- Author and/or review of technical data and reports that will support regulatory submissions, ensuring scientific rigor and accuracy, and presentation clarity
- Author and compile drug product CMC sections of US FDA and Ex-US regulatory applications, and submissions of IND and CTA, including amendments and annual updates. Attention to appropriate regulatory strategy is a must have.
- Contribute to standardizing and preparing information or responses as requested by regulatory agencies, QPs, and other authorities.
- Review of drug product specifications, manufacturing batch records, stability protocols, stability data, expiration dating and related documents, ensuring timely collation, alignment and standardization of data needed for regulatory submission
- Maintain current knowledge and expertise, within the CMC regulatory environment (ICH, FDA, EMA, PMDA, etc.), of topics related to parenteral drug products/combination products.
- Work closely with cross-functional teams including Analytical, Drug Product, Clinical, QA, and Regulatory to help develop drug products, meeting regulatory requirements.
- Perform or lead performance of laboratory studies (e.g., formulation characterization, stability) to support drug product development activities.
- Perform other duties as assigned.
- BS or MS with at least 6 years of related industry experience OR a PhD with at least 3 years of related industry experience in Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry or related major
- Working knowledge of CMC sections (e.g., Module 3 CTD) of regulatory filings
- Self-starter with proven skills in authoring and standardizing technical reports and regulatory documents.
- 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.
- Experience in the sterile drug product development (preformulation, formulation, process development and GMP fill/finish).
- Knowledge of FDA, ICH, ISO, USP guidance documents in product development
- Good technical and regulatory writing skills/experience to support global clinical regulatory filings is a must
- 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 delivering regulatory documents on time in support of the program(s)
- Some travel domestically/internationally may be required, as needed.
Assistant/Associate Director, Pharmaceutical Development - Carlsbad, United States - Ionis Pharmaceuticals Inc.
Description
Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland.For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology.
Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises.Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.
As the first company to fully harness the power of RNA technology for human therapeutics, Ionis' platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.
We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees.We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team.
While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive.
We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation.
From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees.
These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow.
Join us and experience our unique culture while you develop and expand your career.ASSISTANT/ASSOCIATE DIRECTOR
PHARMACEUITICAL DEVELOPMENT
SUMMARY:
Ionis Pharmaceuticals seeks an experienced pharmaceutical development professional to support in the laboratory, review development data, author and standardize technical reports, regulatory dossiers for injectable drug products in development.
The ideal candidate will be an independent self-starter with experience in late-stage drug product development; aseptic manufacturing for injectables and authoring clinical stage drug product dossiers, including regulatory strategy.
The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.
RESPONSIBILITIES:
REQUIREMENTS:
Ionis offers an excellent benefits package Follow this link for more details: Ionis Benefits
Full Benefits Link:
,Benefits,-Employees%20are%20rewarded
The pay scale for this position is $114,800 to $181,300
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.