Manager Ⅱ, CMC

Role Summary

企業概要

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

求人内容

【Purpose Statement】

Mission

・ Develop the CMC part of Briefing Book (BB) for PMDA consultation and Investigator's

Brochure (IB), and execute IP management for the clinical studies conducted in Japan.

・ Develop CTD CMC parts in collaboration with AST and regulatory CMC, and take a lead to

respond PMDA's inquiries for the registration in Japan.

・ Support of group manager in functional activities to carry out the group's mission

Responsibilities

1. Report to CMC Group Manager in a timely manner.
2. Prepare documents for clinical studies and for registration in Japan, and respond inquiries

• from PMDA and clinical sites. And review such documents prepared by other members and
• make advices to them.

1. Directly exchange the relevant information with AST, and advise to AST from the Japanese

• regulatory and scientific points of view. Manage communications and collaborations
• between JAST and AST to make schedules and plans.

1. Coordinate with JAST/AST for supply of IP, make an implementation plan and execute IP

management. Coordinate plans among projects, if necessary.

1. Provide new idea or proposal regarding CMC strategy or enhancing productivities etc., and

support Group manager.

1. Create and execute the career development plan.
2. Attend external trainings and obtain latest information.
3. Educate and motivate group members so as to achieve the group's goal.

• 資格
• ・At least 10-year experience in drug development or related area.
• ・At least 5-year research experience at CMC labs or pilot facility of Drug Substances/Drug
• Products, or Analyses, or CMC Regulatory Affairs.
• ・Knowledge of local regulation in Japan and experiences about IP-GMP related activities.

・English communication skill (TOEIC 700 or more)

• ・A person who has graduated from a department of or completed a master’s course for
• pharmacy, biology, chemistry, pharmacology or related area, or who have relevant skills
• and abilities. It is favorable to be certified for pharmaceutics, physical pharmacy or
• analytical chemistry (Ph.D.).
• その他の情報
• アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。

About the Company

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

R&D Process Engineering Organization, a part of AbbVie’s Development Sciences organization, is responsible for designing and developing scalable processes to make drug substances and drug products, including synthetics molecules, antibody drug conjugates (ADCs) and genetic medicines, throughout pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC (Chemistry, Manufacturing, and Controls) Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products including toxins and cosmetic active ingredients (CAIs). It drives the development of innovative engineering technologies and creates valuable intellectual property through the composition of matter and chemical/bio-chemical processes resulting in cost-effective commercial manufacturing processes for quality products.