Job Description
Senior Specialist, Engineering – Bio Technology and Solutions (BTS) – Tech Hub, focusing on Vaccine and Biologicals processes development for manufacturing. Responsible for process development and support across BTS, Manufacturing, Engineering, Quality and R&D teams. Provide all‑round technological support for production of new (R&D) products.
Primary Responsibilities
- Lead and work independently as a team member on the development and scale‑up of processes or technologies of microbial, virus and cell cultivations, biomolecule concentration, purification and final formulation of veterinary vaccines and therapeutics.
- Transfer processes or technologies of microbial, virus and cell cultivations, biomolecule concentration, purification and final formulation of veterinary vaccines and therapeutics to the production lines.
- Develop processes or technologies and transfer them to the production lines within timelines, ensuring safety, quality, cost‑efficiency, practicality and consistency.
- Conduct technical investigations, validation and process improvement projects.
- Examine issues from diverse perspectives (safety, compliance, automation, equipment, process and people) to understand and resolve root causes.
- Collaborate with team members from QC, Pharmaceutical Technical Support, R&D, Production or Analytical Technical Services to provide direction to scientifically based decisions.
- Implement development, introduction and testing of new technologies; collaborate with R&D and Manufacturing to bring new products to market.
- Lead large cross‑functional teams and demonstrate knowledge of USDA regulatory guidelines and advanced technical knowledge.
- Develop project charters and plans; align with sponsors and stakeholders.
- Define timelines, deliverables, roles and responsibilities, risk identification, tracking and mitigation.
- Coordinate and track team activities; communicate risks and status to stakeholders; raise issues to sponsors as needed.
- Support inspection readiness with Commercialization, Quality and Regulatory; assure application of standardized work and engineering tools.
- Conduct and design experimental protocols using Technical Operations lab facilities and/or production equipment.
- Create and update technical and manufacturing documents for investigations, process design, engineering studies, demonstrations, change control and validation.
- Demonstrate leadership behaviors and high emotional intelligence.
- Collaborate effectively with on‑site and off‑site peers.
- Contribute to international projects.
- Interact with fellow scientists and external collaboration partners as required.
- Improve or accelerate department activities, including Environment Health and Safety.
- Train and guide employees and/or trainees.
Education Minimum Requirement
- Bachelor’s degree in Biochemical Engineering, Biotechnology, Chemical Engineering, Biology, Biochemistry, Protein Chemistry, Microbiology plus 5 years’ experience in vaccine/biopharmaceutical R&D, Process Development or Biological manufacturing, or a Master’s degree with 3 years’ experience, or a PhD in a related field.
Required Experience And Skills
- Excellent written and verbal communication.
- Excellent project management, documentation and writing.
- Excellent teamwork.
- Strong problem‑solving skills and a hands‑on approach inclusive of diverse perspectives (e.g., safety, compliance).
- Experience working in multidisciplinary and international teams.
Preferred Experience And Skills
- Experience in bioprocess scale‑up and vaccine manufacturing.
- Working knowledge of USDA regulations.
- Knowledge of GMP requirements for manufacture and testing of biological products.
- Understanding of statistics applied to process monitoring and control.
- Knowledge of molecular biology, replicon particles, cell cultivation.
Required Skills
- Adaptability.
- Data analysis.
- Interpersonal relationships.
- Manufacturing processes.
- Production process development.
- Project management.
- Regulatory compliance.
- Root cause analysis (RCA).
Equal Opportunity Statement
As an Equal Employment Opportunity Employer, we provide opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities.
US And Puerto Rico Residents Only
Only US and Puerto Rico residents are eligible.
San Francisco Residents Only
Qualified applicants with arrest and conviction records will be considered in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only
Eligible applicants, including those with criminal histories, will be considered in compliance with the City of Los Angeles Fair Chance Initiative for Hiring Ordinance.
Travel Requirements
10%
Benefits
Salary range: $117,000.00 – $184,200.00. Annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation and sick days.