Scientist II, Method Introduction & Support (MI&S)

USA - 3390 Baxalta U.S., Inc.; Los Angeles (CA); On-site; USD 72,000 - 113,000; Full time

Job summary

Takeda Pharmaceutical Co. in Los Angeles seeks a science/engineering professional to plan, develop, lead, and evaluate improvement and compliance projects related to assay validation/remediation and Analytical Instrument Qualification.

You will provide technical support to investigations and document protocols and reports, working with minimal supervision to meet deadlines. The role involves leading validation activities, developing procedures, driving lifecycle projects, and managing CAPAs,

Qualifications

• Requires bachelor’s degree in science, engineering or related field.
• 2+ years of related experience.
• Proficient in written and oral English.
• Strong organizational skills; ability to plan and resolve technical problems.
• Understanding of cGMP/GDP, SOPs and regulatory requirements.

Responsibilities

• Lead assay validation/remediation activities across shifts for Biochemistry and Microbiology labs.
• Develop test procedures, protocols, reports supporting method/equipment revisions and validation.
• Drive Analytical Instrument Lifecycle projects including qualification and relocation.
• Own and drive quality processes, investigations, changes controls, deviations, and CAPAs.
• Author complex technical assessments to assist investigations and problem solving.
• Develop and monitor systems focusing on assay performance indicators and data analytics.
• Lead multiple process/product improvement projects; participate in CAPA, QWT or other groups.
• Assist in audit readiness regarding FDA, Takeda, and other regulatory requirements.

Skills

English proficiency

Communication

Problem solving

Data analysis

Regulatory knowledge

Microsoft Office

Excel

Statistical techniques

Education

Bachelor’s degree in science/engineering or related field

Bachelor’s degree in Chemistry or Biological Science preferred

Tools

Microsoft Office

Microsoft Excel

Statistical software

Job description

About the role

Plan, develop, lead and evaluate improvement and compliance projects relating to assay method validation/remediation, and Analytical Instrument Qualification. Responsible for basic project management and documentation authoring (e.g. protocols and reports). Provide technical expertise and/or support investigation teams in troubleshooting/problem solving activities as applicable. Provide recommendations for decisions of test systems and results of moderate complexity. Self-led individual that works under minimal supervision to meet deadlines/goals.

How you will contribute

• Lead ongoing assay validation/remediation daily department activities across all shifts for the Biochemistry and Microbiology Laboratory including supervision of assigned personnel when performing assays and when required assist other Quality areas in the successful performance of these activities.
• Develop test procedures, generate protocols, reports and other documentation to support method/equipment revisions and validation.
• Lead and drive Analytical Instrument Lifecycle projects including qualification, relocation, decommissioning, risk assessments, and periodic reviews.
• Own and drive quality processes, investigations, and actions for change controls, deviations, and CAPAs.
• Author more complex technical assessments to assist investigations and problem solving.
• Develop, establish and monitor systems that focus on key indicators of assay performance including laboratory control trends and data analytics.
• Be directly involved in and lead multiple process/product improvement projects.
• These projects may be executed through CAPA, QWT, or other focus groups, design of experiments, studies, data generation and analysis, report preparation, presentations, and/or change control.
• Assist in laboratory audit ready status efforts in understanding FDA, Takeda, and other regulatory and quality requirements.
• Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements.
• May present to auditors regarding the various MI&S activities.
• Lead in the development of customer awareness and support activities for Biochemistry/Microbiology and assist and drive such activities throughout the shifts.
• Operational liaison with various customers including Manufacturing, Quality Assurance, and Manufacturing Sciences.
• Interface with other Takeda sites for development, improvement, and alignment of analytical methods, instruments, and technology.
• Prepare, review and revise, as required, methods and SOPs.
• Write memos, reports, protocols, CPAs and other appropriate documentation as they pertain to Biochemistry and Microbiology operations and procedures.
• Drive Lean principles such as 5S throughout daily work activities.
• May perform removal of hazardous waste.

What You Bring to Takeda

• Requires bachelor’s degree in science, engineering, or other related technical field.
• 2+ years of related experience.
• Bachelor’s Degree in Chemistry or Biological Science is preferred.
• Must be proficient in written and oral English.
• Demonstrated track record of managing multiple tasks and projects concurrently and driving projects to completion in a timely manner.
• Strong organizational skills and ability to plan and suggest resolutions to technical problems.
• Strong understanding of critical laboratory, manufacturing and facility processes.
• Understand scientific strategies and be able to recommend different technical strategies and analyses during investigations.
• Effective in utilizing various advanced software applications.
• Computer literate and competent with an effective knowledge of word processing and spreadsheets (such as Microsoft Office and Microsoft Excel).
• Capable of performing advanced data analysis through various applications software.
• Strong interpersonal communication and influencing/negotiation skills.
• Must have strong verbal and written communication skills.
• Effective presentation skills.
• Represent the laboratory through technical presentations, management reviews, problem solving, and other department presentations.
• Apply effective decision-making to problem-solve technical, compliance, or operational problems as assigned.
• Must be able to apply cGMP/GDP, follow methods/SOPs, and meet EHS requirements.
• General knowledge of statistical techniques.
• Working knowledge of QSR, CFR, and USP.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location: USA - CA - Los Angeles U.S. Base Salary Range: $71,800.00 - $112,860.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

USA - CA - Los Angeles

Worker Type

Employee

Sub-Type Regular Time

Type Full time

Job Exempt Yes

Company Overview

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do.

We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.

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