Eli Lilly and Company · 1 day ago
Senior Advisor, Engineering, Biologics Drug Product Development
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$126K/yr - $205K/yr
2+ years expEli Lilly and Company is a global healthcare leader dedicated to improving lives through innovative medicines. The Senior Advisor, Engineering, Biologics Drug Product Development will define clinical manufacturing processes for parenteral drug products, drive collaboration with cross-functional stakeholders, and support regulatory submissions.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Define and develop clinical manufacturing processes for parenteral drug products to support clinical manufacturing
Drive collaboration with cross functional stakeholders to develop manufacturing process control strategies, process performance criteria, and capability criteria
Lead manufacturing related process design including tech evaluation, study design, scale-up model and mentoring junior scientists to define manufacturing process and determine process parameters
Serve as tech lead to drive tech transfer including but not limited to internal and external manufacturing capacity evaluation, gap/risk assessment, defining mitigation strategy, authoring tech transfer documents, as well as reviewing batch records for drug product and placebo
Collaborate with tech/manufacturing service stakeholders to define process qualification and control strategy as well as serve as process tech expert to address critical technical gaps and/or challenges, provide onsite oversight of manufacturing as needed
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 a critical role in facilitating departmental knowledge sharing and initiatives to promote technical excellence
Serve as tech expert to explore, evaluate and implement new technologies applicable to drug product development portfolio from clinical to commercialization
Stay abreast of current process technology to drive evaluation and implementation of new technology from bench test to commercialization to support Lilly parenteral product development portfolio
Understand and comply with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and participate in the establishment and maintenance of departmental Quality systems
Establish effective networks with internal and external stakeholders to promote effective collaboration to accelerate cross-functional decision-making
Qualification
Required
PhD/MS/BS degree in Pharmaceutical Chemistry or Engineering or related field and the following years of direct industry experience:
PhD with minimum of 2 years of industry experience in pharmaceutical development or manufacturing
MS degree with 10 years of industry experience in pharmaceutical development or manufacturing experience
BS degree with minimum of 12 years of industry experience in pharmaceutical development or manufacturing experience
Extensive knowledge and deep understanding of biologics parenteral product development is required
Deep understanding of cGMP requirements, ICH and regulatory guidelines are a must
Demonstrated ability to influence internal and external stakeholders to drive decision-making
Sound understanding of statistics and data management are essential
Strong oral and written communication skills are essential
Preferred
Proven success track in advancing parenteral products from clinical to BLA/NDA regulatory submission is highly preferred
Sound understanding and hands-on experience in developing ADC, mRNA LNP and other new modality manufacturing processes is highly preferred
Benefits
Company bonus
401(k)
Pension
Vacation benefits
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
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reference. (Data Powered by US Department of Labor)
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2025 (514)
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2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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