!*Manufacturing Science & Technology (MST) Manager - Hybrid - Top Bio-Pharma!*
Location: Ideally as close to L'Aquila as possible but open to Italy
Start date: ASAP
Type of position: Freelance. Minimum 12 month contract with the view to extend
Job Description
Planet Pharma are working with a biopharmaceutical organization that focuses on developing innovative medicines, particularly in areas of high unmet medical need. The company combines traditional pharmaceutical expertise with modern biotechnology, investing heavily in research and development to advance therapies for rare diseases and specialized conditions.
Its portfolio includes both established treatments and novel biologics, with a strong emphasis on advancing science from discovery through clinical development and commercialization. The organization also operates manufacturing facilities to support its pipeline and collaborates with global partners to expand access to its therapies
Description:
Execute technology transfer (incoming and outgoing), process scale‑up, and validation at industrial scale. Provide technical and scientific support during the commercial phase to resolve issues and ensure effective life cycle management.
More responsibilities:
* Lead technology transfer projects from a technical perspective for products already registered.
* Perform process validation and re‑validation activities.
* Assess, in agreement with the line manager, the technical feasibility of new products, including industrial scale‑up and validation before and after registration.
* Conduct scale‑up studies and technical batches at industrial scale.
* Support the Quality team during audits by partners or regulatory authorities, acting as subject matter expert on technical aspects.
* Contribute to product maintenance projects addressing recurring issues, and collaborate on the introduction of new suppliers or third‑party providers.
* Carry out studies related to changes in critical product components (e.g., API, excipients, primary packaging) and manufacturing processes (e.g., batch size increase, process optimization, equipment changes) driven by external factors such as supplier changes, cost reduction, or business continuity.
* Provide technical and scientific input during preparation of CTD/NDA/BLA registration dossiers.
* Recommend corrective and preventive measures to strengthen process robustness, supported by feasibility studies and technical/economic analysis.
* Plan and oversee validation, re‑validation, verification, and periodic monitoring activities, consulting and reviewing the process validation master plan.
* Draft validation protocols and reports for process validation and monitoring activities.
* Prepare technology transfer plans, reports, and other documentation relevant to transfer activities.
* Collaborate with cross‑functional teams to resolve deviations and non‑conformities.
* Ensure compliance with applicable laws, ethical standards, regulations, and internal procedures.
Requirements:
* Pharmaceutical Science and Process Development knowledge and experience of most relevant dosage forms (OSD, Oral Liquid, Sterile)
* Statistics applied to pharmaceutical processes
* Specific Scale up and Technology Transfer competencies
* Knowledge and Experience in validation of pharmaceutical production processes in various dosage forms (OSD, Oral Liquid, Sterile)
* GMP standards knowledge.
* Fluent Italian and minimum working professional in English
If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
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 recognized 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.