The MS&T Director (Manufacturing Science & Technology Director) is a senior technical leader responsible for ensuring robust, compliance, and efficient manufacturing processes across the product lifecycle. This role bridges R&D, equipment design and commercial operations, overseeing technology transfer from lab to full scale production, troubleshooting, and continuous improvement initiatives. MS&T Director position ensures compliance with global regulatory standards (FDA, cGMP, ICH) and drives innovation to optimize manufacturing performance. MS&T Director is responsible for facility design, equipment maintenance, process optimization, and compliance with cGMP and regulatory standards. The position ensures that engineering strategies align with company objectives and support efficient, safe production. Acts as a Subject Matter Expert for complex technical challenges
location: Bartow, Florida
job type: Permanent
salary: $210,000 - 260,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
- Strategic Leadership
- Develop and implement engineering strategies to support manufacturing and operational goals.
- Lead capital projects, including feasibility studies, design, construction, commissioning, and validation.
- Lead transfer of new products and processes from development to commercial manufacturing.
- Drive continuous improvement initiatives for equipment reliability and process efficiency.
- Ensure scalability, robustness, and compliance during tech transfer activities.
- Develop strategies for process characterization and validation (FAT/SAT/IQ/OQ/PQ, PPQ).
- Strong knowledge of cGMP and global regulatory requirements.
qualifications:
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- Experience with sterile drug manufacturing and cleanroom operation.
- Familiarity with automation systems and digital manufacturing tools.
- Knowledge of Lean, Six Sigma, and continuous improvement methodologies.
- Ability to manage global engineering and maintenance teams
- Facilities & Equipment
- Oversee maintenance programs, utilities, HVAC systems, production equipment and cleanroom environments.
- Ensure readiness for audits and inspections by maintaining validated systems and documentation.
- Team Development
- Build and mentor a high-performing MS&T team.
- Foster a culture of innovation, compliance, and continuous improvement.
- Compliance & Quality
- Ensure adherence to cGMP, FDA and other regulatory requirements.
- Develop and maintain SOPs for engineering processes, calibration, and preventive maintenance.
- Support change control processes and risk assessments
- Project Management
- Manage engineering budgets, timelines, and resource allocation.
- Coordinate cross-functional teams for new product introductions and facility upgrades.
- Oversee commissioning and qualification activities (FAT, SAT, IQ/OQ/PQ).
- Team Leadership
- Recruit, train, and mentor engineering staff.
- Foster a culture of safety, innovation, and continuous improvement.
- Bachelor's or Master's degree in Mechanical, Chemical, Electrical Engineering, or related field (PhD preferred for process engineering roles).
- 10+ years of experience in pharmaceutical or biopharma manufacturing, with at least 5 years in a leadership role.
- Strong knowledge of cGMP, validation, and regulatory compliance.
- Proven experience in managing facility operations.
- Excellent leadership, communication, and problem-solving skills.
- Experience:
- 10+ years in pharmaceutical manufacturing/MS\&T roles, with at least 5 years in leadership.
- Proven expertise in technology transfer, process validation, and aseptic manufacturing.
skills: Sterile Manufacturing
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.