Senior Technical Lead

hace 4 días

Barcelona, Barcelona, España Mygwork A tiempo completo
About the Role

This is a challenging opportunity to join Bayer UK & Ireland, a leading employer and a member of Mygwork, the largest global platform for the LGBTQ+ business community.

Key Responsibilities
  • Support the development of CMCD (Module 3 and QoS) strategy for Bayer's Consumer Health new and existing product pipeline and have life-time responsibility for all Bayer Consumer Health CMC Documentation.
  • Brand Lead for Consumer Health Products.
  • Manage CMCD Strategy for assigned brands for NPD and LCM projects.
  • Author scientific briefing documents, complex Technical Requirements Documents (TRDs), and responses to health authority questions; approve TRDs for NPDs.
  • Conduct CMC-D assessments for business due diligence projects.
  • Manage CMC-D change impact assessments.
  • Author complex TRDs, and responses to health authority questions; approve TRDs for LCM projects.
  • Lead category continuous improvement initiatives.
  • Provide coaching and training to junior colleagues.
  • Manage relevant functional processes.
Requirements
  • Master's degree or higher, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent, with +4 years of proven hands-on experience (Analytical Development, Formulation Development, Manufacturing).
  • Experience within Medicinal Regulatory-CMC is highly advantageous.
  • Ph.D. degree, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent.
  • Prior hands-on experience in a technical role within the pharmaceutical or related industry is preferred (Analytical Development, Formulation Development, Manufacturing).
  • Strong understanding of product development processes.
  • Knowledge/understanding of ICH.
  • Knowledge of other quality systems guidelines is a plus.
  • Knowledge/understanding of USP, Ph.Eur., and other relevant Pharmacopoeias.
  • Familiarity with regulations, regulatory requirements, and industry standards.
  • Strong understanding of cGMP, principles of Quality Assurance, and equivalent.
  • Analytical and problem-solving abilities, with ability to prioritize and manage multiple projects simultaneously.
  • Good communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
  • Proficient English communication skills, both written and verbal.
  • Other languages are a plus.
  • Detail-oriented with the ability to maintain accurate documentation and records.
  • Ability to work independently and as part of a team in a fast-paced global environment.
About Mygwork

Mygwork is a global platform that connects LGBTQ+ professionals with inclusive employers. We believe that everyone deserves to work in a safe and welcoming environment, and we're committed to helping you find your dream job.

What We Offer
  • A challenging and rewarding role with a leading employer.
  • The opportunity to work with a diverse and inclusive team.
  • A competitive salary and benefits package.
  • The chance to make a real difference in the lives of others.

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