Process Specialist I

The Role:
As a Process Specialist I for Technical Operations, you will provide process science support for GMP manufacturing, technology transfers, development studies, characterization, validation, and continuous improvement projects within a highly matrixed cross functional team for Base Camp programs. The primary responsibility is to the be Subject Matter Expert (SME) for Autologous and or Allogenic drug product manufacturing processes. Additionally, you will write product impact assessments, root-cause analysis reports, sampling plans, technical reports, and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.

Here’s What You’ll Do:
• Represents Technical Operations on project teams as technical subject matter expert (SME) for drug product manufacturing.
• Working cross-functionally across Process Development, Manufacturing, Supply Chain, Regulatory Sciences and Quality to provide technical assessment for technology transfers and process changes in a cGMP environment.
• Delivering technical CMC input for regulatory interactions related to drug product manufacturing processes including IND submissions/amendments, marketing authorization submissions, and inspections.
• Authoring and reviewing technical documentation related to manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.
• Assist in the root cause determined of process related deviations in a timely and conclusion manner. The Candidate will work with a cross functional team to resolve complex problems and deviations using experience and the efficient application of scientific methodology and technical reasoning. This position may execute experiments and perform data analysis to resolve specific deviation questions, prepares technical reports and occasionally proposes comprehensive process solutions and improvements.
• Support gap analyses and risk assessments to support the capital projects and tech transfers.
• Assist in execution of Process Validation activities including authoring protocols and reports.
• Assist in development of data-based process performance monitoring systems.
• Perform process data-driven deviation resolution and improvement projects.
• Identifies and proposes continuous process improvements to management. The candidate will execute and occasionally leads complex process and procedural changes to improve drug product manufacturing process performance, robustness, productivity, safety, and efficiency.
• Design studies, author protocols and reports, for process characterization and validation studies.
• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
• Support implementation of projects at site level with Quality Assurance to ensure on-time creation and lifecycle management of MSAT systems and procedures required for the Quality Management System (technology transfer, comparability, process controls documentation, process performance review, etc.).

Requirements:
• BS/MS/PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 3 years of relevant experience.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development.
• Practical expertise with cGMP manufacturing and regulatory regulations and requirements.
• Previous experience in vector manufacturing (LVV, AVV) is preferred.
• Previous drug manufacturing experience with CAR T, TCR, iPSC and HSC is preferred.
• Use of LOVO, Sepax, CliniMACs devices, automated fillers preferred.
• Understanding of process development, validation, and lifecycle management to support comparability studies, process validation, and licensure changes.
• Highly experienced with leading investigations, writing, deviation reports, change controls, and corrective actions.
• Ability to share complex principles of knowledge to others (team member, stakeholder, external, or inspection) along with strong technical writing abilities.
• Experience working in cross functional teams to obtain project deliverables.
• Knowledge of data management tools and statistical process controls.
• Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus.