Sr Scientist - Vaccine Process Development

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SR SCIENTIST - VACCINE PROCESS DEVELOPMENT

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a SR Scientist - Process Development - Vaccine Operations in our Cambridge, 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.

Objectives

• Analyze data from studies, method development, or tech transfer activities, and author reports for submission to multiple parties, including regulatory agencies such as the FDA and EMA.
• Coordinate information exchange between functional groups within Takeda, including Vaccine Research and Analytics, Drug Product Development, Vaccines Operations, Vaccine Process Technology, Technical Development, and Quality Assurance.
• Recognize problems with experiments, suggest causes, and propose solutions. Prepare protocols, technical reports, summaries, and quantitative analyses of experimental procedures, data, and conclusions.
• Lead and oversee programs conducted both in-house and at 3rd party vendors.
• Design, manage, lead, and execute studies pertaining to Process Development.

Accountabilities

• Proficient in a wide variety of cell culture techniques and/or process development-related laboratory instrumentation/computer platforms.
• Design, schedule, and execute a wide variety of technical experimental studies for Upstream and/or Downstream Process Development for Vaccines
• Develop and utilize scale-down models to facilitate process characterization, optimization, and scale-up.
• Provide expertise to support third parties, R&D, and other functions as required to achieve the project goals and priorities.
• Authoring of laboratory operations and equipment SOPs.
• Develop methods to improve existing techniques/efficiencies and/or methods sourced from journal articles and/or other scientists.
• May participate in scientific conferences and/or author manuscripts for submission to scientific journals.
• Comply with Takeda safety practices and standard operating procedures.
• Effectively compile and analyze data, summarize experimental outcomes.
• Coordinate efforts between internal and external teams such as Vaccine Research and Analytics, Drug Product Development, Vaccine Process Technology, Technical Development, and Quality Assurance.
• Other operational or functional duties as assigned.
• Support the team leader in process development strategies planning and execution of deliverables.
• Lead, train, and provide work direction to other Scientists, Research Associates, and Interns. May be required to manage junior scientists.
• Design, execute or oversee studies with contract manufacturing and testing organizations (CMOs/CTOs) to improve product performance and maximize shelf (if required).
• Write and maintain accurate, complete, and timely data in electronic laboratory notebooks. Review and track department electronic laboratory notebooks to ensure timely closure.
• Prepare protocols, process checklists, technical reports, summaries, and quantitative analyses for distribution and/or presentation to project teams, and for inclusion in reports and regulatory agency submissions using appropriate statistical analyses.

Education, Experience, Knowledge And Skills

• Ph.D. in a scientific discipline with a minimum of 6 years relevant experience (may include post-doctoral experience), MS in a scientific discipline with a minimum of 8 years relevant experience, or a BS in a scientific discipline with a minimum of 10 years relevant experience.
• Experience in laboratory scale process science, including process scale-up and scale-down required.
• Ability to investigate and develop new methods and technologies for project advancement.
• Good oral communication and demonstrable, exemplary writing skills.
• Proven ability to understand the theoretical basis and objectives of experiments and how they fit into overall project goals.
• Familiarity with current applicable scientific literature and contribute to the process of a project within her/his scientific discipline, as well as investigate, create, and develop new methods and techniques for project advancement.
• Experience with upstream and/or downstream process development of virus vaccines/biologics. Well-versed in cell culture techniques including manual cultivation of adherent/suspension cells in small-scale flasks and operation of stirred tank and/or packed bed bioreactors; and/or purification techniques including cell harvest technologies, preparative chromatography, and normal and tangential flow filtration techniques.
• Knowledge of cGMP practices as applicable to process development, formulation, analytical development, technology transfer, or manufacturing would be a distinct advantage.
• Well organized and detail-oriented, with the ability to effectively prioritize tasks, eager to learn, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility.
• Good time and project management skills, ability to execute or oversee several studies simultaneously.
• Working knowledge of Biologics cGMPs including ICH guidance documents would be a distinct advantage.

Location and Salary Information:

Base Salary Range: $105,000 to $150,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.”

What Takeda Can Offer You

• Generous time off for vacation and the option to purchase additional vacation days
• Health & Wellness programs including onsite flu shots and health screenings
• Community Outreach Programs
• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement
• Company match of charitable contributions

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time