Ext. manufacturing small molecule sterile technical operations (fully remote)

Luogo di lavoro: Roma
Adecco italia spa is looking for a major client in pharmaceutical industry an
External Manufacturing Small Molecule Sterile Technical Operations Specialist.
The position is fully remote. We offer a six months fixed-term contract for maternity leave.

The ExM Small Molecule Sterile Technical Operations Organization is seeking a highly motivated individual to fill a contract position to support sterile drug product manufacturing at contract manufacturing (CMO) sites in Europe. The contractor provides technical support to drug product sterile fill finish manufacturing at CMO sites, including process performance, implementation of process improvement strategies, and development of process models. Specifically, this role will be a cross functional project to Externalize Change Control within our platform.
The position has the potential for travel to external sites within Europe

Education:
• Required: Minimum Bachelor's Degree in Engineering, Biological/Chemistry Sciences or related discipline.
Experience:
• Experience in Veeva or other platforms for managing Change Controls
• The incumbent will have technical skills in addition interpersonal and communication skills, as they will be part of high-performance teams.
• Demonstrated strategic ability to develop innovative solutions for undefined problems and business processes to meet the needs of key stakeholders and project sponsors.
• A minimum of 3+ years of experience in support of specific areas such as Sterile Technical Operations, Validation or Operations.
• Excellent command of English (both written and oral).

Preferred:
• Experience with Sterile products manufacturing and introductory experience in OSD.




Responsabilità:

Primary responsibilities for this position include, but are not limited to, the following:

• Provides a single point of technical contact to assigned External Partners (ExP's), impacted Manufacturing Division sites and Commercialization.
• Data analysis, investigation support, support for manufacturing, risk assessments and other initiatives with the ExPs.
• Provides on-going support to External Partners to resolve manufacturing issues and develops plans to meet capacity needs.
• Troubleshooting sterile drug product processing technologies and equipment such as formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation.
• Functions independently or with minimal guidance when providing leadership, support, and oversight on all technical matters pertaining to the external partners.
• Execute and/or support Process Improvements, Investigations and Change Control; Implements opportunities for improvement utilizing MPS (Merck Production Systems) tools. Ensures optimum production runs, identifies constraints and non-conformances and troubleshoots to resolve complex issues in production systems.
• Technical support and resolution on quality issues such as Deviations, Product Complaints and Product Release. Responsible for the technical aspects of fact finding around quality and supply investigations.
• Ensures product robustness and monitors the performance of product performance at External Partners (e.g. process parameters, critical quality attributes and equipment/module(s)/unit operation(s) performance during manufacturing and cleaning). This includes monitoring performance via Product Health Index (PHI), CPV, PPM where applicable.
• Together with the Tier 2 team (Operations, Quality, Technology),
o Establishes a calibrated technical oversight approach based on the product type as well as the capabilities and technical competence of the external partner while complying with all divisional policies, guidelines and procedures
o Participates in periodic Business and Relationship Review Meetings (as appropriate) with strategic partners.
• Any other duties as assigned by the Supervisor.

Titolo di studio:
Laurea Magistrale - Matematico / Scientifico

Lingue conosciute:
Inglese: Comprensione Ottimo

Disponibilità oraria: Full Time

CCNL: Chimica - Farmaceutica Industria