Manufacturing Science & Technology (MSAT) ManagerThe Manufacturing Science and Technology (MSAT) Manager is responsible for leading the development, optimization, and implementation of robust manufacturing processes and technologies in a 503B outsourcing facility. This role ensures the successful transfer of new products into production, the optimization of existing processes, and adherence to regulatory requirements, all while fostering innovation and operational excellence. This role is critical for driving manufacturing excellence, ensuring product quality, and supporting the growth of Leiter's strategic growth plan.
Responsibilities:Process Development and Optimization:- Lead the development and implementation of scalable, reproducible, and compliant manufacturing processes for sterile and non-sterile compounding.
- Optimize existing processes to improve efficiency, reduce costs, and enhance product quality while maintaining compliance with cGMP and FDA regulations.
- Analyze process performance data to identify trends, risks, and opportunities for improvement.
Technology Transfer:- Manage the transfer of new products and processes from Product Development into manufacturing.
- Develop and oversee scale-up strategies, ensuring robust and validated processes.
- Collaborate with cross-functional teams to ensure seamless integration of new technologies and processes into the manufacturing environment.
Regulatory Compliance:- Ensure all processes and technologies comply with FDA 503B guidelines, cGMP standards, and USP requirements.
- Support regulatory submissions and inspections by providing technical expertise and documentation.
- Lead investigations into process deviations, identifying root causes, and implementing corrective and preventive actions (CAPAs).
Technical Leadership and Innovation:- Evaluate and implement new manufacturing technologies to improve productivity, quality, and compliance.
- Act as a subject matter expert (SME) on manufacturing processes and technologies during internal audits, regulatory inspections, and cross-functional discussions.
- Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies.
Team Leadership and Collaboration:- Collaborate with Quality Assurance, Production, Product Development, and Supply Chain teams to ensure alignment on goals and deliverables.
- Provide training and technical support to staff on new processes and technologies.
Risk Management and Troubleshooting:- Conduct risk assessments for new and existing processes to ensure patient safety and product quality.
- Lead troubleshooting efforts for complex technical challenges, ensuring timely resolution and minimal impact on operations.
Supervisory Responsibilities:- Directly hire and lead a team of engineers, scientists and technicians.
- Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
- Conduct regular 1:1's to address performance, feedback and relationship building.
- Identify training and development needs within the team and facilitate as able.
Experience and Necessary Skills:- Bachelor's degree in Chemical Engineering, Chemistry, Industrial Engineering, Biochemistry, or a related field required. Master's degree preferred.
- 7+ years of experience in sterile pharmaceutical manufacturing, with at least 3 years in a leadership role.
- Deep understanding of 503B regulatory requirements, cGMP standards, and USP guidelines.
- Proven expertise in process development, validation, and technology transfer.
- Deep knowledge of Product and Process Development, Process Validation (IQ, OQ, PQ), analytical instrumentation and FDA regulatory requirements (GxP).
- Familiarity with aseptic processing, cleanroom operations, and automated compounding systems.
- Strong problem-solving, project management, and leadership skills.
- Certification in Lean Six Sigma (e.g., Green Belt or Black Belt) preferred.
- Experience with advanced and automated manufacturing technologies is preferred.
- Familiarity with QbD (Quality by Design) principles preferred.
Benefits:- Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
- Flexible Spending & Health Savings Accounts (FSA & HSA) available
- Dental & Vision insurance
- Employer Paid Life Insurance & Employee Assistance Program
- Short Term & Long-Term Disability Insurance
- Up to 4% 401K Matching (100% vested on day one!)
- Generous Paid Time Off Options - vacation, sick, paid leave and holidays!
- $5,250 Annual Tuition Reimbursement after 6 months
- $1,000 Referral Bonus Program with no limit
- Eligible for annual bonus program
Timeline: We will be accepting applications on an ongoing basis until position is filled.
*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
