Senior Manufacturing Scientist Device Injectables at ... at SallyQ AB
752 28 Uppsala, Uppsala län, Sweden -
Full Time


Start Date

Immediate

Expiry Date

26 Jul, 25

Salary

0.0

Posted On

27 Apr, 25

Experience

6 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Requirements, Root, Sme, English, Swedish, Sterilization

Industry

Pharmaceuticals

Description

Galderma, with a science-driven portfolio across Aesthetics, Skincare, and Therapeutics, has been advancing dermatology since 1981. We’re expanding our site in Uppsala with a new state-of-the-art manufacturing facility to meet growing demand for our medicinal products. Join us in shaping the future of dermatology!
We’re looking for driven, collaborative individuals who embrace learning and bring positive energy to join our inclusive, growth-oriented culture. We are now recruiting Senior Manufacturing Scientists for our Device Injectables department.

SKILLS & QUALIFICATIONS

  • Bachelor’s or master’s degree in a relevant scientific or engineering field
  • Approximately 6 years of experience in a biopharmaceutical or medical device.
  • Knowledge of regulatory requirements related to investigations and cGMP
  • Strong knowledge of investigative methodologies and root cause analysis techniques.
  • SME in aseptic filling and or sterilization.
  • Proficient in English, with Swedish as a plus.

How To Apply:

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Responsibilities

ABOUT THE ROLE

As Senior Manufacturing Scientist you’ll act as a subject matter expert (SME), leading new product implementation (NPI) into our manufacturing facility and supporting manufacturing processes. You’ll collaborate with cross-functional teams to conduct investigations, risk assessments, and ensure successful product integration.

KEY RESPONSIBILITIES:

  • 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.
  • Serve as SME representing MS&T in Technology Transfer projects.
  • 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.
  • Maintain comprehensive records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards
  • Write technical manufacturing documentation and dossier sections and provide responses to regulatory authorities as needed.
    The positions are permanent with a 6-month probation period, based in Uppsala, and the employment contract will be directly with Galderma.
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