Almac Group
Senior Analytical Chemist
Almac Group, Souderton, Pennsylvania, United States,
Almac Group is currently seeking a
Senior Analytical Chemist
for our
Souderton, PA
location. The Senior Analytical Chemist is a technical leader in the laboratory. The senior analytical chemist will be responsible for the execution of development, validation, transfer and routine release and stability activities with little to no supervision. The Senior Analytical Chemist will be responsible for training and leading junior chemists as necessary. The Senior Analytical Chemist will perform, monitor and accept accountability for all assigned analytical duties relating to specific analytical projects.
Responsibilities include but are not limited to:
Perform analytical testing right-first-time in order to complete work within the budgeted resource time and in line with agreed project timelines.
This includes:
Stability testing
Release testing in support of non-GMP and GMP projects
Release testing for Clinical Services projects.
Fully competent in the following analytical techniques, as dictated by project and/or departmental requirements:
HPLC
GC
IR
UV
KF
Dissolution
Classical techniques
Develop and suitably validate analytical methods in support of API and/or drug product manufacture and/or stand-alone analytical projects.
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.
Act in the capacity of leader in the laboratory for quality system and process changes. Lead the team by exhibiting leadership qualities with respect to quality and compliance in the laboratory.
Prepare, review and approve data and documents accurately and efficiently, in-line with the Analytical Department’s procedures culture of Right-First-Time.
Be responsible for the generation, training and adherence to of analytical documents (e.g. methods, specifications, SOPs etc.).
Support the execution of work scheduled chemists and technicians and provide supervision when required.
Retain the overall responsibility for the completion of delegated tasks, within agreed budgets and timelines.
Retain an up to date knowledge of analytical techniques and equipment.
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.
Ensure that unplanned deviations (UPDs) are kept to a minimum and that your line manager is notified as soon as UPDs are generated.
Ensure that any corrective or preventative action arising from UPDS is completed in full and within allocated timeframes.
Assist with the identification of alternative test methods and/or equipment to improve efficiency and maximize throughput of testing in the laboratories.
Make suggestions for the improvement of efficiency and/or reduction in operating costs within the Analytical Department and the wider company.
Identify incidents of out of specification results and inform the Analytical Team Leader and/or Analytical Manager.
Assist in the generation of specifications and SOPs relevant to the Analytical Laboratories, ensuring that current versions are available.
Deputize for their supervisor’s absence in the day-to-day running of projects and supervision of analytical activities being performed in their designated laboratory.
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.
Ensure that lab and write-up areas are maintained in an audit-ready condition at all times.
Prepare and present analytical data to customers (telecoms, face-to-face meetings etc.).
Qualifications: Required Experience / Education:
BSc (or equivalent) qualification within an Analytical or Chemistry related discipline.
Previous 5 yrs. of experience within the pharmaceutical industry.
cGMP experience with working knowledge of quality systems.
Hands on experience with HPLC and Dissolution.
Experience authoring technical documents e.g Protocols, Specifications, Investigation and Reports.
Knowledge of the drug development life cycle.
Preferred Experience / Education:
Postgraduate (or equivalent) level qualification.
Previous 10 yrs. of experience in the management of projects within a cGMP/pharmaceutical environment.
Previous 10 yrs. of practical analytical chemistry experience (drug substance and/or drug product).
Hands on knowledge of GC, FTIR, KF, UV/VIS Spectroscopy.
Methods validation, transfer and qualification.
Analytical chemistry, drug substance and drug product.
What Almac Group can offer YOU!
Full
medical, vision & dental
benefits the 1st of the month after start date.
20 days
of PTO
to start plus
12 holidays
per year.
Company paid long and short term disability along with life insurance.
401k
company match.
Professional development programs/ continuous learning opportunities.
#J-18808-Ljbffr
Senior Analytical Chemist
for our
Souderton, PA
location. The Senior Analytical Chemist is a technical leader in the laboratory. The senior analytical chemist will be responsible for the execution of development, validation, transfer and routine release and stability activities with little to no supervision. The Senior Analytical Chemist will be responsible for training and leading junior chemists as necessary. The Senior Analytical Chemist will perform, monitor and accept accountability for all assigned analytical duties relating to specific analytical projects.
Responsibilities include but are not limited to:
Perform analytical testing right-first-time in order to complete work within the budgeted resource time and in line with agreed project timelines.
This includes:
Stability testing
Release testing in support of non-GMP and GMP projects
Release testing for Clinical Services projects.
Fully competent in the following analytical techniques, as dictated by project and/or departmental requirements:
HPLC
GC
IR
UV
KF
Dissolution
Classical techniques
Develop and suitably validate analytical methods in support of API and/or drug product manufacture and/or stand-alone analytical projects.
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.
Act in the capacity of leader in the laboratory for quality system and process changes. Lead the team by exhibiting leadership qualities with respect to quality and compliance in the laboratory.
Prepare, review and approve data and documents accurately and efficiently, in-line with the Analytical Department’s procedures culture of Right-First-Time.
Be responsible for the generation, training and adherence to of analytical documents (e.g. methods, specifications, SOPs etc.).
Support the execution of work scheduled chemists and technicians and provide supervision when required.
Retain the overall responsibility for the completion of delegated tasks, within agreed budgets and timelines.
Retain an up to date knowledge of analytical techniques and equipment.
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.
Ensure that unplanned deviations (UPDs) are kept to a minimum and that your line manager is notified as soon as UPDs are generated.
Ensure that any corrective or preventative action arising from UPDS is completed in full and within allocated timeframes.
Assist with the identification of alternative test methods and/or equipment to improve efficiency and maximize throughput of testing in the laboratories.
Make suggestions for the improvement of efficiency and/or reduction in operating costs within the Analytical Department and the wider company.
Identify incidents of out of specification results and inform the Analytical Team Leader and/or Analytical Manager.
Assist in the generation of specifications and SOPs relevant to the Analytical Laboratories, ensuring that current versions are available.
Deputize for their supervisor’s absence in the day-to-day running of projects and supervision of analytical activities being performed in their designated laboratory.
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.
Ensure that lab and write-up areas are maintained in an audit-ready condition at all times.
Prepare and present analytical data to customers (telecoms, face-to-face meetings etc.).
Qualifications: Required Experience / Education:
BSc (or equivalent) qualification within an Analytical or Chemistry related discipline.
Previous 5 yrs. of experience within the pharmaceutical industry.
cGMP experience with working knowledge of quality systems.
Hands on experience with HPLC and Dissolution.
Experience authoring technical documents e.g Protocols, Specifications, Investigation and Reports.
Knowledge of the drug development life cycle.
Preferred Experience / Education:
Postgraduate (or equivalent) level qualification.
Previous 10 yrs. of experience in the management of projects within a cGMP/pharmaceutical environment.
Previous 10 yrs. of practical analytical chemistry experience (drug substance and/or drug product).
Hands on knowledge of GC, FTIR, KF, UV/VIS Spectroscopy.
Methods validation, transfer and qualification.
Analytical chemistry, drug substance and drug product.
What Almac Group can offer YOU!
Full
medical, vision & dental
benefits the 1st of the month after start date.
20 days
of PTO
to start plus
12 holidays
per year.
Company paid long and short term disability along with life insurance.
401k
company match.
Professional development programs/ continuous learning opportunities.
#J-18808-Ljbffr