CMC Systems Lead
il y a 4 jours
About the Role: We are seeking a forward-thinking Data Analytics & Technology Specialist to join our team at the cutting edge of pharmaceutical manufacturing and operations. This role focuses on harnessing the power of analytic datasets derived from antibodies manufactured externally and leveraging them for a variety of critical functions. From regulatory reporting to optimizing processes using innovative IT and AI solutions, you will play a pivotal role in driving technological advancements across Manufacturing, TechOps, and CMC (Chemistry, Manufacturing, and Controls) domains.
Key Responsibilities:
- Analyse and utilize datasets from external antibody manufacturing to inform and enhance processes.
- Collaborate on projects to explore potential applications of data, such as regulatory reporting and process optimization.
- Identify and integrate technologies, including data analytics platforms and AI, to automate workflows, particularly within regulatory and compliance functions.
- Evaluate systems and tools tailored to the needs of Manufacturing, TechOps, and CMC teams.
- Partner with CDMO collaborators to enhance and streamline data flows, supporting data analytics initiatives.
Example Projects You'll Be Involved In:
- Driving ongoing pilots with CDMO partners to automate data flow, enabling improved data analytics and reporting processes.
- Expanding pilots and initiatives across external and internal partnerships, focusing on automation and efficiency enhancements.
- Exploring AI and data analytics applications to accelerate and bring in-house activities across domains such as batch release, stability reports, and APQR (Annual Product Quality Review).
What We're Looking For:
- Strong experience in data analytics, process automation, and IT systems within manufacturing or pharmaceutical operations.
- Familiarity with regulatory reporting, TechOps workflows, and relevant tools/systems in CMC.
- A collaborative mindset and the ability to work closely with cross-functional teams and external partners.
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
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