At a Glance
- Tasks: Lead bioprocessing projects and oversee manufacturing strategies in biotechnology.
- Company: Join a pioneering biotech firm dedicated to innovation and inclusivity.
- Benefits: Competitive salary, professional development, and a collaborative work environment.
- Other info: Opportunity to mentor a high-performing team and drive cutting-edge projects.
- Why this job: Make a significant impact in gene therapy and advanced therapies.
- Qualifications: BSc in relevant sciences and substantial experience in biotech process development.
The predicted salary is between 80000 - 100000 £ per year.
We are looking for an accomplished bioprocessing scientist to join our growing team as Head of Process Development (PD) & Manufacturing Science and Technology (MSAT). This is a unique strategic and technical opportunity for an individual with significant late stage development, process characterisation, and validation experience in biotechnology and viral vector production.
Specific responsibilities:
- Define, execute, and oversee the strategy for Process Characterisation and Process Performance Qualification (PPQ) of AAV Drug Substance and Drug Product.
- Provide technical and manufacturing oversight for the sourcing and qualification of raw and starting materials (cell banks, plasmids, critical reagents and consumables).
- Accountable for upstream, downstream, and Drug Product fill/finish activities at external partners, ensuring successful technology transfer and routine GMP production.
- Establish the commercial Process Control Strategy, mapping CPPs to CQAs using qualified scale-down models.
- Partner with Research and Vector Design teams to transition early-stage pipeline assets into scalable, robust manufacturing platforms.
- Continue to develop the existing USP and DSP platform process and identify opportunities to optimize the Cost of Goods Manufactured (COGs).
- Review CMC source documents and regulatory filing dossiers (IND/IMPD/BLA/MAA). Review and sign off on process descriptions, risk assessments (FMEAs), validation protocols, and final study reports.
- Work with internal stakeholders and CDMO partners to ensure uninterrupted supply of materials from pre-clinical studies through all phases of clinical evaluation.
- Provide technical expertise on investigations into deviations and OOS (Out of Specification) results. Collaborate with QA on vendor qualification and change controls, and serve as the subject matter expert during regulatory inspections.
- Manage, develop, and mentor a high-performing team of 4-5 scientific staff.
Education and Qualification:
- BSc in biochemical engineering, biological or pharmaceutical sciences with relevant post graduate qualification (or equivalent professional qualification or accreditation).
- Substantial industrial experience in biotechnology process development & GMP manufacturing of viral (gene therapy) and microbial (DNA) products.
Skills and Capabilities:
- Proven track record in managing CDMOs and external partner relationships.
- Experience in cell line development and characterisation.
- Deep technical expertise in the processing of viral vectors (AAV preferred) or advanced therapies.
- Strong mastery of statistical tools (DoE, SPC) and Quality by Design (QbD) principles applied to process validation.
- Understanding of late-stage fill/finish requirements for low volume biotechnology products.
- Comprehensive knowledge of CMC regulations and global registration processes (from IND to BLA/NDA). Commercial experience is desirable.
- Orphan drug or accelerated development timeline experience is highly desirable.
- Demonstrated ability to lead, mentor and develop a small team of direct reports, fostering strong performance, growth and engagement.
- Excellent interpersonal & organizational skills, project management skills & ability in problem solving.
- Attention to detail with documentation and coordination/oversight practices.
- Demonstrated ability to identify critical program risks and develop mitigation plans.
- Ability to prioritize multiple tasks and act decisively.
- Team approach to programme management.
- Able to work both independently and collaboratively in a team.
- Able to influence others and lead complex projects.
At AAVantgarde, we are committed to fostering a welcoming, collaborative, and inclusive environment. We believe in providing equal opportunities for all and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected characteristics. All applicants will receive equal consideration for employment.
Head of Process Development and MSAT in London employer: Aavantgarde
At AAVantgarde, we pride ourselves on being an exceptional employer, offering a dynamic work culture that champions collaboration and inclusivity. As the Head of Process Development and MSAT, you will not only lead a talented team but also have access to unparalleled growth opportunities in the rapidly evolving biotechnology sector. Our commitment to employee development, coupled with our strategic location, ensures that you will thrive in a supportive environment while making a meaningful impact in the field of gene therapy.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Process Development and MSAT in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech field, attend industry events, and join relevant online forums. The more people you know, the better your chances of landing that Head of Process Development role.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and recent advancements in bioprocessing. Be ready to discuss your experience with AAV Drug Substance and how you've tackled challenges in process characterisation.
✨Tip Number 3
Showcase your leadership skills! When chatting with potential employers, highlight your experience managing teams and mentoring staff. They want to see that you can lead a high-performing team in a fast-paced environment.
✨Tip Number 4
Don't forget to apply through our website! It's the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Head of Process Development and MSAT in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in bioprocessing and GMP manufacturing. We want to see how your skills align with the specific responsibilities mentioned in the job description.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for the Head of Process Development role. Share your passion for biotechnology and any relevant achievements that showcase your expertise in process characterisation and validation.
Showcase Your Team Leadership Skills:Since this role involves managing a high-performing team, be sure to include examples of how you've successfully led and mentored teams in the past. We love seeing candidates who can inspire and develop others!
Apply Through Our Website:Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. We can't wait to hear from you!
How to prepare for a job interview at Aavantgarde
✨Know Your Bioprocessing Inside Out
Make sure you brush up on your knowledge of bioprocessing, especially around AAV Drug Substance and Drug Product. Be ready to discuss your experience with process characterisation and validation, as well as any specific projects you've led in this area.
✨Showcase Your Leadership Skills
As a Head of Process Development, you'll need to demonstrate your ability to manage and mentor a team. Prepare examples of how you've developed high-performing teams in the past and be ready to discuss your approach to fostering growth and engagement.
✨Understand Regulatory Requirements
Familiarise yourself with CMC regulations and global registration processes. Be prepared to talk about your experience with regulatory filings and how you've navigated challenges in the past, particularly with INDs and BLAs.
✨Prepare for Technical Questions
Expect in-depth technical questions related to upstream and downstream processing, as well as fill/finish activities. Brush up on statistical tools like DoE and SPC, and be ready to explain how you've applied Quality by Design principles in your previous roles.
