Sr Manufacturing Scientist, Biologics

1 week ago

Uppsala, Uppsala, Sweden Q-Med AB Full time
Job Title: Sr Manufacturing Scientist, Biologics (Drug product)

Location: Uppsala, Sweden (on site)

Job description :

We are looking for a new member to the Biologics team within Manufacturing Science and Technology. The senior manufacturing scientist is a subject matter expert (SME) responsible for new product implementation (NPI) into a manufacturing facility, with a focus on aseptic drug product manufacturing processes.

Key responsibilities:

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Develop NPI strategy and support all aspects of process validation, including writing process validation documentation, executing process validation, performing process data reviews, investigations, risk management, and change implementation.
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Serve as a technical subject matter expert (SME) representing MS&T in Technology Transfer projects.
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Process owner to support day-to-day operations with a focus on continuous improvements. Identify opportunities for process enhancement, cost reduction, and efficiency gains, proactively driving necessary changes.
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Lead and participate in investigations of deviations, incidents, and anomalies within the manufacturing process. Conduct in-depth root cause analysis to identify the underlying reasons for deviations and incidents, focusing on process improvement. Provide SME assessments in investigations and change controls as required. Prepare detailed investigation reports, conveying findings and recommendations to management and relevant stakeholders.
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Collect and analyze data from various sources, including quality control reports, production logs, and other relevant documents, to support investigations and continuous process verification (CPV).
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Develop and lead execution of technical runs/design of experiments (DoE) with data analysis and recommendations.
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Maintain comprehensive records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards
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Write technical manufacturing documentation and dossier sections and provide responses to regulatory authorities as needed.
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Coordinate and collaborate with cross-functional teams, including production, quality assurance, regulatory affairs, and process development, to ensure thorough investigation and timely issue resolution. Gather information to support research studies and claims, as well as perform risk assessments/FMEAs.

Skills & Qualifications

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BSc, MSc, or PhD in a relevant scientific or engineering field, such as Chemistry, Biochemistry, Chemical Engineering, or a related discipline
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Prior manufacturing process experience within the biopharmaceutical industry with a minimum of 6 years of experience in a biopharmaceutical or manufacturing environment
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Experience in drug substance and/or drug product manufacturing within a GMP environment
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Previous experience of drug product manufacturing processes including compounding, filtration, aseptic filling (including setting up aseptic process simulation, APS) and visual inspection
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Experience with regulatory audits and regulatory requirements, risk management (FMEA), investigative methodologies and root cause analysis techniques is highly meriting
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Proficiency in data collection, analysis, and reporting with excellent communication, documentation, and collaboration skills.

What we offer in return

You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

As Galderma's Global Center of Excellence for Aesthetics we have in Uppsala a unique edge as we have on our site the whole product chain from research and development to production and marketing. Here our nearly 600 employees work on our world leading brands such as Restylane, Azzalure and Sculptra.

We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala only a 10-minute bike ride from Uppsala Central Station.

Next steps

We welcome your application via our company website CAREERS | Galderma. Apply as soon as possible, as the selection process is ongoing continuously.

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If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
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The next step is an interview with the hiring manager
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The final step is a panel conversation with the extended team

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

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