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 Senior Scientist – Drug Product Development in the Small Molecule Drug Product Development (SMDD) group where you will design and develop both oral and injectable formulations. You will also optimize their manufacturing processes across various stages of drug development. As part of the SMDD, you will report to the Director of Product Development and may supervise 1-3 Associate Scientists, Scientists, Co-Ops, or Interns.

How you will contribute:

• For the assigned portfolio compounds ranging from the discovery phase to Phase 3 and commercialization, you will be the drug product lead and design, develop, and manufacture phase-appropriate dosage forms and produce relevant data packages to support clinical trials.

• Carry out small-scale drug product development activities at our internal labs, and predominantly through an outsourcing model in close collaboration with our CDMO management group. You will also manage the clinical manufacturing activities at external CDMOs in close collaboration with other supporting functions such as Quality.

• Manage CROs and CDMOs to support drug product development, scale-up, manufacturing process optimization, and GMP manufacturing activities for the drug product. Responsible for drug product manufacturing activities at CMO's including master batch records, protocols GMP manufacturing, batch release, deviations, investigations, CAPAs, and change controls.

• You will represent the drug product function at the CMC team level and work in close collaboration with other functions such as drug substance, analytical, quality, regulatory CMC, clinical supply, and packaging development.

• Author and reviews pharmaceutical development summaries and other CMC-related modules for INDs, IMPDs, NDAs, MAAs, and other global regulatory submissions on all Takeda pipeline compounds. Critically authors and/or reviews and evaluates assigned pharmaceutical development reports from external vendors. Ensure the scientific integrity and quality of all the data, the appropriate interpretation of experimental results, and the adequacy of the final report.

• Help review New Product Due Diligence opportunities, including an overall assessment of the compound/technology, to support business development activities. Articulate the product/manufacturing process-related risks at various governance forums to facilitate business decisions.

• Provide project progress updates/ development reports to the manager to ensure management is engaged and aware of the risks and risk mitigation strategies, project/product development strategies, current activities, and future needs.

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

• Leads departmental (or cross-functional) initiatives to guide scientific and technical innovations. Ensure a productive, respectful, and development-rich environment; provide training/mentoring for junior staff.

• Identifies vendors and builds relationships to gain access to technologies to meet pipeline goals. Manage key vendor relationships across multiple projects, and affect the resolution of issues arising at vendors.

Minimum Requirements/Qualifications:

• Degree in a related scientific discipline (e.g., Pharmacy or Pharmaceutical Sciences, Chemical Engineering, etc.). BS with at least eleven (11) years, MS/PharmD with at least nine (9) years, or a Ph.D. with at least three (3) years of experience in Product Development in the Pharmaceutical industry.

• Experience and demonstrated track record in several drug product development activities such as Drug Discovery support, Pre-formulation, Early phase formulation development, formulation characterization, manufacturing process development, tech transfer, scale-up, and validation.

• Technical expertise in the development of oral or parenteral products with demonstrated experience in one or more formulation techniques including but not limited to solubilization, spray drying, hot melt extrusion, nanoparticles, dry/wet granulation, tablet compression, Wurster process, tablet coating, encapsulation, liquid fill/finish, and aseptic processing.

• Knowledge of common analytical techniques such as HPLC, DSC, TGA, XRPD, IR/Raman spectroscopy, and particle size analysis techniques.

• Knowledge of clinical supply requirements and regulations.

• Experiences in early and late-stage development including product stability and packaging/labeling requirements.

• Ability to work independently, take initiative, and complete tasks to meet deadlines.

• Must have excellent negotiating, planning, supervisory, and communication skills.

• Scientific report writing, reviewing, and editing experience required.

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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