Peter Gelinas
Accomplished Technical Operations Executive Leader with Expertise in Cell and Gene Therapy
- Role
- Chief Technical Officer at Coregen Inc
- Location
- Natick, MA, US
- LinkedIn followers
- 500 followers
About Peter Gelinas
QUALIFICATION HIGHLIGHTS:• Over 15 years of successful experience directing technical operations for cell and gene therapy programs.• Successful in serving as department head and member of site leadership team overseeing all GMP operations• Experienced with multiple indications/processes from development to commercial stage GMP manufacturing.• Expertise in leading cross-functional teams and CDMOs to develop and manufacture high quality CGT products. • Skilled at building agile, efficient organizations to solve novel technical and quality/regulatory problems.• Demonstrated success in the development and authoring of MAA, BLA, IND, and IMPD regulatory submissions. • Adept at developing CMC strategy to ensure readiness for BLA and MAA filings (SKYSONA™ and ZYNTEGLO®).• Proven success in obtaining PRIME and Break Through Therapy Designation for late phase programs.• Practiced in implementing site level program governance to ensure right first-time GMP manufacturing deliverables. • Accomplished in proactively identifying and mitigating risks and reducing deviations to drive profitability.• Proficient in establishing metrics to identify necessary change and utilizing Lean process to drive improvement. • Exceptional leadership, communication, problem-solving, critical thinking, and relationship building skills. KEY COMPETENCIES:Technical Operations • CMC Strategy • Analytical Development • Process Development • MSATManufacturing • Supply Chain and Logistics • People Leadership • Budget ManagementCDMO Management • KPIs • Right First-Time (RFT) • Operational Excellence • LEAN Six SigmaRegulatory Submissions (CMC Module 3) • BLA • MAA • IND • IMPD • Quality AssuranceQuality Control • Deviations • CAPA • Change Controls • GMP Compliance • Regulatory ComplianceFDA Compliance • EMA Compliance • Clinical Trials • Phase I – Commercial • CAR-T Cell TherapyGene Therapy • Oncology • Rare Disease • PPQ • PAI • CPV • Technology Transfer
Experience
Chief Technical Officer
Sep 2025 — Present · Houston, TX, US
Education
Springfield College
Bachelor of Science - BS, Sports Biology
2003 — 2007
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.