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Associate Scientist Product Development Jobs in Indiana

We are seeking a Scientist/Associate Scientist - ADME to join IQVIA Laboratories at Indianapolis ... Support method development, assay optimization, and validation activities under moderate ...

Works hands on to identify problems during product development and/or when quality concerns arise ... Associates may be asked to perform additional tasks depending on strengths and capabilities ...

Works hands on to identify problems during product development and/or when quality concerns arise ... Associates may be asked to perform additional tasks depending on strengths and capabilities ...

Works hands on to identify problems during product development and/or when quality concerns arise ... Associates may be asked to perform additional tasks depending on strengths and capabilities ...

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Associate Scientist Product Development information

What are some common challenges faced by an Associate Scientist in Product Development, and how can they be addressed?

Associate Scientists in Product Development often encounter challenges such as balancing tight project timelines with the need for thorough experimental design and data analysis. They may also need to quickly adapt to changing project priorities or troubleshoot unexpected results in the lab. Collaborating effectively with cross-functional teams, such as quality assurance, manufacturing, and regulatory affairs, is essential to overcome these hurdles. Proactively communicating progress, seeking feedback, and staying organized can help Associate Scientists navigate these challenges and contribute successfully to product advancement.

What does an Associate Scientist in Product Development do?

An Associate Scientist in Product Development plays a crucial role in researching, designing, and testing new products or formulations in industries like pharmaceuticals, biotechnology, or consumer goods. They conduct laboratory experiments, analyze data, and collaborate with cross-functional teams to improve product performance and ensure regulatory compliance. Their work helps bring innovative and safe products to market efficiently.

What is the difference between Associate Scientist Product Development vs Associate Scientist Quality Control?

AspectAssociate Scientist Product DevelopmentAssociate Scientist Quality Control
CredentialsBachelor's or Master's in Life Sciences, Chemistry, or related fieldBachelor's or Master's in Life Sciences, Chemistry, or related field
Work EnvironmentResearch labs focused on product formulation and innovationLaboratories conducting testing and quality assurance of products
Industry UsageUsed in pharmaceutical, biotech, and consumer goods companiesCommon in manufacturing and quality assurance departments
Search IntentComparing roles in product development and formulationLooking into quality testing and compliance roles

Associate Scientist Product Development and Associate Scientist Quality Control are both entry-level roles in the life sciences industry. While they share similar educational backgrounds, the former focuses on creating and improving products, whereas the latter emphasizes testing and ensuring product quality. Both roles are essential in bringing safe, effective products to market, but they differ in daily tasks and objectives.

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

To thrive as an Associate Scientist in Product Development, you typically need a degree in chemistry, biology, or a related field along with strong laboratory and analytical skills. Familiarity with laboratory information management systems (LIMS), analytical instrumentation (such as HPLC or GC), and relevant regulatory guidelines is often required. Attention to detail, teamwork, and effective problem-solving are vital soft skills for success in collaborative and fast-paced environments. These abilities ensure the accurate development, testing, and optimization of products while maintaining compliance and fostering innovation.
What are popular job titles related to Associate Scientist Product Development jobs in Indiana? For Associate Scientist Product Development jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Associate Scientist Product Development jobs in Indiana look for? The top searched job categories for Associate Scientist Product Development jobs in Indiana are:
Senior Research Scientist - Product Development

Senior Research Scientist - Product Development

Elanco Animal Health Incorporated

Indianapolis, IN • On-site

Full-time

Retirement, PTO

Posted 9 days ago


Elanco rating

7.8

Company rating: 7.8 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

43rd of 73 rated pharmaceutical


Job description

At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Position Description
As the Formulations Senior Research Scientist, you will develop robust formulations and manufacturing processes needed to advance Elanco's biopharmaceutical portfolio for global markets. In this role, you will provide day-to-day technical support for formulation activities covering Elanco's biologics portfolio, including monoclonal antibodies, recombinant proteins, and vaccines. A key focus is the modernization of formulation workflows, leveraging automation and high-throughput screening to improve lab efficiency and utilizing AI/ML tools to predict stability and streamline development timelines. This role involves establishing the formulation strategy, identifying future capabilities and leading the technical transfer of robust processes to manufacturing sites. It requires a deep understanding of drug product stability, process scale-up, and sterile manufacturing. Beyond the lab responsibilities, this role also includes authoring and executing batch records, experimental protocols, and technical reports, as well as the preparation and review of the CMC (Chemistry, Manufacturing, and Controls) portion of global regulatory submissions. This position is based in Indianapolis and requires routine interaction with scientists across discovery, development, manufacturing and quality. The ability to independently conceptualize and execute experiments, coupled with a "can do" attitude, is essential. This is a high visibility position serving as the lead scientist on various product teams in R&D, requiring excellent communication skills and the ability to navigate complex US and EU regulatory landscapes.
Key Responsibilities
  • Lead the design and development of biologics formulations, utilizing high-throughput screening (HTS)platforms to rapidly evaluate excipient compatibility and physical-chemical stability. Implement and oversee automated equipment/workflows to improve efficiency.
  • Apply AI/ML modeling and predictive analytics to streamline formulation selection, optimize stability profiles, and significantly reduce development cycles.
  • Leverage knowledge/experience to scale-up and develop a robust sterile manufacturing process.
  • Lead and execute the technical transfer of drug product formulations and manufacturing processes from R&D to clinical and internal commercial manufacturing sites.
  • Lead the Manufacturability Review process, ensuring the delivery of an effective process/product control strategy. Play a leadership role in material delivery activities for pivotal CT and registration stability supply.
  • Lead troubleshooting activities related to parenteral formulation stability, sterility, and manufacturing deviations.
  • Effectively apply QbD principles throughout the development lifecycle to ensure manufacturing concerns are addressed at phase-appropriate points.
  • Write, review or approve high quality technical reports, batch records and global regulatory submissions.
  • Provide technical oversight for Contract Research/Manufacturing Organizations (CRO/CMO) and external consultants. Work effectively across all R&D teams, manufacturing and with external collaborators.

Basic Qualifications
  • Ph.D. in pharmaceutical sciences/ biochemistry/chemical/bio engineering or related field with a minimum of 5 years relevant experience or MS +10 years relevant experience in the pharmaceutical/biotech industry, specifically in biologics formulation and sterile manufacturing.
  • Qualified candidates must be legally authorized to be employed in the United States.

Additional Skills/Preferences
  • Prior relevant process/product commercialization experience with a focus on process robustness/reliability and effective control strategy development.
  • Experience working within a cGMP-regulated environment
  • Familiarity with using machine learning algorithms or predictive modeling software to accelerate drug product development.
  • Hands-on experience with automated platforms (e.g., liquid handlers, robotic samplers) and plate-based high-throughput tools.
  • Experience in multiple technology platforms (e.g. lyophilized products, lipid nanoparticles, adjuvanted formulations).
  • Strong strategic thinking skills with a track record of using innovative technologies to solve complex formulation challenges.
  • Strong interpersonal skills and proven ability to lead project teams and influence cross-functional partners in R&D, Manufacturing, and Quality.

Additional Details
Travel: 5-10%
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
  • Multiple relocation packages
  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
  • 8-week parental leave
  • 9 Employee Resource Groups
  • Annual bonus offering
  • Flexible work arrangements
  • Up to 6% 401K matching

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

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