AGC Biologics A/S | Scientist - Process Validation

A challenging job is open for a quality-minded scientist within the Process Validation Department in Copenhagen, which requires process validation knowledge, ability to drive validation studies and manage internal and external stakeholders in different projects.

The role of Process Validation Scientist offers opportunity to lead, coordinate and oversee process validation activities for late stage projects from initiation to completion. The Process Validation Scientist will be responsible for providing technical inputs and support to internal and external stakeholders in different projects, as required. This includes activities required for process validation, such as: elaborating validation documents (plans, protocols and reports); risk assessments (e.g. FMEA, Extractable and Leachables assessments); mixing and hold time validations, monitoring and trending of process data.

Key responsibilities:

Plan, organize and execute process validation activities for drug substance manufacturing (e.g., mixing and hold time validation, continued process verification, extractables and leachables, elemental impurities and nitrosamines assessments), according to regulatory guidelines and internal SOPs.

• Generate process validation plans, protocols and reports in a timely manner and according to project requirements.
• Use scientific knowledge to analyze and interpret data, propose next steps and actions required. Take timely and appropriate action based on the data output, project needs and internal procedures.
• Interface with internal and external stakeholders, representing the department effectively and professionally as Subject Matter Expert (SME).
• Represent the department as Subject Matter Expert (SME) in audits and regulatory inspections.
• Communicate and present findings at meetings as required.
• Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory guidelines.
• Assess impacts on validated processes and propose mitigatory actions, as required.
• Write, maintain and continuously improve process validation SOPs and department's procedures.

The Department

The Process Validation department currently consists of 10 highly skilled scientists, 1 director, 3 managers and a student assistant. The department comprises Subject Matter Experts (SMEs) in management of PV activities, supporting risk assessments and validations (e.g., mixing and hold time) as well as Continued Process Verification (CPV). We have an open communication and strong support and flexibility within the department.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

Your profile

Our ideal new colleague will have the following:

• Degree in biological sciences, pharmacy, engineering, or a related fields (minimum M.Sc.).
• At least 1 year of relevant experience in validation (preferably in process validation).
• At least 2-3 years of experience in the biopharma industry in related areas (e.g., MSAT, Validation, Quality Assurance, Manufacturing).
• Strong technical writing and presentation skills.
• Familiar with SOPs, cGMP, EMA, FDA, and ICH guidelines for process validation.
• Experience and knowledge in upstream and downstream biopharmaceutical processing (microbial and/or mammalian), either from a development or a manufacturing setting.
• A fast learner, proactive professional, with positive mindset to work with multidisciplinary teams and find (risk and scientific-based) solutions to challenges.
• Familiar with quality risk management concepts.
• Quality mindset.

The company language is English, so excellent written and spoken English communication skills are required.