Principal Scientist (Formulation Development)

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.