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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Senior Scientist where you will provide technical leadership on product development activities encompassing different modalities including small molecules, nucleic acids, and peptides using non-viral delivery technologies. You will also be responsible for the planning and execution of drug product development activities including strategy, formulation/process development, tech transfer, manufacturing, and regulatory filing support. You will be recognized as a technical expert and are expected to represent the DPD group in cross-functional CMC teams and use your DP expertise to communicate data/strategy to the cross-functional team. As part of the Drug Product Development Synthetic Molecules team, you will report to the Director, of Product Development.

How you will contribute:

• Design, execute and/or manage phase-appropriate formulation and process development studies encompassing all activities starting from the early phase to process validation with input from the manager.

• Hands-on experience in early-stage pre-clinical formulation development of lipid nanoparticles (LNP), polymer micro/nanoparticles for delivering peptides, nucleic acids, and small molecules.

• Responsible for the scale-up and process development of LNPs, polymer micro/nanoparticle clinical candidates in-house and through CROs and implementing the manufacturing processes in GMP environment.

• Experience in formulation development of oral dosage forms for traditional synthetic molecules is also desirable.

• Author/review internal development reports, CMC sections of IND/IMPD/NDA, and responses to support regulatory filings/queries.

• Responsible for drug product manufacturing activities at CMOs including master batch records, protocols GMP manufacturing, batch release, deviations, investigations, CAPAs, and change controls.

• Provide project progress updates/reports to the manager to ensure management is engaged and aware of the project strategy, current activities, and future needs.

• Serve as subject matter expert and contribute to complex/multiple projects or functional areas by leading others.

Minimum Requirements/Qualifications:

• Bachelor's degree in chemistry, biology, pharmacy, or related pharmaceutical science and 8+ years relevant industry experience (11 years for Senior).

• Master's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 6+ years relevant industry experience (9 years for Senior).

• Ph.D. in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 0+ years relevant industry experience (3 years for Senior).

• Experience in CMC pharmaceutical development for drug products under cGMP's.

• Sound knowledge of current Good Manufacturing Practices (cGMP).

• Previous experience with the use of contract facilities.

• Previous experience contributing to regulatory filings.

• Technical expertise in the development of nucleic acids and peptides using non-viral delivery methods is preferable.

• Experience and demonstrated track record in several drug product development activities such as early formulation development, formulation characterization, manufacturing process development, tech transfer, scale-up, and validation.

• Demonstrated experience desirable in one or more formulation and process development including solubilization, polymer/lipid nanoparticles, encapsulation, liquid fill/finish, and aseptic processing.

• Knowledge of common analytical techniques and nano/micro particle analysis.

• Experience with process analytical technologies, process modeling, or continuous manufacturing is a plus.

• Well-versed in statistical design and analysis.

• Communicate with senior management; technical writing skills to support authorship and approval of internal technical documents.

• Exercises good time management and prioritization skills to balance multiple project and departmental goals.

• Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors.

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

• Requires approximately 5-10% travel.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and a company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Base Salary Range: $130,200 to $186,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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.

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