Drug Product Development Associate Scientific Fellow

3316 Takeda Development Center Americas•Lexington, MA

5d•Onsite

About The Position

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.

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

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 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