Jobs list of Pharmaceutical
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Job number: JN -072024-33626 Posted: 2024-10-30
マウスゲノムエンジニアリング
病態モデル動物開発の経験をお持ちの方必見です。7 - 13 million yen Kanagawa Pharmaceutical Research & Development
- Company overview
- We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
- Responsibilities
- 創薬研究に用いるヒト外挿モデル動物において、以下の研究を推進する。遺伝子改変動物作製を目的とするベクター構築
発生工学技術を用いた遺伝子改変動物の作製
病態モデル動物の表現型解析
ヒトの病態を外挿するモデル動物の立案および樹立
創薬アイデアの創出とプロジェクトの企画立案
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-13826 Posted: 2024-10-30
低中分子医薬品の分析・物性研究
海外への技術移転並びに海外C(D)MOマネージメント経験をお持ちの方必見です6 - 11 million yen Tokyo Pharmaceutical Research & Development
- Company overview
- We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
- Responsibilities
- 医薬品の研究、開発、製造、販売および輸出入を行う同社において、低中分子医薬品の分析・物性研究をお任せします。低中分子のプロセス開発、及び製品評価のための新規分析法開発、結晶スクリーニングを含む物性研究
国内外製造サイトの分析部門への分析法技術移管
治験・承認申請における最新のグローバル規制要件を満たす品質管理戦略立案、データ取得・申請書類作成
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-10543 Posted: 2024-10-30
タンパク質科学・計算科学分野の専門性を有する研究員
生化学実験、物理化学実験法の業務経験をお持ちの方必見です6 - 10 million yen Kanagawa Pharmaceutical Research & Development
- Company overview
- We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
- Responsibilities
- タンパク質科学や計算科学の専門性を通じた創薬・技術プロジェクトの推進を担う研究員としてご活躍いただきます。
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-34691 Posted: 2024-10-28
Quality Control Specialist
Global, top market share company / international atmosphere4 - 7.5 million yen Shizuoka Pharmaceutical Quality Assurance / Quality Control
- Company overview
- Our client is a contract manufacturer of soft capsules for pharmaceuticals and health foods.
- Responsibilities
- グローバルトップシェアを誇る医薬品・健康食品を製造している工場にて品質管理業務をご担当いただきます。製品及び原料の理化学試験
環境試験の実施
ＳＯＰの作成と改訂
試験方法の改善
Yui Osone
Industrial & Life Science -
Job number: JN -102024-177336 Posted: 2024-10-10
生産プロセス技術開発（バイオ医薬品）
大手日系企業 x 多角的な事業展開5 - 13 million yen Kanagawa Pharmaceutical Research & Development
- Company overview
- We are a major corporation based in Japan, offering a wide range of products and services. Beyond just photographic film and cameras, we also specialize in medical equipment, chemicals, optical devices, and more. Our focus is on the quality, innovation, and sustainability of our products, providing value to customers worldwide. Additionally, we prioritize research and development, contributing to advancements in science and technology.
- Responsibilities
- 当社の各種細胞に関する知見・ノウハウと、優れた生産プロセス技術を組み合わせた研究開発を推進し、さらなる医療の質の向上、人々の健康維持増進に貢献していきます。これらの実現に向けて、バイオ医薬品の生産性を向上する連続生産プロセスを開発し、その製造導入を行います。
業務内容：
バイオ医薬品の生産性を向上する連続生産プロセス（細胞培養・精製）開発～製造導入の推進
ラボスケールでの培養・精製プロセスの要素技術開発
ラボ～パイロット～生産スケールへのスケールアップ技術開発
開発したプロセスの製造導入
Go Ozawa
Industrial & Life Science -
Job number: JN -072024-38002 Posted: 2024-10-02
品質管理 (製品品質試験)
Quality position at mega pharma with strong pipeline6 - 9.5 million yen Hyogo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
- Responsibilities
- 注射剤及び固形製剤の品質管理、分析試験業務（理化学試験、微生物試験）、製品規格試験の実施及びそれに関わるverification
品質管理に係る手順、記録等の作成及び照査
逸脱・トラブルに対する調査及び問題解決策の提案・実施
変更管理
新製品導入に伴う試験法技術移管（海外本社・海外製造所と協働して実施）
部内における業務品質及び生産性改善活動
グローバル・ローカルプロジェクトのリード・参画
その他試験実施に関わる管理業務
Yui Osone
Industrial & Life Science -
Job number: JN -072024-38471 Posted: 2024-10-02
製品品質保証
Quality position at mega pharma with strong pipeline6 - 9.5 million yen Hyogo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
- Responsibilities
- 医薬品、医療機器、コンビネーション製品の国内及び海外製造所等における適正な品質管理の確保
新製品及び既承認品目の承認取得、維持のため、PMDA等による関連製造所へのGMP/QMS適合性調査の対応
製造販売業者の許可取得、維持のための品質確保業務（当局査察の対応を含む）
適用される規制要件及び社内コーポレート基準に従った社内基準の確立並びに維持管理
製造業者、アライアンスパートナー等との取決めの締結並びに維持管理
製造業者、販売業者、社内関係部門及び社内コーポレートとの連携にもとづくGQP/QMS品質保証業務（逸脱、苦情、変更、出荷判定等）の実施
顧客満足の実現を目的とする、製造業者を含む継続的な品質改善活動の指導及び推進
新製品の上市及び既承認品目の承認維持のためのGMP/QMS調査の対応
苦情管理チームとの連携による顧客問い合わせへの回答
Yui Osone
Industrial & Life Science -
Job number: JN -072024-38610 Posted: 2024-10-02
品質システム コンプライアンス
大手外資系Qualityポジション6 - 9.5 million yen Hyogo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
- Responsibilities
- 文書管理システムの運用及び管理
文書管理責任者（又は文書管理担当者）
文書及び記録の保管と管理（GMP Library、GQP/QMS Archive
GMP/QMS/GQP/GDP 上の基本的な文書（GMP/QMS/GQP 総則、手順書類）の維持
手順書類の制定及びメンテナンス、及びこれらに関する他部署へのサポート
署名の管理
トレーニングシステムの運用教育訓練責任者（又は教育訓練担当者）
年間教育訓練計画の作成、実施及び/又はサポート
トレーニングカリキュラムの維持
各業務エリアにおける認定の実施と維持
文書・教育に関連する 社内スタンダード 、Global Quality Standards (GQS) のギャップアセスメント及び対策検討
文書管理システム、及びトレーニングシステムをサポートするためのコンピュータシステム の運用管理Success Factors のデータ管理
文書管理システムの運用・管理、及び適正な運用のための指導（文書管理システム 管理責任者/文書管理システムワークフロー管理者）
社内ののデータ・サイト管理
QSC 内でのトレーニング＆文書管理関連業務が円滑に行えるよう、担当者の管理を行う。
Yui Osone
Industrial & Life Science -
Job number: JN -072024-37534 Posted: 2024-10-02
Project Statistician
Global mega-pharma with strong pipeline5.5 - 7 million yen Hyogo Pharmaceutical Data Management / Biostatistics
- Company overview
- We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
- Responsibilities
- Responsibilities:
The Project statistician provides strong statistical leadership in the process of drug development, develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Project Statistician is also responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.
Other Responsibilities Include But Not Limited To The Following
Statistical Trial Design and Analysis
Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.
Collaborate with data management in the planning and implementation of data quality assurance plans.
Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
Participate in peer-review work products from other statistical colleagues.
Communication of Results and Inferences
Collaborate with team members to write reports and communicate results.
Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
Respond to regulatory queries and to interact with regulators.
Therapeutic Area Knowledge
Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
Regulatory Compliance
Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
Statistical leadership and Teamwork
Introduce and apply innovative methodology and tools to solve critical problems.
Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions.
Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.
Yui Osone
Industrial & Life Science -
Job number: JN -072024-144533 Posted: 2024-10-02
[Osaka] Experienced CRA (including Sr./Pri.)
Global Pipeline with Work Life Balance4 - 10 million yen Osaka Pharmaceutical Clinical Development
- Company overview
- Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development. - Responsibilities
- Work to confirm (monitor) whether clinical trials are conducted in accordance with relevant laws and regulations (GCP) and implementation plans (protocols) at appropriate medical institutions under consignment from clients, and whether the human rights and safety of subjects are protected is. Selection of medical institutions and doctors in charge of conducting clinical trials
Confirmation of clinical trial schedule and contract details, and implementation of briefing sessions for medical institution staff
Clinical trial progress management: Progress management of the number of cases, collection / inspection of case report reports, collation of case report reports with materials
Delivery of investigational drug, confirmation of supply management status, collection
Preparation of monitoring report
Clinical trial completion procedure, confirmation work
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-37400 Posted: 2024-10-02
品質管理部 SQC Operator
Opportunity to work at global maker with strong pipeline5 - 7 million yen Hyogo Pharmaceutical Quality Assurance / Quality Control
- Company overview
- We are a global pharmaceutical and clinical research company based in the United States. Through pharmaceuticals, we help people live healthier, healthier, and longer lives. Through productive agreements and partnerships around the world, we have grown to become one of the world\'s leading pharmaceutical companies by expanding its scale and developing pharmaceuticals at low cost. We have many employees who are committed with sincerity in a culture of excellence and are committed to further expansion.
- Responsibilities
- 注射剤及び固形製剤の品質管理、分析試験業務（理化学試験、微生物試験）、製品規格試験の実施及びそれに関わるverification
品質管理に係る手順、記録等の作成及び照査
上司と共に逸脱・トラブルに対する調査及び問題解決を行う
上司と共に変更管理を実行する
部内における業務品質及び生産性改善活動
グローバル・ローカルプロジェクトへメンバーとしてサポート
その他試験実施に関わる管理業務
Yui Osone
Industrial & Life Science -
Job number: JN -072024-25962 Posted: 2024-09-25
医薬品探索研究職
グローバルに活躍5.93 - 9.78 million yen Shizuoka Pharmaceutical Research & Development
- Company overview
- We specialize in the research, development and manufacture of pharmaceutical products. We mainly provide therapeutic drugs for diseases of the cardiovascular system, bone and joint system, and nervous system, with the aim of improving the health and quality of life of patients. We are committed to creating new drugs and improving existing drugs by utilizing our advanced technological and R&D capabilities. We also set strict standards for product quality control to supply safe and effective medicines to the market. In collaboration with medical and research institutions in Japan and overseas, we also focus on developing treatments that incorporate cutting-edge medical technologies. With an emphasis on a patient-centered approach, we have established ourselves as a trusted pharmaceutical manufacturer.
- Responsibilities
- 蛋白質の機能解析、構造解析研究(X線結晶構造解析、CryoEM)を中心とした医薬品探索
蛋白質発現、精製、構造解析、化合物との相互作用解析手法の立案および試験の実施
構造解析や相互作用解析を中心とした新規創薬技術の調査、検討、立案
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-169609 Posted: 2024-09-25
医薬品分析の委託試験窓口担当者 （プロジェクトマネージャ）
医薬品に関するCMC分析分野での経験をお持ちの方必見です。5 - 8 million yen Kyoto Pharmaceutical Research & Development
- Company overview
- Our client provides solutions from R&D to production for pharmaceutical products.
- Responsibilities
- 主に医療用医薬品（低分子/バイオ医薬品の原薬・製剤）の分析に関するお客様からの発注内容に基づき、窓口として社内外の業務調整を行います。また、営業をサポートして発注前の依頼内容の相談にも対応します。 顧客との打ち合せ、問い合せ対応（Web会議、対面会議、電子メール、電話対応など）
試験に必要な書類の作成（品質（出荷、受入）試験の成績書，安定性試験・開発試験法・分析法バリデーションの計画書/報告書、社内への指図書）
試験担当部門との業務調整
受託試験の進捗把握・管理
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-30558 Posted: 2024-09-25
【茨城】抗体等高分子医薬品の分析並びに薬物動態研究担当
高分子医薬品の生体試料分析の実務経験者必見です!5.4 - 10 million yen Ibaraki Pharmaceutical Research & Development
- Company overview
- We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
- Responsibilities
- 抗体薬物複合体（ADC）及び抗薬物抗体（ADA）の分析法構築、バリデーション試験及び濃度測定の対応（ICH M10等のガイドライン対応）
Ligand binding assay(LBA) Working Group（WG)のリーダー業務及びLBAに関する所員の育成指導
抗体薬物複合体（ADC)の創薬スクリーニング分析及び評価
創薬テーマの低分子化合物の濃度測定及びPK解析の実施
抗体薬物複合体の創薬テーマ窓口業務
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-38296 Posted: 2024-09-25
低分子プロセス化学研究リーダー
CROにおけるプロセス化学研究の業務経験5年以上お持ちの方必見です。5.6 - 8.6 million yen Ibaraki Pharmaceutical Research & Development
- Company overview
- We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
- Responsibilities
- リーダーとして、低分子医薬候補の開発加速化を目指したプロセス化学研究の牽引をご担当いただきます。創薬研究部門における初期プロセス化学研究の牽引
創薬研究部門における開発候補化合物の初期プロセス開発
CMC部門及び各種原薬や中間体製造委託先への製造技術の情報移管
初期プロセス研究効率化のための各種情報収集、技術獲得
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-145700 Posted: 2024-09-25
【群馬】製剤・技術開発※課長候補
製剤開発および技術の実務経験5年以上お持ちの方必見です。7 - 7.5 million yen Gunma Pharmaceutical Regulatory Affairs
- Company overview
- A major pharmaceutical manufacturer.
- Responsibilities
- 当社の製剤開発・技術部門課長候補として、製剤（CMC）関連業務全般をご担当いただきます。医療用医薬品の製剤開発
市販用（OTC）医薬品の製剤開発
左記の申請対応業務
動物薬の製剤開発
食品、動物用飼料の開発
上記全般の生産部門へのスケールアップ、技術移管など生産移行対応
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-168812 Posted: 2024-09-25
【岐阜】開発製剤の分析技術開発、その品質管理戦略に精通した製剤分析研究員
製剤の分析法開発経験者必見です!7 - 9.5 million yen Gifu Pharmaceutical Research & Development
- Company overview
- We are a Japan-based pharmaceutical company dedicated to contributing to the health and well-being of patients worldwide. We have established a global network of research, development, manufacturing, and sales bases to achieve this mission. We focus particularly on areas with high unmet medical needs, such as "cognitive disorders and central nervous system diseases" and "oncology," striving to innovate and provide groundbreaking new drugs. Additionally, we work towards sustainable healthcare by fostering collaborative relationships with healthcare professionals, patients, and local communities.
- Responsibilities
- 製剤の各種分析法の開発、安定性試験の実施、品質管理戦略の立案
自社および委託先など国内外試験サイトへの試験法の移管、或いは技術的指導
Globalでの申請戦略の立案と申請資料の作成、照会事項回答、および査察などの当局対応
多様なモダリティ製剤（経口固形、抗体、ADC）の物性研究や新規分析法の研究、技術開発
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-168813 Posted: 2024-09-25
【岐阜】注射剤開発に精通した製剤研究者
バイオ医薬品の開発経験者必見です!7 - 9.5 million yen Gifu Pharmaceutical Research & Development
- Company overview
- We are a Japan-based pharmaceutical company dedicated to contributing to the health and well-being of patients worldwide. We have established a global network of research, development, manufacturing, and sales bases to achieve this mission. We focus particularly on areas with high unmet medical needs, such as "cognitive disorders and central nervous system diseases" and "oncology," striving to innovate and provide groundbreaking new drugs. Additionally, we work towards sustainable healthcare by fostering collaborative relationships with healthcare professionals, patients, and local communities.
- Responsibilities
- 注射剤の処方設計および製造プロセス開発
注射剤の治験薬製造（自社、もしくは国内外のCMO）
臨床試験に関する申請資料の作成（IND、IMPD、CTNなど）
国内および海外のCMOでの製造プロセスの最適化および商業生産立ち上げ
申請戦略の立案と申請資料の作成（NDA、BLA、MAA、J-NDAなど)および当局照会事項対応
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-168814 Posted: 2024-09-25
原薬研究者
医薬品プロセス開発の経験とスキルをお持ちの方必見です。7 - 9.5 million yen Ibaraki Pharmaceutical Research & Development
- Company overview
- We are a Japan-based pharmaceutical company dedicated to contributing to the health and well-being of patients worldwide. We have established a global network of research, development, manufacturing, and sales bases to achieve this mission. We focus particularly on areas with high unmet medical needs, such as "cognitive disorders and central nervous system diseases" and "oncology," striving to innovate and provide groundbreaking new drugs. Additionally, we work towards sustainable healthcare by fostering collaborative relationships with healthcare professionals, patients, and local communities.
- Responsibilities
- 治験用原薬の製法開発（低分子、ADC（Antibody Drug Conjugate）等各種モダリティの新規医薬品候補化合物の製造法の探索、スケールアップ研究）
商業生産製法に向けた製造プロセスの最終化と品質管理戦略策定、サポートデータ取得、申請書作成
自社、委託先の国内外研究、製造サイトへの技術移管、マネジメント
新規製造法、新規モダリティ関連の技術獲得
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-168817 Posted: 2024-09-25
非臨床安全性研究者
非臨床安全性試験の立案、実施、評価の経験をお持ちの方必見です。7 - 9.5 million yen Ibaraki Pharmaceutical Research & Development
- Company overview
- We are a Japan-based pharmaceutical company dedicated to contributing to the health and well-being of patients worldwide. We have established a global network of research, development, manufacturing, and sales bases to achieve this mission. We focus particularly on areas with high unmet medical needs, such as "cognitive disorders and central nervous system diseases" and "oncology," striving to innovate and provide groundbreaking new drugs. Additionally, we work towards sustainable healthcare by fostering collaborative relationships with healthcare professionals, patients, and local communities.
- Responsibilities
- 各種細胞、動物を用いた非臨床安全性に関する実験、試験の実施その報告書作成（英文）
NGS、Single cell analysis含むオミクスデータの解析、安全性評価への応用。
探索、体内動態、臨床部門等の国内外の関係者との連携による創薬研究の推進
社内外との共同研究の推進
医薬品候補化合物の探索プロジェクトならびに開発プロジェクトの推進
Patrick Chang
Industrial & Life Science