Parenteral Drug Product Development Fellow

USA - 3316 Takeda Development Center Americas, Inc.; Lexington (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda's Drug Product Development group in Lexington, MA and the surrounding area seeks a highly experienced Scientific Fellow to lead parenteral drug product development across one or more programs. You will drive formulation and process development, mentor teammates, and author regulatory documents.

The role requires deep expertise in liquid and lyophilized formulations, aseptic fill/finish, and cross-functional collaboration with Analytical Development, Device, Quality, and Clinical teams to

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

Responsibilities

• 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

Analytical and problem-solving

Excellent communication

Leadership

Team player

Biopharmaceutical product development

Innovation and thought leadership

Expert-level writing skills

Lyophilization knowledge

Cross-functional collaboration

Education

PhD in chemistry/biochemistry/pharmaceutical sciences or related field

Master’s in chemistry/biochemistry/pharmaceutical sciences or related field

Bachelor’s in chemistry/biochemistry/pharmaceutical sciences or related field

Tools

Lyophilization technology

Aseptic fill/finish process development

Job description

Takeda's Drug Product Development group in Lexington, MA and the surrounding area seeks a highly experienced Scientific Fellow to lead parenteral drug product development across one or more programs. You will drive formulation and process development, mentor teammates, and author regulatory documents.

The role requires deep expertise in liquid and lyophilized formulations, aseptic fill/finish, and cross-functional collaboration with Analytical Development, Device, Quality, and Clinical teams to