https://www.linkedin.com/jobs/view/3904159790
Global Manufacturing Engineer - API/Small MoleculeTo contribute to the achievement of the company’s clinical and commercial assets. Responsible for assisting in design, implementation and review of procedures, protocols, validation reports, specifications, equipment, facilities, in-process controls, and release testing involved in pharmaceutical manufacturing processes of
Active Pharmaceutical Ingredients (APIs) in the category of Small Molecules including fill/finish. Duties include researching current and future external manufacturing/testing systems for efficiency and optimization of production. Role will function as a subject matter expert (SME) for
Chemistry, Manufacturing, and Controls (CMC) activities for Telix’s programs from developmental through
commercial manufacturing and supply.
- Ownership of CMC activities related to APIs, bulk formulation, fill/finish, lyophilization, and packaging manufacturing processes of small molecules.
- Ownership of CMC activities with a focus on on-time-delivery of material for clinical use.Responsible for on-time-delivery of complete CMC information from CDMO for submissions.Participate in the sourcing, selection, and recommendation of contract development/manufacturing organizations CDMO/CMOs.
- Evaluate manufacturing processes, specifications, and validation protocols provided by CDMO/CMOs, to ensure efficiency, safety, and compliance with relevant regulations and standards.
- Analyse production processes, schedules, test methods and other data. Identify risks, gaps, and inefficiencies. Drive implementation of process improvements and risk mitigations.
- Work collaboratively with multiple CDMOs to provide technical support and achieve key project milestones.
- Lead or participate in investigations for deviations from procedures and Out of Specification events.
- Lead Change Control processes for specification creation and updates.
- Support authorship and submission of CMC sections in IND, IMPD, NDA, and/or BLA filings.
- Lead and support deficiency responses from regulatory agencies occurring from submissions.
- Design phase appropriate and robust processes throughout the product lifecycle from early-stage clinical through commercialization. Build strategies to support eventual process performance qualification (PPQ) of manufacturing processes.
- Ensure the company’s external manufacturing processes are following all government laws and regulations by working closely with the Regulatory and Quality teams.
- Effectively support internal and external resources to achieve project milestones.
- Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable.
https://www.linkedin.com/jobs/view/3896155041
Organisation Capability and Engagement Specialist
https://www.linkedin.com/jobs/view/3902287719Medical Writer/Senior Medical WriterThis role will provide medical writing support by organizing, analyzing, and interpreting scientific and statistical data. Such documents include all types of regulatory documents, including eCTD summary documents (for INDs/NDAs/BLAs), clinical study reports, clinical study protocol synopses and protocols, Investigator Brochures, patient safety narratives, and briefing books, among others.
- Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments.
(20min delay)
