We are currently looking for a QA Document Controller to join a leading Biotechnology company based in the North of the UK. As the QA Document Controller you will be responsible for assisting in the development and on-going management of the companies Quality Management Systems.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Document Controller will be varied however the key duties and responsibilities are as follows:
1. Responsible for the development and implementation of the Quality Management System (QMS), carrying out day to day activities such as CAPAs, deviations, change controls and supplier qualification.
2. Make sure that the CMO batch documentation are compliant to GXP standards, including the review of GMP documentation.
3. You will work closely with the Quality Specialist, and assist in regulatory inspections and customer audits.
4. You will generate, retrieve, manage, and follow-up quality documents generated both internally and generated by vendors in the QMS.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the QA Document Controller we are looking to identify the following on your profile and past history:
1. Relevant degree in a relevant life sciences discipline
2. Proven industry experience working in a GxP environment - (GMP, GLP, GDP preferred)
3. A working knowledge and practical experience with document / Quality Management Systems, and Electronic Document Management Systems
Key Words: QA | Quality Assurance | QMS | Quality Management Systems | Clinical | GMP | GxP | Biotechnology | QDM | Quality Document Management Systems | Electronic Document Management Systems | Drug Discovery | CAPA | Deviations |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.....Read more...
Join a pioneering team at the forefront of cancer therapy innovation as a Protein Expression Scientist. Based in London, this role is integral to the expansion of the biotechnology companies in-house protein expression platform, contributing to the development of life-changing antibody-drug conjugates.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Protein Expression Scientist will be varied however the key duties and responsibilities are as follows:
1. As Protein Expression Scientist you will be designing and creating plasmids for recombinant protein expression in suspension CHO/HEK cells, including standard antibodies, alternative formats, and antigens.
2. You will be generating stable CHO cell lines for antibody production at multi-gram scale.
3. As Protein Expression Scientist you will be conducting antibody production using fed-batch processes in mid-scale bioreactors.
4. Your role will also involve investigating new technologies within the protein expression domain.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Protein Expression Scientist we are looking to identify the following on your profile and past history:
1. Relevant degree in cell biology or molecular biology
2. Proven industry experience in transient protein expression in CHO and/or HEK293 cells.
3. A working knowledge and practical experience in the generation of antibody producing stable cell lines and large scale bioprocessing.
Key Words: Protein Expression / CHO Cells / HEK293 Cells / Recombinant Proteins / Antibodies / Bioreactors / Cell Line Generation / Bioprocessing / Antibody Production / Molecular Biology / Cell Biology / Biotechnology / Cancer Therapy / Drug Development
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.....Read more...
HRS are looking for a Head of Cell and Gene Therapy to join a leading Diagnostics Biotechnology company based in the Bedfordshire area. As the Head of Cell and Gene Therapy you will develop a team applying your industry knowledge with adeno-associated virus (AAV), and lentivirus purification detection
This is a great opportunity to execute strategy for R&D in the cell and gene therapy space to forge growth and company advancement.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Head of Cell and Gene Therapy will be varied however the key duties and responsibilities are as follows:
1. You will demonstrate your expertise knowledge of AAVs and lentivirus purification, detection, production and characterisation techniques.
2. Applying project management expertise to form new strategies to execute required work ensuring successful technology transfers to customers ensuring their synthetic polymers can be incorporated into relevant applications.
3. You will be responsible for the line management and up-skilling of staff, work with the business's development and technical teams in early feasibility assessment and project proposals, and the Operations Team for scale-up and commercial supply.
4. You will prepare complex technical reports and presentations, and contribute with ideas and solutions in all areas of the company's projects driving them to enable overall goals including new IP generation in the G&CT space.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Head of Cell and Gene Therapy we are looking to identify the following on your profile and past history:
1. Relevant PhD in Biochemistry, Chemistry, Nanotechnology or a suitably related field
2. Proven industry experience in C> R&D Environment managing large teams.
3. A working knowledge and practical experience with AAVs, lentivirus purification, detection and characterisation techniques
Key Words: C> | Cell and Gene Therapy | ATMP | Gene Therapy | AAV | Adeno-associated virus | R&D | Research and Development | QMS | Quality Management Systems | GLP | Polymer Chemistry | PhD | Nanotechnology | Biotechnology | Diagnostics | Bedfordshire | Viral Vector | PhD | Manager | Team Lead |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.....Read more...
HRS are looking for a Senior Principal Scientist - C> to join a leading Diagnostics Biotechnology company based in the Bedfordshire area. As the Senior Principal Scientist - C> you will develop a team applying your industry knowledge with adeno-associated virus (AAV), and lentivirus purification detection
This is a great opportunity to execute strategy for R&D in the cell and gene therapy space to forge growth and company advancement.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Principal Scientist - C> will be varied however the key duties and responsibilities are as follows:
1. You will demonstrate your expertise knowledge of AAVs and lentivirus purification, detection, production and characterisation techniques.
2. Applying project management expertise to form new strategies to execute required work ensuring successful technology transfers to customers ensuring their synthetic polymers can be incorporated into relevant applications.
3. You will be responsible for the line management and up-skilling of staff, work with the business's development and technical teams in early feasibility assessment and project proposals, and the Operations Team for scale-up and commercial supply.
4. You will prepare complex technical reports and presentations, and contribute with ideas and solutions in all areas of the company's projects driving them to enable overall goals including new IP generation in the G&CT space.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as theSenior Principal Scientist - C> we are looking to identify the following on your profile and past history:
1. Relevant PhD in Biochemistry, Chemistry, Nanotechnology or a suitably related field
2. Extensive industry experience with product development in a C> R&D environment managing teams.
3. Extensive working knowledge and practical experience with AAVs, lentivirus purification, detection and characterisation techniques.
Key Words: C> | Cell and Gene Therapy | ATMP | Gene Therapy | AAV | Adeno-associated virus | R&D | Research and Development | QMS | Quality Management Systems | GLP | Polymer Chemistry | PhD | Nanotechnology | Biotechnology | Diagnostics | Bedfordshire | Viral Vector | PhD | Manager | Product Development | Product Management | Senior Principal Scientist | Head of R&D | Head of Product Development
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.....Read more...
The life sciences arm of a significant IP practice is continuing to develop and flourish. With this there is capacity to welcome a talented Biotech Patent Attorney into their stellar team. Ideally, you’ll be at finalist level or recently qualified with experience in Biotechnology and/or affiliated life science matters.
With an impressive and expanding client base of innovators across a plethora of technical areas such as antibody and vaccine technology, gene therapies, small molecule pharmaceuticals and agrochemicals. It would be advantageous if you enjoy and thrive on direct client collaboration and are keen to get involved in business development initiatives.
Flexibly, although this Biotech Patent Attorney role is ideally based in London, there is plenty of scope to work from one of the regional offices on a blended working basis.
If you're ready for a significant and rewarding career change in the new year within an expert and supportive team, then please do contact Catherine French who will be happy to talk you through it on 0113 467 9790 or via: catherine.french@saccomann.com....Read more...
HEAD OF PRODUCTION | CAMBRIDGE AREA | Competitive SalaryBlackfield Associates are currently supporting an exciting biotechnology organisation to recruit for a Head of Production to join their growing team, based in the Cambridge area.Reporting to the Site GM, the core function of the role will be to lead the growing manufacturing team and to oversee the complex and specialised manufacturing and production activities. This role is pivotal in leading the manufacturing operations, driving operational efficiency and developing the Production Department. You will be developing and implementing production strategies, overseeing scheduling of staff and facilities, overseeing management of the aseptic suites, and playing a key role in facility design, capital projects, commissioning, and validation.
To be considered for the role candidates must have a BSc/MSc in a relevant scientific discipling, along with significant management experience. Expertise in GMP manufacturing of ATMPs and proven experience in production management, along with a proven track record of scaling up / scaling out of ATMP manufacturing processes is a requirement. Experience working in the field of Cellular Therapies, and ideally experience within a CDMO setting would be desirable. In order to apply for this role please forward your CV to melissa@blackfieldassociates.com or call Melissa on +44 (0) 2392 322 306 for further details.
STR Limited is acting as an Employment Agency in relation to this vacancy.....Read more...
INSTRUMENT AND CONTROLS ENGINEER - PERMANENT - HERTFORDSHIREA biotech organisation based in Hertfordshire are looking for an Instrument and Controls Engineer to join their engineering team on a permanent basis. Reporting to the Engineering Manager, you will be responsible for providing your instrumentation and controls expertise across manufacturing, quality control and facilities on site as well as identifying, finding solutions and supporting the development of processes and systems. You will work closely with teams across engineering to support maintenance, asset management and continuous improvement activities on across utilities systems such as HVAC, medical gases and analytical equipment. You will be responsible for writing, reviewing and updating maintenance procedures for equipment and systems and work with the site QMS (quality management system) to manage deviations, change controls and CAPA's (Corrective And Preventive Action). You will manage on site contractors ensuring they are working in a compliant manner at all times.Successful candidates will have proven experience in providing instrumentation / calibration support across utilities systems such as HVAC, medical gases and analytical equipment within a similar GMP environment i.e. pharmaceutical, biotechnology, petrochemical or chemical manufacturing. Candidates will hold professional engineering qualifications within an engineering discipline and will have a strong electrical / electronics background with process control skills. To apply for this role please click the 'Apply Now' button or email your updated CV to Rebekah@blackfieldassociates.com
STR Limited is acting as an Employment Agency in relation to this vacancy.....Read more...
Principal Scientist – Protein Engineering – Cambridge, MA
Newton Colmore is partnered with a biotech company in Cambridge MA, and we are searching for a principal-level scientist with expertise in protein engineering.
As a Principal Scientist within this organisation, you will be utilising your expertise to design and execute protein engineering strategies, design and develop new assays for kinetic and stability characterisation and to transfer results from early-stage concept into manufacture-ready developments across multiple therapeutic areas.
You will be part of a tight-knit team, multidisciplinary in nature, all working towards the goal of achieving a step-change in this technology.
To be considered for this exciting role we are looking for scientists with the following attributes;
Hands-on commercial experience in protein engineering.
Expertise with analytical techniques and computational approaches to protein engineering.
Ideally educated to PhD level in molecular biology or biochemistry
Industrial experience with assay development, high-throughput screening and enzyme characterization would be ideal.
In exchange for your skills and expertise, the company offer a highly competitive package and the chance to bring the technology to life.
For more information, make a confidential application now and a member of our team will be in touch with more details.
Newton Colmore is a specialist recruiter operating within the medical devices and biotechnology sectors. We have over ten years worth of expertise of placing candidates with our clients, globally. Our sole aim is to utilise this expertise and knowledge to maximise your chances of securing your ideal role with our clients.
....Read more...
Electronics Engineer – Piezoelectronics – New Product Development – Cambridge
A growing Scientific Engineering organisation is currently seeking an Electronics Engineer to assist in the product development of new piezoelectronics technologies.
You will collaborate with a team of mechanical design engineers, software engineers, and scientists, making teamwork crucial. In this role, you will be the sole electronics specialist, so confidence in your abilities is essential.
Your responsibilities will include electronics design and PCB layout for the new piezoelectronics devices, as well as writing Embedded C software and using other software languages.
While having experience in piezoelectronics would be ideal, it is not a strict requirement. However, we do prefer candidates with experience in highly regulated fields such as Medical Devices, Biotechnology, Scientific Engineering, Pharmatech, or other scientific domains.
While working on cutting-edge technologies, you will also enjoy an excellent starting salary, a generous pension, annual bonuses, private medical cover, life assurance, and other benefits typically associated with larger organisations.
Given the expected high level of interest in this role, we recommend submitting your application promptly if you are interested. We are looking for someone to start relatively soon, though we understand that you may have a notice period.
The interview process will be swift, commencing with a video interview and progressing to an in-person interview. Part of the interview may involve a tour of their state-of-the-art facilities, which are currently being expanded to stay at the forefront of technological advances.
For further information, please do not hesitate to call Andrew Welsh, Director of Medical Devices Recruitment and Scientific Recruitment Specialist at Newton Colmore, on +44 121 268 2240, or submit an application, and a member of our Newton Colmore team will get in touch with you.
Newton Colmore Consulting is a specialist recruitment company within the Medical Devices, Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance, and Field Service Engineering sectors.....Read more...
Validation Engineer – Medical Devices
A growing medical devices company based in Cambridgeshire are in the process of expansion and are actively looking for an experienced Validation Engineer to join the team.
The role as Validation Engineer will give you the opportunity to work on novel and complex medical devices whilst working closely with R&D Engineers, external consultants, and suppliers to ensure the company’s reputation and quality of products remain market leading.
Your work will be vitally important in ensuring the successful execution of validation and verification activities required ahead of regulatory approval, product launch, and mass manufacturing.
You will be heavily involved in readying the company’s product for clinical trial, and the verification and validation test plans and protocols for the product, documenting all activities within the Quality Management System. Another key part of the role is the contribution to the Standard Operating Procedures.
To be considered for the Validation Engineer you will need to have prior experience with medical devices and an ISO 13485 environment, coupled with expertise in writing test protocols and familiarity with QMS.
The company are passionate about delivering a step-change for patients with their technology and they need great people to help them.
In return for your hard work the company offer a salary, tailored to your experience level, and a benefits package that includes bonuses, industry leading pension contributions, 25 days holiday and much more.
Matt Lowdon is taking lead on this assignment and so please do make a confidential application for more details.
Matt has been working with this company for over 12 years and can offer deep insights and knowledge throughout the interview process, with the aim of maximising your chances of securing this role.
Newton Colmore is a specialist executive search and talent solutions company dedicated to the medical devices and biotechnology sectors. Founded in 2015, we have helped our clients find expert scientists and engineers across the globe.
....Read more...
Mechanical Engineer - Medical Devices Validation
Newton Colmore is working with a medical devices company in Cambridgeshire, and we are looking for a mechanical engineer to join their verification and validation team.
In this Mechanical Engineer role, you will be working on novel and complex medical devices whilst collaborating closely with fellow engineers, external consultants, and suppliers to ensure the company’s products deliver a step change.
Your work will be vitally important in ensuring the successful execution of validation and verification activities required ahead of regulatory approval, product launch, and mass manufacturing. This role will initially focus on an FDA submission and after this is complete, the role will naturally evolve, and you will take on extra responsibilities as the company moves to its next phase.
You will be heavily involved in readying the company’s product for clinical trial, and the verification and validation test plans and protocols for the product, documenting all activities within the Quality Management System. Another key part of the role is the contribution to the Standard Operating Procedures.
To be considered for this opportunity you will need to have prior experience with medical devices and an ISO 13485 environment, coupled with expertise in writing test protocols and familiarity with QMS. Ideally this will be from a mechanical engineering background and any experience with CAD would be highly beneficial. For this role, we are ideally looking for a candidate who has 1-to-3 years’ worth of experience.
The company are passionate about delivering a step-change for patients with their technology and they need great people to help them with this mission.
In return for your hard work the company offer a salary, tailored to your experience level, and a benefits package that includes bonuses, industry leading pension contributions, 25 days holiday and much more.
Matt Lowdon is taking lead on this assignment and so please do make a confidential application for more details.
Matt has been working with this company for over 12 years and can offer deep insights and knowledge throughout the interview process, with the aim of maximising your chances of securing this role.
Newton Colmore is a specialist executive search and talent solutions company dedicated to the medical devices and biotechnology sectors. Founded in 2015, we have helped our clients find expert scientists and engineers across the globe.
....Read more...
Are you an experienced Validation Specialist looking for a new exciting job opportunity?
We are currently looking for a Validation Specialist to join a leading pharmaceutical company based in the Caerphilly area.
As the Validation Specialist you will enhance validation practice and compliance; support improvement to validation system; streamline processes. Identify risk areas and required mitigation to meet regulatory inspections e.g. MHRA, FDA, Notified Body etc. through routine compliance activities and specific validation projects.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for ensuring that the Site Validation Master Plan is maintained accurately and Validation Plans are implemented for all relevant aspects of Equipment, Process, Cleaning, Computer Systems, Facilities/Utilities and Analytical Method validation.
2. Additionally, you will also be assisting with all validation activities on equipment before handover / return to system owner and updating all relevant records and schedules. You will be responsible for arranging specialist services to maintain, calibrate and qualify specialist equipment.
3. Technical input into all Validation Lifecycle activities as part of a cross functional team. Provide guidance and support to other internal site departments ensuring compliance with applicable regulatory requirements (MHRA, EU, FDA, U.S., Notified Body and international), International Standards, and quality/validation regulations and guidance documents.
4. You will also prepare and present validation reports and Key Performance Indicators for management review. Review and monitor trends; initiate continuous improvement opportunities, communicate any matters outside the norm to the Validation Manager / Site Director of Quality.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Validation Specialist we are looking to identify the following on your profile and past history:
1. Successful validation experience in a GMP environment (in the pharmaceutical, medical devices, consumer healthcare or semi-conductor industry) is essential for this position. Experience working in a sterile manufacturing facility would be highly desirable.
2. Demonstrated expertise in cGMP's, EU/FDA regulations, GAMP guidelines, assessment of risk and drafting of plans, protocols, reports and procedures.
3. Previous team leadership experience (direct or indirect) desirable, operating in a matrix organization.
Key Words: Validation Specialist | Validation Engineer | Biotechnology | Life Science | Pharmaceutical | GMP | Manufacturing | Sterile Cleanroom | Quality Assurance
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.....Read more...
