Principal Scientist (Formulation Development)
AbbVie
Full-time
Remote friendly (North Chicago, IL)
United States
$164,800 - $230,000 USD yearly
Clinical Research and Development
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Role Summary
Principal Scientist (Formulation Development) Role focusing on lead formulation and process development for late-stage clinical and commercial programs, including scale-up, tech transfer, and regulatory support.
Responsibilities
- Drive formulation and process development activities for late-stage clinical and commercial programs.
- Lead scale-up, tech transfer, and validation to commercial manufacturing sites (internal and external).
- Manage manufacturing activities including monitoring production campaigns, reviewing batch records, and analyzing process batch data.
- Support resolution of quality investigations or events.
- Author and review CMC sections for regulatory submissions.
- Present technical data and strategic decisions to cross-functional teams and senior management.
Qualifications
- Education & Experience
- Must have a BS in pharmacy, pharmaceutics, chemistry, chemical engineering, pharmaceutical engineering, biotechnology or related discipline, and 5 years’ experience as a functional area lead managing small molecule oral solid drug product development.
- Of the required experience, 5 years: leading late-stage oral tablet formulation development, scale-up, formulation characterization, optimization, and process validation; operating under cGMPs and regulatory/quality compliance in pharmaceutical development and manufacturing; overseeing clinical supply manufacturing; preparing written and oral reports for peers, management, and stakeholders in a matrixed organization.
- Alternatively, an MS in a related discipline with 2 years’ experience as a functional area lead managing small molecule oral solid drug product development, with experience meeting i–iv requirements (details provided in the source).
- With either education/experience combination, must have experience writing CMC sections in at least 3 regulatory submissions for late-stage clinical or commercial applications.
Skills
- Regulatory submissions (CMC writing)
- Late-stage formulation development
- Scale-up and tech transfer
- Quality/compliance and cGMP experience
- Cross-functional collaboration and communication
Education
- Bachelor’s degree in pharmacy, pharmaceutics, chemistry, chemical engineering, pharmaceutical engineering, biotechnology or related discipline; or Master’s degree in a related field.
Additional Requirements
- 100% telecommuting permitted.