BioSpace is hiring: Manufacturing Lead Investigator in Round Lake Beach

Manufacturing Lead Investigator – Takeda (BioSpace)

About the Role

The Lead Investigator will initiate and execute deviations in support of Manufacturing. Responsibilities include defining problem statements, documenting the current state, conducting root‑cause analysis, implementing corrective actions, and verifying that the actions are effective. The incumbent provides technical support to manufacturing functions, including filling, inspection, and packaging operations, and works closely with QA, quality assurance, or critical system personnel to investigate suspect results, lead investigation teams, and prepare presentations for management.

Responsibilities

• Conduct and document investigations in a timely manner to support on‑time closure of non‑conformances and meet product fulfillment dates.
• Support problem‑solving sessions through the application of problem‑solving tools and methods; coordinate and/or lead investigation teams, including routine and complex investigations.
• Contribute to team efficiency, solve problems, generate cost savings, improve quality, and provide new product support; lead or support Deviation Free Initiatives.
• Work closely with QA departments and manufacturing operations to determine appropriate corrective actions and drive closure of deviations in accordance with cGMP and quality systems.
• Maintain access to key quality‑system databases and ensure accuracy related to CAPA and other quality databases.
• Maintain data integrity and ensure compliance with SOPs and specifications, FDA, GLP, QSR, and cGMP regulations; investigate deviations and write exception documents when assigned.
• Ensure training requirements are met and training records are current; train and mentor other team members.
• Prepare root cause and/or trend analysis for management during routine operation mechanisms (e.g., Management Review and CAPA Review Board).

What You Bring

• Bachelor’s degree in science, engineering, or related field and 2+ years of related work experience (leadership experience preferred).
• Technical writing experience preferred.
• Ability to work independently and handle multiple tasks concurrently, completing tasks in a timely manner.
• Effective organizational and detail‑oriented skills, with ability to plan and suggest resolutions to technical or resource problems.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Effective interpersonal communication and influencing skills; strong verbal and written communication abilities.
• Understanding of scientific strategies and ability to create new processes or investigative avenues.
• Knowledge of cGMP/GOP, CTP/SOPs, and ability to meet EHS requirements.
• Good process and critical system understanding to create comprehensive investigation write‑ups.
• Capability to navigate Quality systems and working knowledge of event‑management systems.

Role Details

• Location: USA – IL – Round Lake – Drug Delivery (Round Lake Beach, IL)
• Salary Range: $70,000 – $110,000 (USD)
• Employment Type: Full‑time, Regular Employee
• Job Exempt: Yes

Working Environment

• Controlled environment requiring gowning and protective clothing; may include hearing protection for loud areas.
• Make‑up, jewelry, contact lenses, nail polish, and artificial fingernails must be removed while in the manufacturing environment.
• Work may involve cold, wet conditions and multiple shifts, including weekends or supplemental hours as necessary.
• Exposure to chemicals such as alcohol, acids, buffers, and Celite may require respiratory protection.

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.