Drug Product Development Associate Scientific Fellow
Takeda
Summary
The Drug Product Development Associate Scientific Fellow is involved in the development of Takeda's parenteral products, including monoclonal antibodies, recombinant proteins, peptides, antibody-drug conjugates, and small molecules. You will participate in cross-functional Chemistry, Manufacturing, and Controls (CMC) teams and lead all drug product activities for one or more programs. Responsibilities include developing robust liquid or lyophilized formulations for drug substance and drug product throughout the product life cycle, as well as developing and transferring scalable and robust drug product manufacturing processes from early phase through process validation. This role supports Takeda's mission by developing and implementing drug product presentations and manufacturing processes to deliver new medicines to patients.
Job description
How you will contribute:
- As a member of the CMC team for one or more programs, lead all parenteral drug product development activities with a high level of independence
- Collaborate with key partners such including Analytical Development, Drug Substance Development, Device Development, Quality, Commercial Manufacturing, and Clinical development to ensure delivery of the cross functional project needs
- Design and execute phase-appropriate DP formulation development, process development, and process characterization studies
- Provide technical leadership for clinical drug product process development and clinical drug product manufacturing
- Lead the design and execution of PPQ for validation of late-stage processes
- Author and review development documents including regulatory submissions and responses
- Identify, evaluate, adopt, and develop formulation and drug product technologies to continuously improve product development capabilities
- Support drug product manufacturing deviation investigations, CAPAs, and change control management
- Communicate with leadership and provide guidance in the most complex situations
- Mentor team members and share subject matter knowledge across the function
Skills and qualifications:
- PhD in chemistry, biochemistry, pharmaceutical sciences, or a related field, and 7 or more years of relevant experience, or a Master's degree in chemistry, biochemistry, pharmaceutical sciences, or a related field, and 13 or more years of relevant experience, or a Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, or a related field, and 15 or more years of relevant experience
- Recognized expert in drug product development, with deep knowledge of liquid and lyophilized formulation development and aseptic fill/finish process development
- Analytical and problem-solving skills are required. Able to troubleshoot critical issues or problems using appropriate information and determine causes and possible solutions
- Experienced and demonstrated track record in biopharmaceutical product development including but not limited to drug product development, drug product process characterization, QbD, and control strategy
- Expert in innovation, recognized internally or externally as a thought leader, capable of coaching others and driving strategic ideation for novel or improved products and technologies
- Possesses expert-level writing skills, recognized for strong command of language, structure, and content creation, capable of coaching others and setting writing standards
- Experienced in lyophilization and/or combination drug product development with good understanding of the inter-relationship among formulation parameters, process parameters, product delivery, and quality
- Excellent communication, technical, organizational, interpersonal and leadership skills are required
- Must be a team player prepared to lead, work effectively and efficiently in a team-based environment
Requirements
- PhD in chemistry, biochemistry, pharmaceutical sciences, or a related field, and 7 or more years of relevant experience, or a Master's degree in chemistry, biochemistry, pharmaceutical sciences, or a related field, and 13 or more years of relevant experience, or a Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, or a related field, and 15 or more years of relevant experience
- Recognized expert in drug product development, with deep knowledge of liquid and lyophilized formulation development and aseptic fill/finish process development
- Analytical and problem-solving skills are required. Able to troubleshoot critical issues or problems using appropriate information and determine causes and possible solutions
- Experienced and demonstrated track record in biopharmaceutical product development including but not limited to drug product development, drug product process characterization, QbD, and control strategy
- Expert in innovation, recognized internally or externally as a thought leader, capable of coaching others and driving strategic ideation for novel or improved products and technologies
- Possesses expert-level writing skills, recognized for strong command of language, structure, and content creation, capable of coaching others and setting writing standards
- Experienced in lyophilization and/or combination drug product development with good understanding of the inter-relationship among formulation parameters, process parameters, product delivery, and quality
- Excellent communication, technical, organizational, interpersonal and leadership skills are required
- Must be a team player prepared to lead, work effectively and efficiently in a team-based environment
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.