Principal Scientist - Drug Substance, Process Development
Greater Los Angeles Area
Salary: $120,000 - $130,000 + bonus + excellent benefits (local candidates preferred)
A growing pharmaceutical company is looking to hire a Principal Scientist focused on Drug Substance and Process Development for their Cell Culture and Purification manufacturing processes. This is a growth hire due to recent expansion plans and success of current clinical pipeline. This person will work alongside the Manufacturing Sciences department and will be responsible for overseeing day to day manufacturing support, global process alignment/improvements, and initiatives of commercial and clinical manufacturing operations of a multi-product manufacturing plant.
This pharmaceutical company is one of few players in this space that has a strong clinical and commercial pipeline of products that are manufacturing and are looking to manufacture. This opportunity allows for extremely fast career progression potential with the chance of being one of the leaders in terms of the strategic direction of the team.
Responsibilities:
- Lead and coordinate technical and cross-functional teams in technology transfer, process optimization, and investigative tasks.
- Manage and oversee Quality by Design activities and documentation, including process FMEAs and risk assessments.
- Develop, review, and implement study and validation protocols and reports.
- Serve as a Subject Matter Expert in manufacturing investigations and process performance monitoring (Lifecycle Process Validation Stage 3 Continuous Process Verification), ensuring quality, yield, capacity, and timelines are met, while troubleshooting GMP equipment and processes and providing technical input for SOPs and production records.
- Partner with global counterparts to support shared initiatives and strategies.
- Contribute to and manage, when necessary, Validation Master Plans, Process Validation, and Material Qualification activities for capital projects, process improvements, technology transfers, and material changes.
- Function as a subject matter expert for audits, change controls, and regulatory submissions.
Requirements:
- Bachelor's degree in scientific field or related with at least 10 years of relevant experience, MS with at least 8 years, or Ph.D. with at least 4 years of relevant experience.
- Extensive knowledge in cell culture, purification, process scale-up, troubleshooting, and technical evaluations of processes, with strong skills in statistical analysis and experimental design.
- Comprehensive understanding of laboratory and pharmaceutical production equipment, including bioreactors, chromatography, ultrafiltration, diafiltration, sterile filtration, process tanks, and CIP/SIP systems.
- Skilled in conducting Product Impact Assessments to support process deviations.
- Expertise in generating risk assessments for change controls and qualification activities.
- Proficient in preparing and executing study protocols for quality scientific experimentation aimed at troubleshooting, scaling up, or optimizing processes.
- Capable of interpreting experimental results and recommending process improvements, considering regulatory requirements, business objectives, and cost factors.
- Experienced in leading projects, technology transfers, and teams to support manufacturing activities.
- Knowledgeable about basic chemical and biological safety procedures.
- Familiar with regulatory agency requirements and preparing submissions for the biopharma industry.
- Experienced in participating in regulatory compliance audits.
- Excellent communication skills, both written and verbal, to effectively work in a cross-functional team environment.
- Possesses personal attributes such as integrity, trustworthiness, a strong work ethic, sound judgment, intellectual honesty, pragmatism, courage, and conviction.
