BSA Lead Production Technician

Main Responsibilities Perform production in accordance with business needs and effective procedures. Ensure all materials required for production are available prior to need. Ensure completion of sampling and corresponding documentation. Complete move tickets and picklists accurately and on time to ensure accurate inventory. Resolve production issues; understand next steps and guide others through the process. Understand the science behind process steps and technology. Ensure all facility areas are adequately covered at all times; seek and advise on next steps. Ensure team planning and ahead-of-schedule work where possible. Complete tasks and documentation as required by cGMP; complete at least one developmental class annually (including at least one outside core competencies). Become trained in all assigned training modules. Training coordinator/trainer: train and guide personnel on work procedures, equipment use, cGMPs, safe work techniques, and SAP to assure consistent, timely signoffs. Maintain qualified trainer status; comply with procedures to ensure safety of self and others. Participate in monthly safety meetings; utilize +QDCI boards; report safety issues/concerns/incidents/near misses; participate in safety walkthroughs. Provide input for safety improvements and corrective/preventative actions; lead safety team efforts and training on safety initiatives. Ensure production of a safe and efficacious product; maintain thorough working knowledge of cGMPs. Identify deficiencies and recommend improvements. Identify deviations; assist with investigations and root cause analysis. Complete quality documentation (deviation investigations, BPRs, logbooks, etc.) accurately and timely; review completeness and release commodities as required. Work with quality and technical services on deviations, change controls, documentation, and CAPAs; ensure effective solutions are implemented and trained. Participate/lead team and cross‑functional meetings; actively communicate improvement ideas, issues, and concerns; mentor team members. Lead operator/room lead/SME in BSA areas; ensure “right the first time” quality. May provide leadership across processing areas; may schedule assignments and drive continuous incremental improvements to reduce operator errors. Inform managers of production problems/concerns and recommend solutions. Ensure processes/operations are documented timely and accurately; understand end‑to‑end BSA process and related business areas. Break down problems using proven standard approaches; fully investigate root causes of deviations. Write/review/revise BPRs, SOPs, and SWIs as needed. Continually monitor production activities with emphasis on safety, quality, efficiency, and cost. Ensure site safety and HR policy compliance; coordinate repair, PMs, and calibration of equipment. All other duties as assigned. Requirements / Qualifications Experience in a cGMP area; prior/related experience recommended. Knowledge and access to systems: SAP (including key user access). Knowledge and access to applicable building/process systems (SFD, PI); qualified to complete BPR section reviews. Good mechanical and computer skills; detail oriented; mechanical aptitude, comprehension/retention, troubleshooting, and manual dexterity. Basic Qualifications HS equivalent and 5+ years in cGMP or pharmaceutical experience. OR Associate’s with 3+ years in cGMP or pharmaceutical experience. OR Bachelor’s with 2+ years in cGMP or pharmaceutical experience. Preferred Qualifications Meet all Sr. Production Technician requirements. 1+ year leading teams in a production environment. 1+ year training others in cGMP tasks. Benefits (explicitly stated) Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs. At least 14 weeks’ gender-neutral parental leave. #J-18808-Ljbffr Scorpion Therapeutics