Digital Product Development Scientist
3 days ago
Takeda Pharmaceutical is a global biopharmaceutical leader with a commitment to delivering innovative treatments to patients worldwide. We are seeking an experienced Digital Product Development Scientist to join our team in Lexington, MA.
About the Role:This exciting opportunity will involve developing robust formulations for drug substances and products throughout their lifecycle. You will provide technical guidance on formulation and drug product development efforts, authoring technical protocols, designing and implementing experimentation, generating technical reports, and authoring related CMC sections to support regulatory submissions.
As a key member of our cross-functional Process Development and CMC team, you will collaborate with technical services, drug substance process development, analytical development, quality control, quality assurance, and supplier relationship and manufacturing leads. Additionally, you will interface with external contract organizations as required.
Your Key Responsibilities:- Provide technical expertise in execution of biologics product formulation development
- Provide technical expertise for clinical drug product process development/engineering and clinical drug product manufacturing support
- Author/review development documents and support regulatory submissions and responses
- Provide technical expertise in modern computational techniques
- Represent drug product development within cross-functional project teams, organizational initiatives, and technology development groups
- Bachelor's or Master's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science with a heavy emphasis on Computer Sciences, Data Science, Bio-Informatics, and 5+ years relevant industry experience
- Familiarity with current Good Manufacturing Practices (cGMP)
- Previous experience with the use of contract facilities
- Experience working in a multi-disciplinary team environment
- Good understanding of protein degradation background and stabilization strategies applicable to common dosage forms
We offer a competitive salary range of $96,600 - $151,800 per year, depending on qualifications and experience. In addition, we provide a comprehensive benefits package, including medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
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