Director Process Development

4 weeks ago

United Kingdom Northreach Full time

A well-funded startup in the biotechnology sector specializing in ophthalmology. As a leader in developing innovative products, our mission is to protect and restore the vision of patients suffering from various eye diseases. We are expanding our Chemistry, Manufacturing, and Controls (CMC) team to support our ocular therapies into late-phase clinical trials.


Role Overview:

We are seeking an experienced Process Development Subject Matter Expert (SME) to provide insights into mammalian cell culture processes. This role will focus on technology transfer and scaling up support for late-phase clinical development and Investigational New Drug (IND) studies for multiple assets.


Responsibilities:

  • Downstream Process Oversight: Manage activities at Contract Development and Manufacturing Organization (CDMO) sites, including optimization, technology transfer to Good Manufacturing Practices (GMP) environments, and Process Performance Qualification (PPQ) batches.
  • Process Development: Develop and implement downstream processes that align with the company's goals and meet established regulatory requirements.
  • Stakeholder Collaboration: Engage regularly with both internal and external stakeholders to ensure alignment and progress on key projects.
  • Technical Scope Definition: Work closely with CDMO counterparts to define technical scopes, monitor execution, and review data from optimization studies.
  • Validation Strategy Design: Design process validation strategies for manufacturing processes in collaboration with CDMOs, adhering to regulatory requirements and industry best practices.
  • Risk Management: Identify potential risks to CMC processes, propose enhancements to improve efficiencies, and reduce development timelines.


Skills, Knowledge, & Experience:

  • Educational Background: Bachelor’s degree in Biochemical Engineering, Biotechnology, or a related field.
  • Downstream Development Experience: Extensive experience in early-stage and late-stage downstream development for complex biologics, with a strong emphasis on purification technologies applied to mammalian cell culture-based manufacturing.
  • Technical Proficiency: Deep technical knowledge of downstream unit operations, including column chromatography, filtration, harvest, and viral clearance validation.
  • Regulatory Knowledge: In-depth understanding of GMP regulations and guidelines related to biologics manufacturing.
  • Project Management: Excellent project management skills, with the ability to effectively manage timelines and coordinate with stakeholders.
  • Communication Skills: Strong ability to collaborate and communicate with a global remote team.


Location: This is a remote-based role with the flexibility to be located anywhere in the United Kingdom. However, there is an expectation to travel to the company’s site in London twice per month.

  • Legal Counsel

    3 weeks ago

    United Kingdom The Legal Director Full time

    We are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE. Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if...

  • Legal Counsel

    3 weeks ago

    United Kingdom The Legal Director Full time

    We are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE. Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if...

  • Development Director

    2 weeks ago

    United Kingdom European Recruitment Full time

    Become a part of a leading Semiconductor organization in the UK as they search for a Director of Research & Development. Established history of effectively overseeing and accomplishing projects within designated timelines in a managerial role. Sound comprehension of semiconductor device physics, characterization, and process flow. Proven background in...

  • In House Counsel

    1 month ago

    United Kingdom The Legal Director Full time

    We are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE. Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if...

  • In House Counsel

    4 weeks ago

    United Kingdom The Legal Director Full time

    We are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE. Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if you...

  • In House Counsel

    1 month ago

    United Kingdom The Legal Director Full time

    We are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE. Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if...

  • In House Counsel

    1 month ago

    United Kingdom The Legal Director Full time

    We are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE.Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if you...

  • In House Counsel

    1 month ago

    United Kingdom The Legal Director Full time

    We are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE.Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if you...

  • Business Development Director

    5 days ago

    United Kingdom Remote Worker Ltd Full time

    2 weeks ago Be among the first 25 applicants Responsibilities Our reputable client is looking for an experienced Business Development Director join their business in this standalone role. The successful Business Development Director will work closely with the MD and will be responsible for sourcing and securing new business through their existing channel...

  • Business Development Director

    4 days ago

    United Kingdom Remote Worker Ltd Full time

    2 weeks ago Be among the first 25 applicants Responsibilities Our reputable client is looking for an experienced Business Development Director join their business in this standalone role. The successful Business Development Director will work closely with the MD and will be responsible for sourcing and securing new business through their existing channel...

  • Development Director

    7 days ago

    United Kingdom Soil Association Full time

    Location flexible, with regular travel to Bristol The Soil Association is the only UK charity which works across the spectrum of human health,the environment and animal welfare. Since 1946, we’ve dug deeper to transform the way we eat, farm and care for our natural world,to support a future with good health, in balance with nature, and a safe climate....

  • Director Pharmaceutical Development

    1 month ago

    United Kingdom Nouscom AG Full time

    Nouscom is a private clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. In Q1 2024 the company announced closing of heavily oversubscribed €75M / $82M Series 'C' financing, to advance the clinical development of its wholly owned programs.  We are looking for a Senior Director, Business...

  • Director Pharmaceutical Development

    1 month ago

    United Kingdom Nouscom AG Full time

    Nouscom is a private clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. In Q1 2024 the company announced closing of heavily oversubscribed €75M / $82M Series 'C' financing, to advance the clinical development of its wholly owned programs.  We are looking for a Senior Director, Business...

  • Director-Training and Development

    2 weeks ago

    United Kingdom Verian Group Full time

    Permanent, Full Time Hybrid working: 3 days a week in the office 2 days working from home In 2024, we focus on delivering tailored research and consultancy services to policy makers working at the highest levels of national government. This is a full-time, permanent hybrid home/office role and the successful applicant will report to a Senior Director...

  • Senior Director

    3 days ago

    United Kingdom tdm recruitment Full time €110,000 - €140,000

    Land Director Bicester £110k - £140k Are you a proven land acquisition professional looking to work for a privately owned developer where you'll be given the freedom to run the team and do deals? We are working with a privately owned house builder and property developer that is looking to appoint a Land Director to lead the team in securing land and...

  • Senior Director

    4 days ago

    United Kingdom tdm recruitment Full time €110,000 - €140,000

    Land Director Bicester £110k - £140k Are you a proven land acquisition professional looking to work for a privately owned developer where you'll be given the freedom to run the team and do deals? We are working with a privately owned house builder and property developer that is looking to appoint a Land Director to lead the team in securing land and...

  • Senior Director

    5 days ago

    United Kingdom taylorollinson Ltd Full time

    Industry Sector Biotechnology , Chemical , Medical Devices , Pharmaceutical , Other Profession Laboratory Operations & Research , QA & Regulatory Location UK , East Anglia Salary Competitive Base + bonus + share options Description Contract: Full-time and permanent (Monday to Friday) (Part-time and hybrid working will be considered on a case by case...

  • Senior Director

    1 month ago

    United Kingdom taylorollinson Ltd Full time

    Industry Sector Biotechnology , Chemical , Medical Devices , Pharmaceutical , Other Profession Laboratory Operations & Research , QA & Regulatory Location UK , East Anglia Salary Competitive Base + bonus + share options Description Contract: Full-time and permanent (Monday to Friday) (Part-time and hybrid working will be considered on a case by case...

  • Development Director

    1 week ago

    United Kingdom Capstone Property Recruitment Full time

    Director, Development – National Markets (SEGRO) Salary: Excellent, plus bonus, LTIP, car allowance + benefits Rugby (moving to Coventry), some flexible hybrid available Capstone are delighted to be working in partnership with SEGRO, a leading owner, asset manager and developer of modern warehousing and industrial property, in search of a highly...

  • Development Director

    1 month ago

    City of London, United Kingdom Skillsearch Limited Full time

    Skillsearch is helping an AAA gaming studio find a Development Director to join them in London. This full-time Development Director role comes with a generous salary and benefits package, including flexible working. As a Development Manager, you will direct and drive a game's overall development plan, constantly focused on team performance and health whilst...