Drug Product Development Associate Scientific Fellow

Takeda; Lexington (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking a Drug Product Development Associate Scientific Fellow in Lexington, MA to lead parenteral drug product development for multiple programs, including monoclonal antibodies and biopharmaceuticals. You will drive formulation development, process development, and PPQ activities across the product lifecycle with independent leadership in a cross-functional setting.

You will collaborate with Analytical Development, Drug Substance, Device Development, 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

• 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

Formulation development

Lyophilization

Process development

QbD

Regulatory submissions

Leadership

Written communication

Problem solving

Biopharmaceutical development

Education

PhD in chemistry/biochemistry/pharmaceutical sciences

Master's in related field

Bachelor's in related field

Job description

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.

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

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$154,400.00 - $242,550.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.