Location hayward, ca
Remote available
We are looking for a principal engineer, bioprocess to join our consulting team and provide market leadership to the life science industryThis is a full time salaried position with bonus and a benefits package to attract top talent.
Job functions
Will be a supporting member of the process development and production teamThis position will be focused on the support of clinical production in a cgmp facility, as well as, support of equipment design, scale-up, specifications, installations, commissioning, and qualification.
Responsible for identifying opportunities to optimize client’s process technologies and improve qualityThis includes data collection and analysis to support new and ongoing process development and scale up activities.
Provide broad based consulting services to regulated life sciences clients; such services will include potential new client sales, develop proposals, project management as well as execution of project deliverables.
Serve as a qbd subject matter expert with respect to formulation development, process development, process transfer and scale up, and process validation.
Design processes for validation, product/process transfers and continued process verification; including data analysis, gap analysis, identification of critical technical and compliance requirements, technical and compliance documentation review, and process metrics.
Identify opportunities to reduce process variability which includes, but not limited to, conceptualizing and directing equipment solutions and refining /updating procedures and operational checklists and training guides
This position will execute complex tasks and experiments independently, while mentoring and leading others during the course of a project
Evaluate incoming processes for operability and develop risk assessment plans
Qualifications
Bachelor degree in a scientific or engineering related major plus 10 years’ experience within a gmp manufacturing environment in the biotech or pharmaceutical industry is required
Proven autologous, allogeneic cell and/or gene therapy industry leader with a minimum of 5 years specific hands-on expertise in development and and/or commercial operations.
Applied expertise in best practices with cell & gene therapy companies at various stages of the product lifecycle - r&d, clinical, and commercialFacility design a plus.
Knowledge of quality target product profile, critical quality attributes, and critical process parameters as well as a working familiarity with quality by design (qbd) is essential
Excellent understanding of process design and optimization principles, cmc, root cause analysis methodologies is required
Proficient with gdp, cgmps, glps, ich, cfr, and global regulations as appropriate.
Travel without restrictions up to 20% for business development and to client project sites both domestically and internationally required.
Strong understanding of equipment qualification, validation, scale up and tech transfer
Knowledge of cgmps and experience working in a gmp biotechnology or pharmaceutical manufacturing setting
Detailed knowledge of facilities, systems, and infrastructure within a regulated industry
Strong knowledge of upstream and downstream bioprocessing and fill/finish
Experience in design of experiments (doe) and statistical analysis software (jmp)
Working knowledge of design (solidworks) and fabrication of parts and assemblies
Pharmatech associates, incProvides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
