Research Scientist

Job Description

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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 Research Scientist in our Thousand Oaks, CA 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.

The Research Scientist will be involved in the transfer, execution and analysis of process scale-down models supporting Drug Substance manufacturing at the Takeda Thousand Oaks Manufacturing facility. Responsibilities also include the transfer, non-GxP qualification and execution of analytical assays. The successful candidate will design, author, execute technical studies and reports. Additionally, the individual will be expected to support and make recommendations for product impact investigations as well as process and yield improvements opportunities.

The Scientist will provide technical guidance to lab technicians/associates regarding the design, execution and evaluation of lab studies and reports. The Scientist will be expected to lead experimental design while developing protocols to ensure the data generated can be translated into yield and process improvements, as well as to support product deviation investigations.

The Scientist may closely collaborate with cross-functional teams such as Global Manufacturing Sciences, Process Development, CMC team members, Regulatory, Manufacturing and Quality while supporting various Product Life Cycle Management projects.

This position will primarily focus on Drug Substance operations; however, support of Drug Product operations may be requested as needed.

Essential Duties and Responsibilities

• Provide technical expertise in execution of biologics drug substance. (Drug product operations technical expertise would be a plus.)
• Design/Author/Review experimental protocols intended to drive GMP processes efficiency, yields and investigation support
• Represent Thousand Oaks Manufacturing Sciences within cross functional project teams, organizational initiatives, and technology development groups
• Support drug substance and drug product manufacturing deviation investigations, CAPAs, and change control management.
• Assists with development of project strategy and communicates complex data/decisions within department and cross-functionally as necessary

Qualifications

• Experienced and demonstrated track record in biopharmaceutical development, analytical science or other laboratory discipline
• Preferably, experienced in drug substance development
• Excellent communication, technical, organizational, interpersonal and leadership skills are required
• Must be a team player prepared to lead, work effectively and efficiently in a team-based environment
• Able to critically evaluate results and have the ability to defend strategic guidance

Education and/or experience

• Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience
• Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience
• PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ years relevant industry experience
• Bachelors or Masters: 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

Physical Demand

• Physical Demand Level – MEDIUM.
• Rarely Lifting – Up to 50 pounds.
• Frequent Lifting 15 – 35 pounds
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility. Total standing and walking can be up to 6 hours in a 8 hour workday (depending upon shift schedule requirements).
• Sitting – Frequent – Production of reports.
• Pushing/Pulling – Frequent – Required in some positions to inspect equipment, access alternative areas of facility, move labeling carts.
• Overhead reaching – Occasional- to obtain and place materials for inspection or reach needed materials.
• Squatting – Occasional – To observe materials and equipment at floor level.
• Hand/Finger Feel – Frequent – Employees are required to handle the individual packages and handle small fine parts. Parts will have multitudes of textures and sizing.
• Gripping/Grasping – Frequent – Employees are required to use hand tools and possible other equipment to assist in the manufacturing and quality assurance of products.
• Communication – Constant – Employees must be able to communicate orally and in writing in a clear, concise understandable manner to supervisor and instruct co-employees and staff. Including use of computer, telephone, and related communication instruments.

Working Environment

• Normal office, lab and warehouse areas.
• This job posting excludes CO applicants.

EEO Verbiage for US Reqs

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.

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