Associate Director, Tech Management Lead mAb
Daiichi Sankyo
- Basking Ridge, NJ
- Permanent
- Full-time
- Create, communicate, and implement manufacturing plans at the site which are aligned with cross-functional CMC strategic discussions. Manage timelines, deliverables, and coordinate the input of technical and functional experts as needed. Participate as site launch team representative in the CMC working group meetings, as needed, and communicate clear, timely and detailed updates on tech transfers and site activities. Recommend remediations, CAPAs and provide inspection support as appropriate to mitigate risks or gaps at the manufacturing sites.
- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug Product, or New Modality) perspective. Support technical recommendations for future manufacturing sites and their selections. Collect and share key data from KPI perspective for CDMOs to improve (mAb, Drug Substance, Drug Product, or New Modality) manufacturing site performance.
- Communicate outcomes of key meetings to stakeholders and functional areas (i.e., stage gates, working group meetings – upstream, downstream, analytical, shipping logistics). Interface with various site locations globally, other functions in the Technology Unit, and key business partners. Establish and maintain good working relationships with internal and external stakeholders. Coordinate with lab units, SC, RACMC, QA to drive collaboration and solves issues in Tech Mgmt. (mAb, Drug Substance, Drug Product, or New Modality) team.
- Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory questions, briefing books.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)- Bachelor's Degree Bachelor's degree in chemistry, biochemistry, pharmaceutics or related disciplines in the pharmaceutical/biotechnology sciences and at least 7 years of industry experience. required
- Master's Degree Master's degree in chemistry, biochemistry or pharmaceutics or related disciplines in the pharmaceutical/biotechnology sciences with at least 7 years of industry experience preferred
- PhD PhD in chemistry, biochemistry, pharmaceutics or related disciplines in the pharmaceutical/biotechnology sciences with at least 5 years of industry experience.Experience Qualifications- 7 or More Years Bachelor’s degree in chemistry, biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences with at least 7 years of industry experience required
- 7 or More Years Master's degree in chemistry, biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences with at least 7 years of industry experience preferred
- 4 or More Years Ph.D. in chemistry, biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences with at least 5 years of industry experience preferred
- 4 or More Years Extensive experience in CMC related functions including (mAb, Drug Substance, Drug Product, or New Modality) process and product development preferredTravelAbility to travel up to 30%. Global and domestic travel required. International collaboration and communication across all global times zones required.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.