Senior Chemist – Pharmaceuticals (The position has been filled)
Permanent Full Time Role with ASX listed Australian Company
Professional, Friendly and Supportive Work Environment
Growing Company, Excellent Culture and Facilities, including onsite Parking
Our client is an established company within the medical product category, and operates its manufacturing operation in Melbourne, Australia. Their products are Sold, Marketed and Distributed around the globe, including market leadership position in some existing markets. With a very clear purpose and vision, product pipeline and significant regulatory approvals expected in their developing markets, this company is set for significant growth.
Investment in new facilities has been very recently completed with some regulatory approvals already granted, and the remaining imminent. Manufacturing core products from this facility will significantly improve cost, quality & consistency, and support the sales growth projection in untapped markets.
This is an exciting opportunity for a hands-on Chemist experienced in the use of GC including operation, method development and validation, and troubleshooting within a pharmaceutical testing laboratory.
The company has brand new facilities so the successful candidate will be lucky enough to work in a brand new laboratory with new equipment. All testing has been so far sent out to Consulting Laboratories so this is a newly created role. One of the main instruments at this stage is a Gas Chromatograph (GC) which will be will be used for the testing of raw materials, intermediates and finished products. The position will also support R&D activities and contribute to the smooth operation of the manufacturing plant, by providing assistance when any of their GCs have problems.
Main duties include:
Day to day operation of QC laboratory and testing
Observing and complying with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
Observing and complying with company Health and Safety Policies
Sampling and testing of raw materials, intermediates and finished products using current pharmacopoeias, any associated ‘wet’ chemistry and instrumental techniques (GC, IR) as appropriate
Ensuring handing and testing of materials maintains traceability and identity
Preparing quality reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA) (for finished products) and stability reports
Stability testing of products for new formulations and ongoing stability trials, using physical (pH, ‘wet’ chemistry) and instrumental (GC, IR) techniques, as appropriate
Creating and executing method development and method validation test protocols for finished products and generating the appropriate analytical methods
Calibrating analytical equipment, as and when required
Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers
Working with all members of staff to maintain and develop the positive progressive culture within the company
To be successful you will have a ‘can do’ attitude, proven track record and ability to be part of a champion team.
As the successful candidate, you will have a high degree of initiative and will be able to operate with a high degree of autonomy, exhibiting clear thinking and sound judgement.
Interpersonal communication skills will be paramount for this rewarding role, including excellent written communication, due to the highly technical nature of the industry and the range of personnel you will be interacting with on a daily basis.
A summary of required criteria include:
Tertiary qualifications in Analytical Chemistry or similar. Post graduate studies desirable but not necessary
A minimum of five years’ experience in a pharmaceutical or medical device laboratory as an Analytical or QC Chemist
Excellent Gas Chromatography skills
Highly proficient in the use of various analytical equipment including FTIR, and Karl Fisher, and the testing of finished products
Minimum 5 years’ experience in a highly regulated pharmaceutical manufacturing or other GLP/GMP environment
Proven ability to optimise, validate and verify analytical test methods for the testing of raw materials and finished products, in particular GC methods, according to ICH and FDA guidelines and compendial requirements, as appropriate
Experienced in adhering to pharmaceutical regulatory requirements throughout Quality Control (QC) and stability programs as required
Proven ability to perform/ensure work is performed to a high quality work standard and in accordance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and required time frames.
Experienced with laboratory maintenance and calibrations, logistics, quality and continuous improvement activities as required
MUST have a good eye for detail, superior written communication skills, be a good team player and a problem solver
Ability to multitask and to take assignments/projects to completion
Hands on approach with a ‘can do’ attitude
Proficient with Microsoft Office suite
Full working rights
To discuss this excellent opportunity please call our team on 03 9516 0100. After hours, please feel free to call Helen on 0438 620 434. To apply, please click the ‘Apply Now’ button. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.
Thank you for taking the time to apply for these roles. As we receive a large number of applications every day, we can only contact short-listed candidates. If you do not receive a call from our Recruiters, then your details will remain on our database for future suitable roles.