Deputy Head of Operations Manufacturing Lead
Deputy Head of Operations Manufacturing Lead
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Job Description
About ANGLE:
ANGLE is a worldleading liquid biopsy company commercialising a patent protected platform technology that can capture rare circulating tumour cells (CTCs) from blood in a minimally invasive way for downstream analysis.
ANGLEs Parsortix system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood. Parsortix technology comprises a microfluidic device that captures CTCs from blood based on their size and compressibility. CTCs are cancer cells that have detached from the primary tumour and entered the blood circulation and they play a critical role in initiating metastasis. Once harvested the CTCs can be comprehensively analysed to provide a wealth of information about the patients tumour advancing cancer research and potentially personalized medicine. This technology has the potential to deliver profound improvements in clinical and health economic outcomes.
ANGLE has established a CTC harvest and analysis service from our UKbased Clinical Laboratory based in Guildford for customers worldwide. In alignment with company priorities we plan to rapidly expand our services to include molecular profiling of CTCs and ctDNA using digital PCR and NGS to add to our imagebased assays.
Join our Team:
This is an exciting time at ANGLE and ourteam inGuildfordare looking for a Deputy Head of Operations (Manufacturing Lead) Youwill oversee the daily operations of the manufacturing department ensuring products meet high quality safety and compliance standards in line with GxP regulations (GMP GCP GLP). This role requires a scientific background a strong understanding of biotech processes and handson experience in a regulated environment.
At ANGLE we foster a dynamic entrepreneurial approach to translating leadingedge translational research into clinical diagnostics. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas.
We are always in search of potential employees who share our vision and want to make a difference today. In your submission please describe your background and what you can bring to our team along with attaching your resume.
Principal Accountabilities:
The Senior Manufacturing Manager will play a critical role in scaling operations improving production efficiency and maintaining compliance with industry and regulatory standards.
- Operational Leadership: Oversee daytoday manufacturing activities ensuring production goals quality standards and timelines are met. Responsible for and delivery and resolving any issues with the relevant teams
- GxP/ISO13485 Compliance: Maintain and enforce GxP (Good Manufacturing Practice Good Laboratory Practice Good Clinical Practice) compliance within manufacturing processes. Ensure adherence to FDA ISO and other applicable regulations.
- Team Management: Lead and mentor the manufacturing team fostering a culture of excellence accountability and continuous improvement.
- Process Improvement: Identify and implement process improvements to optimise production efficiency reduce costs and enhance product quality.
- CrossFunctional Collaboration: Work closely with Quality Assurance R&D and Regulatory Affairs teams to ensure manufacturing processes meet required specifications and are aligned with product development goals.
- Lead Tech Transfer of Products: Develop and deliver transfer plan with R&D to understand and transfer all the technical aspects of the product.
- Documentation & Reporting: Responsible for creating and writing all manufacturing documentation and ensuring it is accurate uptodate and compliant with regulatory requirements. Key signatory for manufacturing documentation such as MI WI BMR and other. Prepare reports for senior leadership identifying key metrics and areas for improvement.
- Resource Management: Plan and manage manufacturing resources including personnel equipment and materials to meet production demands.
- Risk Management: Identify potential risks within manufacturing processes and implement corrective and preventive actions to mitigate those risks.
- Budget Control: Responsible for manufacturing budget
- Any other ad hoc responsibilities as required such as handson manufacturing lab work
- Deputy for Head Operations when required
Qualifications Experience Knowledge and Attributes:
- Bachelors or Masters degree in a scientific discipline (e.g. Cell Biology Oncology or Molecular Biology) is required.
- Minimum of 810 years in a manufacturing role within the biotech pharmaceutical or medical device industry with at least 35 years in a management capacity.
- Experience working to strict quality standards such as Medical Device regulations and standards including but not limited to 21 CFR 820 ISO/42/EEC IVD 98/79 EC ISO14971.
- Strong knowledge and experience with GxP regulations including GMP (Good Manufacturing Practice) GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) within a biotech or medical device environment.
- A strong understanding of the importance of accurate record keeping within a strictly controlled quality system is essential.
- Understanding of biotech manufacturing processes and proficiency with manufacturing technologies and software.
- Proven track record of managing mentoring and developing highperforming teams in a regulated manufacturing environment.
- Strong analytical and problemsolving skills with a focus on continuous improvement.
- Clear and effective communication skills for both internal teams and crossfunctional collaboration.Written and verbal.
- Entrepreneurial thinking and work ethic
Job Requirements:
Due to the nature of the role our requirement is for this position to be Guildford based office hours five days per week.
As a member of our highly skilled team you will receive opportunities for training and development and a competitive benefits package.
Please let us know if you require disabilityrelated accommodation during the recruitment process so that we can work with you to meet your needs.
Furthermore please be advised that if you submit an application to us for this position your application and personal details will be processed in accordance with ourData Privacy Notice for Job Candidates.
Important notice to Employment Businesses/ Agencies:
ANGLE does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact our ANGLE recruitment team to obtain prior written authorisation before referring any candidates. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ANGLE. ANGLE shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Required Experience:
Director
Employment Type
Full Time
