Assistant Director, Analytical Development & Quality Control

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); In loco; USD 95.000 - 175.000; Tempo pieno

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Benefits package

Descrizione del lavoro

Ionis Pharmaceuticals, Inc. in Carlsbad, CA is seeking an Assistant Director for Analytical Development & Quality Control to lead analytical strategies for oligonucleotide projects.

The role requires deep expertise in LC-MS, HPLC, GC and GMP environments, with a track record of scientific leadership. You will manage analytical activities, coordinate testing, oversee outsourced work, develop methods and specifications, and author CMC sections for regulatory filings.

Competenze

• Minimum 8 years with BS or 6 years with MS in Analytical Chemistry
• PhD with a minimum of 3 years of industry experience in Analytical Chemistry
• Skilled in operating LC-MS, HPLC, and GC for analysis of samples
• Strong GMP knowledge and familiarity with ICH/FDA method validation guidelines
• Excellent written and verbal communication and ability to work in a matrix environment

Mansioni

• Manage analytical activities for oligonucleotide development projects
• Coordinate and execute testing of drug substance and drug product samples for release and stability
• Oversee outsourced analytical activities at external contract labs
• Develop and validate analytical methods and transfer protocols
• Author CMC sections of regulatory filings and present at meetings

Conoscenze

Analytical Chemistry

Mass Spectrometry

GMP experience

Communication skills

Formazione

PhD in Analytical Chemistry

MS in Analytical Chemistry

Strumenti

LC-MS

HPLC

GC

Descrizione del lavoro

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!

ASSISTANT DIRECTOR,

ANALYTICAL DEVELOPMENT & QUALITY CONTROL

Seeking an experienced analytical chemist to join our Analytical Development & Quality Control (ADQC) group at the Assistant Director level. The ideal candidate will be familiar with a broad range of analytical chemistry techniques with an emphasis on mass spectrometry, possess a strong work ethic and strong technical background, demonstrate excellent oral and written communication skills, and have experience working in a GMP environment. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.

WORK LOCATION:

onsite in Carlsbad, CA

Responsibilities

• Manage the analytical activities for oligonucleotide therapeutic development projects
• Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples for release and stability studies
• Manage outsourced analytical activities at external contract labs
• Conduct analytical investigations
• Develop and optimize analytical methods
• Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology
• Design and execute method validation and method transfer protocols
• Author scientific reports and portions of the CMC section of regulatory filings
• Present at internal and cross-functional scientific meetings

Requirements

• A minimum of 8 years for BS or 6 years with a Master's of industry experience in Analytical Chemistry or related discipline
• Ph.D. with a minimum of 3 years of industry experience in Analytical Chemistry or a related discipline
• Skilled in operating LC-MS, HPLC, and GC for the analysis of drug substance and drug product samples
• Good understanding of the drug development process
• Practical knowledge of GMP requirements, with hands-on GMP experience preferred
• Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies
• Ability to solve problems, manage priorities and maintain aggressive timelines for multiple projects
• Ability to work productively and independently within a team or matrix environment
• Excellent written and verbal communication skills

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 $95,411 to $174,695

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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