Drug Substance Lead Upstream Bioprocess Science CBTL Product Research & Development

General Information

Job Advert Title: Drug Substance Lead, Upstream Bioprocess Science, CBTL, Product Research & Development

Location: Tsukuba,Ibaraki

Division: Product Research & Development

Employment Class: Permanent

Description

/ Purpose & Scope

Astellas Pharma's Product Research & Development (PR&D) organization, including Chemical & Biological Technology Labs. (CBTL), plays a key role in advancing innovative therapeutics from discovery through clinical development and commercialization by leveraging end-to-end CMC capabilities and cutting-edge science and technology.

Within CBTL, the Upstream Bioprocess Science Lab (USBP) enables the development of biologics, including monoclonal antibodies and other modalities, by performing cell culture-based upstream process development, process characterization studies, and technology transfer of manufacturing processes to internal and external manufacturing sites. USBP is also responsible for establishing appropriate control strategies and preparing 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 provide scientific, technical, and strategic leadership in upstream process development for biologics projects. The successful candidate will lead complex upstream process development and technology transfer activities across multiple projects, serve as a team leader within USBP, mentor and develop scientists, drive resolution of complex technical and regulatory issues, and contribute to strengthening USBP capabilities and functional strategy, while advancing broader organizational leadership through technical excellence and innovation. Depending on the candidate's experience and qualifications, the role may also include people management responsibilities.

&CMC

(USBP) (Process Characterization Studies)IND/BLA

USBPUSBP

/ Essential Job Responsibilities

Serve as a Drug Substance Lead for biologics projects, including monoclonal antibodies, leading the development and execution of CMC strategies and plans, and driving achievement of project objectives through collaboration with cross-functional stakeholders.

Lead upstream process development, technology transfer, and commercialization-related activities, providing scientific and technical leadership across development stages.

Lead the preparation of regulatory submission documents (e.g., IND/BLA), responses to regulatory authorities, and the resolution of critical technical challenges, contributing to the successful advancement of projects and CMC activities.

Provide strategic direction and technical solutions for complex technical challenges based on advanced process and biological knowledge, while leading stakeholders and driving scientific and strategic decision-making.

Drive the evaluation and implementation of innovative upstream bioprocess technologies in collaboration with internal and external partners, contributing to the enhancement of organizational capabilities and competitiveness.

Promote the development of team members through coaching, and mentoring of team members, while leading team activities and fostering technical excellence, knowledge sharing, and organizational capability building.

Actively contribute to laboratory operations by driving continuous improvement of business processes, talent development, resource optimization, and a culture of collaboration and innovation.

Contribute to the development and execution of strategic initiatives across the laboratory and broader organization, as appropriate, and demonstrate leadership across functions and organizational boundaries.

Drug Substance LeadCMC

IND/BLACMC

/ Specific Physical or Environmental Requirements

This role may involve early-morning or late-night meetings with global stakeholders, which may be attended from home.

This role may require travel to manufacturing sites to provide on-site support and participate in person-in-plant activities.

/ Qualifications

/ Required

Master's degree in a relevant scientific field with experience in the pharmaceutical or biotechnology industry.

Demonstrated advanced expertise and a strong track record in upstream cell culture process development for biologics, including monoclonal antibodies.

Experience leading technology transfer activities to internal and/or external manufacturing sites across development stages from early development through commercialization, or equivalent knowledge and accomplishments.

Experience leading upstream process development or overall drug substance process development within cross-functional project teams in biologics development and driving the development and execution of CMC strategies in collaboration with diverse stakeholders.

Strong knowledge of CMC development, including control strategies, process characterization and regulatory submissions (e.g., IND/BLA).

Business-level communication skills in English, with experience leading technical and/or strategic discussions in global cross-functional teams.

Demonstrated leadership and strong problem-solving skills, with the ability to work independently and proactively while contributing to talent development, organizational capability building, and/or functional strategy execution.

CMC

IND/BLACMC

/ Preferred

Ph.D. in a relevant scientific field.

Experience in process validation, commercial manufacturing readiness, and/or regulatory submissions (e.g., BLA/MAA) for biologics.

Experience leading key technical strategies or drug substance development activities in global development projects.

Knowledge of multiple modalities (e.g., bispecific antibodies, ADCs, AAVs and cell therapies) and their upstream processing requirements.

Demonstrated experience in the evaluation and implementation of innovative technologies, application of digital technologies, and/or driving innovation initiatives.

Experience leading talent development, organizational capability building, and/or cross-functional initiatives.

Proven track record of external scientific engagement through conference presentations, scientific publications, or participation in industry forums.

BLA/MAA

ADCAAV

/ Application Documents

Resumes

/ Selection details

1

※

CV screening First interviewAptitude test 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."