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Job vacancy Project Manager & CMC Senior Manager
Announced
16 April, 2024
Job Type
Empleado
Job Status
Tiempo Completo
Job Title
Project Manager & CMC Senior Manager
Job Presentation
Our firm is searching for two Biologics Business Executives, experts in their respective fields to become part of a highly qualified and experienced team within a well-known and multi-facetted biologic and biosimilar solutions services company.
RequirementsProject Manager
Ideally should be based in Boston
- Experience working closely with start-ups in Gene and Cell Therapy Companies in developing Regulatory, CMC, Clinical and Commercialization Strategies.
- Business Development experience is a must
- Leads the strategy for both pre-clinical and clinical programs in support of 351K submission
- Manages start-up and commercial manufacturing initiatives for multiple Clients
- Provides regulatory and quality to support successful FDA audits
- Should bring process development expertise for new products
- Experience orchestrating the regulatory resources in accordance with established regulatory strategies to support product filing in US and EMEA
- Takes care of workplan & dashboard
- PMP certification is highly desirable
- Required industry experience: Biotechnology or Biosimilars
- Proficiency in MS Project is required.
- 7+ years of leadership management background
- Must be able to present business growth strategies to Top Tier Executives and Board Members.
- Work base location: Boston, MA / Some travel may be required and will be reimbursed
CMC Senior Manager
Ideally should be based in Boston
- We look for a CMC Senior level leader to help with the FDA Inspection readiness
- Must have experience working directly with the FDA
- A proven track record in the delivery of complex biologics RA CMC projects for FDA, EMA, and/or other Global Health Authorities.
- Experience taking a product from concept through to launch including scale-up and transfer to manufacture.
- Experience in complex biologics, vaccines, cell therapy, and/or gene therapy; combination products is a plus.
- Experience defining CMC content (data and documentation) requirements for regulatory submissions and writing/reviewing this content for conformance with established requirements, including GMP and EMA/FDA/ICH/WHO/Global regulations and guidelines.
- Plans, executes, and manages RA CMC components of IND/CTA, including vendor management and writing/review of key module 3, IMPD sections, and related CMC documentation and quality processes.
- 5+ years of direct experience in Global Drug/Biologics development in the biopharmaceutical/biotechnology industry.
- 2+ years of direct experience in Regulatory Affairs CMC position.
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
Salary
Commensurate with candidate experience.
Reference number
54398
Valid Till
16 Aug, 2024 (104 days left)
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