Manufacturing Lead

Job Requisition ID:  32143
Department:  502 COGs - General Production (502)
Category:  Production
Location: 

Wales

Date:  2 Feb 2024



Come and Save Lives with Us!

The Company is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases.  We have over 400 employees in 16 countries.
Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

  • We make patients our priority    
  • We act with integrity and accountability 
  • We work together as one team  
  • We look for better ways forward

 

Broad Function
To ensure that the Production facility at the Wales site is in a fully cGMP compliant and inspection ready state at all times. Responsible for overall compliance within the clean rooms, ensuring that the fabric is of a high standard, cleaning schedules are adhered to, equipment is maintained in accordance with maintenance schedules and in a validated state.
To lead the Production (Commercial Products) department to ensure that output is manufactured in accordance to cGMP and Regulatory expectations. To maintain Environmental, Health and Safety compliance by ensuring that suitable controls and practices are implemented and maintained according to the latest legislation.

 

Principle Responsibilities
1.    To ensure the Commercial manufacturing facility is in a state of regulatory compliance at all times.  This will be achieved through regular facility inspection, close interaction with the engineering and validation departments and a high presence within the facility.

2.    To ensure that Environmental, Health and Safety Compliance is maintained. Generate a proactive safety culture to reduce the risk of accidents and incidents in the area. Completing, when required, and reviewing departmental risk assessments.
3.    To manage and support the Senior Production Technicians and Production Technicians in drawing up adequate plans to provide appropriate resources that enable production to be completed in the most efficient manner.
4.    Responsible for ensuring that the department, premises and equipment are maintained and operated to the required standards and in a safe manner.
5.    Ensure that the validation schedule for the facility equipment and systems is maintained.
6.    Responsible for the delivery of the departments quality metrics and SLAs.
7.    To ensure all required end of day and weekly checks within the Production department are completed on time and in full.
The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

 

Education and Experience
•    A degree in an appropriate scientific discipline with proven supervisory and/or manufacturing management experience in a biopharmaceutical or closely related industry.
•    Alternatively, a relevant qualification with extensive and strong technical and supervisory/management experience in a biopharmaceutical or closely related industry environment.
•    Computer literate.
•    Solid understanding of cGMP and Regulatory requirements.
 

Skills and Attributes
•    Proven and well developed man-management and communication skills essential.
•    Proven ability to take responsibility for, motivate and engage a team of individuals utilising good people skills.
•    Confidence and ability to train others and deliver clear instruction to individuals.
•    Proven problem solving skills with an open minded approach and an ability to bring about positive change.
•    Ability to challenge existing processes with an eye for detail, to ensure that practices are continuously updated and operating in the most cost efficient manner.
•    Strong presentation skills to enable clear and concise feedback to all levels.
•    A flexible and willing attitude is essential.
 

 

 

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.