Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals.
At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees.
With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.
We are building on our rich history, and believe our greatest achievements are ahead of us.We invite you to apply and join us if you're passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization.Experience and contribute to our unique culture while you develop and expand your career!
RESEARCH ASSOCIATE II - SENIOR SCIENTIST
PHARMACEUTICAL DEVELOPMENT
Ionis Pharmaceuticals seeks an experienced pharmaceutical development professional to support clinical and preclinical drug product formulation activities, analytical testing, and management of activities supporting drug product development and manufacture. The ideal candidate will be an independent self-starter with experience in parenteral drug product formulation along with the ability to manage complex projects on tight timelines. The successful candidate will be able to perform the following responsibilities, which spans the scope of pharmaceutical product development, with a high degree of independence and attention to detail.
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.

REQUIREMENTS:

• 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.
• 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.

The successful candidate is expected to have prior laboratory experience in related fields such as analytical testing, physical characterization or formulation development. The candidate is expected to work with a sense of urgency within a multidisciplinary team to be both productive and yet thorough even during intense timelines. The candidate will have a good understanding of the drug development process and technical experience in parenteral manufacturing is a plus, particularly aseptic processing and analytical method transfer in a GMP environment - where strong attention to detail is required for both data integrity and good scientific principles. It is anticipated that the candidate will have a good understanding of the science relating to critical product characteristics for parenteral product configurations.
Please visit our website, http://www.ionis.com , for more information about Ionis and to apply for this position; reference requisition #IONIS003445
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=to Applicants »-,Benefits,-Employees are rewarded
The pay scale for this position is $68,250 to $137,802
Pay scale for Research Associate II/Senior Research Associate (non-PHD) is $68,250 to $108,002
Pay scale for Scientist/ Senior Scientist (PHD) is $79,960 to $137,802
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
/Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.