MSAT Specialist

The Manufacturing Science and Technology (MSAT) department reports through Operations and owns the scientific and technical oversight of the commercial manufacturing processes. This team acts as a bridge between Production and other groups, including but not limited to R&D Product Management, Quality Assurance, Quality Control, and Process Engineering, to ensure the company develops and maintains compliant, robust, efficient, and maintainable manufacturing processes.

• Authoring deviations and investigations utilizing Root Cause Analysis tools. Providing organized updates to stakeholders.
• Implementing corrections
• Authoring and maintaining Production SOPs, Work Instructions.
• Identifying and supporting process improvement projects.
• Preparing production Change Controls. Communicating changes to stakeholders, including through training as applicable. Implementing changes and coordinating with other task owners to ensure the change is effectively implemented.
• Preparing and presenting Operations Metrics and KPIs and taking action to reduce waste and/or improve capacity, yield, technology, or other operational efficiencies.
• Contributing to a professional, dynamic, cooperative, and high-achieving work environment for the team.
• Supporting day-to-day activities response to production issues, for example, assessing Visual Inspection defects, supporting complex GDP corrections, evaluating raised issues to determine if a deviation is required, engaging the appropriate other cross-functional teams such as QA for involvement, etc.
• Performing physical walkthroughs of the Production spaces to ensure audit readiness and cGMP compliance, and addressing or escalating findings.
• Supporting audits, including providing documents and information during the audit, and addressing Production related observations.

• REQUIRED:
  
  Bachelor’s degree in scientific discipline
• Thorough understanding of applicable mathematics and scientific practices.
• Proficient in Microsoft Office Applications.
• Excellent communication skills, both oral and written. Ability to work in a team and/or independently. Emphasis in technical writing ability, however communication may include a variety of audiences (technicians, technical support staff, management, customers, etc.)
• Able to resolve conflicts and provide solutions.
• Must be able to function in a team environment.
• Must be able to read, understand and follow GMPs, SOPs, Specifications, and industry guidelines as they relate to the process.
• Time management skills and the ability to manage their workload and deadlines. Projects must be completed in a timely manner despite aggressive timelines.

• Minimum 1 year of experience and/or knowledge in a Pharmaceutical cGMP environment. Other regulated environments, or experience with manufacturing processes or equipment, or laboratory / analytical shall be considered.
• Experience in technical writing for multiple audiences.
• Familiarity with Six Sigma / DMAIC methodologies and the ability to apply them.
• Experience with Smartsheet, PowerBI, SharePoint, ACE or other Document Management Software, Adobe Acrobat.
• Experience with reading and interpreting regulatory guidance documents.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

This position is currently accepting applications.