Drug Product Development Associate Scientific 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

Drug Product Development Associate Scientific Fellow

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

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.

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.

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: Yes

It 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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.