Production Scientist - Simply Biotech
Production Scientist- Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company! Then we've got the right team for you! In this role, you're responsible for the duties listed below. Immediate opening for a Production Scientist with a biotech company in Torrance, CA who possesses: -Master's Degree or PHD in Chemistry/Biochemistry/Chemical Engineering or similar-3+ years of professional experience in the Biotech/Pharmaceutical Manufacturing industry (CDMO ideally)-Good communication and ability to work with both customers and internal departments
Email resumes to sgriner@talentzok.com or call 424.488.7104.FULL DESCRIPTION: The Production Scientist plays a key role in scaling R&D small-scale processes to GMP large-scale manufacturing, overseeing production activities, and ensuring compliance with quality standards. This role involves authoring and reviewing quality documents, analyzing GMP data, improving yields and processes, and keeping customers updated on project status.
The Production Scientist contributes directly to delivering high-quality products on time while maintaining production efficiency.
The selected candidate will be responsible for:
-Document Review & Authoring: Approve and author quality documents, including MBPRs, SOPs, deviations, CAPAs, validation, and process change controls.-Production Oversight: Provide technical support to production teams, troubleshoot issues during project execution, and manage batch preparation, IPC validation, and hold time studies.-Process Improvement: Conduct root cause analyses, risk assessments (e.g., CRIA, FMEA), and bottleneck or gap analyses to optimize production processes.-Stakeholder Communication: Prepare and deliver regular updates to internal and external stakeholders, including presentations and reports on project progress and investigations.-Technology Transfer: Support the transfer of processes from R&D to GMP by preparing comparability reports, identifying critical process parameters, and reviewing PPQ documents.-Data Analysis: Collect, trend, and analyze in-process data to monitor yields, identify process changes, and improve performance.-Training & Mentorship: Train and mentor operators and team members in upstream and downstream processes, MBPRs, and unit operations.-Collaboration: Work closely with cross-functional teams, including QA, QC, Development, Regulatory, and Supply Chain, to plan and execute manufacturing operations.-Regulatory Support: Assist QA and regulatory teams with document reviews, submissions, and responding to client comments.-Continuous Improvement: Lead process improvement initiatives, design small-scale experiments, and conduct cost analysis and forecasting to enhance efficiency and productivity.-This position ensures smooth production operations, high-quality output, and effective communication with stakeholders while driving continuous improvement initiatives.
The selected candidate will also possess: Education & Experience
- Required Education: Master's degree in chemistry, Biochemistry, Engineering, or related fields + 3 years of experience.
- Preferred Education: PhD in chemistry, Biochemistry, or related filed + 1 years of experience.
- Minimum 3 years in pharmaceutical manufacturing GMP production or MS&T team.
- Peptide manufacturing experience is preferred.
- Technical Skills: Basic understanding about SPPS GMP manufacturing, Proficiency in HPLC systems, cGMP processes, Data analysis (Minitab experience is preferred).
Performance Metrics
-Meet or exceed 90% of on-time MBPR, technical reports, and quality related documents delivery targets.
- Complete all assigned process mapping, route and formulas, & process evaluation.
- This job might be entitled to a customer facing/ updates in a timely manner.
- Completed all related data collection for the GMP projects and performed trending as needed.
For immediate and confidential consideration, please email your resume to sgriner@talentzok.com or call 424.488.7104.More information can be found at www.simplybiotech.com