12 days old

QC Analyst II - HPLC

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421
  • Job Code
    R0036553

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Job Description

Title: Quality Control Analyst II - HPLC

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 II - 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.

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.

Discretion/Latitude:

Work is performed under general direction with general supervision.

Work may be reviewed upon completion for adequacy in meeting objectives

Impact:

Contributes to the completion of organizational projects and goals. Errors in judgement or failure to achieve results would normally require a moderate expenditure of resources to rectify.

Specific HPLC Focus Areas:

  • 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

RESPONSIBILITIES:

  • Receives assignments in the form of objectives and establishes goals to meet objectives.
  • Provides guidance to subordinates to achieve goals in accordance with established policies.
  • Work is reviewed and measured based on meeting objectives and schedules.
  • Establishes and recommends changes to policies which effect subordinate organizations.

40-50%:

  • Testing execution, participate in training analysts, trouble shooting of methods

30-40%:

  • QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)

10-20%:

  • Participate in training analysts, troubleshooting of test methods including involvement in various departmental and cross-functional teams and initiatives, inspection and regulatory support

KEY SKILLS, ABILITIES, AND COMPETENCIES:

Knowledge:

  • 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.

Complexity and Problem Solving:

  • Develop solutions to a variety of complex problems.
  • May refer to established precedents and policies.
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
  • Networks with senior internal and external personnel in own area of expertise.

Internal/External Contacts:

Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organization

Contacts external to QC may include: Analytical Development, R&D, Quality Assurance and other Quality functions, Regulatory , Manufacturing, Facilities and Engineering

ADDITIONAL JOB REQUIREMENTS:

  • 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

TRAVEL REQUIREMENTS:

  • Relevant travel between MA sites may be required.

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

This post excludes CO applicants

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

Title: Quality Control Analyst II - HPLC

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 II - 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.

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.

Discretion/Latitude:

Work is performed under general direction with general supervision.

Work may be reviewed upon completion for adequacy in meeting objectives

Impact:

Contributes to the completion of organizational projects and goals. Errors in judgement or failure to achieve results would normally require a moderate expenditure of resources to rectify.

Specific HPLC Focus Areas:

  • 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

RESPONSIBILITIES:

  • Receives assignments in the form of objectives and establishes goals to meet objectives.
  • Provides guidance to subordinates to achieve goals in accordance with established policies.
  • Work is reviewed and measured based on meeting objectives and schedules.
  • Establishes and recommends changes to policies which effect subordinate organizations.

40-50%:

  • Testing execution, participate in training analysts, trouble shooting of methods

30-40%:

  • QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)

10-20%:

  • Participate in training analysts, troubleshooting of test methods including involvement in various departmental and cross-functional teams and initiatives, inspection and regulatory support

KEY SKILLS, ABILITIES, AND COMPETENCIES:

Knowledge:

  • 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.

Complexity and Problem Solving:

  • Develop solutions to a variety of complex problems.
  • May refer to established precedents and policies.
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
  • Networks with senior internal and external personnel in own area of expertise.

Internal/External Contacts:

Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organization

Contacts external to QC may include: Analytical Development, R&D, Quality Assurance and other Quality functions, Regulatory , Manufacturing, Facilities and Engineering

ADDITIONAL JOB REQUIREMENTS:

  • 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

TRAVEL REQUIREMENTS:

  • Relevant travel between MA sites may be required.

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

This post excludes CO applicants

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
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Sponsored by:
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QC Analyst II - HPLC

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421

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