Drug Product Development Associate Scientific Fellow
Takeda
September 02, 2026
On-site
Lexington, MA
$154,400 - $242,550 USD yearly
Clinical Research and Development
Job Description:
The Drug Product Development Associate Scientific Fellow leads parenteral drug product development across programs, including monoclonal antibodies, recombinant proteins, peptides, antibody-drug conjugates, and small molecules. Responsibilities include developing robust liquid or lyophilized formulations throughout the product life cycle, and developing/transfer scalable, robust manufacturing processes from early phase through process validation.
How you will contribute
- Lead parenteral drug product development activities for one or more programs with high independence
- Collaborate with Analytical Development, Drug Substance Development, Device Development, Quality, Commercial Manufacturing, and Clinical Development
- 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 manufacturing
- Lead the design and execution of PPQ for validation of late-stage processes
- Author/review development documents including regulatory submissions and responses
- Identify, evaluate, adopt, and develop formulation and drug product technologies
- Support deviation investigations, CAPAs, and change control management
- Communicate with leadership and provide guidance in complex situations
- Mentor team members and share subject matter knowledge
Skills and Qualifications
- PhD (7+ years), or Master’s (13+ years), or Bachelor’s (15+ years) in chemistry/biochemistry/pharmaceutical sciences or related field
- Expert in drug product development (liquid and lyophilized formulations; aseptic fill/finish)
- Analytical and problem-solving/troubleshooting skills
- Experience in biopharmaceutical product development (e.g., QbD/control strategy)
- Innovation/thought leadership; ability to coach and drive ideation
- Expert writing skills
- Experience in lyophilization and/or combination drug product development
- Excellent communication, technical, organizational, interpersonal, and leadership skills; team-oriented
Application Instructions
- Apply via the “Apply” button (employment application process begins; information processed per Privacy Notice and Terms of Use).
The Drug Product Development Associate Scientific Fellow leads parenteral drug product development across programs, including monoclonal antibodies, recombinant proteins, peptides, antibody-drug conjugates, and small molecules. Responsibilities include developing robust liquid or lyophilized formulations throughout the product life cycle, and developing/transfer scalable, robust manufacturing processes from early phase through process validation.
How you will contribute
- Lead parenteral drug product development activities for one or more programs with high independence
- Collaborate with Analytical Development, Drug Substance Development, Device Development, Quality, Commercial Manufacturing, and Clinical Development
- 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 manufacturing
- Lead the design and execution of PPQ for validation of late-stage processes
- Author/review development documents including regulatory submissions and responses
- Identify, evaluate, adopt, and develop formulation and drug product technologies
- Support deviation investigations, CAPAs, and change control management
- Communicate with leadership and provide guidance in complex situations
- Mentor team members and share subject matter knowledge
Skills and Qualifications
- PhD (7+ years), or Master’s (13+ years), or Bachelor’s (15+ years) in chemistry/biochemistry/pharmaceutical sciences or related field
- Expert in drug product development (liquid and lyophilized formulations; aseptic fill/finish)
- Analytical and problem-solving/troubleshooting skills
- Experience in biopharmaceutical product development (e.g., QbD/control strategy)
- Innovation/thought leadership; ability to coach and drive ideation
- Expert writing skills
- Experience in lyophilization and/or combination drug product development
- Excellent communication, technical, organizational, interpersonal, and leadership skills; team-oriented
Application Instructions
- Apply via the “Apply” button (employment application process begins; information processed per Privacy Notice and Terms of Use).