This responsibility requires hands-on contribution to the development of analytical methodology, execution of experiments to generate key data, and support of regulatory documents (e.g., IND, NDA)
This responsibility requires hands-on contribution to the development of analytical methodology, execution of experiments to generate key data, and support of regulatory documents (e.g., IND, NDA)
Author and defend dissolution and biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions across global markets, including biowaiver justifications and IVIVC/IVIVR ...
Author and defend dissolution and biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions across global markets, including biowaiver justifications and IVIVC/IVIVR ...
Author and defend dissolution and biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions across global markets, including biowaiver justifications and IVIVC/IVIVR ...
Author and defend dissolution and biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions across global markets, including biowaiver justifications and IVIVC/IVIVR ...
Director, Analytical Chemistry - Genetic Medicines; Analytical Development - BR&D
Indianapolis, IN · On-site
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). Monitor and assess emerging regulatory guidance and precedents to proactively shape Lilly ...
Director, Analytical Chemistry - Genetic Medicines; Analytical Development - BR&D
Indianapolis, IN · On-site
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). Monitor and assess emerging regulatory guidance and precedents to proactively shape Lilly ...
Director - Dissolution Science & Biopharmaceutics
Indianapolis, IN · On-site
$148.50 - $257.40/hr
Author and defend dissolution and biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions across global markets, including biowaiver justifications and IVIVC/IVIVR ...
Director - Dissolution Science & Biopharmaceutics
Indianapolis, IN · On-site
$148.50 - $257.40/hr
Author and defend dissolution and biopharmaceutics content in IND/CTAs, NDA/MAAs, and responses to health authority questions across global markets, including biowaiver justifications and IVIVC/IVIVR ...
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). Monitor and assess emerging regulatory guidance and precedents to proactively shape Lilly ...
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). Monitor and assess emerging regulatory guidance and precedents to proactively shape Lilly ...
Radiology, Join a Leading Independent Radiology Group | 12 Weeks PTO & 2-Year Partnership Track &nda
$33.75 - $46/hr
Fort Wayne Radiology , in partnership with Parkview Health , is actively recruiting Board Eligible / Board Certified Radiologists to join their team. Radiologists are employed by Fort Wayne Radiology ...
Radiology, Join a Leading Independent Radiology Group | 12 Weeks PTO & 2-Year Partnership Track &nda
$33.75 - $46/hr
Fort Wayne Radiology , in partnership with Parkview Health , is actively recruiting Board Eligible / Board Certified Radiologists to join their team. Radiologists are employed by Fort Wayne Radiology ...
Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing (P
Indianapolis, IN · On-site
$123K - $180K/yr
Experience with process validation, technology transfer, and regulatory filings (IND/NDA/BLA) is highly preferred. Lilly is dedicated to helping individuals with disabilities to actively engage in ...
Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing (P
Indianapolis, IN · On-site
$123K - $180K/yr
Experience with process validation, technology transfer, and regulatory filings (IND/NDA/BLA) is highly preferred. Lilly is dedicated to helping individuals with disabilities to actively engage in ...
Author and review regulatory documents to support regulatory submission of IND, BLA and NDA as well as address any process related regulatory inquiries. * Author and review technical reports. * Play ...
Author and review regulatory documents to support regulatory submission of IND, BLA and NDA as well as address any process related regulatory inquiries. * Author and review technical reports. * Play ...
Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing (P
Indianapolis, IN · On-site
$123K - $180K/yr
Experience with process validation, technology transfer, and regulatory filings (IND/NDA/BLA) is highly preferred. Lilly is dedicated to helping individuals with disabilities to actively engage in ...
Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing (P
Indianapolis, IN · On-site
$123K - $180K/yr
Experience with process validation, technology transfer, and regulatory filings (IND/NDA/BLA) is highly preferred. Lilly is dedicated to helping individuals with disabilities to actively engage in ...
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). * Provide technical guidance for analytical activities executed within the external network. Ensure ...
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). * Provide technical guidance for analytical activities executed within the external network. Ensure ...
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). * Provide technical guidance for analytical activities executed within the external network. Ensure ...
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). * Provide technical guidance for analytical activities executed within the external network. Ensure ...
Have experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets. * Provide technical guidance for analytical activities ...
Have experience authoring IND/CTA, NDA/MAA, and country-specific response to questions and/or registering products across global markets. * Provide technical guidance for analytical activities ...
Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing (P
Indianapolis, IN · On-site
$123K - $180K/yr
Experience with process validation, technology transfer, and regulatory filings (IND/NDA/BLA) is highly preferred. Lilly is dedicated to helping individuals with disabilities to actively engage in ...
Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing (P
Indianapolis, IN · On-site
$123K - $180K/yr
Experience with process validation, technology transfer, and regulatory filings (IND/NDA/BLA) is highly preferred. Lilly is dedicated to helping individuals with disabilities to actively engage in ...
... NDA's and other relevant topics related to Human Resources Competencies, Skills & Abilities • Strength with Organizational Design, and Employee Relations • Must be able to manage and prioritize ...
... NDA's and other relevant topics related to Human Resources Competencies, Skills & Abilities • Strength with Organizational Design, and Employee Relations • Must be able to manage and prioritize ...
... NDA/CTD Module 3, Section 3.2.S) Additional Preferences: * Previous supervisory experience * Excellent communication (written and verbal) * Exceptional teamwork/interpersonal/leadership/vision
... NDA/CTD Module 3, Section 3.2.S) Additional Preferences: * Previous supervisory experience * Excellent communication (written and verbal) * Exceptional teamwork/interpersonal/leadership/vision
GSOC Operator
Indianapolis, IN · On-site
$25/hr
... NDA and maintain strict confidentiality. • Must be able to communicate effectively, both verbally and in writing. • Must be able to disseminate information effectively and confidently to ...
GSOC Operator
Indianapolis, IN · On-site
$25/hr
... NDA and maintain strict confidentiality. • Must be able to communicate effectively, both verbally and in writing. • Must be able to disseminate information effectively and confidently to ...
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). * Provide technical guidance for analytical activities executed within the external network. Ensure ...
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). * Provide technical guidance for analytical activities executed within the external network. Ensure ...
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). * Provide technical guidance for analytical activities executed within the external network. Ensure ...
Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ). * Provide technical guidance for analytical activities executed within the external network. Ensure ...
Author and review regulatory documents to support regulatory submission of IND, BLA and NDA as well as address any process related regulatory inquiries. * Author and review technical reports. * Play ...
Author and review regulatory documents to support regulatory submission of IND, BLA and NDA as well as address any process related regulatory inquiries. * Author and review technical reports. * Play ...
Nda information
See Indiana salary details
$19.90 - $24.29
4% of jobs
$24.29 - $28.68
0% of jobs
$28.68 - $33.06
11% of jobs
$36.04 is the 25th percentile. Wages below this are outliers.
$33.06 - $37.45
15% of jobs
$37.45 - $41.84
14% of jobs
The median wage is $43.16 / hr.
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21% of jobs
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10% of jobs
$50.74 is the 75th percentile. Wages above this are outliers.
$50.61 - $55
18% of jobs
$55 - $59.39
7% of jobs
$59.39 - $63.78
0% of jobs
$63.78 - $68.16
0% of jobs
$19
$44
$68
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What is an NDA job?
An NDA (Non-Disclosure Agreement) job refers to a position that requires employees to handle confidential or sensitive information under a legal agreement. These roles are common in industries like technology, healthcare, finance, and government, where protecting proprietary data is critical. Employees in NDA jobs must ensure that restricted information is not shared with unauthorized parties. Violating an NDA can lead to legal consequences, including fines or termination.
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Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 27 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
Organization Overview:
The Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, peptides, oligonucleotides, and other emerging therapeutic modalities spanning oncology, immunology, neuroscience, and metabolic diseases. By cultivating a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients. This is an exceptional time to join SMDD and help shape the future of pharmaceutical development.
About This Opportunity:
SMDD has an exciting opportunity for an Advisor - Analytical Chemistry Research to join our collaborative team as an individual contributor in a primarily laboratory-based role. This position uniquely positions you at the forefront of pharmaceutical innovation, working hands-on across multiple cutting-edge modalities (oligonucleotides, peptides, and small molecules) while directly impacting patient lives through medicines that advance from bench to bedside.
As a lab-based scientist empowered by access to state-of-the-art analytical platforms, structured mentorship programs, and extensive pharmaceutical development experience spanning the entire drug lifecycle, you will conduct hands-on experimental work while shaping analytical strategies for some of the most promising therapeutic advances in the industry. SMDD scientists gain versatile technical expertise highly valued throughout pharmaceutical development-experience that accelerates career growth and opens doors to senior scientist roles and technical leadership opportunities. Our collaborative team values diverse perspectives, supports work-life integration, and celebrates both scientific rigor and creative problem-solving.
Position Responsibilities:
As an individual contributor, analytical scientists in SMDD enable the comprehensive characterization of materials and processes necessary to ensure the quality, safety, and efficacy of Lilly's medicines through direct laboratory work. This responsibility requires hands-on contribution to the development of analytical methodology, execution of experiments to generate key data, and support of regulatory documents (e.g., IND, NDA). Scientists in this position are expected to:
- Perform hands-on laboratory work to support the design, development, and implementation of product control strategies for oligonucleotide, peptide, and/or small molecule programs, directly enabling clinical milestones and regulatory submissions.
- Demonstrate proficiency in multiple analytical technologies through daily laboratory work, with an emphasis on chromatography and mass spectrometry. Operate cutting-edge instrumentation and apply emerging analytical techniques.
- Execute analytical method development, generate data to justify specifications, conduct stability studies, perform starting material testing for synthetic processes, identify and characterize impurities, and test drug product performance characteristics (e.g., dissolution/disintegration).
- Conduct hands-on laboratory research to support internal process development in a fast-paced environment. This includes experimental design, sample preparation and analysis, instrument operation and troubleshooting, and data interpretation.
- Provide technical input for analytical activities executed within the external network. Review methods to ensure they are technically sound, well developed, and fit for purpose. Support technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
- Identify and implement innovative laboratory solutions to development challenges, monitor emerging trends in analytical chemistry, and maintain familiarity with applicable regulatory requirements.
- Demonstrate strong written and verbal communication skills; effectively convey technical results and implications of laboratory data; collaborate with development partners across regulatory, clinical, and manufacturing functions; contribute to internal technical reports and regulatory submission documents.
- With experience, provide informal mentorship to junior scientists and contribute technical expertise to cross-functional project teams while maintaining focus on individual contributor laboratory responsibilities.
Basic Qualifications:
- PhD in Analytical Chemistry, Biochemistry, Chemistry, or related field
- Master's degree in Analytical Chemistry, Biochemistry, Chemistry, or related field with >8 years relevant experience
- Bachelor's degree in Analytical Chemistry, Biochemistry, Chemistry, or related field with >12 years relevant experience
Additional Skills/Preferences:
- Experience across multiple analytical techniques (e.g., HPLC, mass spectrometry, NMR, etc) and demonstration of strong hands-on laboratory skills and technical problem-solving abilities.
- PhD Candidates with >2 years of post-PhD hands-on laboratory experience in pharmaceutical development or related analytical chemistry roles
- Experienced candidates should demonstrate a track record of hands-on laboratory contributions to pharmaceutical development projects, including support of regulatory submissions (IND/NDA), method development and validation, and analytical testing strategies.
- Previous hands-on laboratory experience in the pharmaceutical industry or with analytical techniques directly applicable to pharmaceutical development (e.g., HPLC, MS).
- Deep fundamental understanding of and hands-on experience with reversed-phase, ion exchange, size-exclusion, chiral, and/or gas chromatography.
- Working knowledge and practical laboratory experience with optical spectroscopy (e.g., Raman, FTIR), NMR, structure elucidation, and powder characterization techniques (e.g., XRPD, particle size distribution).
- Strong hands-on technical skills, learning agility, ability to prioritize laboratory workload, and aptitude in navigating experimental challenges.
- Motivated to work both independently and collaboratively in a dynamic laboratory environment.
- Passion for applying analytical chemistry through hands-on laboratory work to solve real-world pharmaceutical development challenges and improve patient outcomes.
What We Offer:
Lilly is recognized as a top employer for innovation, employee development, and commitment to bringing medicines to patients who need them. We offer competitive compensation, comprehensive benefits, and a culture that values scientific excellence, collaboration, and continuous learning.
Additional Information:
- Laboratory-based position with daily hands-on experimental work
- Possible exposure to chemicals, allergens, and loud noises
- Occasional travel (0 to 10%)
- Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)
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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600
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