Biologics Drug Product Senior Scientist - Sant Feliu de Llobregat, España - Almirall

Almirall

Empresa verificada

Sant Feliu de Llobregat, España

hace 2 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Date:15 May 2024

Location:
SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain

Company:
Almirall

Mission:

We are a growing team involved in many Biologics projects where everyone contributes to bring the best products to patients.

We are looking for a Biologics Drug Product Senior Scientist to join us in our R&D centre in Barcelona.

Our biologics pipeline is growing, and we need your competences to secure our end goals are met.

As our Drug Product Specialist, you will expand our competences within Primary Packaging, Sterile Fill-Finish processes, Drug Product technology, and Drug Product analytics and formulation support.

You are already a specialist in one or more of the following topics:
Primary Packaging Systems (e.g. syringes, vials, cartridges, closures, siliconization, and various material technologies as glass/COC/COP) and have experience with Fill-Finish production technology and/or lyophilization.

You will work in close collaboration with colleagues across the organization, as a member in our multidisciplinary project teams and in close contact with our network of global Contract Development Manufacturing Organizations (CDMOs).

This position is a great development opportunity where you will be part of defining future configurations and manufacturing strategies of biologics within Almirall and work in an exciting interphase with various internal and external stakeholders.

Tasks and Responsabilities:

Your job and key responsibilities in Biologics Development will involve:

Subject Matter Expert (SME) for Primary Packaging Systems and biologics.
Subject Matter Expert (SME) for Sterile Fill-Finish manufacturing processes and technology.
Work in close collaboration with our Formulation Development SMEs to identify the optimal DP formulation in combination with a Primary Packaging System.
Work in close collaboration with our Analytics SMEs to stablish specifications and methods for our finished products.
Support design and development of drug product manufacturing processes according to best practice and establish documentation needed for GMP manufacturing of drug products in collaboration with the CDMOs. Oversee non GMP and GMP batch manufacturing at CDMOs.
Supporting regulatory filings and other interactions with Health Authorities.

Education and Experience:

Bachelor of Science, Master of Science or PhD in engineering, chemistry, biological science or equal. In addition,
5+ years of experience working with primary packaging, Fill-Finish production, or drug product development, as well as experience from working with CDMOs.

Specific Knowledge:

Advanced knowledge within Primary Packaging System with focus on prefilled syringes, vials, and stoppers
Experience in collaborating with leading vendors of Primary Packaging components.
Experience with the interface between Primary Packaging and Device (e.g. pen systems, OBI, etc.)
Advanced knowledge within Sterile Fill-Finish manufacturing including processes and equipment
Experience within DP manufacturing of protein formulation for parenteral administration
Experience within process designs and Quality Risk Management
Experience within the field of formulation development and protein stability
Advanced knowledge of cGMP requirements, regulations, and guidelines.

Competencies:

A team player with a positive attitude and the ability to work effectively in matrix teams in a fastpaced environment with changing priorities and a high urgency
Good communication and stakeholder management skills when representing the team in crossfunctional and crosssite teams and with CDMOs
Empowered, with the ability to plan and proactively handle multiple tasks simultaneously
Experienced with working in an international setting with different cultures and the ability to trave

Values: