Head of API Manufacturing

We have an exciting opportunity available for a Head of API Manufacturing to join a growing pharmaceutical and life sciences company based in the Kent area.



Our client are looking to enhance their client services, and are developing an existing small-scale manufacturing facility and associated analytical functions to deliver active pharmaceutical ingredient (API) products that are compliant with Good Manufacturing Practices (GMP).

As the Head of API Manufacturing you will be initially responsible for commissioning of the existing facility to meet with regulatory and industry requirements and subsequently leading manufacturing facilities, equipment and process validation programs and processes.

You will also be responsible for overseeing the manufacture of small molecule and peptides APIs to current cGMP standards.

This could be a great opportunity for someone looking to develop their career in a large, well established company.



KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Head of API Manufacturing will be varied however the key duties and responsibilities are as follows:

1.

Lead, develop and implement validation policies and procedures based on current regulations, industry standards and best practices.

2.

Have overall responsibility for all drug substance (API) activities, running and maintenance of the cGMP kilo-lab.

3.

Develop and approve cGMP documents including, but not limited to, master validation plans, SOPs, protocols and forms.

4.

Writing and reviewing documents for INDs / regulatory section submissions.

5.

Provide technical opinions and recommendations to the members of the process development team in order to elaborate chemical manufacturing processes that are safe, economical and in compliance with cGMP requirements.

6.

Work with clients for an efficient transfer and implementation of the technical and analytical information.

7.

Provide validation expertise for issue resolutions to support deviations or CAPAs and audit findings.

8.

Effectively hire, develop and train team members.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Head of API Manufacturing we are looking to identify the following on your profile and past history:

1.

Ideally a PhD in a Pharmaceutical, Chemistry or related discipline.

Alongside this, you will require substantial experience working in a GMP pharmaceutical setting.

You will be expected to drive quality and a highly compliant culture forward.

2.

Experience in supply chain management and working with Quality Management Systems (e.g.

Deviations, CAPAs, change management).

You will also require the ability to investigate and review information and draw conclusions in support of CAPA, customer complaints.

3.

Proven experience in hosting/supporting regulatory inspections and customer audits.

You will have the ability to develop audit schedules and training initiatives.

The role is based in Kent, but you will be expected to travel to other sites in the UK on occasion.



Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development.

We welcome applications for any applicant who fulfil the role requirements for this position.

HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists.

We look forward to helping you with your next career moves.




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