DATE: / August 2017
POSITION: / Plant Chemist
BUSINESS UNIT: / Sciences
LOCATION: / Craigavon
REPORTING TO: / Principal Plant Chemist
RESPONSIBLE FOR (PEOPLE): / NA
OVERALL ROLE OBJECTIVE:
Working as part of a highly trained shift team your main role is to be the process scale up expert for your shift to aid the transfer of chemical processes from the laboratory into the GMP Manufacturing Plant. This will be achieved through close working with the production staff, development chemists, chemical engineering, solid state group, HSE and other supporting departments to ensure that the laboratory chemistry is safe, and suitable for scale up. A thorough knowledge of plant equipment and competent operation will aid this transfer process. Compilation of Manufacturing Directions (MD’s), critical process awareness training of Plant technicians, deviation reporting and limited IPC analysis are some of the tasks required for this role. Working as part of the shift team you will be expected to work closely with all the shift members and offer sound practical advice when troubleshooting situations arise. The ability to quickly assimilate information and offer sound advice to the shift supervisor is a key attribute for this role. The role will involve adopting shift patterns to match manufacturing requirements
JOB SPECIFIC RESPONSIBILITIES:
The post holder will:
1. Compile MD’s, special instructions and other documentation which may be required. Attention to detail is a pre-requisite to ensure error free documentation
2. Be competent in the operation of all plant process equipment, utilities and equipment set ups
3. Recommend effective cleaning methods for plant equipment
4. Complete CAPA for deviations associated with the GMP Manufacturing Plant.
5. Carry out Safety Event reporting with respect to any incidents in the GMP Manufacturing Plant.
6. Requisition raw materials in good time prior to Manufacture to avoid delays
7. Ensure chemistry handover is included in the main plant shift handover i.e. one handover.
8. Participate in relevant focus groups. Look for efficiency improvements across the whole of the manufacturing area and take the lead where necessary in order to implement the improvement.
9. Conduct regular, structured meetings with the development chemists and to demonstrate an active input into the laboratory process. Challenge the rationale for reagent excesses, temps, times and cool down profiles etc
10. During the development phase, highlight any areas that may present difficulty in scale up where additional equipment, training, engineering or health and safety input may be required.
11. Demonstrate a thorough knowledge of the laboratory chemistry. This will ensure laboratory experiments demonstrate a certain degree of robustness for scale up and are underpinned by scientific rationale. Focus on Product isolation is required which will include phase separations and product filtrations.
12. Take ownership for laboratory process scale up. This includes
a. Regular updates to plant management
b. Equipment selection and set up.
c. Notify Operations Management of equipment choice to be included in the manufacturing schedule
d. Provide process and chemistry training to other shift team members
e. Represent Operations at the COHA meetings.
f. To ensure that the” how” is captured in all manufacturing documents
13. Ensure that all COHA recommendations are captured in the Manufacturing documents and training - be it MD, PI sheets or Special Instructions
14. Review and report on completed processing campaigns and summarise the learning for all staff involved in the project.
15. Ensure that the appropriate equipment is chosen both from vessel fill and MOC considerations.
16. Ensure that all manufacturing documentation is fully closed out prior to start up – this will minimize the need for last minute changes
GENERAL ROLE RESPONSIBILITIES:
Quality / Ensure GMP is adhered to in all areas of work.Health & Safety
/ Understand Company’s Health & Safety Policy and follow all company HSE procedures. Report all accidents or any unsafe conditions in the work place.Training and Development
/ Ensure training has been received before undertaking specific duties and that all training is recorded in training records.Human Resource Management
/ Adhere to all HR policies and procedures, to include all absence policies and procedures.Communication
/ Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular and timely basis. Provide regular updates to your line manager regarding progress on required duties and the status of any projects.Equal Opportunities
/ Observe and adhere to the company's Equal Opportunities and Dignity at Work policies ensuring that a neutral and harmonious work environment is maintained in which bullying and/or harassment does not occur.Core Competency Framework
/ Ensure that all job specific responsibilities relating to the overall role objective are carried out in accordance with the requirements outlined within the Almac core competency framework.By signing this Job Description I accept that I have received and read the Job Description and have accepted the responsibilities identified therein.
EMPLOYEE’S SIGNATURE:
PRINT NAME:
DATE:
This job description should not be regarded as conclusive or definitive. It is a guideline within which the individual jobholder works. It is not intended to be rigid or inflexible and may alter as the Company’s strategic direction changes.
Page 5 of 5
PERSON SPECIFICATIONDATE: / August 2017
POSITION: / Plant Chemist
BUSINESS UNIT: / Sciences
LOCATION: / Craigavon
REPORTING TO: / Principal Plant Chemist
RESPONSIBLE FOR (PEOPLE): / NA
/ ESSENTIAL
REQUIREMENT /
DESIRABLE
REQUIREMENT
/ ASSESSMENT METHODQUALIFICATIONS / BSc (or equivalent) in Chemistry (or related discipline) / PhD in Chemistry (or related discipline) Good working knowledge of cGMP would also be advantageous. / Application Form and Documentary Evidence
EXPERIENCE / Practical experience of:
process chemistry safe scale up, and familiarisation of complex process development and scale up projects.
Excellent working knowledge of analytical techniques, including HPLC and NMR / Previous experience of late stage validation projects
Practical experience of a pre-approval inspection,
Previous experience of the contract chemistry commercial environment / Application Form and Interview
KEY SKILLS / Proficiency in the use of Microsoft Office packages (to include Word, Excel and Outlook)
Proven ability to organise, plan and prioritise tasks within a high volume, varied workload whilst maintaining a high level of accuracy in all work undertaken
Proven ability to work effectively on own initiative and effectively contribute within a team environment
Proven communication skills of an exceptional standard (both written and oral) / Interview
ALMAC CORE COMPETENCIES
COMPETENCY / BEHAVIOUR /
ASSESSMENT METHOD
RESULTS DELIVERY / Delivers results on time, within constraints and in line with company policy and procedure and organisational strategy. Demonstrates a continuous drive for quality and a commitment to excellence. / InterviewPROACTIVE SOLUTIONS / Analyses and uses experience and logical methods to make sound decisions which solve difficult problems. Seeks practical/workable and innovative methods to deliver solutions. / Interview
LEADS BY EXAMPLE / Promotes a clear vision and mission. Acts as a positive role model for the organisation, fostering a climate of teamwork and development. / Interview
COMMUNICATION / Communicates clearly and effectively. Promotes the exchange of ideas and information across the organisation. Fosters dialogue to ensure everyone understands what is going on. / Interview
CUSTOMER FOCUS / Strives to exceed the expectations and requirements of internal and external customer; acts with customers in mind and values the importance of providing high-quality customer service. / Interview
JOB SPECIFIC KNOWLEDGE / Demonstrates required job knowledge and understanding to successfully and competently fulfill or exceed the requirements of their post. Follows correct procedures and guidelines (SOPs).
Proactively demonstrates a desire to enhance and develop their job knowledge. / Interview
Page 5 of 5