awareness for The Steely Group. This detail-oriented position requires strong verbal and written communication skills... and prioritization skills with ability to multi-task About The Steely Group The Steely Group is a national preclinical, clinical...
This position serves as the lead engineer for engineering projects related to existing product manufacturing, scale-up... and expansion. The role requires strong engineering and biologic manufacturing aptitude, particularly related to recombinant protein...
closely with our team of R&D scientists and engineers. Key Responsibilities Reports into R&D Science team within the new... product development group, working closely with scientists and engineers Laboratory work focused on setting up and performing...
In this vital group leader role for the Pivotal Biologics, Drug Product Technologies group you will provide technical... and project leadership while integrating information generated by multi-functional teams to ensure success through the...
Reporting to the Vice President of Regulatory Affairs, the Director, CMC Regulatory Affairs is responsible... for overseeing the development and implementation of global regulatory CMC strategies for development projects. The Director...
support in development and execution of regulatory strategies in support of the global clinical trial applications, marketing..., you will play a key role in maximizing the client's technology and progressing their novel therapeutics. Responsibilities...
The Director, Regulatory Operations functions as the subject matter expert providing leadership in all aspects..., publishing, quality control, dispatch, tracking and archival activities to enable successful IND, NDA, BLA applications and the...
development activities. Independently manages high complexity programs with greater risk to the business including... those which are novel or new to the company, including electromechanical, and/or internally developed. Responsible to represent CPOQ...
. This role will report to the Senior Manager of Data Sciences and will be part of a cross-functional data governance team... to ensure timely and accurate data for business analysis and decision making. Responsibilities: Lead the US commercial Data...
The Director, Regulatory Affairs will serve as a Health Authority liaison and Regulatory Project Leader for our client... and manage regulatory activities for compounds through all phases of development, post-approval, and for the life-cycle of the...