General Information

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

Location: Tsukuba,Ibaraki

Division: Gene Therapy Research & Technical Operations

Employment Class: Permanent

Description

【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) has an opportunity for this role to develop and establish the downstream process for the viral vectors which meets our quality target product profiles based on a deep understanding of complex manufacturing process.


【職務の内容 / Essential Job Responsibilities

- Develop downstream process to meet our quality target product profiles with a deep understanding of manufacturing process.

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

- Evaluate the process deeply with identification of the characteristics and properties of the viral vectors.

- Plan and execute the process characterization, especially for the downstream.

- Support the project team as a process development member.

- Support and collaborate with the team members.

- Technology transfer to GMP 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


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

- Knowledge and experience in the process development for biologics especially for downstream

- Over 5 years of experience in biopharmaceuticals (viral vectors, cells, antibodies, 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

応相談

Will be decided according to the candidate's flexibility


【契約期間 / Contract Duration

期間の定めなし

Not limited to specified period


【試用期間 / Probation Period

試用期間原則なし

No probation period in principle[


【給与 / Salary

①基本給:当人の経歴・技術・技能等を考慮して決定

②裁量労働制の場合:裁量労働手当として職務グレードに応じて50,000100,000円支給

③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給

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

年一回

Once a year


【賞与 / Bonus

2回(7月、12月)

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

裁量労働制の場合、所定労働時間を働いたものとみなす。

8:30~17:30MonThu)、8:3015:45Fri

Flex-time system or Discretionary Work System


【休日 / Holidays

完全週休2日制、祝日、51日、夏季、年末年始

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.

astellas.recruit@jp.astellas.com

※本職種についてのご質問は、上記までお問い合わせください。


"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."