Director – CMC Upstream Process Sciences

JOB DESCRIPTION

Section: Upstream Process Sciences      

Reports to: VP CMC

Reports: Expanding section to ~ 12 scientists                                   

MAIN PURPOSE OF JOB                                                                                                                          

As the Director of the CMC Upstream Process Sciences section, you will be a pivotal member of the CMC leadership team at Evox. You will generate and execute and upstream process development (USPD) and cell line development (CLD) strategies for manufacturing cell line delivery, process development, optimization, intensification, scale-up and validation of upstream processes. Accountability for the USPD and CLD CMC strategies throughout the product lifecycle is a key component of this role. You will provide leadership and mentorship to the upstream process and cell line development Group Leaders and scientists engaged in USPD, CLD, external manufacturing technology transfer and process characterisation activities supporting Drug Substance development enabling first-in-human trials and eventually through late-stage trials, commercialization, and post approval changes to marketed products.

KEY ACCOUNTABILITIES

• Lead the groups within CMC Upstream Process Sciences section to deliver robust manufacturing cell lines, define, develop, optimize, scale-up and validate upstream mammalian cell culture processes to deliver high titre high exosome product quality, exploiting QbD concepts, PAT, statistical DoE and in compliance with applicable ICH guidelines and FDA/EMA/applicable global regulatory requirements and expectations.
• Role model the Company values and leadership behaviours, cultivating high performing and highly engaged teams.
• Lead science-driven, phase appropriate, and risk-based development and process specification setting to support clinical programs from proof of concept to commercial registration.
• Serve as a subject matter expert and author and/or review relevant sections of CMC documentation in support of regulatory submissions, amendments, and scientific briefing documents.

• Lead characterization, CPP assessments, development/optimization, setting scientifically justifiable cell line testing, specification, and upstream process control strategies.

• Collaborate with internal and external stakeholders to identify trends, best practice and expectations and incorporate them into Evox’s USPD and CLD strategies.
• Work collaboratively with Research Department and Product Development and Supply (Downstream development and pre-clinical manufacturing), Analytical Sciences, Quality, and external partners to ensure goal alignment and execution of priorities.
• Manage upstream and cell line technology transfers - internally to pre-clinical manufacturing and externally to Contract Manufacturing Organisations.
• Manage and oversee all aspects of section organizational performance and development.
• Support strategic decisions in consultation with the VP CMC and other key senior leaders to advance Evox’s platform and pipeline projects.
• Build strong working relationships with enabling functions, including Finance, IP, Legal, Business Development and HR to ensure the optimal environment for delivery within the Upstream Process Sciences section.
• Present regularly to the internal senior leadership team and provides timely provision of data and documentation reports to support intellectual property filings and regulatory submissions.

PERSON SPECIFICATION

It is expected the person will have extensive USPD research and development expertise gained with protein and/or viral vector biologics and will have an entrepreneurial mindset. The person must also be comfortable working in an agile and team-oriented environment with colleagues across different disciplines.   

Experience & knowledge

• Proven leadership experience (10+ years) in the biotechnology or pharmaceutical industry with demonstrated expertise in mammalian upstream process development and ideally cell line development gained through the development of protein and/or viral vector biologics.
• PhD in a relevant scientific discipline such as Biochemistry, Biochemical Engineering, Molecular Biology, Cell Biology or related field.
• Significant experience with scaling up, development of scale down models, process characterisation, process validation and transfer of manufacturing processes to GMP manufacturing.
• Strong working knowledge and interpretation of FDA/EU and ICH regulations and guidelines.

• Expertise in ‘de-novo’ establishment of platforms and mammalian upstream process development and working in partnership with downstream development and analytical teams to deliver an appropriate control strategy for the associated product.

• Proven leader, who has experience of operational and strategic leadership & development of teams.
• Will have an entrepreneurial attitude and able to work in a fast paced and agile environment, self-motivated with a high level of attention to detail.
• Proven communication & interpersonal skills with experience managing and presenting complex scientific data.
• Excellent general problem solving and project management skills, with a proven ability to oversee operational aspects
• Excellent written and verbal communication skills
• Strong collaborative and team-oriented mindset

KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF

People with Purpose – We are innovative and creative in the way we work and deliver. We treat each other with respect and dignity and work collaboratively to learn from each other’s strengths.

Driven to Deliver – We strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.

Agile and Accountable – We respond to challenges impacting our progress and find creative and innovative solutions to overcome obstacles. We are brave and not afraid to change our approach to achieve a positive outcome in optimum time.

Candid and Constructive – We communicate with honesty and transparency throughout the team.  We value giving and receiving constructive feedback to each other and our partners.