Key Roles/Responsibilities:
* Execute defined procedures to manufacture high potency ADC/ API’s product in support of launched products and clinical trial programmed to GMP standards.
* Working effectively in an organized manner in order to adhere to the planned schedule
* Contribute effectively to a team working environment but also have the ability and confidence to work on an individual basis within the production team.
* Accurately recording information required for batch records
* Updating and reviewing plant documentation, from PI Sheets to SOP’S.
* Maintain high ESH Standards, carrying out all work in accordance with appropriate EHS systems.
* Have a working knowledge of risk management systems and procedures enabling escalation of deviation as appropriate.
* Demonstrate flexibility, self-control, and interpersonal awareness within the team environment.
Competencies:
Teamwork -As a team member, the ability and desire to work cooperatively with others on a team
Communication -The ability to ensure that information is passed on to others who should be kept informed.
Building Collaborative Relationships -The ability to strengthen partnerships with others inside the organization who can provide information, assistance, and support.
Attention to Detail -Ensuring that one’s own and others’ work and information are complete and accurate
Personnel Credibility -Demonstrated concern that one be perceived as responsible, reliable, and trustworthy.
Forward Thinking -The ability to anticipate the implications and consequences of situations and take appropriate action to be prepared for possible contingencies.
Interpersonal Awareness -The ability to notice, interpret, and anticipate others’ concerns and feelings, and to communicate this awareness empathetically to others.
Customer Awareness - The ability to demonstrate concern for satisfying one’s external and/or internal customers
Qualifications
Essential Qualifications:
* Degree in a scientific subject or the equivalent GMP experience.
* Possess good verbal and written communication skills
Essential Experience
* Good chemical/bio-processing industry knowledge
* Good working knowledge of GMP
* Understand chemical unit operations and process chemical reaction hazards.
* Possess good verbal and written communication skills
* Experience of working in clean rooms (desirable)
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