Site Head of Validation

Company: ExecuNet
Location: Somerville
Posted on: May 3, 2021

Job Description:

Job #: 652350Release Date: 4/01/2021Company: Biotech, Cambridge, MASalary: ConfidentialRemarks:How will you make an impact?The Site Head for Process Validation will be responsible for successful PPQ executions for multiple viral vectors. The Process Validation Head will lead a team of validation engineers and contractors to ensure site PPQ readiness, PPQ completion, and client communication. The candidate will work closely with the Upstream, Downstream, Analytical and DP MST groups as well as clients to author process justification reports, process control strategy, PPQ protocols and reports. The site head will also oversee the CPV program from various products at the Cambridge site and ensure compliance of the site validation program with the regulatory agencies and company policies. What will you do?Provide technical leadership to scientists, validation engineers and associates within MST working on process validation of manufacturing processes. Must stay current with relevant technologies and forward thinking to identify new approaches.System owner for Process Validation at the Cambridge site within VVS. Responsible for ensuring system is current with best practices and SOPs and templates are established.System owner for Continued Process Verification (CPV) program at the Cambridge site within VVS. Responsible for ensuring system is current with best practices and SOPs and templates are established.System owner for the Discoverant system at the Cambridge site within VVS. Responsible for ensuring system is current with best practices and SOPs and templates are established.Oversee commercial process validation and associated documentation and maintain PPQ dashboards and remove barrier to successful execution of PPQ batches.Manage preparation and review of necessary technical documentation for successful and timely execution of PPQ and CPV.Lead PPQ related investigations and data analysis to address deviation and implement change controls as necessaryProvide on-site support during the process validation campaigns and associated documentation and regulatory filings, as required.Represent VVS as an SME during external and internal regulatory compliance inspections. Participate in writing, reviewing and approving CMC sections of US and international clinical trial applications, regulatory question responses, supplemental biologics license applications and international variationsWork with counterparts within Process Development, Process Characterization, MST and Cambridge Manufacturing, Quality, Project Management teams etc. to lead PPQ readiness, successful execution, and reporting.Education Bachelor's degree required in cell biology, chemistry, biochemistry, chemical engineering or related field. Master's Degree is preferredExperience10+ yrs. hands on experience in process validation of vaccines and/or biologics, preferably with cell therapy and/or gene therapy product experience.6+ years in leading validation / technology groups in a fast-paced production environment.Experience in defending execution and approaches, policies and procedures, in regulatory inspections is required.Strong experience in defending process validation approach and protocols to regulators during site inspections.Experience in managing internal and external customers (i.e. Clients) and communicating sound scientific decisions along with timelines.Knowledge, Skills and Abilities:Strong technical expertise in biopharmaceutical manufacturing and/or process development.Proven expertise in late stage/commercial process validation biopharmaceutical/gene transfer vector manufacturing is required.Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.Knowledge of cell and gene therapy vector production highly desirable.Ability to analyze, interpret and compile data, define problems, establish facts, draw valid conclusions and make decisions.Understanding of guidelines required by FDA, EMA, and other regulatory bodiesExcellent troubleshooting skills and ability to solve complex technical issuesStrong interpersonal and communication skills, verbal and writtenSDL2017

Keywords: ExecuNet, Somerville , Site Head of Validation, Other , Somerville, Massachusetts