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Stability Biologics Jobs in Indiana (NOW HIRING)

Support the transfer of potency assays for QC release and stability testing to meet product and ... MS in Molecular Biology, Immunology, Biochemistry, Bioanalytical Chemistry or a related field with ...

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Support the transfer of potency assays for QC release and stability testing to meet product and ... MS in Molecular Biology, Immunology, Biochemistry, Bioanalytical Chemistry or a related field with ...

New

Foster Care Case Manager

Indianapolis, IN · On-site

$38K - $46K/yr

... stability, and overall well-being. We are seeking a compassionate and dedicated Foster Care Case ... Provides reunification services to the biological families when required by treatment plan.

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Stability Biologics information

What is stability biologics?

Stability Biologics refers to a company that specializes in the development, manufacturing, and distribution of biologic products, particularly those used for tissue repair and regenerative medicine. These biologics include allografts and tissue-based products that support healing in orthopedic, spine, and wound care applications. The company ensures that these products maintain their safety, efficacy, and integrity through rigorous quality control and stability testing processes. Stability Biologics works closely with healthcare providers to supply innovative solutions that enhance patient outcomes.

What are the key skills and qualifications needed to thrive as a stability biologist?

To thrive as a Stability Biologist, you need a solid background in biology, chemistry, or pharmaceutical sciences, often with a relevant degree. Familiarity with laboratory equipment, stability testing protocols, and regulatory guidelines such as ICH is crucial, along with experience using LIMS (Laboratory Information Management Systems). Strong analytical thinking, attention to detail, and effective communication skills help ensure accurate data interpretation and reporting. These competencies are vital for maintaining product quality and compliance with regulatory standards in pharmaceutical development.

What are some common challenges faced by professionals working in stability biologics, and how can they be addressed?

Professionals in stability biologics often encounter challenges such as managing complex testing protocols, adhering to strict regulatory requirements, and handling the variability of biological samples over time. Ensuring accurate data collection and interpretation is critical, particularly when products may behave unpredictably under different storage conditions. These challenges can be addressed by maintaining clear documentation, staying up-to-date with regulatory guidance, collaborating closely with quality assurance teams, and leveraging validated analytical methods to ensure consistency and compliance throughout the stability study process.

What is the difference between Stability Biologics vs Quality Control Analyst?

AspectStability BiologicsQuality Control Analyst
Required CredentialsBachelor's degree in biology, biochemistry, or related field; experience in biologics manufacturingBachelor's degree in life sciences; experience in lab testing and quality assurance
Work EnvironmentBiotech manufacturing facilities, laboratories, quality assurance teamsLaboratories, testing facilities, quality assurance departments
Employer & Industry UsageBiotech companies, biologics manufacturing firmsPharmaceutical companies, biotech firms, contract labs

Stability Biologics professionals focus on product stability testing and formulation, while Quality Control Analysts primarily perform lab testing to ensure product quality. Both roles require similar educational backgrounds and work in biotech or pharmaceutical environments, but their specific responsibilities differ within the product development and quality assurance processes.

What are popular job titles related to Stability Biologics jobs in Indiana?

For Stability Biologics jobs in Indiana, the most frequently searched job titles are:

What cities in Indiana are hiring for Stability Biologics jobs?

Cities in Indiana with the most Stability Biologics job openings:

Senior Biologist

Eli Lilly and Company

Indianapolis, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 3 days ago

New


Eli Lilly and Company rating

8.8

Company rating: 8.8 out of 10

Based on 63 frontline employees who took The Breakroom Quiz

11th of 86 rated pharmaceutical


Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Overview
The Bioproduct Research and Development (BR&D) organization delivers innovative medicines through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, antibody-drug conjugates (ADCs), novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep scientific expertise that collaborates closely with discovery and manufacturing partners. Located in Indianapolis, IN, our scientists have access to world-class pharmaceutical development and engineering capabilities.
In this role, you will join a collaborative team of scientists dedicated to advancing bioassay science in support of Lilly's growing portfolio of biotherapeutics and next-generation modalities.
You will play a critical role in ensuring that the potency and biological activity of Lilly's medicines are accurately characterized from early development through commercialization, directly supporting patient access to safe and effective therapies. This is an opportunity to work hands-on with cutting-edge technologies - including cell and gene therapy platforms, engineered cell lines, and genome editing tools - while building deep technical expertise in bioassay development, a discipline central to both product quality and regulatory success. You will partner closely with colleagues across Analytical Development, Quality Control, Manufacturing, and Regulatory Affairs, gaining broad visibility into the end-to-end product lifecycle and the chance to shape how new assay technologies are evaluated and adopted across the organization.
For scientists looking to grow their careers in bioanalytical and cell-based assay science within a fast-paced, innovation-driven environment, this role offers meaningful technical challenges alongside strong mentorship and cross-functional exposure.
Responsibilities
  • Support the development, optimization, and implementation of assays to assess the biological activity of therapeutic proteins, peptides, and new modalities, including gene and cell therapies, in the laboratory.
  • Support the transfer of potency assays for QC release and stability testing to meet product and corresponding regulatory requirements.
  • Execute experiments, review and analyze data, author technical documents, and contribute to sections of regulatory submissions.
  • Support bioassay lab operations, including cell culturing, reagent acquisition and qualification, and instrument purchase and qualification.
  • Coordinate and collaborate with internal and external partners as part of cross-functional teams.
  • Evaluate and assess emerging technologies suitable for bioassay development.

Basic Requirements
  • MS in Molecular Biology, Immunology, Biochemistry, Bioanalytical Chemistry or a related field with a minimum of 0-2 years of experience in the pharma/biotech industry; or
  • BS in Molecular Biology, Immunology, Biochemistry, Bioanalytical Chemistry, or a related field with a minimum of 2-3 years of experience in the pharma/biotech industry
  • Hands-on experience executing potency assays, such as binding assays (e.g., ELISA, SPR) and/or cell-based assays (e.g., luciferase reporter assays)
  • Proficiency in mammalian cell culture techniques, including maintenance of adherent and suspension cell lines, passaging, and cryopreservation
  • Experience working with engineered cell lines (e.g., stable reporter lines, knockout or knock-in lines) commonly used in bioassay development and qualification
  • Strong interpersonal and communication skills, with the ability to collaborate effectively across cross-functional teams
  • Demonstrated ability to prioritize and manage workload in a fast-paced, deadline-driven environment
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Skills/Preferences
  • Experience with genome editing techniques (e.g., CRISPR-Cas9, HDR, NHEJ), including design, execution, and confirmation of edits via molecular characterization
  • Experience with core molecular biology techniques, including PCR, qPCR, gel electrophoresis, cloning, plasmid preparation, and sequencing
  • Understanding of GMP quality systems
  • Knowledge of FDA/EMA regulations governing potency assay development
  • Experience with statistical analysis of bioassays using software such as SoftMax Pro, PLA 2.0, or JMP (SAS)

Additional Information
  • Location: Onsite at Lilly's Tech Center North campus, Indianapolis, IN

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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About Eli Lilly

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Eli Lilly, based in Indianapolis, IN, US, is one of the pioneers in the pharmaceutical industry with a rich history dating back to 1876. This global pharmaceutical company focuses on discovering, developing, manufacturing and selling pharmaceutical products in approximately 120 countries. The company's product categories include endocrinology, oncology, cardiovascular, neuroscience, and immunology. Having invested over $9 billion in research and development in the past decade, Eli Lilly is also committed to creating high-quality medicines that meet real needs. As a recipient of several awards and recognitions, Eli Lilly is known for its focus on life-saving research and drug development. Their mission is to make medicines that help people live longer, healthier, and more active lives.

Industry

Pharmaceutical product wholesalers

Company size

10,000+ Employees

Headquarters location

Indianapolis, IN, US

Year founded

1876