methods meet industry standards and comply with regulatory requirements. Analytical Development is a critical part of bringing new biopharmaceutical products from the lab to the market.

What are the key skills and qualifications needed to thrive as an Analytical Development Biotech professional, and why are they important?

To thrive as an Analytical Development Biotech professional, you need a strong background in analytical chemistry, biochemistry, or a related field, typically supported by at least a bachelor's or master's degree. Familiarity with analytical instrumentation such as HPLC, GC, mass spectrometry, and relevant quality systems like GMP or ICH guidelines is crucial. Strong problem-solving, attention to detail, and effective communication are important soft skills for collaborating across multidisciplinary teams. These competencies ensure accurate data generation, regulatory compliance, and successful development of biotechnological products.
What are popular job titles related to Analytical Development Biotech jobs in Indiana? For Analytical Development Biotech jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Analytical Development Biotech jobs in Indiana look for? The top searched job categories for Analytical Development Biotech jobs in Indiana are:
What cities in Indiana are hiring for Analytical Development Biotech jobs? Cities in Indiana with the most Analytical Development Biotech job openings:
Analytical Development Biotech jobs near you
R&D Formulation Scientist

R&D Formulation Scientist

Astrix Inc

Columbus, IN • On-site

$27 - $30/hr

Full-time

Re-posted 3 days ago

Job description

Pay Rate Low: 27 | Pay Rate High: 30
Our client is a leader in contract manufacturing and integrated product development, formulation science, technical operations, packaging expertise, and in-house analytical and stability programs to deliver results-from innovative new systems to modernized legacy brands. Come join the team!
Schedule: Monday-Friday, 8:00 AM - 5:00 PM
Job type: Direct Hire
Pay rate: $27/hr. -$30/hr.
Summary
We are seeking an experienced and detail-oriented Senior Microbiologist / Formulation Scientist to join our Research & Development team. The ideal candidate will have 3-5+ years of industry experience with a strong background in formulation development, microbiology, and analytical method validation. This role will be responsible for developing and optimizing formulations, executing microbiological testing, writing and validating laboratory methods, and supporting product development initiatives from concept through commercialization.
Key Responsibilities
  • Develop, optimize, and evaluate formulations for new and existing products.
  • Design, execute, and document formulation studies and stability testing.
  • Write, review, and execute analytical and microbiological test methods.
  • Lead and support method validation and method transfer activities in accordance with applicable regulatory and quality requirements.
  • Perform microbiological testing including media preparation, culturing, plating, microbial enumeration, and environmental monitoring.
  • Maintain aseptic technique and ensure compliance with laboratory best practices.
  • Analyze experimental data, prepare technical reports, and present findings to cross-functional teams.
  • Accurately document laboratory activities in notebooks, protocols, and electronic systems.
  • Support investigations related to microbiological results, contamination events, and product performance.
  • Maintain laboratory equipment, calibration records, inventory, and overall laboratory organization.
  • Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to support product development and commercialization efforts.
  • Adhere to all safety guidelines, SOPs, and Good Laboratory Practices (GLP).
Qualifications
  • Bachelor's degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific field; advanced degree preferred.
  • 3-5+ years of relevant industry experience in microbiology, formulation development, or product development.
  • Strong hands-on experience with formulation development and optimization.
  • Experience writing, executing, and supporting method validation protocols and reports.
  • Solid microbiology background with experience in:
    • Microbiological testing
    • Aseptic techniques
    • Environmental monitoring
    • Microbial identification and enumeration
    • Bioburden and contamination investigations
  • Strong understanding of laboratory documentation requirements and data integrity principles.
  • Experience with stability studies, product testing, and analytical techniques is preferred.
  • Excellent problem-solving, organizational, and communication skills.
  • Ability to work independently while contributing effectively within a collaborative team environment.

Preferred Skills
  • Experience in regulated environments such as pharmaceutical, biotech, personal care, cosmetics, medical device, or consumer products industries.
  • Familiarity with GLP, GMP, USP microbiological methods, and validation requirements.
  • Proficiency with laboratory software, data analysis tools, and technical report writing.
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