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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