Supervisor Quality Control at Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts

Job Description:

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Job Description

Primary Duties

Job Summary/Operations Involvement:

Primary duties of this position will include serving as a lead for various technical aspects of the HPLC area. Primary focus on providing both subject matter expertise as well as technical leadership on the daily lab operations and execution of testing to support manufacturing operations/validation or development studies.  Other activities as assigned include method related projects (transfers & validation), investigations, quality system events, data analysis & trending, key program oversight (e.g. assay control, invalids, critical reagents), and cross functional interaction on various teams to enable appropriate overall QC support on projects and programs.  The position is expected to maintain operational and GMP readiness of the QC areas. In addition, the individual will lead 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 will also assist in managing departmental and/or cross functional teams occasionally.

Discretion/Latitude:

Works autonomously and receives general instructions on new assignments. Proposes technical strategies and frequently discusses soundness of technical judgement and reviews progress in meeting objectives and timelines with supervisor.  Participates in determining objectives of assignments.  Plan schedules and arranges own activities in accomplishing objectives.  Work may be reviewed upon completion for adequacy in meeting objectives.

Impact:

Exerts some influence on the overall objectives and long-range goals of the organization.   Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.

Specific HPLC Focus Areas:

• Role is responsible for HPLC laboratory 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:

Job Scope

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.

• 30-50% of Time: Management  of daily/weekly/monthly and longer term activities of staff and operational oversight of group, data review, scheduling, oversight of group training.


• 20-40% of Time: GMP documentation related activities. 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)


• 20-30% of Time: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support

Education and Experience Requirements

• Typically requires a bachelor’s degree and  a minimum of 6+ years of related experience.  (science related degree is preferred)

Additional Specific Experience:

• Relevant supervisory experience


• Excellent communication, interpersonal and organizational skills.


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


• Ability to prioritize work and multitask.


• Previous experience in a GMP QC role is preferred


• 5S/OE experience

Key Skills, Abilities, and Competencies

Knowledge:

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

Key Skills: Strong and effective people management skills. MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong 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 and 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

Other Job Requirements

• Limited to no travel expected. Travel between sites is required.

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

Locations

Worker Type

Worker Sub-Type

Time Type

Full time