Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Purpose of position/responsibility:

Support the Supervisor, MS&T Process & Cleaning Validation in ensuring the management of the customer and related products: The goal of this brand-new figure is to lead everything is around the product history from the engineering phase to commercial launch.

One of the main responsibility is to write product report, a document that certifies the history of the product throughout the years. Product Manager must be considered the first reference for technical feasibility assessments and responsible for leading changes inherent to the product itself, in compliance with current regulations (laws, GMP, FDA, EMA etc.), and with company quality standards.

Most crucial responsibility is also to coordinate internal and external resources to request production process changes in the commercial phase.

SPECIFIC TASKS/PRIMARY ACTIVITIES:

Drafting of Product Lifecycle History document, including all information relating to technology transfer documentation, validation and change control to commercial manufacturing relating to product manufacturing. Handle dedicated product change requests, evaluate their impact on the current GMP status, define and supervise the action plan for the implementation of the change and prepare the closing report.

Customer interface: First point of contact for the customer, responsible for identifying the client's needs, accurately conveying any requests to the internal functions of the Site. Technical reference to evaluate feasibility/modification requests on existing processes.

Activity coordination: Responsible for the coordination of activities relating to product-specific projects, in order to ensure the achievement of the set objective, identify priorities and guarantee compliance with the defined achievements, the accurate carrying out of the activities and accurately addressing any support requests

Requirements and qualifications:

Degree in Pharmacy, Chemistry, Biotechnology, Biology, similar scientific degrees or consolidated experience;Previous experience in management and customer relationships;Proficient English (both written and spoken);IT knowledge: Company IT systems (PMX, LIMS, Trackwise, Minitab) and Microsoft Office tools;Technical background: Strong overview of production pharmaceutical industry, GMP, regulations;Personal skills: Excellent interpersonal skills, proactivity, ability to work in a team.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.