Process and Product Science, Senior Analyst
Takeda
Summary
As the Process and Product Science, Senior Analyst, you will manage and perform scientific research, development, and testing of new products, manufacturing processes, and raw materials. You will provide technical support to Manufacturing Science at the Round Lake site.
Job description
About the role
As the Process and Product Science, Senior Analyst, you will manage and perform scientific research, development, and testing of new products, manufacturing processes, and raw materials. You will provide technical support to Manufacturing Science at the Round Lake site.
How will you contribute
- Provide deviation and CAPA support, including authoring and reviewing records (e.g., investigation reports, root cause analyses, CAPA plans) in accordance with GMP and site procedures.
- Serve as a technical and scientific subject matter expert (SME) for investigations, evaluating process and product data to determine root cause and assess impact.
- Plan, lead, and execute yield improvement projects, working independently with limited supervision.
- Apply scientific and engineering principles to improve manufacturing processes, making them more efficient, robust, and streamlined.
- Collect, trend, and analyze process data to build a deeper understanding of process performance and variability, and to drive data-based recommendations.
- Perform basic laboratory analyses, including microscopic analysis, to support investigations and process understanding.
- Author, execute, and report on technical protocols and studies, including experimental design and data summaries.
- Partner cross-functionally with Manufacturing, Quality, Engineering, and Technical Services to implement improvements and resolve process issues.
What you bring to Takeda
- Bachelor's degree in Chemical Engineering, Biological Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific or engineering discipline required.
- 5+ years of related experience in pharmaceutical, biotechnology, biologics, medical device, or other regulated manufacturing environments.
- Experience applying scientific and engineering principles to manufacturing processes, product performance, investigations, process improvement, or technical problem solving.
- Working knowledge of GMP regulations, quality systems, and manufacturing process controls.
- Experience analyzing technical data and authoring or contributing to technical reports, protocols, investigations, risk assessments, or other controlled documentation.
- Experience working cross-functionally with functions such as Manufacturing, Quality, Engineering, Technical Services, or Regulatory preferred.
Physical Demands
Must be able to carry, lift, push/pull up to 70lbs with assistance of material handling equipment and/or two-person lifts. Must be able to stand and/or walk for extended periods over an 8-12 hour shift. May require bending, twisting, reaching overhead, and/or squatting. Work in a cold, wet environment and around chemicals requiring respiratory protection. Indoor working conditions with exposure to loud noises requiring hearing protection. Will work around moving equipment and machinery. Must follow gowning requirements and wear protective clothing. May be required to work in confined spaces/areas. May be exposed to and must not be allergic to cephalosporin. May require immunization. Must be able to work multiple shifts, including weekends, and non-traditional hours as needed.
Requirements
- Bachelor's degree in Chemical Engineering, Biological Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific or engineering discipline
- 5+ years of related experience in pharmaceutical, biotechnology, biologics, medical device, or other regulated manufacturing environments
- Experience applying scientific and engineering principles to manufacturing processes, product performance, investigations, process improvement, or technical problem solving
- Working knowledge of GMP regulations, quality systems, and manufacturing process controls
- Experience analyzing technical data and authoring or contributing to technical reports, protocols, investigations, risk assessments, or other controlled documentation
- Experience working cross-functionally with Manufacturing, Quality, Engineering, Technical Services, or Regulatory preferred
- Must be able to carry, lift, push/pull up to 70lbs with assistance
- Must be able to stand and/or walk for extended periods over an 8-12 hour shift
- Must be able to work multiple shifts, including weekends, and non-traditional hours as needed
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.