バイオ薬品、再生医療等製品の市場動向、研究開発、品質管理について話せます

エキスパート

氏名:開示前


■背景
私は大学院を修了後、免疫研究者としてワクチンやバイオ医薬品の研究開発に従事しました。その後、民間企業で低分子・中分子医薬品や再生医療等製品の研究開発、品質管理、製造管理、品質保証に携わりました。この過程で査察や監査を経験し、受ける側としての経験を得ると同時に、質問する側の視点も理解することができました。さらに、医薬品の基礎研究から製品出荷、市販後調査まで幅広く経験したことで、多角的な視点を持ち、運用や実際の作業を深く掘り下げ、課題抽出や問題解決のスキルを習得することができました。

■話せること
・遺伝子治療におけるCDMOサービスについて
・細胞培養容器の品質管理について
・細胞治療及び遺伝子治療について
・バイオ医薬品関連企業における、遺伝子治療薬・抗体医薬品製造における課題
・ユニバーサルドナー細胞の開発動向
・遺伝子治療や細胞治療のCMC、開発について
・医療領域における技術系ベンチャー企業の動向について
・再生医療等製品について

プロフィール 詳細を見る


氏名:開示前

- With over 16 years of experience in drug discovery research, prescription design and formulation, test procedure and criteria development, evaluation of efficiency, pharmaceutical regulatory applications, and inquiry support for medicine, my expertise in the pharmaceutical industry is extensive.
- Understood the entire process from searching for the seeds to making the final product for medicine, including
identifying and solving any issues or challenges that may arise during each step and operation.
- Experienced as both a device manager and an operation manager for analytical instruments, including
preparing SOPs, test records, and documents, as well as performing QA checks.

[QUALIFICATIONS]
- Over 16 years’ experience in R&D in my career and 4 years of quality control in pharmaceutical industry.
- Strong expertise of immunology and molecular/cellular biology as recombinant DNA technologies, cell culture, transfection, protein expression / purification and screening of extracts in cell-based technology.
- Led any project, preparation of SOPs, various records, documents, performed QA check as the manager.
- Engaged in prescription design and formulation by analyzing and developing test procure and criteria.
- Technology transfer and negotiation with related departments internally and externally (outsourcing).
- Contributed to the administration of the corporation by participating in the committee for Safety, Genetic modification and animal experiment.

[Research & Development]
1. Possess extensive knowledge in Infection, inflammation, antibody engineering
2. Have experience dealing with various issues and biological materials, learning to multi-faceted research
3. Development of screening system to evaluate the enhancement or inhibitory or immunopotentiating

[Leader substitute]
- knew the Responsibility of the work surrounding the research and the difficulty in guide to subordinate person.

[Personality]
Mentally and physically tough, hard work tirelessly against everything. In particular, coordination and problem solving skills are confident, has been to solve various problems.
The field of inexperienced, inexperienced technology opens up, it is able to act positively from their own type.

[Motto]
1. Just drove myself to the limit,the results are good products
2. My work is connected society
3. Others believe, important to build the relationship

Specialties: Immunology, Virology, Biotechnology, Antibody engineering


職歴

株式会社医学生物学研究所

  • ユニット長 2022/11 - 現在

社名非公開

  • マネージャー 2021/7 - 2022/10

社名非公開

  • 課長補佐 2020/6 - 2021/7

社名非公開

  • マネージャー 2018/5 - 2020/4

謝礼金額の目安

¥50,000 / 1時間

取引の流れ


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