Job Description
Title: Director/Senior Director, CMC
Location: Hybrid (Minimum one day per week in Cambridge, UK)
Reporting line: Vice President, CMC
The Company
Apollo therapeutics is a pioneering biopharma company headquartered in Cambridge, UK with a presence in Boston, US. Apollo are focused on developing treatments for major chronic health conditions, spanning a range of modalities and therapeutic areas, encompassing both small and large molecule assets.
Apollo’s therapeutic pipeline includes 20 programs with 6 cutting edge new therapies in the clinic. They seek to redefine the future of healthcare, improve lives and reduce the global burden of disease. Apollo are well funded having raised a total of $450m to date, and partnered with a number of significant industry and academic partners.
To discuss this opportunity in more detail, please contact the search partner for this hire, Christopher Gibson at Barrington James – cgibson@barringtonjames.com or 0044 1293 776 690.
The Role
This position presents a real, genuinely impactful challenge. An opportunity to have genuine influence and accountability for Apollo’s lead asset, a monoclonal antibody currently in Phase 2b for Atopic Dermatitis.
Ensuring Phase 3 readiness, managing the Phase 3 CMC program and leading commercial readiness for the lead asset is the primary focus of the role. That being said, as the assets earlier in the clinical development process move towards Phase III and commercialisation you will also take accountability for those.
You will be technically focussed with strong experience and knowledge of later stage Biologics CMC and be accountable for all CMC aspects of the program including development milestones from clinical POC to regulatory approval as well as program level budget accountability.
We’re looking for an individual looking to apply their CMC expertise to develop novel therapeutics within an exciting and growing organisation. The individual will need to demonstrate a good balance of strategic leadership with operational delivery, requiring adaptability and expertise in both areas.
- Define the programme CMC strategy to Phase 3 and for some assets to registration in major markets.
- Own and drive the end-to-end technical and operational delivery of Biologics programmes to Phase 3 readiness through an external CDMO, ensuring process optimisation (PO), process characterization (PC), PPQ readiness, and Phase 3 clinical supply are executed on time, and aligned with regulatory requirements while acting as the single accountable interface between Apollo and the CDMO.
- Accountability for CMC related topics in meetings with regulatory agencies.
- Act as point of accountability for responses to CMC Regulatory questions related to process understanding.
- Co-ordinate the outsourcing, management and oversight of development and GMP manufacture for the timely delivery of phase-appropriate global clinical trials supplies.
- Build and lead effective partnerships with the CROs and CDMOs.
- Ability to prepare and lead a vendor selection process.
- Maintain, refine and update the overall CMC plan for the program. Effective communication and integration of the CMC plan into wider Development plans.
- Communicate program status / risks / issues / results and the related business impact to wider project teams.
- Lead the overall CMC activities, working closely with project management colleagues to ensure delivery on time and in budget.
The Person
- > 15 years of experience within a CMC, with a minimum of 5 years’ leadership experience in biologics development and manufacturing.
- Knowledge and leadership experience for later stage Biologics PO / PC / PPQ / PV requirements. Experience of leading projects through these activities.
- Has led FMEA meetings and good understanding of potential CPPs and CQAs for Biologics manufacturing process.
- Proven track record of leading successful CMC teams in the biologics industry, with expertise in navigating regulatory filings and submissions (IND, BLA, etc.).
- Extensive knowledge and experience in biologics process development, scale-up, and manufacturing, incorporating both drug substance and drug product.
To discuss this opportunity further, please contact Christopher Gibson at Barrington James on cgibson@barringtonjames.com or 0044 1293 776 690