Job added in hotlist
Applied job
Contract job
Recruiter job
Employer job
Expanded search
Apply online not available
Similar Jobs
Staff Engineer - Biologics Process Development
Takeda Pharmaceutical Company Limited.
Lexington, MA
Apply Now >
Scientist (Medicinal Chemistry)
Jnana Therapeutics
Boston, MA
Apply Now >
Research Scientist I
Takeda Pharmaceutical Company Limited.
Boston, MA
Apply Now >
Research Engineer - Andover, MA
Lockheed Martin Corporation
Andover, MA
Apply Now >
Life Sciences Quality Engineer
Boston, MA
Apply Now >
View more jobs in Lexington, MA
View more jobs in Massachusetts

Job Details

Staff Engineer / Senior Staff Engineer - Biologics Process Development

Company name
Takeda Pharmaceutical Company Limited.

Lexington, MA, United States

Employment Type

Engineering, Chemistry, Sciences, It

Posted on
Jul 13, 2021

Valid Through
Oct 26, 2021

Apply for this job


Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a

Staff Engineer / Senior Staff Engineer -

Biologics Process Development (Purification Focus) in our Lexington, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver 

Better Health and a Brighter Future

 to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.


Provides theoretical/conceptual input to the design, development and execution of research assignments for a specific project or projects within the functional area. Independently plans and executes most unit operation characterization and optimization experiments within expertise and develops an awareness of unit operations in other areas.

The role will have cross-functional leadership opportunities on high visibility projects. Responsible for significant or sole technical leadership within project or complex study. Prepares technology transfer documentation, regulatory documents, and validation plans and reports or coordinates with team members to ensure execution.  Represents line functions on CMC teams as appropriate/necessary. Proactively identifies process or study issues/challenges and proposes potential resolutions.

Develops project or significant technical strategy within area of expertise. Leverages technical skill(s) as a resource/expert within the department. Identifies and plans broader technical objectives (project and scientific related) and initiates processes meet objectives with input from manager as needed. Identifies and recommends vendors as appropriate. Coordinates cross-functional teams and resolutions, with a focus on scientific /technical challenges.


The role will have cross-functional leadership opportunities on high visibility projects. The successful candidate will lead interns/co-ops and potential future contractors. 

Develops and leverages strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions across CMC and other development functions.

Contributes significantly to complex/multiple projects or functional areas through leading or influencing others.

Influences and supports initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.

The Staff Engineer / Senior Staff Engineer -

Biologics Process Development


eviews, interprets and communicates data cross functionally within CMC and project teams.

Coordinates with others in creating technical reports including reviewing and editing.

Conducts analysis of technical and conceptual risk and trends.

Identifies process trends and defines/champions process strategy or use of novel technologies.

Recognized as a technical expert and resource within function.

Significant technical responsibility for a project area/technical program within the department and potentially across CMC.

Represents functional area on project teams by communicating activities from designated functional area to project team.

Identifies topics for initiatives and leads local/global initiatives as directed by senior staff.

Ensures a productive and development-rich environment; provides training/mentoring for junior staff.

Defines more complex/novel approaches and methodologies to solving complex technical challenges .

Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.

Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors.

Initiate and influence project direction outside department


Education and Experience:

PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0-3 years relevant industry experience

Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6-10 years relevant industry experience

Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8-12 years relevant industry experience

Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP’s

Sound knowledge of current Good Manufacturing Practices (cGMP)

Previous experience with the use of contract facilities

Experience in working in a multi-disciplinary team environment

Previous experience contributing to regulatory filings


The position will be a key contributor within a group responsible for upstream and downstream process development. In support of purification process development the group performs the following activities: small-scale experiments, scale-up, technology transfer and support for programs that bring new bio-pharmaceutical products to pre-clinical, clinical and commercial manufacturing phases. The candidate will design and carry out experiments for purification process development, optimization and characterization studies for therapeutic proteins. The scope includes IND- and BLA-enabling studies and preparation of regulatory submissions. The experimental studies involve both lab scale and pilot plant runs, including, but not limited to toxicology, clinical and validation batches.

This person must have extensive knowledge and experience on phase-appropriate purification process development and associated unit operations, including

Product harvesting (clarification and capture) from production bioreactors

Purification from both microbial and mammalian sources

Purification of different biologic modalities: Non-Fc recombinants, MAbs, and Fc-fusion proteins

Chromatography (IEX, Affinity, HIC, Mixed-mode)

Filtration (depth filtration, viral filtration, sterilizing filtration, ultrafiltration/diafiltration)

Familiarity with cell culture processes and analytical characterization of proteins is preferred.

The candidate must have experience in design of experiments, process monitoring, process risk assessment, statistical analysis and the ability of interpreting data and deriving conclusions. The candidate must demonstrate excellent written and verbal communication skills. Contributes to the preparation of CMC sections of regulatory filings. Authors and reviews high quality technical reports and presentations for management and peers. Independently refers to procedures, policies and practices for guidance. Contributes to publications in the field of expertise. Knowledge of cGMP manufacturing is required.

Knowledge and Skills:

Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions

Teamwork -- Ability to work well on global cross-functional teams.

Communication Skills -Able to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates with  senior management; technical writing skills to support authorship and approval of internal technical documents

Organization – Exercises good time management and prioritization skills to balance multiple project and departmental objectives

Technical - Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors

Knowledge Sharing - Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use

Resource Management -Project management skills; ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal external resources (vendors)

External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Interacts with external vendors for projects

Leadership Skills – Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives.


May require approximately 10% travel.


401(k) with company match and Annual Retirement Contribution Plan

Tuition reimbursement

Company match of charitable contributions

Health & Wellness programs including onsite flu shots and health screenings

Generous time off for vacation and the option to purchase additional vacation days

Community Outreach Programs

Empowering Our People to Shine

Discover more at

No Phone Calls or Recruiters Please.


*This job posting excludes CO applicants*


Lexington, MA

Worker Type


Worker Sub-Type


Time Type

Full time


Save Job

Share This Job




Explore The Area

Related Jobs

View All of Our Available Opportunities

Recently Viewed jobs

No jobs have been viewed recently.

Saved jobs

Sorry, you do not have any saved jobs.

Related Content

Biotech Site in Covington, GA

Explore More

Innovators in Science Award Winners

Explore More

The History of Takeda

Explore More

Sign up for Job Alerts

Sign up to receive the latest career opportunities directly to your inbox.

First Name

Last Name

Phone Number

Email Address

Interested In

Select a job category from the list of options. Select a location from the list of options. Finally, click “Add” to create your job alert.

Job Category

Select a Job Category

Automation and AI

Business Administration

Business Development

Clinical Development

Communications and Public Affairs

Contingent Workers

Data Sciences

Drug Safety


Environmental Health & Safety

Ethics and Compliance


General Management

Human Resources

Information Technology

Insights & Analytics



Manufacturing Sciences


Medical Affairs


Patient and Market Access

Pharmaceutical Sciences

Plasma Management

Process Improvement


Project/Program Management


Real Estate, Facilities, and Security

Regulatory Affairs

Research Science

Sales and Marketing

Supply Chain

Therapeutic Area Unit


United States of America (Inactive)


Select Location

Alabama, United States

Algiers Province, Algeria

Almaty, Kazakhstan

Arizona, United States

Baden-Württemberg, Germany

Bangkok, Thailand

Beijing Municipality, China

Brandenburg, Germany

Bratislava, Slovakia

Brussels Capital, Belgium

București, Romania

Budapest, Hungary

Buenos Aires F.D., Argentina

Cairo Governorate, Egypt

California, United States

Campeche, Mexico

Canton of Neuchâtel, Switzerland

Canton of Zurich, Switzerland

Capital Region, Denmark

Carinthia, Austria

Central and Western District, Hong Kong SAR

Central District, Israel

Central Java, Indonesia

Central Serbia, Serbia

Connecticut, United States

District of Columbia, United States

East Java, Indonesia

East Kalimantan, Indonesia

England, United Kingdom

Florida, United States

Fujian, China

Fukuoka, Japan

Georgia, United States

Guangdong, China

Haryana, India

Hawaii, United States

Hlavní město Praha, Czechia

Idaho, United States

Île-de-France Region, France

Illinois, United States

Indiana, United States

Iowa, United States

Istanbul, Turkey

Jakarta Special Capital Region, Indonesia

Kanagawa, Japan

Kentucky, United States

Kyiv City, Ukraine

Land Berlin, Germany

Latium, Italy

Leinster, Ireland

Łódź Voivodeship, Poland

Lower Austria, Austria

Madrid, Spain

Maharashtra, India

Maine, United States

Maryland, United States

Massachusetts, United States

Mazovia, Poland

Mecca Region, Saudi Arabia

Mexico City, Mexico

Michigan, United States

Minnesota, United States

Minsk City, Belarus

Mississippi, United States

Missouri, United States

Montana, United States

Moscow, Russia

Nevada, United States

New Hampshire, United States

New Jersey, United States

New Mexico, United States

New South Wales, Australia

New York, United States

Nizhny Novgorod Oblast, Russia

North Carolina, United States

North Holland, Netherlands

North Sumatra, Indonesia

Novosibirsk Oblast, Russia

Nur-Sultan, Kazakhstan

Ohio, United States

Ontario, Canada

Oregon, United States

Ōsaka, Japan

Pennsylvania, United States

Primorskiy (Maritime) Kray, Russia

Rhode Island, United States

Riau, Indonesia

Rostov Oblast, Russia

Salzburg, Austria

Samara Oblast, Russia

São Paulo, Brazil

Saratovskaya Oblast, Russia

Selangor, Malaysia

Seoul, South Korea

Shanghai Municipality, China

Sichuan, China

South Carolina, United States

South Sulawesi, Indonesia

South Sumatra, Indonesia

Special Region of Yogyakarta, Indonesia

St.-Petersburg, Russia

Stockholm County, Sweden

Styria, Austria

Sverdlovsk Oblast, Russia

Taiwan, Taiwan

Takao, Taiwan

Tamil Nadu, India

Tatarstan Republic, Russia

Tennessee, United States

Texas, United States

Tianjin Municipality, China

Tokyo, Japan

Tuscany, Italy

Tyrol, Austria

Tyumen’ Oblast, Russia

Upper Austria, Austria

Utah, United States

Uusimaa, Finland

Veneto, Italy

Vermont, United States

Vienna, Austria

Viken, Norway

Virginia, United States

Wallonia, Belgium

Washington, United States

West Bengal, India

West Java, Indonesia

Wisconsin, United States

Yamaguchi, Japan

Yaroslavskaya Oblast’, Russia

Zhejiang, China


Pharmaceutical Sciences, Lexington, Massachusetts, United States



Upload Resume


Confirm Email

By submitting your information, you acknowledge that you have read our applicant privacy notice

and consent to receive email communication from Takeda Pharmaceuticals.


Terms of Use

Privacy Policy

EEO Statement



Job Seekers: Protect yourself against identity theft

Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.

At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports:;

2) file a complaint with the U.S. Federal Trade Commission:;

and/or 3) file a report with your local police department.

Copyright 1995-2021 Takeda Pharmaceutical Company Limited. All rights reserved.

Connect with us:

Visit us at LinkedIn

Visit us at Twitter

Visit us at Glassdoor

Visit us at YouTube


Company info

Takeda Pharmaceutical Company Limited.
Website :

Similar Jobs:
Apply on the Company Site Jobs Rated 82nd **_At Siemens Healthineers, we are passionate aboutenabling healthcare professionals to deliver high quality patient care, and todo so affordably. A leading global healthcare company, Siem...
The Pivotal Drug Product Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug product manufacturing processes for all late-stage programs across the Amgen portfolio.Amgen is cur...
Scorpion Therapeutics is a precision oncology company founded in February 2020 by a preeminent group of scientists from Harvard University/Massachusetts General Hospital – Keith Flaherty, M.D., Gaddy Getz, Ph.D. and Liron Bar-Pele...
EmploymentCrossing provides an excellent service. I have recommended the website to many people..
Laurie H - Dallas, TX
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ChemistryCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ChemistryCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2021 ChemistryCrossing - All rights reserved. 168 192