STERLING SOLUTIONS is looking for employees for positions:
chemist
Benefits
mutual
Responsibility
performing analysis and reporting results in accordance with cGMP requirements
communicating with the process owners internally to provide key updates on a regular basis
investigating analytical deviations and out of specification results with appropriate rigour and contributing to their root cause resolution
supporting R&D Chemists with analysis of process development and investigation samples
organising the calibration and maintenance of analytical laboratory equipment
optimising analytical methods and implementing testing procedures to support the transfer of new processes into production
performing routine auditing of laboratory areas
accompanying customers during site visits for plant observation
Requirements
must have a degree in Chemistry or other relevant scientific discipline
must have a degree in Chemistry or related subject
previous laboratory experience is essential, ideally in a GMP environment
previous manufacturing experience would be highly desirable
experience and knowledge of HPLC and GC techniques is essential
an understanding of cGMP and EHS compliance would be preferred
good verbal and written communication skills
must be flexible and able to manage changing priorities
manager
Trade
management
Management
Benefits
mutual
Responsibility
working with the project and business development managers from receipt of RFPS to develop firm proposals and subsequent project delivery
maintaining and expanding the cGMP QC services which encompasses chemical, biochemical, cell biology and microbiology analyses
managing the ongoing environmental monitoring and water testing of the GMP facility and operation
managing the investigation of out of trend, out of specification and any deviations events
budgetary responsibility for the QC Department including management of spend and equipment capital expenditure ensuring development and testing service is provided in a cost-effective manner whilst meeting key milestone deliveries
ensuring that all regulatory expectations are met regarding any GMP QC samples or data collected, manipulated, reported, stored or archived
leading and managing the multifunctional QC team of 16+ analysts ensuring compliant and effective training and development
providing timely and accurate testing updates for materials, samples, products and stability studies to internal parties and external clients
Requirements
degree or equivalent in Chemistry/Biochemistry or a related scientific/technical field
previous supervisory/management experience within a cGMP QC laboratory
knowledge/experience of testing protein therapeutics
expertise in chemical, biochemical and microbiological method development, qualification, and statistical quality control
excellent knowledge of cGMP and their variation across the major global territories; MHRA, EMEA, FDA, MHLW, ANVISA, Health Canada etc
excellent verbal and written communication skills, experience with scientific writing including authoring and revising SOP’s and technical reports
used to working in a fast-paced complex environment, able to work to flexible schedules
experience in working with highly potent samples and associated containment and safe working practices
group financial accountant
Benefits
mutual
Requirements
professional accounting qualification desirable but not essential
excellent knowledge of principles and practices of accounting, computerised accounting systems and accounting data analysis
excellent knowledge of principles and procedures of financial record keeping and reporting
advanced problem-solving capabilities
ability to analyse trends and give insights on business performance
high attention to detail
excellent time management skills
good organisational skills
Responsibility
ensure that the group accounting manual is maintained and updated as required
group accounts and statutory accounts for all relevant jurisdictions. This includes consolidation, narrative reporting and coordination with external auditors
laboratory technician
Responsibility
assisting the QC team in the preparation of reagents, equipment set-up, raw material sampling as well as packaging and shipping samples
cleaning and waste management, routine self-inspections and stock control, supporting the re-order systems and communicating with key suppliers
conducting basic laboratory tests including pH, conductivity, osmolality, Total Organic Carbon content and basic microbiological techniques
following standard operating procedure and documenting laboratory results in accordance with current good manufacturing practice and company procedures
maintaining and improving knowledge of analytical techniques
ensuring personal training status is compliant with matrix requirements
contributing to team building, training and problem-solving initiates internally and cross site as applicable
ensuring that all laboratory activities are conducted in compliance with all Health and Safety guidelines with particular reference to COSHH and Biological Safety Regulations and Health and Safety at Work Act 1974
Requirements
previous laboratory experience is desirable but not essential
A degree in a relevant biological/biochemistry subject area would be desirable but not essential
must have excellent communication and interpersonal skills
must be organized, flexible and able to work as part of a team
must be self-motivated and willing to learn
microbiologist
Benefits
mutual
Responsibility
performing daily laboratory maintenance and housekeeping
maintaining stock of all media and consumables within the Micro Labs and QC Labs as a whole, ensuring continuous testing ability
analytical testing to perform TOC, conductivity, nitrates and appearance of WFI samples
ensuring testing and documentation is completed and reported in a timely manner
WFI sampling, sampling aseptically and transferring to QC Lab for testing within a given timeframe
sampling preparation, culturing and identifying samples with any contamination from microbiological testing
performing microbial testing, performing routine microbiological testing on, raw materials, in process samples, product and WFI samples to detect microorganisms
ensuring equipment is calibrated and maintained for accurate testing
Requirements
must have a degree in Microbiology, Biology or Biomedical Science to be considered
an understanding of microbiology techniques would be preferred but not essential
attention to detail and accuracy in testing
understanding of data analysis
problem solving skills to assess and perform contamination investigations
must align to our company values; Be Transparent, Be Willing, Be Reliable and Be Caring