MSAT Drug Product SME

Conteúdo do emprego

DPS

DPS is a leading Project Management and Engineering Company serving industries around the world for over 40 years. Specialising in the life sciences, medical technologies, oil and gas, energy and advanced technologies sectors, the Group provides consultancy and process engineering expertise to leading clients globally via their four operating business units.

One of these business units is DPS Contract Services. We provide contingent contract and temporary labour to the existing customer base within the engineering field for clients in the scientific and technology sectors throughout Europe via their network of offices located in Ireland, UK, Belgium and Holland. We also provide engineering staff to the various DPS divisions on a contract basis.

Role

• You will be a key part of the Sterile Injectables Manufacturing Science and Technology Group which aims to deliver on process robustness and customer satisfaction through innovative solutions to manufacturing issues. In scope is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting and process improvements.
• Supporting both Internal and External (CMO) sites
• You will work in a diverse team and will be based in Puurs, travel (20%) can be required
• You will provide advanced technical subject matter expertise and issue resolution for major/complex investigations for aseptic sterile injectables, biologics and vaccines and assisting in completing all required documentation in a timely manner
• Participating in the Co-Development process, particularly in Late Stage Development/Phase 3 Clinical Supply to commercialization and continued product support
• Apply technical knowledge and skills to achieve goals at the business unit level
• Preparing, reviewing, and approving documents including protocols, reports, technical assessments, memos, study plans, and meeting minutes, as needed
• Collaborating with wet and analytical labs to execute exploratory or feasibility studies
• Contributing to and occasionally leading complex projects
• Maintaining monthly project updates in project tracking system and other methods, as requested

Profile

• Masters with minimum of 5+ years or Bachelors with minimum of 7+ years experience in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
• A strong operational or engineering background inDrug Product operations is a requirement
• Knowledge of cGMP requirements and compliance
• Excellent communication and technical writing skills; very good knowledge of English required
• Ability to manage own time to meet agreed targets and develops plans for short-term and long-term activities
• Ability to think creatively and find innovative solutions is a plus
• Good project management skills are needed
• Strong analytical, strategic and interpersonal skills. Ability to synthesize concepts and requirements and effectively communicate them to all stakeholders
• Strong influencing skills and ability to work in a matrix organization to deliver results

Extra

• A green/black belt Six Sigma
• Experience as a Drug Product expert is definitely a plus