CMC Department Senior Manager ~ Rapidly Growing Bio Venture

Company:

Fast-growing bio-venture
We are developing pharmaceutical products specializing in the areas of "cancer, blood, and autoimmune diseases."

The company is working on the development of new drugs that focus on the “blank treatment area” that is expanding with structural changes in the pharmaceutical industry, and aims for sustainable growth as a company through activities that meet unmet medical needs.

Position:

As a manager of the CMC department of a listed (TSE Growth) pharmaceutical company, you will be involved in the following operations.
(1) As a person in charge of the investigational drug supply department related to the development theme, you will be involved in the investigational drug supply business in line with the clinical development plan
(2) Formulation and execution of a technology transfer plans in cooperation with related parties inside and outside the company and related departments.
(3) Application / notification of approval or change (creation of CMC related documents)
(4) Provide necessary CMC support for the internal departments related to product maintenance.

Treatment:

Health insurance, welfare annuity insurance, employment insurance, workers' accident compensation insurance (social insurance: Tokyo Pharmaceutical Health Insurance Association)

Commuting allowance: 6-month commuter pass
Severance pay system: Defined contribution pension (~ 60 years old), Contribution reserve (60 years old ~)

72 years old

■ In-house study session
■ In-house training (invited lecturer)
■ OJT
■ Attendance of external training

■ Comprehensive welfare group term life insurance
■ Health checkup assistance: As a general rule, various checkups designated by the health insurance company will be fully borne by the company, and the human dock will be subsidized up to 10,000 yen.
■ Empliyee Stock Purchase System: Incentive 8%

Experience: CMC (formulations, especially injectables) related development, manufacturing, analysis work, CMC for domestic and international applications
Document writing experience
Knowledge: Knowledge of Pharmaceutical Machinery Law, related laws and regulations, GxP (GMP / GQP / GDP), JP, USP, EP, ICH, etc.
Ability: Ability to negotiate with contractors and partners, ability to manage schedules for collaborative work

Basic communication skills with foreign companies in English are required