DATE: / January 2018
POSITION: / Analytical and Senior Analytical Chemists (Analytical Services and Development)
BUSINESS UNIT: / Sciences
LOCATION: / Craigavon
REPORTING TO: / Technical Leader/Team Leader
RESPONSIBLE FOR (PEOPLE): / N/A
OVERALL ROLE OBJECTIVE:
To perform, monitor and accept accountability for all assigned analytical duties relating to specific analytical projects.
JOB SPECIFIC RESPONSIBILITIES:
The post holder will:
1. Develop and suitably validate analytical methods in support of API and/or
drug product manufacture and/or stand-alone analytical projects.
2. Perform routine analytical testing in-line with project requirements.
This includes:
· Stability testing
· Testing in support of chemical development activities (process development, protein and peptide technologies & radiolabelling)
· Release testing in support of in-house non-GMP and GMP projects as well as release testing for Clinical Services projects.
3. Be trained and be fully competent in the following analytical techniques, as dictated
by project and/or departmental requirements:
· HPLC
· GC
· NMR
· IR
· UV
· MS
· KF
· Classical techniques
4. Perform analytical duties right-first-time in order to complete work within the budgeted resource time and in line with agreed timelines.
5. Generate data and documents accurately and efficiently, in-line with the Analytical Department’s procedures culture of Right-First-Time.
6. Take responsibility for the provision of all analytical activities associated with allocated projects so as to ensure successful project outcomes as measured by QQTE (Quantity, Quality, Timeliness & Efficiency) metrics.
7. Be responsible for the generation, training and adherence to of analytical documents (e.g. methods, specifications, SOPs etc).
8. Retain the overall responsibility for the completion of delegated tasks, within agreed budgets and timelines.
9. Retain an up to date knowledge of analytical techniques and equipment.
10. Be responsible for the management of own work schedule and provide regular updates to line manager and team members especially with respect to any circumstances that alter agreed timescales and budgets.
11. Ensure that unplanned deviations (UPDs) are kept to a minimum and that your line manager is notified as soon as UPDs are generated.
12. Ensure that any corrective or preventative action arising from UPDS is completed in full and within allocated timeframes.
13. Assist with the identification of alternative test methods and/or equipment to improve efficiency and maximise throughput of testing in the laboratories.
14. Make suggestions for the improvement of efficiency and/or reduction in operating costs within the Analytical Department and the wider company.
15. Identify incidents of out of specification results and inform the Analytical Team Leader and/or Analytical Manager.
16. Assist in the generation of specifications and SOPs relevant to the Analytical Laboratories, ensuring that current versions are available.
17. Deputise for their supervisor’s absence in the day-to-day running of projects and supervision of analytical activities being performed in their designated laboratory.
18. Ensure that laboratory equipment remains in calibration and functions as required. Where this is not the case inform the appropriate persons for them to action.
19. Ensure that lab and write-up areas are maintained in an audit-ready condition at all times.
20. Prepare and present analytical data to customers (telecoms, face-to-face meetings etc)
21. Perform other duties as may be deemed appropriate by your supervisor and that fall within the general remit of the post.
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.
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PERSON SPECIFICATIONDATE: / January 2018
POSITION: / Analytical and Senior Analytical Chemists
BUSINESS UNIT: / Sciences
LOCATION: / Craigavon
REPORTING TO: / Technical Leader/Team Leader
RESPONSIBLE FOR (PEOPLE): / N/A
/ ESSENTIAL
REQUIREMENT /
DESIRABLE
REQUIREMENT
/ ASSESSMENT METHODQUALIFICATIONS / 5 GCSE (or equivalent) passes, grades A-C, in Mathematics and English Language
Degree level qualification (or equivalent) in a Life Science related discipline / Degree level qualification (or equivalent) in an Analytical related discipline / Application Form and Documentary Evidence
EXPERIENCE / Previous analytical experience within industry (i.e. pharmaceuticals/fine chemistry)
Experience of drug substance or drug product analysis in a GMP/GLP environment / Previous experience within a supervisory role
Experience in HPLC method development and/or validation
Working knowledge of COSHH
Working knowledge of multiple analytical techniques
(GC, IR, NMR, MS, KF) / Application Form and Interview
KEY SKILLS / Basic level ability in the use of Microsoft Packages (Word, Excel etc)
Excellent communication skills (verbal and written)
Proven ability to apply a meticulous approach to tasks undertaken
Proven ability to organise and plan work both independently and in conjunction with team members / Proficiency in the use of Microsoft Packages (Word, Excel etc) / 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
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