Team Horizon is seeking applicants for a QC Scientist role. The primary function of this role is to Perform assay development, characterization, optimization, transfer, validation, and investigation for the QC chemistry group.
And to provide technical support, guidance, and supervision for release, stability, and in-process testing and assay development.
Why you should apply :
This is an opportunity to join a select team that is already leading the way in the Pharmaceutical / Biotech industry.
Our client regularly features as a top employer within the pharma and biopharma industry.
You are ambitious and desire a career with an innovative forward-thinking company.
You thrive in a fast-paced start-up environment and want to grab a world-class opportunity!
This role is generously compensated and offers career development prospects
What you will be doing :
Performs assay development / validation for QC Chemistry or Biochemistry groups.
Reviews new test procedures and assays.
Evaluates and bring in new methodologies / techniques when needed
Facilitate assay transfer from R&D and to business partners.
Organize analytical assay transfer internally and externally
Lead technical troubleshooting and problem investigation.
Review analytical development report, assay, and process validation report and other technical documents for technical correctness and regulatory compliance.
Participates in training programs for analysts.
Represent QC in project teams and provide Quality input across functional areas
Oversee Contract Laboratory testing
Position requires strong technical and troubleshooting skills in combination with strong communication skills in order to meet QC objectives
Requires approximately 30 to 40% of direct time in the laboratory
Write and review CMC sections for regulatory submissions
What you need to apply :
A Ph.D. in Biochemistry, Chemistry, Biology or related field, with 2+ years of relevant experience / MSc in Biochemistry, Chemistry, Biology or related field with 4+ years’ relevant experience / BSc in Biochemistry, Chemistry, Biology or related field with 8+ years’ relevant experience.
Previous experience working in a GMP manufacturing environment is desirable.
Excellent communication skills, both verbal & written.
Experience with electronic systems such as LIMS, SoftMax, Empower, Qumas, Trackwise, etc., is an advantage.
Adaptable and flexible, willing to travel when needed.
Collaboration and teamwork. Maintains the highest standards of ethical behaviour.
Results and performance-driven.
Strong analytical ability and associated problem-solving.
Good time management and attention to detail.
Knowledge and proficient in the use of Microsoft products including, Excel, Word, and PowerPoint.