We are currently seeking a highly motivated Pharmaceutical Drug Product Engineer.   You will have an opportunity to be an integral part of the company’s growth trajectory from early to late state clinical trials. We offer a highly collaborative, fast paced, innovative culture with comprehensive benefits, 401k plan and participation in our stock option program.

Position will be responsible for establishing and overseeing the development of methods and technologies associated with late-stage drug product production/fill/finish process development, API manufacturing, product and materials characterization and drug product definition finalization including regulatory authoring. The selected candidate will work with our vendors for manufacturing and our analytical team for validation and implementation of the test method and specification development for drug product and APIs, primary packaging container closures, and secondary packaging component.

Responsibilities include:

• Oversee and manage aspects of late-stage small molecule drug product fill/finish process development, scale-up and characterization with current and potential new drug product manufacturing vendors.
• Oversee and manage aspects of late-stage small molecule active pharmaceutic ingredient process development, scale-up and characterization with current and potentially new manufacturing vendors.
• Drive the planning, design, execution, and documentation of fill/finish process development, scale-up, batch manufacturing, characterization, and stability studies. Support process validation, packaging, and transportation activities.
• Evaluate new technologies applicable to sterile injectable drug product container closures and the devices.
• Develop and oversee test methods and specifications for APIs, drug product, container closures, devices, filters, labeling and packaging.
• Author and defend technical protocols, reports, product impact assessments and CMC regulatory sections in support of IND amendments and marketing application submissions.
• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials.
• Lead and complete complex projects in a matrixed environment, including manufacturing, quality, and external research and development partners, to ensure technical recommendations are aligned with business needs, agency guidelines and internal quality standards.
• Quality and data analysis of production processes and other data generated by the company.

Qualifications:

• BS (MS preferred) Degree in Chemical Engineering (1-3 years relevant experience).
• Passion for technology and engineering, along with an eagerness to learn and grow within the organization.
• Knowledge of aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables and the associated device documentation and regulatory filings.
• Experience providing technical oversight of process development and support.
• Experience managing development and manufacturing activities at CDMOs.
• Industry experience in GMP biopharmaceutical fill/finish process development, process characterization, technical transfers and regulatory authoring preferred.
• Understanding of GMP requirements and regulations for clinical and commercial CMC drug development and manufacturing. Including knowledge of control strategy frameworks as established in various regulatory guidelines.
• Strong problem solving and effective interpersonal skills.