Manufacturing Lead Investigator- Day shift at Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts

Job Description:

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Job Description

Day shift 8am to 5pm Monday thru Friday
The Manufacturing Lead Investigator will lead investigations for low to medium risks deviations and manage closure within the established timelines.
Leads cross-functional teams to conduct comprehensive investigations to determine product impact, identify root cause and implementation of corrective and preventative actions.
Develops novel and innovative solutions to a diverse scope of complex problems. Refers to established precedents and policies, but also continuously improves best known practices and establishes guidance’s and job aides for junior members of the team.
Demonstrates a high degree of engagement and involvement in all job-related activities. Exercises good judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Networks with senior internal and external personnel.
Responsibilities: Job Function and Description

• 70% - Lead investigation teams to identify root cause, evaluate technical impact, and provide recommendations on batch disposition for deviations of significant complexity; supports EMs and OOTs as needed


• 10% - Provide subject matter expertise on manufacturing process to support deviations owned by other departments


• 15%- Lead continuous improvement initiatives


• 5% -Provide front-room support during inspections

Education and Experience Requirements Essential:

• Bachelor’s in Science, Engineering or a related discipline


• Typically a minimum of 2 - 3 year of related experience in the manufacturing and/or development of biologics or pharmaceuticals


• Previous technical writing experience required.

Key Skills, Abilities, and Competencies

• Regardless of format, all technical communications will allow the end user, specifically QA personnel and regulatory inspectors, to arrive at the intended conclusions.


• Proactively updates stakeholders in a timely manner.


• Demonstrates ability to lead / facilitate group discussions in a constructive and positive direction.


• Demonstrates high-level of professional and business judgment when communicating cross-functionally and across levels of the organization.


• Proactively identifies potential sources of conflict and resolve independently or escalates in a timely manner as required.


• Experienced in interpreting technical drawings & reports


• Familiar with basic statistical analysis


• Familiar with Lean/6 sigma approaches, and root cause analysis tools


• Familiar with basic Project Management skills


• Proficient with the following software applications ( Standard Microsoft Office applications, Microsoft Visio, Project, and SharePoint, TrackWise, or equivalent system, LIMS, SAP, OSI/PI)
  

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Complexity and Problem Solving

• Demonstrates capability to analyze and resolve the majority of complex issues with minimal supervision and escalation.


• With supervisory guidance defines areas outside of personal expertise and identifies/ involves internal and cross functional subject matter experts and external consultants/SMEs as required.


• Functions as a key participant on cross functional teams with internal/external SMEs.

Internal and External Contacts

• Regularly interacts with internal functions and senior internal personnel on significant matters. Internal contacts include but not limited to:


• Manufacturing


• QC / QA


• Support functions (Engineering, Facilities, Validation, Manufacturing Science, Process Development, etc.)


• Regulatory / Qualified Persons / Product Quality Management


• Serves as external spokesperson during Health Agency Inspections on major matters pertaining to investigations.

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.

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Full time