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Analytical Development Biotech Jobs in Indiana (NOW HIRING)

MEDVACON

Aseptic Process Development - CDMO

IN · On-site

... biotechnology. A successful background will be strong in Lab, Process and Analytical development including working knowledge of cGMPs related to the production of viral therapeutics and the ability ...

Cardinal Health

Manager, Product Development

Indianapolis, IN · On-site

$109K - $136K/yr

... biotechnology industry. A background in product research and development preferred. * Demonstrated experience in the operation, use, and maintenance of pharmaceutical production and analytical ...

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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
Advisor - Molecular Biology, Analytical Development - BR&D

Advisor - Molecular Biology, Analytical Development - BR&D

Eli Lilly and Company

Indianapolis, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 5 days ago

Eli Lilly and Company rating

8.8

Company rating: 8.8 out of 10

Based on 62 frontline employees who took The Breakroom Quiz

10th of 74 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.
Position Overview:
The BRD Analytical Development team is seeking an Advisor to support analytical development for genetic medicines and advanced therapy medicinal products (ATMPs). This role is primarily laboratory-based, with responsibility for developing and qualifying analytical methods that characterize drug substance and drug product quality attributes across the genetic medicines portfolio, spanning early-phase IND-enabling studies through commercial BLA readiness. The successful candidate will have practical expertise in molecular biology and nucleic acid analytics and will contribute to GMP analytical activities within a cross-functional CMC development environment.
Key Responsibilities:
  • Develop, qualify, and execute PCR-based methods (qPCR, ddPCR/dPCR) for viral vector genome titration, residual DNA quantitation, and related nucleic acid analytes in support of genetic medicine programs.
  • Experience with immunoassay platforms (ELISA, MSD, Gyrolab) for residual host cell protein or impurity testing.
  • Apply molecular biology techniques including 1- and 2-D gel electrophoresis, blotting, and restriction enzyme analysis for product characterization.
  • Contribute to analytical control strategies for genetic medicine drug substance and drug product, including identification of critical quality attributes (CQAs) and appropriate test methods.
  • Support assay qualification, verification, and validation activities per ICH Q2(R2) and applicable regulatory expectations for genetic medicine and ATMP products.
  • Contribute analytical data and technical content supporting stability study design and execution across DS and DP matrices.
  • Ensure all analytical work is conducted in compliance with GMP, GLP, and applicable HSE requirements; maintain awareness of internal quality procedures and regulatory expectations.
  • Author and review analytical methods, protocols, qualification/validation reports, method transfer packages, and technical summaries with high scientific accuracy and clarity.
  • Maintain rigorous electronic laboratory notebook (ELN) practices and documentation standards for all experimental records.
  • Support technology transfer of analytical methods to CRO/CMO partners and Lilly manufacturing sites; participate in cross-site qualification or co-validation studies.
  • Provide technical input during interactions with external analytical partners; review and interpret externally generated data packages.
  • Maintain awareness of emerging analytical technologies, regulatory guidance updates, and industry best practices relevant to genetic medicine analytical development.
  • Collaborate within cross-functional project teams including process development, quality, regulatory affairs, and clinical operations to deliver analytical support for clinical trials and regulatory submissions.
  • Communicate analytical results, timelines, and technical challenges clearly to team members and project stakeholders in oral and written formats.
  • Contribute to a positive, inclusive, and scientifically rigorous team culture; share technical knowledge and support the growth of colleagues.

Basic Qualifications:
  • Ph.D. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 0-5+ years of relevant pharmaceutical or biotech industry experience; or
  • M.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 6+ years of relevant pharmaceutical or biotech industry experience; or
  • B.S. in Molecular Biology, Biochemistry, Biology, or Analytical Chemistry; with 12+ years of relevant pharmaceutical or biotech industry experience.
  • Practical proficiency with qPCR and/or ddPCR/dPCR for quantitative nucleic acid analysis in a pharmaceutical or biotech development context.
  • Practical proficiency with immunoassay platforms (ELISA and/or related technologies) for quantitative analysis of process-related impurities or product quality attributes in a pharmaceutical or biotech development context.
  • Hands-on experience with molecular biology techniques (gel electrophoresis, blotting, restriction analysis) applied to biopharmaceutical or genetic medicine characterization.
  • Demonstrated ability to independently design experiments, generate high-quality data, and interpret results in a development environment.
  • Familiarity with GMP/GLP requirements and their application to analytical method development and documentation.

Additional Skills & Preferences
  • Experience with viral vector (AAV, LVV) or cell therapy analytical programs, including genome integrity, residual DNA, and encapsidation efficiency assessments.
  • Familiarity with NGS workflows (library preparation, sequencing, bioinformatic interpretation) as an orthogonal characterization approach for genetic medicine products.
  • Knowledge of FDA/EMA regulatory expectations for nucleic acid-based CQA testing in genetic medicine CMC submissions.
  • Experience supporting analytical aspects of IND or BLA/MAA submissions, including contributing to Module 3 analytical sections.
  • Experience with method transfer to external CRO/CMO organizations and participation in inter-laboratory comparability studies.
  • Proficiency with electronic laboratory notebooks (e.g., Benchling) and data management systems.
  • Effective oral and written communication skills; ability to present complex technical information to multidisciplinary audiences.
  • Demonstrated ability to manage multiple priorities and work productively in a fast-paced, collaborative team environment.

Additional Information
  • Travel: 0 to 15%.
  • Potential exposure to chemicals, allergens, and loud noises.

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
$126,000 - $244,200
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

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