Assistant / Associate Director, Pharmaceutical Development

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!

ASSISTANT / ASSOCIATE DIRECTOR, PHARMACEUTICAL DEVELOPMENT

SUMMARY:

Ionis Pharmaceuticals seeks an experienced pharmaceutical development scientist as an Assistant or Associate Director to contribute to developing injectable drug products, including formulation studies, analytical testing, and drug product manufacturing. The ideal candidate will be a highly motivated and independent scientist with a strong background in parenteral drug product formulation development and aseptic manufacturing. This role requires the ability to execute responsibilities with a high degree of independence and attention to detail.

RESPONSIBILITIES:

• Lead and support various aspects of drug product development of oligonucleotides unconjugated or conjugated to small molecules, peptides, or proteins, including dose configuration, formulation, stability, manufacturing, release/stability testing, and authoring regulatory filings.
• Manage fill/finish contract manufacturing of GMP clinical batches, which may include authoring and reviewing manufacturing batch records, SOPs, stability study protocols, analytical method transfer, and qualification/validation protocols.
• Interface with outside parties, including CMOs, vendors, and analytical testing labs.
• Design, execute, and interpret experiments for pre-formulation, formulation, and drug delivery studies. Conduct analytical and physical testing, including HPLC, LC/MS, viscosity, turbidity, moisture content, particle size, and UV/Vis spectrometry.
• Clearly document all work to ensure data integrity.
• Author and/or review technical data and reports, summarizing development studies and supporting formulation development and regulatory submissions, ensuring scientific rigor, accuracy, and clarity of presentation.
• Author and/or review drug product specifications, manufacturing batch records, stability protocols, stability data, expiration dating, and related documents, ensuring timely data reporting.
• Collaborate effectively with cross-functional teams, including Analytical, Drug Product, Clinical, QA, and Regulatory, to develop drug products that meet regulatory requirements.
• Perform other duties as assigned.

REQUIREMENTS:

• BS with at least 8 years, MS with at least 6 years, or a PhD with at least 3 years of related industry experience in Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry, or a related major.
• Experience managing all aspects of drug product manufacturing at CMOs.
• Hands-on analytical and laboratory experience in developing and characterizing formulations. Experience with HPLC and LC-MS is highly desirable.
• Working knowledge of fill/finish drug manufacturing processes and supporting analytical methods.
• Demonstrated ability to work independently and collaboratively within internal and external cross-functional teams. Excellent communication skills are essential.
• Experience in sterile drug product development, encompassing pre-formulation, formulation, process development, and GMP fill/finish.
• Knowledge of relevant regulatory guidance for product development.
• Ability to work efficiently and effectively in a fast-paced, cross-functional environment. Excellent time and project management skills are necessary to manage multiple time-sensitive projects.

The position level may be adjusted based on the candidate’s qualifications

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003631

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=our employee spotlight-,Benefits,-Employees are rewarded

The pay scale for this position is $126,203 to $187,200
The pay scale for the Assistant Director position is $126,203 to $162,791
The pay scale for the Associate Director position is $136,526 to $187,200

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.