Role: Senior Process Engineer
Location: Brisbane, CA
Type and Length: 12 month Contract w/ extension and conversion possibilities
Reports to: Associate Director, Cell & Gene Therapy Formulation and Fill/Finish
Department: Technical Operations - Formulations & Fill/Finish
- The client is seeking a highly motivated individual with experience establishing and supporting drug product (DP) manufacturing facility and process. The fill/finish facility will be used to manufacture best-in-class viral vector and cell therapy DP.
- The candidate will be responsible for assessing, strategizing, developing, implementing, and supporting end-to-end DP infrastructure and processes based on the facility and product needs.
- This includes assessment of novel production facilities and tools such as modular DP filling, single use systems and components, ready-to-use primary packaging systems, small-scale models for process design, characterization, and validation, and process analytical capabilities to enable a robust facility and process for clinical DP production.
- We are looking for a candidate who is versed with the latest technological developments and insights in the cell and gene therapy manufacturing industry.
- The candidate is expected to drive project milestones in a fast-paced matrix organization with strong negotiation and interpersonal skills to develop close working relationships with internal and external stakeholders.
- The candidate should create a positive work atmosphere with strong team spirit, effectively communicate, motivate, and inspire teams to excel in achieving short and long-term goals.
- Work closely with other engineers (site, mechanical, structural, electrical, chemical etc) to assess, install, qualify, and verify/validate a modular DP filling system with associated DS compounding and filtration containers and components
- Collaborate with the downstream process development group to ensure a smooth transition from purification and final formulation production steps to fill and finish activities
- Design and execute process development, characterization, and validation studies to support fill/finish infrastructure and process requirements to support the production of pipeline genomic medicinal products for clinical supply and resupply
- Lead scale up and technology transfer of products across internal and external manufacturing sites.
- Author, review functional and cross-functional process characterization/validation protocols, multivariate studies, reports and drive timely execution with quality oversight
- Provide on-going fill-finish manufacturing support including MAR support, process capability analysis, and impact assessments during quality investigations to ensure product and process health
- Lead teams to generate production SOPs and other related guidance documents and templates
- Contribute to the compilation and review of master batch/production records, change controls, standard operating procedures, and guidance documents
- Author regulatory section in support of investigation new drugs (IND) and marketing application submissions
- Manage, train, and supervise contractors and consultants if needed to drive program milestones and deliver organizational goals
- Provide strategic guidance to the team in leveraging QbD tools & RRF strategy to take informed risk and accommodate accelerated timelines
- Motivated to work in a challenging environment requiring innovative solutions, quick decision making, prioritization of competing priorities, and ability to listen to others in a respectful way
- Drive innovation and strategic agility to build a futuristic vision and work packages for cell and gene therapy DP process development
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Ph.D. in chemical or biomedical engineering, pharmaceutical sciences, biochemistry, or related discipline and a 2+ years' experience in industry. Will consider BS/MS with 6+ years of experience. Level will be dependent on educations., skills and experience.
- Experience in the assessment, installation, and qualification of DP production equipment and associated consumables and components following cGMP requirements
- Experience in designing and qualification of unit operations such as freeze/thaw, pooling/mixing, filtration, filling, capping, visual inspection, packaging etc.
- Experience with biopharmaceutical product and process development, process-engineering, aseptic fill/finish operations and cGMP knowledge.
- Experience in QbD methodologies and statistical analysis using JMP or Minitab
- Excellent analytical and communication (oral and written) skills are required
- Proven ability to work effectively in a cross-functional organization and to meet team objectives
- Self-starter, solution oriented with collaborative mindset and strong executive presence with strategic and analytical mindset
- Previous experience with gene and cell therapy products is a plus
- Experience with regulatory filings and HA communications is desirable