仕事内容How you will contribute:
Independently design and execute diverse range of process analytical technologies to develop, optimize, monitor, model, and control pharmaceutical processes, with emphasis on continuous processing of drug substance and drug products.
Expertise with inline spectroscopic methods (UV, IR, Raman) and chemometrics is required.
Familiarity of regulatory requirements (ICH Q2/Q14) for analytical method qualification and validation are desired.
Analytical control strategy/comparability knowledge of existing offline and online/inline methods to facilitate bridging away from the current standard.
Expected to independently propose and implement resolutions to complex technical challenges.
Responsible for significant or sole technical leadership within own program(s), provide technical guidance related to expertise across programs, delivering to organizational DDT (Digital Data and Technology) strategies.
Serves as a technical resource within function, mentoring and training junior employees across multiple technologies.
Reviews and interprets complex data, communicating clearly to functional leadership and relevant line functions.
Leads technology transfer internally and externally, building key vendor relationships.
Able to develop project strategy within AD and cross functionally and guide junior staff.
Prepares documentation for regulatory filings, authors technical reports, may author publications.
Able to work on multiple programs and represent AD within PS/project teams.
Complete all required training appropriate to role and function in a timely manner.
経験・資格Minimum Requirements/Qualifications:
Bachelors degree with relevant experience, Masters degree with relevant experience, Ph.D. with relevant experience
Competent in multiple analytical techniques with advanced knowledge in specific analytical and real-time monitoring techniques relevant to analytical function, understands wider PS deliverables and project timelines.
Able to communicate complex data clearly, able to work cross functionally, good scientific writing skills, able to work independently with minimal supervision,
Good command of English language is required
勤務地
Recruiting No.
社名
事業内容
東証プライム上場 老舗光学機器メーカー FPD装置事業部 構想設計エンジニア
東証プライム上場 日系大手コンサルティングファーム コンサルティング本部 シニアコンサルタント
大手総合人材サービス会社 テクノロジー本部 デジタルテクノロジー統括部 データサイエンティスト
多くの人が待ち望み、誰も作れなかった新薬を高度な技術で生産し、世界市場に届けます。
医師が安心して意見交換できる会員制サイト『MedPeer』。臨床の「集合知」が新しい価値を生み、ビジネス拡大中です。
「ODMメーカー」として、業界の中で独自の事業展開をしていこうとしています。
真摯で熱い気持ちを持ったメンバーが揃っている会社です
相手と意思疎通を図る、何かしらのツールを持っていて欲しい
