Senior Process Engineer – Biologics Technology Transfer

Job Title – Engineering Project Lead / Senior Process Engineer Location: Boston, MA (100% onsite preferred)Duration: 12 MonthsRole SummaryHiring a Senior Process Engineer to support biologics drug substance technology transfers across early phase, late phase, and commercial programs. The role involves full process oversight, manufacturing support, documentation, regulatory activities, and raw material control strategy development.This is a fast-paced, cross-functional role requiring strong biologics manufacturing knowledge and the ability to work independently with minimal ramp-up.Key ResponsibilitiesTechnology TransferSupport biologics tech transfer activities between development and manufacturingCoordinate timelines, deliverables, and execution readinessImprove transfer processes through SOPs, tools, and training materialsManufacturing SupportReview Master Production Records (MPRs)Author/review process descriptions and technical reportsSupport change controls and deviation investigationsProvide floor support during GMP manufacturingMonitor and trend batch performance dataDocumentation & RegulatoryPrepare technical and process documentationSupport IND/IMPD and BLA/MAA regulatory submissionsEnsure GMP and regulatory complianceRaw Material Control StrategyDevelop and support raw material control strategiesConduct risk assessments for alternate materialsJustify specifications for regulatory submissionsSupport material-related regulatory documentationCross-Functional CollaborationWork closely with:Process DevelopmentManufacturing OperationsQuality AssuranceRegulatory AffairsExternal manufacturing partnersRequired Skills2–3+ years of biologics industry experienceTechnology transfer experienceKnowledge of upstream/downstream biologics processesGMP manufacturing understandingTechnical writing skillsChange control and deviation investigation experienceRegulatory submission exposureStrong communication and collaboration skillsPreferred SkillsHands-on manufacturing floor support experienceRaw material control strategy experienceStatistical analysis knowledgeContinuous improvement/project leadership experienceEducationBS with 8+ years, ORMS with 6+ years, ORPhD in Engineering or Life SciencesImportant NotesRole is not limited to upstream or downstream; requires end-to-end process understandingFully onsite role with up to 25% travelCandidates must be comfortable supporting GMP manufacturing environments and cross-functional activities