AbbVie

Senior Scientist – Neurotoxin & Biologics Product Development

Employer
AbbVie
Location
Irvine, California
Posted
Sep 25, 2021
Ref
2105600
Required Education
Doctorate/PHD/MD
Position Type
Full time
About AbbVie
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.

 

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 neurotoxin and biologic drug products. Conducts research in the area of formulation sciences in support of innovative product development for new biologic 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 Sciences. 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, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.
  • Apply current CMC regulatory requirements and guidances 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.
  • Have excellent communication (oral and written) and interpersonal skills.

 

Key Responsibilities:

  • Primary focus: Plans, directs, and executes drug product formulation & manufacturing process development activities in support of development of new neurotoxin and biologic products intended for clinical trials and commercialization. The position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.  AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

 

  • Provides scientific and technical leadership on one or more areas of formulation development and dosage form design. Develops and maintains a current in-depth knowledge of global CMC regulatory submission requirements and GLP/GMP requirements. Review internal and external technical documents, writes technical memos/reports, patents and scientific articles.

 

  • Represents department at CMC/project team meetings and work closely with other Pharmaceutical Sciences departments, Toxicology, Regulatory Affairs, Quality, Clinical Development and Marketing to meet project timelines and objectives.

 

  • Performs supervisory duties including reviewing progress of assignments against established project timelines, assistance on daily work direction, problem solving and advice to junior staff to enhance their work effectiveness in generating data, ensuring good record keeping of all laboratory data, adherence to lab safety and general staff development.

 


Qualifications

Requirements:

  • Ph.D.-level education in pharmaceutical sciences, biochemical/chemical engineering, biology, chemistry or other related scientific with 4+ years of applicable experience.
  • Must be able to operate as a functional area leader and utilize knowledge of pharmaceutical science 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 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 experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and enables innovation to reality.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.