Trainee

To efficiently support ongoing activities and needs, we are looking for a highly motivated Trainee for an internship position in Drug Product Manufacturing Project Leaders group in the clinical manufacturing area who is the responsible for ensuring the assigned technical activities are running in accordance with the project development process and GMP compliance. The trainee will work closely to Drug product Manufacturing Project Leaders in their day-by-day activities and will have the chance to learn about their main responsibilities.
Background in solid oral formulation production, especially for the most traditional technologies such as blending, granulation, tableting, capsule filling and coating and familiarity with Quality and Compliance aspects of a clinical manufacturing campaign, is preferred.
Main Responsibilities of DP Manufacturing Project Leader role:
Act as primary reference for all the drug product manufacturing activities related to the assigned projects
Support operational teams for completion of the manufacturing campaigns to agree quality standards and timelines
Plan, compile, and review batch documentation (Master batch Record and Executed Batch Record), sample plans, manufacturing protocol, etc
Complete the batch documentation in a timely manner. Be able to identify unplanned procedural deviations, documenting properlythe actions.
Ensure all raw materials including API, excipients, primary and secondary packaging, cleaning agents, solvents are suitable and approved for clinical use. Ensure the quantities are sufficient and the date of expiry is suitable.
Support the operators with technical input during performance of clinical batches in agreement with client expectation.
Write and/or review scientific and technical documentation
Requirements:
Degree or PhD in appropriate technical fields.
Familiar with formulation development both for conventional approaches and bio-enhanced ones.
Good understanding of the Drug Product development process including but not limited to the related GMP procedures batch records.
Commitment to the assigned deadlines and ability to deliver tight deadlines.
Effective communication, both verbally and in written form, to Sponsors as well as members of internal teams.
Familiar with cGMP guidelines.
Fluent in written English.
Able to work on your own and as part of a team.
Flexible and adaptable with an open minded view and creative problem solving skills.
Strong sense of accountability for the outcome.
Creative and solution orientated thinking

Others