Manager Msat Device Injectables
Q-Med AB / Kemiingenjörsjobb / Uppsala
2025-10-01
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Location: Uppsala, Sweden (Hybrid)
Job description:
In this exciting leadership role, you'll manage a skilled team of scientists working with Device Injectables - focused on both new product implementation (NPI) and commercial production support.
Together, you'll turn cutting-edge technologies into real-world manufacturing capabilities by applying science, solving problems, and driving continuous improvement.
You'll play a key part in bridging innovation and production - ensuring that what's developed in R&D can be scaled, validated, and successfully transferred to manufacturing.
Key responsibilities:
As Manager MSAT Device Injectables, you and your team will:
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Lead NPI activities - from early prototyping to full-scale manufacturing
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Ensure smooth tech transfer from R&D into commercial production
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Own and optimize end-to-end assembly and packaging processes
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Ensure design solutions from engineering teams support manufacturing efficiency, reliability, and quality
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Develop and validate processes for bulk and fill-finish manufacturing of injectable device products
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Drive process validation (PV), trending, and continuous process verification (CPV)
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Provide expert technical support for daily operations, audits, and regulatory submissions
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Own change controls and ensure compliance with all relevant regulatory frameworks (LoRR, MDR, etc.)
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Be responsible for process material specifications and post-validation documentation
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Own design control documentation after product transfer to production
In this role, you'll collaborate closely with QA, Engineering, R&D, Regulatory Affairs, and external partners - helping to solve complex challenges and enable seamless production.
You'll also serve as a trusted advisor to senior leaders, guiding them on best practices, systems, and process strategies to ensure high performance across functions.
Skills & Qualifications
We're looking for a pragmatic, hands-on leader with a deep understanding of injectable manufacturing - someone who thrives where science meets execution and isn't afraid to take technical ownership.
You bring experience from the shop floor to senior decision-making, and you know how to drive products from R&D into full-scale production - efficiently, compliantly, and collaboratively.
You're likely a great match if you have:
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8+ years in biopharma or medical device manufacturing, especially with injectables
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Solid knowledge of bulk formulation, sterile filtration, fill-finish (syringes, vials), visual inspection, and sterilization
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Strong background in tech transfer, process validation (IQ, OQ, PQ, PPQ, FAT, SAT), and commercial manufacturing
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Hands-on experience managing CAPA, deviations, audits, and documentation ownership
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Proven ability to lead process implementation, equipment qualification (including URS), and supplier collaboration - ideally with CAPEX exposure
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Familiarity with GMP, ISO 13485, 21 CFR Part 11, and MDR
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End-to-end process responsibility: from design input to commercial readiness
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Leadership experience with at least 2 direct reports
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Excellent communicator, confident across functions like QA, R&D, Production, and Engineering
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Fluent in English (Swedish is a plus)
Bonus points if you bring:
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Skills in problem-solving frameworks (e.g. 5 Whys, FMEA, Ishikawa)
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Experience in global or matrix-driven organizations
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A project management certification (PMP, PRINCE2, or equivalent)
Why Join Galderma in Uppsala?
Our site in Uppsala is Galderma's Global Center of Excellence for Aesthetics - home to over 800 professionals working across R&D, manufacturing, clinical development, and marketing, all under one roof.
You'll be part of a multidisciplinary team where science meets application.
What we offer:
• Career development & learning opportunities
• Attractive benefits and bonus models
• Innovative projects
• Global & inclusive culture
• Strong team spirit & engagement
• Work-life balance & wellbeing
Are You the One We're Looking For?
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2025-10-29
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "JR012361".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Q-Med AB (org.nr 556258-6882)
Arbetsplats Galderma
Kontakt Galderma
peter.frost@galderma.com Jobbnummer 9536156