Arbetsbeskrivning
Job Title: Sr Manufacturing Scientist, API manufacturing
Location: Uppsala, Sweden (on site)
Job description :
You will enable and maintain robust and reliable manufacturing through right first-time technology transfers, process validations, and new product implementation (NPI) with a focus on milling and sieving manufacturing processes.; strong process ownership by turning technologies into manufacturing capabilities by applied science and technical investigations, ensuring continuous process improvements, through consistent methodology.
Key responsibilities:
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Implement plans and programs and support policies and practices related to the end-to-end manufacturing processes of new product introduction (NPI) projects at all stages, from prototyping to final stage, within API process chemistry.
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Enable smooth transition of products from R&D into full production readiness, representing MS&T in Tech Transfer projects.
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Ensure suggested design made by engineering optimizes the production process in terms of process efficiency, cycle time, reliability, and serviceability.
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Support day-to-day operation ensuring continuous improvements.
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Experience with process development and DoE (Design of Experiments). Performing experiments and analysis including gathering and preparing samples. Lead and participate in investigations into deviations, incidents, and anomalies within the API manufacturing process
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Conduct in-depth root cause analysis to identify the underlying reasons for deviations and incidents, focusing on process improvement.
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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.
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Maintain comprehensive records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards, including process descriptions and master batch records. Write technical manufacturing documentation and dossier sections.
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Coordinate with other experts and collaborate with cross-functional teams, including quality assurance, regulatory affairs, and process development, to ensure thorough investigation and timely issue resolution. Gather information to support research studies and claims, perform risk assessments/FMEAs. Team management experience.
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Identify opportunities for process enhancement, cost reduction, and efficiency gains, proactively driving necessary changes.
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Write validation documentation and execute process validations.
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 with API and raw material handling would be a strong advantage
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.