Duties and Responsibilities:

• Review and approve quality and validation documents as the production representative that does not need managers approval (MBPR, CC, SOP, PQE, PPQ related documents, educational certificates etc.)
• Perform Operational assessments.
• Prepare weekly slide deck presentations on project updates to internal and external stakeholders.
• Lead and/or prepare and/or support product investigations using root cause analysis techniques (interviewing, fishbone diagram, 5 whys etc) and summarizing findings in written reports and oral presentations to internal and external stakeholders (QIRM, OOT, OOS, RCI, CAPA/Task)
• Author, prepare and support Deviations, process change controls, CAPA during project execution.
• Prepare Change Control Change Request and list of change document as part of MBPR generation (CC general and for MBPR)
• Draft and review Standard Operating Procedures (QUMAS)
• Conduct Risk Assessment (CRIA, RIA, FMEA)
• Approve quality documents as the production representative that does not need managers approval (MBPR, ARM, CR, SOP, PQE, validation documents, educational certificates etc.)
• Generate detailed Gannt chart of batch schedule.
• BOM generation and Process mapping (soon to include route & formula)
• Provide on-floor and remote 24/7 technical support to Production during project execution (including weekends, grave, and night shifts), e.g. make go/no go decisions on IPC-results regarding process steps or troubleshooting issues.
• Project management of operation activities related to batch preparation/ execution (equipment/ IPC validation, hold time study, etc…)
• Draft, format and improve MBPR template.
• Support technology transfer activities (generation of comparability report, identification of CPPs, review and approve validation PPQ documents, generation of BPR etc).
• Author and review campaign reports.
• Raw material OOS assessment
• Conduct Bottle neck analysis and Gap analysis of unit operations.
• Prepare Process capability analysis.
• Conduct cost analysis and forecasting.
• Liaise with cross functional groups (Production, QA, QC, Development, Project Management, Sale, Regulatory, Supply Chain etc.) to support the planning and execution of manufacturing operations.
• Collaborate with PD to Design small scale experiments to support investigations or process improvement initiatives.
• Lead, mentor and train Operators and team members as part of upstream and downstream process knowledge transfer on MBPR and unit operations.
• Support continuous improvement initiatives.
• Manually Collect, trend, and analyze in process data as part of process monitoring to determine yields and change points.
• Support QA and regulatory with responding to comments by clients on executed BPR and NDA/BLA, submission.
• Support Validation activities during the planning execution of PPQ runs (prepare supporting PPQ document, e.g. equipment calibration and suitability, analytical methods, hold time study, PPQ strategy etc).
• Support regulatory review of documents.
• Process Mapping
• Routes and Formula on AX to be added to our responsibilities

Qualifications:

• Required Education: Bachelor’s degree in chemistry, Biochemistry, Engineering, or a related field.
• Preferred Education: Advanced degree or certifications bachelor’s degree in chemistry, Biochemistry, Engineering.
• Experience: Minimum 3 years in pharmaceutical manufacturing GMP production or MS&T team, peptide manufacturing experience preferred.

Skills & Competencies

• Technical Skills: Basic understanding about SPPS GMP manufacturing, Proficiency in HPLC systems, cGMP processes, Data analysis (Minitab experience is preferred).
• Soft Skills: Strong problem-solving, collaboration, Microsoft Data analysis (Minitab experience is preferred), Technical writing, and communication skills, and Microsoft office.

Work Environment & Physical Demands

• Physical Requirements: N/A

• Work Environment: Able to adjust priorities based on business need, able to oversee multiple projects/ processes arranging throughout SPPS manufacturing to product release.

Salary: $88k-$115k

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.