Develop CMC-related submission content outlines and establish submission timelines in collaboration with relevant project team members; manage execution of submission preparation, review, approval and delivery to the appropriate Regulatory Authority.
Strong knowledge of residuals and impurities analysis of biologics including immunoassays, ELISA (enzyme-linked immunosorbent assay), residual DNA analysis, PCR (polymerase chain reaction), and chromatography methods and equipment.
Establish process characterization and validation strategy; presentation of validation and characterization study results to internal teams; design and execute small scale and large scale validation studies.
Ensure that all work is performed in a compliant manner and behave in accordance with site SOP's, EHS standards and guidelines and relevant legal requirements and assure that activities meet all quality standards for cGMP and other applicable regulatory agencies.
Coordinates the scheduling and assignment of auditors and consultants to perform vendor audits of contract manufacturers, contract testing laboratories, suppliers and service providers within the Master Control systems.
Leads process development, scale-up and technical transfer of Drug Product manufacturing processes, making detailed observations, analyzing data, interpreting results, maintaining documentation, and preparing precise technical reports, summaries and protocols.
Develop and qualify chromatography, capillary electrophoresis, and biophysical methods for release, stability, and characterization of protein-based products according to compendial and regulatory guidances.
Responsible for contributing to the department's annual budget and quarterly forecasting processes; manages head count and expenses to meet approved spending plan while achieving all departmental commitments and project objectives.
Current understanding of GCP and regulatory requirements as they relate to data management systems and activities; demonstrated current understanding of Good Clinical Data Management Practices (GCDMP).
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development.
Ensures that study design is scientifically robust, suitable to test the trial's hypothesis, and likely to meet the objectives of the study while ensuring the safety of the patients participating in the Company's sponsored clinical trials.