Manager – Pharmaceutical Operations

Position Overview

The Manager of Pharmaceutical Operations will provide phase appropriate CMC GMP support for LJPC’s drug candidates. The position manages and supports drug substance and drug product manufacture at LJPC’s contract manufacturing partners inclusive of process transfers, scale-up, registration lot manufacture and process validation.

Core Responsibilities include:

  • Author, review, and support execution of technical reports, SOPs, validation protocols/reports, Quality system documents and CMC-related regulatory documents;
  • Work closely and collaboratively with LJPC’s internal development team and external manufacturing partners to develop, optimize, and scale GMP manufacturing processes;
  • Collaborate with and approve CMO master batch records, perform CMC technical review of executed of batch records for drug substance, drug product, and packaging/labeling, resolve any deviations or technical issues with Quality Assurance;
  • Provide CMC support to development project teams, assist with forecasting requirements for drug substance/drug product supporting stability, clinical, and pre-clinical project milestones;
  • Work with Pharm Ops stability and analytical to establish specifications and assure release test and stability programs are in place to support IND and IMPD filings
  • Support supply chain as needed for clinical trial packaging / labeling and logistics

Qualifications:

  • Bachelor of Science in Biology, Chemistry, or related field with a minimum of five years of relevant experience in a cGMP pharmaceutical environment
  • Experience with small molecules, biologics, and peptides preferred
  • Experience in drug product formulation and manufacturing (tablets, capsules, parenteral injectables)

Specialized knowledge:

  • Working knowledge of phase appropriate CMC regulatory requirements
  • Experience with IND and IMPD CMC writing
  • Knowledge of analytical methods supporting characterization and release test of products
  • Knowledge/understanding of drug/device combination requirements

Other skills/ abilities:

  • Demonstrated ability to work in a team/matrix environment to achieve goals
  • Demonstrated ability to manage multiple projects in parallel

Ability to travel up to 10% may be required