Assistant Director / 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 DIRECTOR / ASSOCIATE DIRECTOR, PHARMACEUTICAL DEVELOPMENT

SUMMARY:

Ionis Pharmaceuticals seeks an experienced pharmaceutical development professional to support the development of injectable drug-device combination products. The ideal candidate will be an independent self-starter with experience in drug product process engineering for the development and manufacturing of combination products, along with authoring technical documents to support regulatory submissions. The successful candidate will be able to perform the following responsibilities with a high degree of attention to detail.

RESPONSIBILITIES:

• Lead, coordinate, and serve as person-in-plant for fill/finish of aseptic contract manufacturing of vial, prefilled syringe, and other related dosage forms from phase I clinical through process performance qualification (PPQ) in a GMP regulated environment.
• Manage the pharmaceutical operations/process technology for process design/engineering of clinical and commercial sterile dosage forms at contract manufacturing organizations (CMO), as well as hands-on internal process engineering laboratory support. Identify, develop, and/or transfer process analytical technology (PAT) and/or other related methods to support control of the process. The scope of work includes using statistical tools (e.g., JMP) for process design/control and process justification while applying formulation chemistry knowledge to process design.
• Author/review various drug/combination product development reports and CMC regulatory dossiers (CTD Module 3- Quality) to support clinical and commercial products. The scope of work includes data analysis using statistical tools and writing responses to regulatory
• Support preclinical pharmaceutical operations such as hands-on aseptic filling of test articles.
• Laboratory bench support of drug/combination product development, including stability studies.
• Other duties as assigned.

REQUIREMENTS:

• Position level may be adjusted as appropriate based on the candidate’s qualifications.
• BS or MS with at least 8 years of related industry experience OR a PhD with at least 4 years of related industry experience in a Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry, or related major.
• Experience leading and coordinating CDMO drug product development and GMP aseptic manufacturing activities, including process design.
• Good technical and regulatory writing skills/experience to support global clinical and commercial regulatory filings.
• Knowledge of ICH and other relevant global regulatory standards, such as ISO.
• Direct experience developing biologics (i.e. proteins and peptides) and/or oligonucleotides (i.e. ASOs and siRNAs) drug products is a strong plus.
• Hands-on experience with the development of drug-device combination products (i.e. PFS and autoinjectors) is preferred.
• Ability to travel domestically and internationally as needed (typically less than 25% travel) to support technology transfer, process engineering, and GMP production of drug-device products.

A strong candidate will have a combination of practical experience and first principles understanding of the science and engineering related to the development and manufacturing of drug-device injectable products, along with a good understanding of the inter-relationships of all key disciplines such as Pre-clinical/Tox, Quality, Clinical, and Regulatory Affairs.

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003633

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 $126,158 to $187,402

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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