Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Associate Director, DMPK in our Cambridge office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
The new hire will be part of the bioanalytical group within the Global DMPK department at our Cambridge, MA site. She/he will focus on preclinical stage bioanalytical support of PK/CK, Bio-distribution, PD, immunogenicity, and biomarker studies for discovery and development of our biologics, cell, and gene therapy pipelines. She/he must have strong technical expertise and extensive industry experience, and, apply internal and external (CRO) resource to develop appropriate bioanalytical assays to enable the delivery of project related key performance indicators (KPI). This individual will have work closely with DMPK project representatives, Drug Discovery Units (DDUs), DSRE and QTS Groups.
- Embrace and adopt innovative technologies and platforms to develop appropriate bioanalytical assays to support the discovery and development of biologic modalities.
- Use internal and external (CRO) resources to provide strategic guidance and scientific expertise for design, development, troubleshooting, transferring, and monitoring of qualification/validation/reporting of immunogenicity, and biomarker assays to timely and quality support of drug discovery and nonclinical development activities.
- Prepare/scientific review of analytical data and methods, protocols, and reports generated by internal and external laboratories.
- Maintain abreast with the latest bioanalytical methods and technologies, current GLP regulation, regulatory guidance, and industry s best practices.
- Scientifically manage and interact/collaborate with CROs, as necessary to support projects.
- Participate and present results in departmental and cross-functional project team meetings.
- Serve as Bioanalytical representative to interact with the DMPK and project reps on discovery/development programs.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- PhD in molecular biology, biochemistry, genetics, cell biology, or other related field with a minimum of 8 years or MS with a minimum of 12 years of relevant industry research experience and a strong publication record.
- In-depth knowledge and hands-on experience in complex biological and biomarker assays development and troubleshooting using qPCR, RT-PCR, ddPCR, ELISA, MSD, Gyros, Simoa, FAC, or other novel platforms for different drug modalities.
- Familiarity with common molecular biology software such as SnapGene, DNASTAR, LaserGene, Primer 3 for primer/probe Tm value /secondary structure analysis, and bioinformatics software/database such as GenBank, UNIGENE, PDB, UniProt, and BLAST for DNA/RNA/protein structure and sequence analysis, homologue analysis and multiple sequence alignment, is a plus.
- Experience in PCR method qualification/validation, cell-based assay development such as NAb assay, or flow cytometry are highly desirable.
- Solid experience in analytical method development and qualification and validation of relevant methods in a GLP compliant environment is highly desirable.
- Strong experience and track record with bioanalytical support of nucleic acid drug (such as siRNA, ASO, mRNA, or gene therapy) is highly desirable.
- A strong self-starter, independent strategic thinker, with a strong attention to details and excellent problem solving and complexity reduction skills.
- Good understanding of regulatory expectations and evolutions on bioanalytical and immunogenicity assay development/validation and sample analysis to support non-clinical development of new modality therapies.
- Strong scientific background and familiarity with early stage drug development.
- Excellent communication, interpersonal, and presentation skills, capable of conveying technical information in a clear and thorough manner.
- The ability to work in a fast-paced and dynamic team environment, managing multiple projects with a high emphasis on quality and timelines, overcoming challenges, developing, and implementing effective strategies are essential.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- 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
Empowering Our People to Shine
Discover more at takedajobs.com
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