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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Scientist II - Sterile Sustained Release & Solids Product Development

Irvine, California Req ID 2206556 Category Research and Development Division AbbVie

Plans, directs, and executes product formulation & process development activities in support of development of new products intended for clinical trials and commercialization with focus on sustained release implant and injectable particulate drug delivery systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products.

The essential components of this position are in-depth understanding of pharmaceutical formulation principles, manufacturing process unit operations, global CMC regulatory requirements as well as strong organizational skills to develop formulations intended for clinical trials and commercialization. Specifically,

  • Provide scientific and technical leadership for product formulation development projects and in general, Pharmaceutical Development function. Applies the principles of quality by design (QbD) and statistical process design/analysis to formulation and process development.
  • Demonstrate scientific excellence through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents.
  • Represent department at CMC/Project Team meetings and work closely with other Pharmaceutical Sciences departments, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
  • Apply current CMC regulatory requirements and guidance to support global registration of new products.
  • Exhibit leadership skills that result in good performance and career development of junior staff.
  • Keeps abreast of current developments in pharmaceutical technology, leading edge technologies and regulatory affairs to contribute to the technical base at AbbVie.
  • Have excellent communication (oral and written) and interpersonal skills.

Plans, directs, and executes product formulation & process development activities in support of development of new products intended for clinical trials and commercialization with focus on sustained release implant and injectable particulate drug delivery systems. Conducts research in the area of formulation sciences in support of innovative product development both for new chemical entities and life-cycle management of marketed products.

The essential components of this position are in-depth understanding of pharmaceutical formulation principles, manufacturing process unit operations, global CMC regulatory requirements as well as strong organizational skills to develop formulations intended for clinical trials and commercialization. Specifically,

  • Provide scientific and technical leadership for product formulation development projects and in general, Pharmaceutical Development function. Applies the principles of quality by design (QbD) and statistical process design/analysis to formulation and process development.
  • Demonstrate scientific excellence through scientific reports, published articles in peer-reviewed journals, society participation, regulatory filings, and/ or patents.
  • Represent department at CMC/Project Team meetings and work closely with other Pharmaceutical Sciences departments, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
  • Apply current CMC regulatory requirements and guidance to support global registration of new products.
  • Exhibit leadership skills that result in good performance and career development of junior staff.
  • Keeps abreast of current developments in pharmaceutical technology, leading edge technologies and regulatory affairs to contribute to the technical base at AbbVie
  • Have excellent communication (oral and written) and interpersonal skills.

Qualifications:

  • Ph.D.-level education preferably in pharmaceutical sciences or chemical engineering with 4+ years of applicable experience or M.S with 10+ years of relevant experience.
  • Must be able to operate as a functional area leader and utilize knowledge of pharmaceutical science, chemical engineering, literature and experience to guide decisions in complex situations.
  • Knowledge of fundamental applications of statistics is preferred.

Key Leadership Competencies:

  • Builds strong relationships with peers and cross functionally with partners outside of the immediate team to enable higher performance
  • Learns fast, grasps the “essence” and can change course quickly where indicated
  • Raises the bar and is never satisfied with the status quo
  • Creates a learning environment, open to suggestions and experiments to drive the science in the field of interest
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
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