General Information

Job Advert Title: Associate Manager - Manager, Gene Therapy Process & Analytical Development

Location: Tsukuba,Ibaraki

Division: Gene Therapy Research & Technical Operations

Employment Class: Permanent


【募集の背景 / Purpose & Scope】

Astellas Pharma has positioned gene therapy as one of the Primary Focuses in its research and development strategy and has established Astellas Gene Therapies as the Center of Excellence for its activities and is striving daily for research and development in order to deliver medical care to patients.

Process and Analytical Development department in Gene Therapy Technical Operations (GT-TO) have an opportunity for this role to establish and execute the evaluation road map for the critical quality attribute, physicochemical property, characterization of the gene therapy products based on deep understanding of complex manufacturing process.

【職務の内容 / Essential Job Responsibilities

- Develop analytical approaches to evaluate the quality attributes, structure, physicochemical properties, and characteristics of gene therapy products such as viral vector with a deep understanding of manufacturing process.

- Develop analytical methods not only for in-process evaluation but for release and stability testing.

- Investigate, understand and incorporate the latest analytical technology in gene therapy field.

- Advance the project team as a person in charge of analytical development.

- Support and lead the team members.

- Qualify analytical methods under the regulation. Technology transfer to QC branch with appropriate GMP-related action. Prepare the regulatory dossier for the authorities.

- Work closely with the US colleagues of GT-TO, GT-RTO (Gene Therapy Research&Technical Operations)

- Be enthusiastic about creating high-quality pharmaceuticals

- Be proactive, open, and collaborative

Specific Physical or Environmental Requirements

- Working location: Tsukuba in Japan (business trip to the US, could be transferred to the US)

- Language: Japanese and English

- Others: Engage in experiments with recombinant viruses under the regulation and guidelines

【応募要件 / Qualifications

<必須 / Must

- Master's degree or higher or equivalent skills

- Over 10 years of experience in biopharmaceuticals (viral vectors, cells, antibodies, etc.)

- Knowledge and experience in the development of analytical methods for biologics, such as physicochemical property assessments, characterization assay, in-vitro functional assay, etc.

- Communication skills inside and outside the company, including overseas

- Language ability: both native-level Japanese and business-level English

- Be proactive, open, and collaborative "Find a Way, Care Deeply, Get Stuff Done"

<歓迎 / Want

- Experience in CMC development for gene therapy product

- Knowledge and experience of GMP related work

- Experience of regulatory application

【勤務地 / Location

茨城県つくば市 アステラス製薬 つくば研究センター

Tsukuba, Ibaraki

【勤務開始日 / Start Date】


Will be decided according to the candidate's flexibility

【契約期間 / Contract Duration


Not limited to specified period

【試用期間 / Probation Period


No probation period in principle

【給与 / Salary




①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.

【昇給 / Salary Raise


Once a year

【賞与 / Bonus


Twice a year (July, December)

【諸手当 / Allowance

裁量労働手当、住宅手当、通勤手当 等

Discretionary work allowance, Housing allowance, Commutation allowance, etc.

【勤務時間 / Working Hours

8:30~17:30(月~木)、8:3015:45(金)、企画業務型 裁量労働制



Flex-time system or Discretionary Work System

【休日 / Holidays


Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays

【休暇 / Vacation Leave

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.

【福利厚生 / Welfare

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System

【お問い合わせ / Contact

アステラス製薬株式会社 採用担当 / Japan Recruiting team, Astellas Pharma Inc.


"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."