1. シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ)
  2. シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ) 採用情報
  3. シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ) の求人一覧
  4. Group Leader ※US Office
Group Leader ※US Office | シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ)

シミックグループは日本初のCRO(Contract Research Organization:医薬品開発受託機関)として、自由な発想と先見性で、医薬の世界に新たなサービスを生み出してきました。現在では医薬品開発だけでなく、製造、販売まで、製薬企業の全てのプロセスを支援するサービスを提供しています。30周年を迎えた現在、個人のヘルスバリューを高めるために新たな挑戦のステージに入っています。従来のビジネスを武器に事業拡大していく中で、グループ横断的に様々なプロジェクトやタスクが複数開始される予定です。

POSITION PURPOSE:
The Group Leader (C-1) is an inspiration to the group, motivating and leading group activities and functions.  In this role, you are responsible for leading and performing laboratory activities in accordance with applicable Methods, Plans, SOPs/SWPs, GxP regulatory guidelines and 21 CFR Part 11 independently.  You will serve as a Principal Investigator (PI); managing a team of analysts and achieving unit objectives within time constraints by successfully managing and conducting multiple study initiations, executions and completions within designated client timelines and budget, meeting company quality standards.  You are expected to recommend alternative methods for solving a problem.  Effectively communicate with clients; present experimental results to internal and external clients.  Document work and maintain study documentation and lab records.  Maintain effective daily lab operations including providing direction, mentoring and coaching to lesser-skilled teams of analysts to build skillsets.    You will participate in the quotation process, SOP and other technical related document preparation and training; participate in marketing efforts, publications, presentations and posters. 

RESPONSIBILITIES:

  • Comply and mentor a team of analysts with GLP requirements, Methods, Plans and SOP/SWPs and related lab procedures; comply with safety policies, comply with company policies.
  • Serve as a Principal Investigator (PI) successfully managing and conducting multiple study initiations, executions and completions within the time constraints while still maintaining the quality standards of the company. 
  • Ability to present experimental results during group, team and management meetings.  Provide written summaries of work for presentation to clients and communicate directly with clients.
  • Manage, mentor and coach a team of analysts.  Build and maintain a cohesive team.  Perform evaluations and set goals; ensure unit goals are being met.  Address performance related concerns.
  • Act of a subject matter expect. Troubleshoot, recommend alternative methods of solving a problem and develop solutions to problems.
  • Actively participate in lab improvement including operation efficiency.
  • Participate in the quotation process; audit process; audit visits; client visits.
  • Professional communication (both oral and written) with clients and management.
  • May participate in interview process.
  • Effective time management, organization, and teamwork skills as well as attention to detail with the ability to multitask.
  • Responsible for confidential and time sensitive material.
  • Participate in marketing efforts through publications, presentations, posters.
  • Assumes other activities and responsibilities as assigned.

REQUIREMENTS:

Qualifications:

5 years working in a GLP Bioanalysis laboratory environment performing timely study management from bioanalysis sample processing, validation, and conducting and troubleshooting pre-study work independently with instrument hands-on experience of LC-MS/MS and/or UHPLC-UV; UHPLC-FD for small molecule.  Supervisory duties
M.S. in related field or Equivalent. PhD preferred.

Experience and skills:

  • Proficient in method development, method validation, bio-sample preparation and study sample analysis.
  • LC-MS/MS (SM)
  • UHPLC-UV (SM)
  • UHPLC-FD (SM)
  • Proficient troubleshooting skills.
  • Maintain quality execution and work.
  • Demonstrated effective oral and written communication skills.
  • Staff, team management with the ability to mentor, coach and build analysts skillsets
  • Effective time management skills; complete unit goals in a timely manner and within allotted budget. (i.e. maintain timelines).
  • Manage lab equipment usage and maintain lab equipment appropriately for assigned tasks.
  • Understand and mentor GxP requirements, SOP/SWPs and related lab procedures; safety policies and company policies.
  • Ability to proactively prevent non-compliant issues in lab operations.
  • Ability to handle confidential information.
  • Proficient presentation skills.
  • Proficient in MS Office and to be adept at learning new systems.

APPLICATIONS:

Application method Interested parties please apply via HR@cmicgroup.com

Responsible Person Contact details
Name: Denise Washick
Email: Denise-Washick@cmicgroup.com

職種 / 募集ポジション Group Leader ※US Office
雇用形態 正社員
給与
非公開
勤務地
 
会社情報
会社名 シミックホールディングス株式会社/CMIC HOLDINGS Co., Ltd. (HQ)
創業 / Foundation
1992年(会社設立:1985年3月14日)
In 1992 (The Company was established on March 14, 1985)
代表者 / Representative Directors
代表取締役CEO 中村 和男 / Kazuo Nakamura, Chairman and CEO
代表取締役COO 大石 圭子 / Keiko Oishi, President and COO
従業員数 / No.of Employees
7,878名(連結子会社含む)※2022年5月現在
7,878 (as of April 1, 2022 on a consolidated basis)