Sr. Manager / Assistant Director, Clinical Supplies Label Operations

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.

SENIOR MANAGER/ ASSISTANT DIRECTOR, CLINICAL SUPPLIES LABEL OPERATIONS

SUMMARY:

This position is responsible for providing comprehensive information about Clinical Supplies Labels and ensuring continuous supply of labels for use in clinical packaging activities.  Reviews country regulatory requirements for clinical labels and maintains a label phrase library for use in all countries. Designs appropriate label strategy in collaboration with the clinical supply leads.  Designs specifications for labels to be printed in house and outsourced. Oversees variety of logistics activities, including but not limited to label stock inventory control, shipment of labels to packaging sites.  Identifies key stakeholders to ensure on time availability of labels for packaging operations.  Leads process improvement efforts and may develop specific department plans and procedures on label production. Creates and revises Standard Operating Procedures as required. 

This position may also be responsible for managing label contractors as well as oversee internal staff, as appropriate.

CORE RESPONSIBILITIES

1. Maintenance of compliant label phrase library
2. Delivery of approved label proofs
3. Ensuring timely printing of labels for use in clinical packaging

COMPETENCIES IDENTIFIED FOR SUCCESS

1. Attention to detail
2. Ability to maintain focus on critical elements
3. Ability to understand and interpret country regulations as it pertains to label requirements.

EDUCATION, EXPERIENCE, AND OTHER REQUIREMENTS

1. Individual should have a bachelor’s degree and a minimum of 3 years relevant experience in the pharmaceutical industry or related medical field.
2. Must have in depth knowledge of Clinical Supplies, pharmaceutical technology and computer systems.
3. Must work independently under cGMP, cGCP, and SOPs.
4. Communicates effectively and strategically.
5. Adept at solving complex problems in creative and effective ways.

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition #IONIS003355

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

Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $86,305 to $152,250

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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