Director Pharmaceutical Development Jobs (NOW HIRING)

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’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.  With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and 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 that our success is a direct result of the exceptional talents 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, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. 

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

SENIOR RESEARCH ASSOCIATE / SENIOR SCIENTIST, PHARMACEUTICAL DEVELOPMENT

SUMMARY: 

Ionis Pharmaceuticals seeks an experienced pharmaceutical development scientist to support laboratory experiments, review development data, and author and standardize technical reports for injectable drug products in development. The ideal candidate will be an independent self-starter with experience in analytical, formulation and process support for early and late-stage development of oligonucleotide-based drug products including conjugated with small molecules, peptides and proteins. 

The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.

RESPONSIBILITIES:

• Analytical support for formulation development, development stability and drug product manufacturing process development of early and late-stage parenteral drugs.
• Perform laboratory experiments to develop formulation and aseptic manufacturing processes and to assess development stability and characterize combination products.
• Statistical treatment of data sets including DOE
• Author and/or review of technical data and reports, summarizing development studies and supporting regulatory submissions, while ensuring scientific rigor and accuracy, and presentation clarity
• Author / review of drug product specifications, manufacturing batch records, stability protocols, stability data, expiration dating and related documents, ensuring timely data reporting for regulatory submission
• Work closely with cross-functional teams including Analytical, Drug Product, Device, Clinical, QA, and Regulatory to develop drug products while meeting regulatory requirements
• Perform other duties as assigned

REQUIREMENTS: 

• BS with a minimum of 5 years, MS with a minimum of 3 years, or PhD with a minimum of 2 years of related industry experience in Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry, or related major
• Experience with compendial and separation methods (chromatography, electrophoresis) supporting preformulation, formulation development and development stability are required.
• Self-starter with proven skills in designing experiments, analyzing data sets including statistical treatment, presenting technical presentations and authoring technical reports
• Excellent communication skills and the ability to work independently as well as cohesively with internal and external cross-functional teams
• Able to think, perform independently, strategically, analytically, and creatively to solve technical and project challenges
• Knowledge of FDA, ICH, ISO, USP and relevant guidance documents in product development
• Good technical writing skills/experience
• Work efficiently and effectively in a fast pace, cross-functional environment with excellent time and project management skills to manage multiple time-sensitive projects.
• Strong interpersonal, communication, and collaboration skills along with strengths in meeting project deliverable(s).
• Role is onsite and does not support remote working; 3 – 5 days of laboratory work per week is expected

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS004037

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits

The pay scale for this position is $87,500 to $154,461
The pay scale for Senior Research Associate (B.S. or M.S. Degree) is $87,000 to $108,662

The pay scale for Senior Scientist (PhD) is $99,696 to $$154,461

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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