cmc担当(遺伝子治療)

2ヶ月前

Tokyo Greenstaff Life Sciences Japan
AAV遺伝子治療の未来を共に創る
当社は、視機能回復を目指す次世代 AAV遺伝子治療 を開発するステルス創薬スタートアップです。
製造プロセスはすでに確立されており、現在は承認申請・商用化に向けて 中流〜出口(Late Phase)のCMC 体制を強化しています。
この重要なフェーズを推進するため、Late-Phase CMC担当者(Scientist / Manager) を募集しています。

ポジション概要
本ポジションでは、確立済みAAVプロセスの 中〜後期CMC業務 をリードします。
CDMOや社内外の関連部門と連携し、GMP準拠の製造体制、プロセス特性解析、規制当局提出文書の整備など、承認に向けた実行力を発揮していただきます。

業務内容
AAVベクターの中~後期CMC戦略を推進
プロセス特性解析、バリデーション準備、比較性評価
スケールアップ計画、PPQサポート、商用化準備
CDMO管理および GMP準拠の製造モニタリング
後期開発に必要な分析法Q/Vのサポート
IND改訂、BLA/MAA提出に向けたCMC文書作成
品質、薬事、治験薬供給、外部パートナーとの協働

応募条件
必須
バイオ医薬または遺伝子治療領域での 後期CMC実務経験
GMP準拠の製造経験 または AAVベクターCMC/製造経験(いずれか必須)
プロセス特性解析、バリデーション、商用CMC要件の理解
歓迎
CDMO管理経験や規制当局対応経験
スタートアップ特有のスピード感で業務を進められる方

ポジションの魅力
プロセス構築は既に完了しており, 承認に直結する後期CMCに専念できる
AAV遺伝子治療の商用化に大きく貢献できるハイインパクトな役割
ミッションドリブンで協働的なカルチャー
裁量の大きい環境と競争力のある待遇

ご興味があれば、お気軽にご連絡ください。

Drive the Future of AAV Gene Therapy
A Japan-based stealth biotechnology venture is developing a next-generation AAV gene therapy for vision restoration.

With the core manufacturing process already established, the company is now strengthening its mid-to-late phase CMC capabilities as programs advance toward pivotal development and commercialization.

To support this mission, we are seeking a Late-Phase CMC Scientist / Manager who will play a central role in preparing our AAV program for regulatory submissions and future commercial readiness.

Position Overview
As a member of the CMC organization, you will lead mid-to-late phase activities for an established AAV manufacturing process.
You will collaborate cross-functionally and with external partners to ensure GMP-compliant operations, robust process characterization, and regulatory-ready documentation.

This position is ideal for individuals with late-stage CMC or AAV experience who want to directly shape the path to commercialization within a fast-moving startup environment.

Key Responsibilities
Lead mid-to-late phase CMC workstreams for AAV vector development
Drive process characterization, validation readiness, and comparability assessments
Oversee scale-up planning, PPQ support, and commercial readiness preparations
Manage CDMO activities and monitor GMP-compliant manufacturing
Support analytical method qualification/validation for late-phase requirements
Prepare CMC documentation for IND amendments and future BLA/MAA submissions
Collaborate across Quality, Regulatory, Supply Chain, and external partners
Qualifications
Required
Hands-on experience in late-phase CMC (biologics or gene therapy)
GMP-compliant manufacturing experience or AAV vector CMC/manufacturing experience (either is acceptable)
Strong understanding of process characterization, validation, and commercial CMC requirements
Preferred
Experience managing CDMOs and interacting with regulatory authorities
Ability to thrive in a fast-paced, mission-driven startup environment
Opportunity
Join a team where the core process is already built—your mission is to drive it to the finish line
High-impact role directly influencing the commercialization of a novel AAV therapy
Collaborative, agile, and mission-focused culture
Competitive compensation and growth opportunities
If interested, please feel free to reach out directly.
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