The Drug Product Process Engineer will report to the Head of Manufacturing and Supply Chain and is responsible for drug product manufacturing and development activities being conducted at Adagio’s Contract Manufacturing Organizations (CMOs). The individual in this role will make key contributions towards successful technology transfer, process scale-up, process characterization, process validation, and clinical and commercial manufacturing supply efforts.
- Serve as a subject matter expert and provide direct oversite (as person in plant) for drug product manufacturing activities at CMOs including formulation, aseptic filling, visual inspection, and packaging.
- Lead and manage the execution of various drug product related studies including filter validation, extractables and leachables, in-use material compatibility, and shipping.
- Facilitate timely execution, disposition, and release of drug product batches through detailed technical review of master batch records... executed batch records, and other cGMP documentation.
- Support technology transfer and oversee transfer activities for drug product unit operations.
- Provide technical support and participate in formulation development activities.
- Ensure that assigned processes are cGMP compliant and are designed to meet FDA and EMEA requirements.
- Provide relevant information for drug product sections of regulatory filings (including INDs, IMPDs, briefing packages, and other regulatory dossiers)
- Other responsibilities as assigned.
- BS/MS in Pharmaceutical Engineering, Chemical Engineering, or related Scientific/Engineering field with 5-10 years of Biopharmaceutical, Pharmaceutical, or Biotechnology industry experience.
- Experience in biologics drug product manufacturing and development including tech transfer, scale-up, late-stage validation, and commercial manufacturing.
- Experience with aseptic filling of liquid vials, pre-filled syringes, and lyophilized drug product.
- Knowledge of best current industry practices and trends in disposable sterile technologies.
- Working knowledge of relevant FDA, EU, and ICH guidelines and regulations.
- Knowledge of cGMP regulations, process validation principles, and aseptic processing principles.
- Must have strong decision-making, leadership, and interpersonal skills. Able to effectively communicate with external partners, peers, and senior management.
- This position is remote, work hours are typically 9:00 a.m. to 5:00 p.m. Eastern Standard Time; there may be an occasional meeting outside of normal business hours with our national employees, vendors, partners, and international partners