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Pharmaceutical Development Scientist Jobs in Indiana

Elanco

Sr Research Scientist

Indianapolis, IN · Hybrid

$94K - $120K/yr

PhD in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field with a minimum of 5 years of experience in pharmaceutical development; M.S. in a related field with a minimum of 10 ...

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Pharmaceutical Development Scientist information

What are some common challenges pharmaceutical development scientists face when transitioning a drug from the lab to large-scale manufacturing?

Pharmaceutical Development Scientists often encounter challenges related to scaling up a drug formulation from laboratory experiments to full-scale production. This process requires careful optimization to ensure that the product maintains its efficacy, safety, and quality while being manufacturable at a commercial scale. Issues such as ingredient compatibility, process reproducibility, and regulatory compliance frequently arise, demanding collaboration with cross-functional teams in manufacturing, quality assurance, and regulatory affairs. Adaptability and problem-solving skills are essential for overcoming these hurdles and ensuring successful product development.

What does a pharmaceutical development scientist do?

A Pharmaceutical Development Scientist is responsible for researching, designing, and developing new drugs and medications. They work on formulating drug compounds, ensuring their safety and efficacy through laboratory testing, and optimizing production processes. These scientists collaborate with regulatory agencies to ensure compliance and play a key role in advancing medicines from concept to market. Their work is critical in improving healthcare outcomes and meeting regulatory standards.

What is the difference between Pharmaceutical Development Scientist vs Formulation Scientist?

AspectPharmaceutical Development ScientistFormulation Scientist
CredentialsBachelor's or Master's in Pharmacy, Chemistry, or related fields; often requires experience in drug developmentBachelor's or Master's in Pharmacy, Chemistry, or related fields; focus on formulation techniques
Work EnvironmentResearch labs, development departments, pharmaceutical companiesResearch labs, manufacturing, pharmaceutical companies
Industry UsageInvolved in early-stage drug development, formulation, and process optimizationSpecializes in creating and testing drug formulations for stability and delivery

The main difference is that Pharmaceutical Development Scientists focus on the overall development and process optimization of new drugs, while Formulation Scientists concentrate specifically on designing and testing drug formulations. Both roles require similar educational backgrounds and work environments, but their core responsibilities differ within the drug development process.

What are the key skills and qualifications needed to thrive as a pharmaceutical development scientist?

To thrive as a Pharmaceutical Development Scientist, you need a solid background in chemistry, biology, or pharmaceutical sciences, often supported by an advanced degree such as a Master's or Ph.D. and relevant laboratory experience. Familiarity with analytical instrumentation (like HPLC and mass spectrometry), regulatory compliance systems (such as GMP), and data analysis software is crucial. Strong problem-solving, attention to detail, and effective teamwork and communication skills set top professionals apart. These abilities are vital for developing safe, effective medications and ensuring regulatory compliance in a highly collaborative and precise environment.
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Pharmaceutical Development Scientist jobs near you

Principal Research Scientist - Analytical Development Synthetic Technical Development

Elanco Animal Health Incorporated

Indianapolis, IN • On-site

Full-time

Retirement, PTO

Re-posted 28 days ago

Elanco rating

7.8

Company rating: 7.8 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

51st of 86 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!
Your Role:
Principal Research Scientist, Analytical Development (SynTD)
As the Principal Research Scientist, Analytical Development, you will support Elanco's Technical Development (TD) organization. This position is broadly responsible for analytical development activities of animal health products with a concentrated expertise in dissolution control strategy and synthetic molecule analytical development. As part of technical development teams, the role is expected to support drug development with a diverse range of responsibilities.
Your Responsibilities:
  • Develop and deliver relevant analytical and dissolution methods and specifications, ensuring compliance with industrial (GxP) and regulatory requirements (VICH/ICH).
  • Interpret results, evaluate data, and draw relevant conclusions.
  • Report and present scientific/technical results internally, create external publications, and present at scientific conferences.
  • Write or support the generation of international registration documents and interact with global health authorities.
  • Partner with manufacturing and regulatory representatives to drive drug product commercialization activities and technical submissions to global health authorities.
  • Drive the evaluation and implementation of new technologies in dissolution and analytical development, applying the latest scientific thinking to help bring new drug products to market.
  • Mentor and coach emerging technical talent within the function.
  • Ensure compliance with external and internal guidelines/quality standards (e.g., SOPs, GxP, HSE, and Animal Welfare).

What You Need to Succeed (minimum qualifications):
  • Education: PhD in Analytical Chemistry, Pharmacy, Pharmaceutical Sciences, or a related field, with a minimum of 7 years of experience in pharmaceutical development; experience specifically in analytical development is highly preferred, ideally with experience in various dosage forms. M.S. in a related field with a minimum of 12 years of experience in the pharmaceutical industry, or B.S. in a related field with a minimum of 16 years of experience in the pharmaceutical industry.
  • Experience: Strong expertise in chromatographic (HPLC/UPLC) and spectroscopic (UV/VIS) method development, and recognized expertise in dissolution, particularly with USP Apparatus II (Paddles) and IV (Flow Cell).
  • Top 2 skills:
    • Extensive knowledge of current quality and regulatory requirements for new drug products.
    • Demonstrated track record of interacting with regulatory agencies (e.g., FDA/CVM, EMA) on analytical topics.

What will give you a competitive edge (preferred qualifications):
  • Significant experience with dissolution development and preparing regulatory submissions.
  • Experience working in regulated environments (e.g., GMP).
  • Proven scientific leadership skills.
  • Strong collaborator with the ability to positively impact interdisciplinary and international teams.
  • Strong problem-solving skills, including strategic and creative thinking.
  • Experience in analytical method development in areas outside of dissolution.

Additional Information:
  • Travel: Approximately 10% travel required.
  • Location: Indianapolis, IN - Hybrid Work Environment

Don't meet every single requirement? Studies have shown underrecognized 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.

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