Ionis Pharmaceuticals, Inc. · 3 days ago
Research Associate II - Senior Scientist, Pharmaceutical Development
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Responsibilities
Design, perform and interpret experiments for preformulation, formulation, and drug delivery studies.
Conduct prototype stability, excipient and material compatibility, and formulation characterization experiments.
Perform analytical and physical testing including HPLC, LC/MS, viscosity, turbidity, osmolality, moisture content, pH, particle size, and UV/Vis spectrometry.
Clearly document all work in batch records and laboratory notebooks to ensure data integrity.
Support GMP drug product operations, including setting drug product specifications and authoring, managing, and coordinating stability studies and maintaining relevant datasets.
Manage activities associated with document reviews and approvals, including interfacing with internal and external stakeholders to coordinate review of GMP and development documentation.
Manage extractables/leachables activities to support regulatory submissions.
Summarize work in both written and verbal communications.
Author technical protocols and reports related to preformulation, formulation, analytical, and manufacturing activities.
Other duties as assigned.
Qualification
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Required
BS or MS with at least 3 years of industry experience OR a PhD with at least 2 years of relevant experience in Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry or a related field.
Minimum of 2 years of experience in preformulation, parenteral formulation development, drug delivery, process development, analytical development, or related areas.
Self-starter and ability to work independently as well as part of a cross-functional team.
Hands-on analytical and lab experience in developing and characterizing formulations.
Experience in HPLC and LC-MS is desirable.
Effective project management skills.
Excellent written and verbal communication skills.
Preferred
Knowledge of the technical and regulatory aspects of extractables and leachables as they relate to parenteral drug products is a plus.
Experience with cGMP fill/finish of sterile injectable drug products and writing relevant sections of regulatory submissions is a plus.
Position level may be adjusted based on the candidate’s qualifications.
The job is an on-site laboratory-based position located in Carlsbad, California.
Benefits
Excellent benefits package
Company
Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been a leader in RNA-targeted therapy, pioneering new markets and changing standards of care.
H1B Sponsorship
Ionis Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (3)
2022 (5)
2021 (5)
Funding
Current Stage
Public CompanyTotal Funding
$1.25B2023-06-06Post Ipo Debt· $500M
2021-04-08Post Ipo Debt· $550M
2012-08-27Post Ipo Debt· $201.25M
Leadership Team
Recent News
2024-06-04
San Diego Business Journal
2024-06-04
SeekingAlpha
2024-06-01
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