Scientist Downstream Bioprocess Science CBTL Product Research & Development

General Information

Job Advert Title: Scientist, Downstream Bioprocess Science, CBTL, Product Research & Development

Location: Tsukuba, Ibaraki

Division: Product Research & Development

Employment Class: Permanent

Description

/ Purpose & Scope

Downstream Bioprocess Science Lab (DSBP) in Chemical & Biological Technology Labs., Astellas Pharma Inc. performs downstream process development for biologics such as monoclonal antibodies and other modalities, process characterization studies, and process technology transfer of manufacturing processes to internal and external manufacturing sites. DSBP is also responsible for establishing appropriate control strategies and preparation of submission documents for IND/BLA filings, as well as supporting the maintenance of commercial manufacturing based on robust quality control.

We are seeking a highly motivated scientist to proactively drive process development, technology transfer, and technical development activities within assigned areas for biologics projects in early- and late-phases as a member of the project and technical teams.

(DSBP)(Process Characterization Study)IND/BLA

(PJ)

/ Essential Job Responsibilities

Execute downstream process development for biologics such as monoclonal antibodies, and support technology transfer activities to internal and external manufacturing sites for early- and late-phase projects.

Establish appropriate control strategies for IND/BLA submissions and support the maintenance of commercial manufacturing to ensure a stable supply with consistent quality within project teams.

Evaluate the introduction of innovative technologies in downstream processing in collaboration with internal and external partners.

Participate in meetings with CDMOs and internal stakeholders across different time zones as a representative or member of the technical team.

May serve as Drug Substance Lead in biologics projects, designing and executing project CMC development strategies, driving planning and operational excellence, and ensuring seamless collaboration across CMC functions.

PJIND/BLA

CDMO

Drug Substance LeadCMCCMC

/ Specific Physical or Environmental Requirements

It will be permitted to join early morning/midnight meeting from home.

/ Qualifications

/ Required

Experience in downstream process development for biologics.

Master's degree and experience in the pharmaceutical or biotechnology industry.

Basic business communication skills in English.

Cross-functional collaboration skills.

Problem-solving capabilities and a proactive, hands-on mindset.

/ Preferred

Experience of purification process development for monoclonal antibody and other modalities

Experience in process scale-up

Experience in technology transfer to internal or external manufacturing sites

Experience in process validation and/or support for BLA submissions for biologics.

Knowledge of Antibody-Drug Conjugation

Ph.D. degree with relevant experience in the pharmaceutical or biotechnology industry.

Business communication skills in English and/or experience collaborating with global stakeholders

BLA

(ADC)

/ Application Documents

Resumes

/ Selection details

1

※

CV screening Aptitude test First interview Final interview

• Please be advised that there might be a change in the process.

/ Location

Tsukuba, Ibaraki

※JRTX)

/ Start Date

Will be decided according to the candidate's flexibility

/ Contract Duration

Not limited to specified period

/ Probation Period

No probation period in principle

/ Salary

1

250,000100,000

3

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.(50,000100,000yen, based on the Grade)

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

/ Salary Raise

/ Bonus

/ Allowance

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

/ Working Hours

8:3017:308:3015:45

8:3017:30MonThu8:3015:45Fri

Discretionary Work System

/ Holidays

251

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

/ Vacation Leave

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

/ Welfare

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

/ Career web site

https://re-jp.astellas.com/jp/recruit/newgraduates/

For more information about Astellas, please visit our career web site.

"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."