Date: 4 Sep 2024 Location: SFEL - RD 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 RD 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 Responsibilities 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 establish 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 equivalent.
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 pre-filled 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.
Candidates not fulfilling all the listed qualifications are still encouraged to apply, as the position can be adjusted according to qualifications and development is part of the career path in Almirall.
Competencies A team player with a positive attitude and the ability to work effectively in matrix teams in a fast-paced environment with changing priorities and a high urgency.
Good communication and stakeholder management skills when representing the team in cross-functional and cross-site 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 travel.
Values Care Courage Innovation Simplicity #J-18808-Ljbffr
