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 ...
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 ...
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 ...
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 ...
Scientist, Analytical Development
Tustin, CA · On-site
$120K - $135K/yr
Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative ... In the Scientist, Analytical Development role you will have the opportunity to focus on developing ...
Scientist, Analytical Development
Tustin, CA · On-site
$120K - $135K/yr
Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative ... In the Scientist, Analytical Development role you will have the opportunity to focus on developing ...
Scientist, Analytical Development
$120K - $135K/yr
Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative ... In the Scientist, Analytical Development role you will have the opportunity to focus on developing ...
Scientist, Analytical Development
$120K - $135K/yr
Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative ... In the Scientist, Analytical Development role you will have the opportunity to focus on developing ...
Senior Director of Analytical Development
Fort Lauderdale, FL · Remote
$250K - $275K/yr
This role oversees analytical method development, qualification, validation, transfer, and lifecycle management for single‑ and multi‑component biological products, with emphasis on antibodies ...
Quick apply
Senior Director of Analytical Development
Fort Lauderdale, FL · Remote
$250K - $275K/yr
This role oversees analytical method development, qualification, validation, transfer, and lifecycle management for single‑ and multi‑component biological products, with emphasis on antibodies ...
The Scientist I, Analytical Development, is responsible for executing analytical testing and contributing to analytical method development activities for biologics/vaccine development programs. This ...
The Scientist I, Analytical Development, is responsible for executing analytical testing and contributing to analytical method development activities for biologics/vaccine development programs. This ...
Head of Biologics Development & CMC
$170K - $230K/yr
This person will initially manage a small team of downstream process development and analytical ... Deep experience in biologics development, with a technical foundation in downstream process ...
Head of Biologics Development & CMC
$170K - $230K/yr
This person will initially manage a small team of downstream process development and analytical ... Deep experience in biologics development, with a technical foundation in downstream process ...
Head of Biologics Development & CMC
Manhattan, NY · On-site
$170K - $230K/yr
This person will initially manage a small team of downstream process development and analytical ... Deep experience in biologics development, with a technical foundation in downstream process ...
Quick apply
Head of Biologics Development & CMC
Manhattan, NY · On-site
$170K - $230K/yr
This person will initially manage a small team of downstream process development and analytical ... Deep experience in biologics development, with a technical foundation in downstream process ...
Catalent Biologics is making significant investments in people and capabilities. This is a unique ... The The Analytical Development team is responsible for evaluating client analytical methods and/or ...
Catalent Biologics is making significant investments in people and capabilities. This is a unique ... The The Analytical Development team is responsible for evaluating client analytical methods and/or ...
Catalent Biologics is making significant investments in people and capabilities. This is a unique ... The The Analytical Development team is responsible for evaluating client analytical methods and/or ...
Catalent Biologics is making significant investments in people and capabilities. This is a unique ... The The Analytical Development team is responsible for evaluating client analytical methods and/or ...
Head of Biologics Development & CMC
Manhattan, NY · On-site
$170K - $230K/yr
This person will initially manage a small team of downstream process development and analytical ... Deep experience in biologics development, with a technical foundation in downstream process ...
Head of Biologics Development & CMC
Manhattan, NY · On-site
$170K - $230K/yr
This person will initially manage a small team of downstream process development and analytical ... Deep experience in biologics development, with a technical foundation in downstream process ...
Senior Manager, Biologics Analytical Development (Bioassay)
$150K - $224K/yr
The Sr. Manager, Biologics Analytical Development (Bioassay) will execute and support the development, qualification, and lifecycle management of bioassays supporting biologics programs from early ...
Senior Manager, Biologics Analytical Development (Bioassay)
$150K - $224K/yr
The Sr. Manager, Biologics Analytical Development (Bioassay) will execute and support the development, qualification, and lifecycle management of bioassays supporting biologics programs from early ...
... and biologic products within a Contract Development and Manufacturing Organization (CDMO ... Execute analytical method transfer, verification, validation, and troubleshooting activities ...
... and biologic products within a Contract Development and Manufacturing Organization (CDMO ... Execute analytical method transfer, verification, validation, and troubleshooting activities ...
Design and execute experiments to evaluate product attributes relevant to regulated bioprocessing, biologics development, and drug-quality monitoring. * Develop analytical strategies to assess ...
Design and execute experiments to evaluate product attributes relevant to regulated bioprocessing, biologics development, and drug-quality monitoring. * Develop analytical strategies to assess ...
... biologic products from natural sources. He/she will lead the groups to drive the development of ... The Director will ensure that all analytical deliverables are achieved within set timelines ...
Quick apply
... biologic products from natural sources. He/she will lead the groups to drive the development of ... The Director will ensure that all analytical deliverables are achieved within set timelines ...
Design and execute experiments to evaluate product attributes relevant to regulated bioprocessing, biologics development, and drug-quality monitoring. * Develop analytical strategies to assess ...
Design and execute experiments to evaluate product attributes relevant to regulated bioprocessing, biologics development, and drug-quality monitoring. * Develop analytical strategies to assess ...
... and biologic products within a Contract Development and Manufacturing Organization (CDMO ... Execute analytical method transfer, verification, validation, and troubleshooting activities ...
... and biologic products within a Contract Development and Manufacturing Organization (CDMO ... Execute analytical method transfer, verification, validation, and troubleshooting activities ...
Catalent Biologics is making significant investments in people and capabilities. This is a unique ... The The Analytical Development team is responsible for evaluating client analytical methods and/or ...
Catalent Biologics is making significant investments in people and capabilities. This is a unique ... The The Analytical Development team is responsible for evaluating client analytical methods and/or ...
Scientist, Analytical Development
$110K - $135K/yr
D. in Immunology, Cell Biology, Neuroscience or related field with 2-5 years or M.S. with 6+ years of analytical development relevant industry experience. * Deep expertise in multiparameter flow ...
Scientist, Analytical Development
$110K - $135K/yr
D. in Immunology, Cell Biology, Neuroscience or related field with 2-5 years or M.S. with 6+ years of analytical development relevant industry experience. * Deep expertise in multiparameter flow ...
Scientist, Analytical Development
San Diego, CA · On-site
$110K - $135K/yr
D. in Immunology, Cell Biology, Neuroscience or related field with 2-5 years or M.S. with 6+ years of analytical development relevant industry experience. * Deep expertise in multiparameter flow ...
Quick apply
Scientist, Analytical Development
San Diego, CA · On-site
$110K - $135K/yr
D. in Immunology, Cell Biology, Neuroscience or related field with 2-5 years or M.S. with 6+ years of analytical development relevant industry experience. * Deep expertise in multiparameter flow ...
Analytical Development Biologics information
See salary details
$18.03 - $19.86
5% of jobs
$19.86 - $21.70
9% of jobs
$22.75 is the 25th percentile. Wages below this are outliers.
$21.70 - $23.54
18% of jobs
The median wage is $24.98 / hr.
$23.54 - $25.37
22% of jobs
$25.37 - $27.21
9% of jobs
$28.38 is the 75th percentile. Wages above this are outliers.
$27.21 - $29.04
17% of jobs
$29.04 - $30.88
13% of jobs
$30.88 - $32.71
4% of jobs
$32.71 - $34.55
0% of jobs
$34.55 - $36.39
0% of jobs
$36.39 - $38.22
2% of jobs
$18
$26
$38
How much do analytical development biologics jobs pay per hour?
What are the key skills and qualifications needed to thrive as an Analytical Development Biologics professional, and why are they important?
What are some common challenges faced by Analytical Development Biologics professionals when transitioning from research to process development?
What is the difference between Analytical Development Biologics vs Analytical Development Chemist?
| Aspect | Analytical Development Biologics | Analytical Development Chemist |
|---|---|---|
| Credentials | Bachelor's or Master's in Life Sciences, Biochemistry, or related fields; relevant certifications | Bachelor's or Master's in Chemistry, Biochemistry, or related fields; relevant certifications |
| Work Environment | Pharmaceutical or biotech labs focused on biologics; working with proteins, antibodies, and cell-based products | Labs working on small molecules, chemicals, and drug compounds; analytical testing and method development |
| Industry Usage | Primarily in biologics and biotech companies | In pharmaceutical, chemical, and research organizations |
Analytical Development Biologics and Analytical Development Chemist roles share similar skills in analytical techniques but differ mainly in the type of products they focus on. Biologics roles emphasize working with complex biological molecules, while chemist roles focus on small molecules. Both positions require strong analytical skills and relevant scientific backgrounds, but their specific expertise and work environments vary significantly.
What is Analytical Development in Biologics?
Advisor - Molecular Biology, Analytical Development - BR&D
Indianapolis, IN • On-site
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 4 days ago
Eli Lilly and Company rating
8.8
Based on 62 frontline employees who took The Breakroom Quiz
10th of 74 rated pharmaceutical
Job description
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