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 Quality Control Analyst I - HPLC 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.

POSITION OBJECTIVES:

Primary duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations/validation or development studies.  Testing may include but not limited to samples from in process, drug substance/product and various protocol studies using analytical test methods derived from non-compendial sources.  The position is expected to maintain operational and GMP readiness of the QC area. In addition, the individual will participate in more complex projects, operational excellence initiatives including 5S/lean improvements, method/equipment validation, method transfer and various quality systems (deviations, change controls, investigations) with little to no supervision, and maybe asked to take lead roles for the QC organization on these projects.  Position is expected to act as a role model for junior staff in the various QC areas.  

POSITION ACCOUNTABILITIES:

Role is responsible for HPLC laboratories performing a broad range of analytical based techniques such as SE-HPLC, RP-HPLC, IEX, CE-SDS, glycan and peptide analyses in order to support in-process, release and stability testing.  

Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.

Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.

Specific QC Focus Area:

Product testing: Areas of focus on techniques such as HPLC and SDS-PAGE for purity, identity, potency and charged heterogeneity.

• Perform and troubleshoot HPLC based assays (SE-HPLC, IEX, RP-HPLC, CE-SDS, Peptide Mapping, and Glycan Mapping) of release and stability


• Review QC analytical assays


• Execute and lead method qualification and validation assays as needed


• Perform and lead OOT, OOS, GMP Investigations, data analysis, deviation and data trending


• Maintain GMP condition of the lab

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Typically requires a bachelor’s degree and  a minimum of 0-2 years of related experience.  (science related degree is preferred)

Additional Specific Experience:

• Excellent communication, interpersonal and organizational skills.


• Ability to work well both independently and in a team environment.


• Ability to prioritize work and multitask.


• Experience in a GMP QC role is preferred

General understanding and application principles, concepts, practices and standards. Full knowledge of industry practices.  Position requires critical thinking.

Key Skills: MS Office, LIMS, SAP, Trackwise, Waters Empower, Thermo Fisher Chromeleon, EDMS, compliance and science understanding.

The following physical abilities are required in order to fulfill the job duties:

• Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)


• Ability to work around chemicals (if working around the laboratories)


• Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases


• Ability to walk and stand for periods of time


• Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

WHAT TAKEDA CAN OFFER YOU:

• 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 takedajobs.com

No Phone Calls or Recruiters Please.

Location and Salary Information:

• This job posting excludes CO applicants.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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