Principal Scientist (Formulation Development)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Key Responsibilities

• Drive formulation & process development activities for late-stage clinical & commercial programs.
• Lead scale-up, tech transfer, & validation to commercial manufacturing sites (internal & external).
• Manage manufacturing activities including monitoring production campaigns, reviewing of batch records, & process batch data.
• Support resolution of quality investigations or events.
• Author & review CMC sections for regulatory submissions.
• Present technical data & strategic decisions to cross functional teams & senior management.

Qualifications

Education & Experience

Must have a BS in pharmacy, pharmaceutics, chemistry, chemical engineering, pharmaceutical engineering, biotechnology or related discipline, & 5 years’ experience as a functional area lead managing small molecule oral solid drug product development.

Of experience required, must have 5 years:

1. leading late-stage oral tablet formulation development, scale-up, formulation characterization, &  optimization, and process validation;
2. operating under cGMPs &  associated regulatory &  quality compliance in the pharmaceutical development & manufacturing environment;
3. overseeing clinical supply manufacturing;
4. preparing, written & oral reports, for peers, management &  business stakeholders within a matrixed organization.

Alternatively, would accept MS in pharmacy, pharmaceutics, chemistry, chemical engineering, pharmaceutical engineering,  biotechnology or related discipline & 2 years’ experience as a functional area lead managing small molecule oral solid drug product development.   Of