About this role
Lead Biologics Process and Technical Engineering for multiple manufacturing facilities, driving technical excellence, facility fit assessments, and technology transfers with a focus on NPI and continuous improvement.
Key Responsibilities
- Technical leadership for facility-fit assessments
- Prioritize and resolve engineering issues
- Oversight during process transfers
- SME in biologics equipment
- Growth and capability development
Technical Overview
Strong expertise in biologics manufacturing, process equipment, automation, and cross-functional collaboration; responsibilities include digital twin development and site readiness for future state molecules.
Ideal Candidate
The ideal candidate is a senior engineer with 9+ years in biopharma manufacturing, deep expertise in biologics, NPI, and GMP; strong leadership and change management capabilities to drive site readiness across multiple facilities.
Must-Have Skills
B.S.M.S.or Ph.D. in a relevant Engineering or Science disciplineA minimum of 9 years' experience in biopharmaceutical manufacturing and/or developmentDemonstrated technical excellence with deep understanding of biologics moleculesmanufacturing processesprocess equipmentand automationExperience in biologics drug substance developmenttechnical operationsand new product introductionStrong crossdivisional networking and collaboration skillsExperience working within technical operations at a manufacturing siteExperience with regulatory filingsquality notificationsinvestigationsand CAPA managementProven leadership with the ability to influence at all organizational levelsStrong talentbuilding capabilitieswith both strategic and detailoriented strengthsSolid understanding of product management systemsbusiness and financial principles
Nice-to-Have Skills
Lean Six Sigma (LSS)
Required Skills
Biopharmaceuticals; Change Management; Cross-Functional Leadership; Engineering Process Management; GMP Operations; Manufacturing Systems; New Product Introduction (NPI); People Leadership; Technical Leadership; Technical Operations
Hard Skills
BiopharmaceuticalsChange ManagementCross-Functional LeadershipEngineering Process ManagementGMP OperationsManufacturing SystemsNew Product Introduction (NPI)People LeadershipTechnical LeadershipTechnical Operations
Soft Skills
LeadershipCollaborationStrategic thinkingProblem solvingCommunication
Certifications
Preferred
Lean Six Sigma (LSS)
Keywords for Your Resume
process and technical engineering leadbiologicschange managementcross-functional leadershipengineering process managementgmp operationsmanufacturing systemsnew product introduction (npi)people leadershiptechnical leadershiptechnical operationsdunboynehybridbiopharmaceuticalsbiologics drug substanceautomationregulatory filingsprocess engineeringnew product introductionleadershipcross-functionalengineeringmanufacturing
Deal Breakers
Lack of biologics manufacturing experience, Less than 9 years in biotech/biopharma engineering, No experience with NPI or GMP operations
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