Active Pharmaceutical Ingredients (API) Shift Manager

Job Title: Active Pharmaceutical Ingredients (API) Shift Manager
Location: Sheppey, Kent

We are currently looking to recruit an experienced API Shift manager with experience in Active Pharmaceutical Ingredients manufacturing to come and join us on an permanent basis. You will be working across our API site. Ideally we are looking for candidates that are either strong shift leaders looking to gain the next step in their API career or established API shift managers and have pharmaceutical experience, however if you have worked in a manufacturing environment or have an interest in this area we would still like to hear from you to see how we can help.

As a global contract manufacturer, we have operations spanning Europe, the USA and Asia. Aesica provides extensive opportunities to develop your career throughout the world and we create opportunities for employee development in an exciting, rewarding and fun environment.

Main Purpose of the Job

• To manage the Active Pharmaceutical Plant (API) production shift teams and adhere to the production plan as determined by the customer shipment schedule, across all the Queenborough Active Pharmaceutical Ingredients plants (API), whilst maintaining required regulatory and internal safety, environmental and quality standards.
• Co-ordinate with other departments, peers and support functions as required ensuring timely resolution of process problems and the smooth running of the production unit.
• Develop and execute training plans, personal development and discipline of their shift teams.
• Identify and implement improvement ideas.
• Performs the role of Site Incident Controller.

Some of your tasks will consist of:-

• Ensure that all activities are carried out to appropriate regulatory standards e.g. cGMP, FDA, MHRA, EMEA, HSE and EA.
• Manage, structure and ensure training is current within the production shift team ensuring:
a. That production schedules are achieved.
b. Holiday / sickness cover, capability / disciplinary actions are managed.
c. Appropriate standards of cleanliness are maintained.
d. Personnel development reviews are performed and individuals development action plan for shift teams are current.
e. Operating instructions (BOPs) and Manufacturing Instructions (WO) documentation are briefed, trained and reviewed as required.
f. When requested develop new operating instructions (BOPs) that are effective and compliant.
g. All documentation is compliant with cGMP, inclusive of, Process Deviations, Housekeeping logs, Work order documentation, Equipment Cleaning Logs, Lot Registers, Handover Logs, Daily Check Lists. Be involved in the preparation, training and auditing of these systems.
h. All operations are safely executed by engaging in Risk Assessments, these taking the form of the Risk Assessment procedure, Permit To Works, HAZOPs, COSHH, Manual Handling, EWO’s, Engineering Change Control Forms and process deviations.

• Exhibit a pro-active approach in:
a) Preparing for new batches and new campaigns to avoid unnecessary delays and operational problems.
b) Co-ordinating with other departments as required ensuring timely resolution of process problems.
c) Communicating and / or working with peers, superiors and support functions.
• Perform incident investigations concerning:
d) Equipment failures.
e) Water and Air Outages.
f) Accidents.
g) Environmental releases.
h) Yield outages.
i) Process failures.
• Perform the duty of Site Incident Controller.

Skills / Competencies required

• Qualified to degree level or equivalent in Chemistry / Chemical Engineering or a science related discipline.
• Extensive Active Pharmaceutical Ingredients (API) manufacturing experience
• Strong cGMP Chemical Industry experience will be considered as an alternative.
• Sound understanding of processing equipment and engineering.
• Has a proven track record in man management or demonstrates a potential in this area to manage a team of people.

Aesica Pharmaceuticals – part of the Consort Medical Group

Aesica is renowned for developing and manufacturing both APIs and finished dose forms to the pharmaceutical industry. We are constantly developing the technical and analytical skills of our people to ensure that we are capable of meeting the ever-changing demands of our customers. Aesica operates across several stages of the pharmaceutical services supply chain:-

• Drug discovery
• Process development
• API manufacture
• Formulation development
• Formulated product manufacture
• Packaging (Fill and finish)

We are Head Quartered in Hemel Hempstead and have facilities in:

• Newcastle, UK
• Cramlington, UK
• Queenborough, UK
• Nottingham, UK
• Monheim, Germany
• Zwickau, Germany
• Pianezza, Italy

With over 1,250 staff we are well established and growing on a daily basis.
Benefits

• Salary (Inclusive of shift allowance) £46,800 – £55,200
• Working a Continental 5 shift pattern
• EBITDA bonus
• Salary sacrifice company contribution pension scheme
• Life insurance
• Flexi-car scheme
• Cycle to work scheme
• Childcare vouchers
• Company sickness, maternity, paternity payments
• Long service awards