MSAT Process SME II

About the role

The Manufacturing, Sciences, and Technology (MS&T) Process SME will support GMP manufacturing operations. A Process SME is actively engaged with the manufacturing team in resolving process related issues, developing efficiency improvements, authoring GDP documentation, and providing immediate problem resolution, in collaboration with quality assurance or a cross functional team, to ensure schedule adherence.

Responsibilities

• Support GMP manufacturing operation as the MS&T Process SME and point of contact.
• Provide rapid response to manufacturing issues and use problem solving techniques to quickly resolve issues.
• Serve as team liaison for process and product investigations and author investigation reports.
• Participate in manufacturing daily Tier meetings and closely follow manufacturing schedule to identify critical process steps where priority support is needed.
• Investigate process non-conformances to determine root cause by following a problem-solving methodology.
• Implement Corrective and Preventive actions on the manufacturing floor.
• Real time review equipment parameters during processing on the floor and anticipate risk of deviation.
• Author and own/manage the following documentation: Quality Systems – Change Control (tech transfer, process improvement, emergency etc.), Deviations (complex manufacturing investigations), CAPAs (complete ownership), Action Items (management and execution).
• Study or investigational protocols and corresponding reports.
• Process Characterization, Validation, Qualification protocols and reports.
• Product Impact and Risk Assessments, Failure Modes Risk Analysis.
• SOPs, COPs, MSAT MBRs.
• Manage and own Technology Transfer campaigns for new product introductions, and process improvements to manufacturing processes.
• Provide hands-on manufacturing process training to manufacturing personnel as part of process tech transfer in suite as needed.
• Other duties as assigned.

Qualifications

• B.S degree required in Chemical Engineering, Chemistry, Industrial Engineering, Biochemistry or a related field, or equivalent industry experience.
• Master’s degree preferred.
• A minimum of 3 years of relevant hands-on operations experience for commercial production in the life sciences industry.
• Experience in aseptic techniques.
• Knowledge and understanding of GMP systems and FDA regulations within a manufacturing facility.
• Ability to organize, analyze manufacturing process data, and provide potential process improvements.
• Excellent oral and written communication skills.
• Strong technical writing ability required.
• Ability to work cross functionally within the organization as part of a project team.
• Technical skills with an emphasis on applying the needs of end-users to manufacturing processes.
• Strong collaborative skills with an emphasis on seeking advice and gaining the consensus of subject matter experts.
• Basic understanding of Lean Principles.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Must be comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Proficient written, verbal and oral English communication skills are required.
• Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.

Benefits

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• FSA & HSA available
• Dental & Vision insurance options
• 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
• Referral Bonus Program with no limit
• Eligible for Annual Bonus Program