Senior Manufacturing Science and Technology Specialist

We are looking forSenior Manufacturing Science and Technology Specialist for our client in Drive Davie, FL

Job Title: Senior Manufacturing Science and Technology Specialist

Job Location: Drive Davie, FL

Job Type: Contract

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:

• Adapt 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.

Position Requirements:

Education / Certification / Experience:

• 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.

Skills / Knowledge / Abilities:

• 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.