Senior Manufacturing Science and Technology Specialist
Cynet SystemsDavie, FLjob_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionAdapt Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, and enhance safety for commercial products. Coordinate manufacturing of batches as required and prepare comprehensive technical reports. Perform continuous process verification and cleaning verification, including statistical assessments and trend analysis for both development and commercial products. Conduct root cause investigations, implement corrective and preventive actions (CAPAs), and provide timely product impact assessments to avoid back-order situations. Evaluate supplier material evaluation team (SMET) changes such as API process changes, raw material sourcing updates, or packaging modifications. Execute experimental and process confirmation studies in collaboration with planning, manufacturing, quality, LTS, and project management groups. Analyze analytical and statistical data to support pre-validation work and ensure acceptance criteria are met. Write deviation reports, technical assessments, and validation documentation as required. Support pre-validation commercial scale reports including QEPs, CPPs, and CQAs assessments. Coordinate with R&D, Engineering, EHS, and PM groups to identify equipment requirements and prepare Capital Expenditure Requests (CERs). Participate in internal (corporate and QA) and external (FDA, MHRA) audits; remediate observations and complete action items on time. Maintain accurate documentation including protocols, reports, laboratory notebooks, and SOP compliance. Provide technical support to manufacturing and quality teams during commercial pre-validation. Lead multiple new product introductions, site transfer projects, and cleaning validation activities. Ensure 100% compliance with all training requirements. Maintain work areas in compliance with company policies, cGMP, SOPs, and safety standards. Perform additional related duties as assigned. Ph.D. in Chemistry (entry-level candidates considered) OR Master’s degree in Pharmaceutical Sciences (or equivalent) with at least 12 months of relevant experience in MS&T for solid oral pharmaceuticals. Basic certifications in Power Platform, AI, or Project Management preferred. Strong understanding of pharmaceutical unit operations, including : High shear granulation. Dry granulation (slugging and roller compaction). Compression. Particle and tablet coating (pan and fluid bed). Encapsulation. Laser drill and packaging. Cleaning validation and troubleshooting. Proven ability to prepare high-quality technical documentation (batch records, change controls, protocols, summary reports, technical assessments, validation reports, deviations, and investigation reports). Ability to manage multiple projects and assignments in parallel. Strong analytical and problem-solving skills, with the ability to apply practical solutions in complex situations. Excellent written and verbal communication skills. Knowledge of cGMPs, validation principles, and regulatory requirements.
Job Description :
- The MS&T Scientist will be responsible for supporting manufacturing science and technology (MS&T) activities with a focus on operational excellence, process verification, cleaning validation, and new product introduction for solid oral pharmaceuticals.
- This role involves troubleshooting, data analysis, technical documentation, and cross-functional collaboration to ensure compliance, product quality, and efficiency in commercial and development environments.
Essential Areas of Responsibility :
Position Requirements :
Education / Certification / Experience :
Skills / Knowledge / Abilities :
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Senior Manufacturing • Davie, FL
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