Senior Analytical Scientist
Q-Med AB / Kemistjobb / Uppsala
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hela Sverige At Galderma we're unique and we embrace difference.
Whether it's the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising and rewarding people for the contribution they make - working here isn't like anywhere else.
At Galderma, we actively give our teams reasons to believe in our 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.
Job Title: Senior Analytical Scientist
Location: Uppsala, Sweden (hybrid)
Job Description
Unlock your potential as a Senior Analytical Scientist at Galderma! Join our team dedicated to designing and overseeing Small Molecule drug substance and product control strategies. Make an impact by contributing to scientific studies, ensuring compliance with regulatory requirements, and supporting manufacturing processes.
Key Responsibilities
* Oversee outsourcing for key activities: product characterization, method development/optimization/validation/transfer, specification, analytical control strategies, stability program design, and packaging safety.
* Author, review, and approve critical documents: method development reports, validation protocols/reports, comparability protocols/reports, justification of specifications, stability protocols/reports, and regulatory filing sections.
* Collaboratively solve complex problems (deviations, OOS) by bringing fresh perspectives through effective teamwork.
* Contribute to analytical development strategy for Drug Substance and Drug Product in alignment with business priorities and Quality by Design principles.
* Apply extensive analytical knowledge and experience to the development, performance, and characterization of drug substances and drug products.
* Design stability programs for Drug Substance and Drug Product in close collaboration with internal subject matter experts and external partners.
* Liaise closely with Operations to facilitate technical transfers, troubleshooting, and maintenance activities in the late stage of development.
* Identify, technically qualify, and recommend external partners (e.g., CDMO, CRO) to enhance collaboration and project success.
Skills & Qualifications
* Master's degree or Ph.D. in Analytical Chemistry, Chemistry, Biotechnology, or Pharmaceutical Sciences
* Expertise in Analytical Chemistry, Pharmaceutical Chemistry, or a related scientific discipline, with substantial experience in a pharmaceutical setting (10+ year).
* Sound technical qualifications and deep knowledge in developing and validating analytical methods, including comparability studies and various analytical instrumentation (e.g. LC, GC, LC-MS, NMR, FTIR, DSC)
* Sound technical knowledge of analytical sciences related to solid state characterisation (e.g microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), powder rheology, surface area determination by BET, particle size and particle shape and morphology techniques)
* Experience in supporting troubleshooting of legacy products with OOS investigations, root cause analysis, determination of degradation pathways, impurities' characterisation.
* Expertise on preparing, evaluating and filing analytical CMC source documents (IND/IMPD and NDA/CTD) to support Regulatory Affairs and supporting Health Authorities Q&A.
* Familiarity with cGMPs/GLPs, ICH guidelines, FDA, and CMC regulatory standards.
* Excellent communication skills, with proficiency in English.
If you're ready to be a key contributor in a dynamic pharmaceutical environment, apply now and elevate your career with Galderma.
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 450 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 in English via our company website CAREERS | Galderma. Apply as soon as possible though no later than the 15th of March. The selection process is ongoing and the role may be filled prior the last application date.
* If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
* The next step is a virtual conversation with the hiring manager
* 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.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2024-03-15
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "JR008826".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Q-Med AB (org.nr 556258-6882)
Arbetsplats Galderma
Kontakt Galderma
mathilda.ostensson@galderma.com Jobbnummer 8491206
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