Quality Control Manager
vor 2 Wochen
RRxCo is partnered with a UK-based business established in 2010 focusing on antibody, protein and peptide drug conjugate medicines and technology. The bioconjugation team was formed in 2011 and moved into a state-of-the-art facility in 2018. The facility has been built for containment; with the safety of their people and the environment in mind, and bespoke laboratories have been designed specifically to accommodate highly potent bioconjugations.
Antibody Drug Conjugates combine the cell and tissue specificity of monoclonal antibodies with the cell-killing potential of highly potent small molecules and represent one of the fastest-growing sectors in the oncology field.
Key Notes
- Relocation Support Provided.
- Sponsorship Available.
- Candidate must hold biologics experience ideally with protein/antibodies experience (this does not include ATMP/Cell & Gene Therapy).
- Candidates must have experience in a Quality Control environment.
- Candidates must have experience with BioChemistry/BioAnalytical/BioAssay techniques.
Summary
The QC Manager is responsible for managing and leading the QC department at Deeside. This includes personnel, equipment and facilities in the cGMP quality control function/laboratory to support the contract manufacture of parenteral protein-drug conjugate drug substances for pre-clinical, clinical and commercial use. This comprises testing of raw materials, products, process intermediates, stability and environmental samples using a variety of chemical, biochemical and microbiological methods. The manager is responsible for ensuring a state of continuous cGMP compliance and audit readiness within the QC laboratory. Alongside this and of paramount importance the manager is responsible for ensuring appropriate health and safety systems are in place for handling hazardous/toxic analytes. This is also a client-facing role that is essential to the efficient and timely delivery of multiple projects in parallel for a range of pharma clients from small biotech to large pharma, with project scope varying from quick turnarounds to strategic partnerships lasting over several years.
Deliverables
- Lead, manage and, recruit the multifunctional Quality Control (QC) team of 16+ analysts ensuring compliant and effective training and development.
- Work with the project and business development managers from receipt of RFPS to develop firm proposals and subsequent project delivery.
- Ensure current Good Manufacturing Practice (cGMP) compliance.
- Maintain a safe working environment compliant with all relevant Environment, Health and Safety (EHS) requirements.
- Maintain and expand the cGMP QC services which encompasses chemical, biochemical, cell biology and microbiological analyses.
- Define all equipment requirements, procure and qualify new equipment and maintain them a state of compliance; URS, DQ, IQ, OQ, PPM programs.
- Responsible for the creation, review and approval of all necessary documentation including but not limited to analytical methods, raw material and product specifications, Certificates of testing, Stability Study Protocols, Method Qualification Protocols and Reports.
- Manage the ongoing environmental monitoring and water testing of the GMP facility and operation.
- Manage the investigation of out-of-trend (OOT), out-of-specification (OOS) and any deviation events.
- Ensure that all regulatory expectations are met regarding any GMP QC samples or data collected, manipulated, reported, stored or archived.
- Provide timely and accurate testing updates for materials, samples, products and stability studies to internal parties and external clients.
- Has 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.
Profile of Individual
- Degree (preferably Masters/PhD) or equivalent in chemistry/biochemistry or a related scientific/technical field.
- Extensive years of relevant experience in a cGMP QC laboratory with at least 5 years in a supervisory/management role with demonstratable progression in managerial responsibilities.
- Ideally knowledge/experience of testing of protein therapeutics (ideally antibodies, more advantageous if specifically, antibody-drug conjugates).
- Expertise in chemical, biochemical and microbiological method development, qualification, and statistical quality control.
- Thorough knowledge of cGMP (MHRA, EMEA, FDA, MHLW, ANVISA, Health Canada, etc.) and regulatory expertise in those related to analytical method development and validation (ICH, USP, EP, JP, etc.)
- Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOP's and technical reports.
- Used to working in a fast-paced complex environment, able to work flexible schedules.
- Past or current experience working with highly potent samples and associated containment and safe working practices.
- Ideally prior experience in supporting regulatory and client audits.
- Experience working in a CDMO, CRO or similar service provider environment is preferred.
-
Quality Control Manager
vor 22 Stunden
Shire Of Manjimup, Österreich Energy Jobline ZR VollzeitJob Description RRxCo is partnered with a UK-based business established in 2010 focusing on antibody, protein and peptide drug conjugate medicines and technology. The bioconjugation team was formed in 2011 and moved into a state-of-the-art facility in 2018. The facility has been built for containment; with the safety of their people and the environment in...
-
Production Manager
vor 2 Wochen
Shire Of Manjimup, Österreich Control Recruitment Solutions Ltd VollzeitProduction ManagerLocation DeesideSalary Negotiable + pension + benefitsA genuinely superb & quite unique opportunity for a production manager to join a market leading business to help setting up and shaping a department.The Job: * Reporting into the Head of Manufacturing, initially there will be 2 x Team Leaders reporting into the Production Manager but...
-
Production Manager
Gefunden in: Whatjobs AU C2 - Vor 4 Tagen
Manjimup, Österreich Control Recruitment Solutions Ltd VollzeitProduction ManagerLocation DeesideSalary Negotiable + pension + benefitsA genuinely superb & quite unique opportunity for a production manager to join a market leading business to help setting up and shaping a department.The Job:* Reporting into the Head of Manufacturing, initially there will be 2 x Team Leaders reporting into the Production Manager but this...
-
Steel Senior Site Manager in Deeside
Vor 6 Tagen
Shire Of Manjimup, Österreich DCT Recruitment VollzeitDCT Recruitment Ltd - Temporary Senior Site Manager DCT Recruitment Ltd are looking for a Temporary Senior Site Manager who specializes in steel projects. Our very successful client is looking to expand their team and has landed a 2-year contract on a construction project in Deeside. Roles & Responsibilities Liaising with clients and reporting on progress...
-
Electronics Inspector
vor 1 Woche
City of Devonport, Österreich Luton Bennett VollzeitElectronics Inspector (Quality Control)Dyce - AberdeenCompetitive DOE + 33 Days Holiday inclusive of Public Holidays (Increasing to 33 after 5 years' service) + Pension Scheme + Death in Service Benefit Scheme + Private Medical Insurance + Cycle to Work Scheme + Long Service Awards Monday to Friday,9am to 5pm (some flexibility may be available).Electronics...
-
Maintenance Manager
vor 2 Wochen
Shire Of Manjimup, Österreich Energy Jobline CVL VollzeitMaintenance Manager Location Deeside Salary Negotiable + pension + benefits A genuinely superb & quite unique opportunity for a maintenance manager to join a market leading business to help setting up and shaping a department. The Job: * Help set up the plant / factory * Assist with installation and commissioning of new machinery and equipment *...
-
Steel Senior Site Manager in Deeside
Gefunden in: Whatjobs AU C2 - Vor 4 Tagen
Manjimup, Österreich DCT Recruitment VollzeitDCT Recruitment Ltd - Temporary Senior Site ManagerDCT Recruitment Ltd are looking for a Temporary Senior Site Manager who specializes in steel projects. Our very successful client is looking to expand their team and has landed a 2-year contract on a construction project in Deeside.Roles & ResponsibilitiesLiaising with clients and reporting on progress to...
-
Design Manager
vor 2 Wochen
Shire Of Manjimup, Österreich Anderselite VollzeitDesign Manager - Industrial Type: Contract Rate: £400 - £450 per day (Outside IR35) Location: Shotton Deeside Start Date: ASAP We are seeking an experienced Design manager with an impressive portfolio of new build Industrial projects to take lead on all onsite design management requirements for 3 key Industrial projects spanning 24 months. The ideal...
-
Head of Quality
vor 22 Stunden
City of Wyndham, Österreich The Axiom Group VollzeitQuality Assurance & Control (Manufacturing, Transport & Logistics) Specialising in a range of balcony solutions, including balustrades, screens, planter boxes, and architectural metalwork such as window shrouds and battens, Axiom stands as an expert in the field.Job Description: We are seeking a dynamic and experienced Head of Quality to join our team....
-
Processing Manager
vor 21 Stunden
Mareeba Shire, Österreich Jack Murat Coffee VollzeitPosition Summary:Jack Murat Coffee is seeking a Process Manager to oversee the end-to-end coffee processing operations, from coffee cherry to the final finished green bean. Reporting to the Farm Manager, this pivotal role encompasses strict oversight of the entire coffee processing chain, ensuring the highest standards of quality and efficiency. The Process...
-
Specialist Senior Mine Monitoring
vor 2 Wochen
Shire Of Boddington, Österreich South32 VollzeitSpecialist Senior Mine Monitoring & Control Mining - Operations (Mining, Resources & Energy) SPECILAIST SENIOR MINE MONITORING & CONTROLDISCOVER A BRIGHTER FUTUREAt South32, we're meeting the challenge of enabling a sustainable future through our focus on responsibly producing commodities critical for a low-carbon world. As a collaborative, caring and...
-
Project & Performance Manager - Quality
vor 21 Stunden
City of Knox, Österreich Parmalat Australia Ltd VollzeitProject & Performance Manager – Quality WE ARE LACTALIS AUSTRALIAWe are owned by the Lactalis Group, the world’s largest producer of dairy goods. With a range of more than 2,000 products, Lactalis is committed to playing a daily role in the health and well-being of consumers throughout the world, via the provision of nutritious dairy products—milk,...
-
Assistant Buyer
vor 2 Wochen
Shire Of Manjimup, Österreich Reed VollzeitJob Title: Assistant Buyer Location: North Wales Salary: Competitive Salary Role & Responsibilities: We are seeking an enthusiastic and detail-oriented Assistant Buyer to join our procurement team. As an Assistant Buyer, you will play a vital role in supporting our Senior Buyer and contributing to the efficient operation of our procurement function. Your ...
-
Quality Engineer
vor 1 Woche
City of Port Adelaide Enfield, Österreich Acciona VollzeitACCIONA is a global company, leading in the development of regenerative infrastructure that creates a positive impact on society. Our workforce consists of more than 41,500 professionals, present in more than 40 countries across the five continents, all contributing in our mission to design a better planet. Are you a passionate individual who wants to make a...
-
Site Manager
vor 22 Stunden
Council of the City of Sydney, Österreich CONCRETE PARTNERSHIPS PTY LTD VollzeitOur client was established over 20 years ago and founded on family values, honesty, integrity and trust. The business places a large amount of care and commitment to both is clients and people, delivering top quality projects. The company delivers 1st class projects across Small to Medium scale commercial, Leisure, Hospitality, Education, Health & Aged Care...
-
Engineering Manager
vor 1 Woche
Shire of Mornington Peninsula, Österreich INGHAMS Heart OF THE Table VollzeitIt’s a great time to join our 8,000 friendly people at Ingham’s – oneof Australia and New Zealand’s largest integrated protein producers.Founded in 1918 as a family business, Ingham’s has a proud history anda bright future. Today, our business is undergoing substantial growth, where every day presentsnew and exciting opportunities to thrive.With a...
-
Finance Controls Analyst
Vor 7 Tagen
City of Melbourne, Österreich Ausnet VollzeitFull time Employer of Choice + Attractive Salary + Benefits Ensure an effective control environment within the finance functionPrepare key financial statements & assist with statutory reporting tasksPermanent role > Collaborative > Inclusive > Flexible Work EnvironmentWhen you choose AusNet, you’ll join genuine people working together, making...
-
Pest Control Technician
Vor 6 Tagen
City of Moreton Bay, Österreich Mojo Recruit VollzeitAre you a qualified Pest Control Technician, looking for a career with a leading Australian company? Work car, equipment and stock provided + competitive salary and commissions Work/life balance and generous employee benefits and rewards In this role, you'll join the friendly local Flick family, servicing areas North of the Brisbane River to South of...
-
Design Manager
Gefunden in: Whatjobs AU C2 - Vor 4 Tagen
Manjimup, Österreich Anderselite VollzeitDesign Manager - IndustrialType: ContractRate: £400 - £450 per day (Outside IR35)Location: Shotton DeesideStart Date: ASAPWe are seeking an experienced Design manager with an impressive portfolio of new build Industrial projects to take lead on all onsite design management requirements for 3 key Industrial projects spanning 24 months.The ideal candidate...
-
Senior Technical Analyst
vor 2 Wochen
Shire Of Manjimup, Österreich Shorterm Group VollzeitSenior Technical Analyst, Infrastructure ServicesDeeside.Are you an IT professional seeking an opportunity to make a significant impact in a dynamic and innovative environment? Look no further! Our company, a leader in design, manufacturing, and MRO services for a diverse range of products, including hydraulic pumps, aircraft holdback bars, and...