Essential Pharma is a global pharmaceutical company working to make a difference for patients in niche populations. Everything at Essential Pharma is driven by the fact that every patient matters. We are focused on developing and delivering medicines for patients in small, underserved or rare disease populations. Our team of 100+ people has an entrepreneurial spirit, challenging convention and working creatively to deliver results. Our headquarters are in Surrey, UK, and we have offices in Malta, France, Spain and Switzerland. We are an international business, with a growing product portfolio that reaches patients in approximately 70 countries. We cover multiple therapy areas with a particular focus on rare disease, CNS, ophthalmology and gastroenterology. Our first development-stage asset is an anti-GD2 antibody for the treatment of high-risk neuroblastoma. We have a proven track record of acquiring, investing in and commercialising treatments.
About the Role
The Principal Scientist will apply strong scientific, technical and project management expertise to enhance the value of the EP product portfolio across its lifecycle. Working closely with CMO partners and cross functional teams, they will help ensure product quality, operational efficiency and continuity of supply to patients. If you are keen to join a patient centric, high-growth company, then read on and apply today!
Job Responsibilities
Tech Transfer and oversight
- Lead complex site to site transfers of manufacturing, analytical and packaging processes, providing technical guidance and engaging key stakeholders for successful outcomes.
- Apply risk-based problem solving to technical, scientific, compliance and Quality issues, working with peers across CMOs and CROs and escalating as needed.
- Manage technical documentation and Quality records, including MBRs, PQRs, validation protocols, risk assessments, stability data, Change Controls and deviations, to maintain compliance.
- Ensure clear communication and visibility across the program lifecycle aligned to functional priorities and business goals, supporting project kick offs and handovers.
Technical Portfolio Management and Product Maintenance
- Support product and process improvements across CMO sites, , recommending transfers or consolidations to keep the CDMO network aligned.
- Conduct technical due diligence on M&A target medicines, assessing manufacturing complexity, raw material risks, transfer timelines and value opportunities, and presenting findings to support decision making.
- Provides CMC technical expertise for registrations, and advise on batch failures, variations and recalls, escalating complex issues as needed.
- Advise procurement and finance on CAPEX and CoGs with CMOs, escalating complex evaluations as needed.
Project leadership and management
- Contribute to the development of project initial value blueprints, and track key drivers through the project lifecycle and ensuring timely handover of the business model.
- Project manage end to end, defining scope, timelines and cross functional coordination.
- Establish governance through KPIs, risk registers and cost tracking.
- Coach and influence stakeholders to drive best practice and project outcomes.
External operational partnership management
- Supports selection and evaluation of new CMO suppliers, contributing relevant financial and COGS insight and escalating recommendations as needed.
- Builds CMO partner relationships and define governance, KPIs and milestones and payment points aligned with technical delivery.
- Provide operational oversight, measuring and reporting performance.
- Act as the primary point of contact for operational project activities between EP and CMO partners.
What You Will Bring
Qualifications
- Life Sciences degree in Pharmacy, Pharmaceutical Sciences or Chemistry,
- Desirable: Project management certification Prince2, PMP or other.
Experience
- Strong demonstratable experience in personally performing site to site tech transfers including wide exposure to pharmaceutical manufacturing, QC testing and packaging including serialization.
- Strong experience across small molecule formats including sterile products, capsules, creams, gels, ointments and solid dose
- Proven track record of successful project leadership and execution including successful site Tech Transfers.
- Global exposure to manufacturing, registering and distributing pharmaceuticals.
- Strong experience of Quality Management Systems, including Change Control and Deviation management, leading Investigations, document creation, review and approval.
- Demonstrable experience of successfully implementing and leading continuous improvement projects and deployment of lean management practices.
- Experience of operational budget management including forecasting and monitoring and analysis, ensuring strategic alignment by tracking spend and managing risks.
- Demonstrable experience of successfully establishing and utilizing Technical Project Management tools and templates including timelines, trackers, Gap Analysis, risk registers, managing cross functional team meetings, charters and lessons learned.
- Demonstratable experience of managing financial/COGS implications when selecting CMOs.
Core Competencies
- Operates with a degree of autonomy, making decisions independently and taking ownership of outcomes with minimal oversight.
- Possesses strong technical knowledge, applying subject matter expertise to guide decisions.
- Strong Agile thinker who can adapt to situations of high-speed change.
- Problem solver who can work through complex issues and assimilate data from a wide range of scientific areas.
- Employee must demonstrate a Growth mindset and willingness to learn.
- Employee must demonstrate integrity and high ethical standards.
- Employee must have a dynamic and positive outlook.Actively demonstrating effective working as part of team with strong collaboration.
- Demonstrates a willingness to achieve goals together and respect the view of others.
- Results orientated and accountable for actions.
- Excellent organisational and time management skills with a keen eye to detail.
- Excellent communication skills, both written and spoken.
- An established technical leader, freely provides feedback and positively influences business outcomes across borders and boundaries.
- Is developing strategic thinking in successfully delivering outcomes.
What We Offer
- Discretionary annual performance bonus
- We understand that productivity requires balance, so we offer office-based contracts and allow flexibility on locations of work when required and appropriate. This can be different for each department so please have that conversation at interview
- Pension – you contribute 5% and we offer 5%
- Life Insurance – lump sum (tax free) death benefit of 4 x basic salary
- Enhanced family leave
- 25 days annual leave
What To Expect
At Essential Pharma, every colleague matters: we want every member of the team to thrive and grow during their time with us. Right from the interview stage, we encourage candidates to ask us questions, voice opinions and be curious. This is a dynamic, fast-paced working environment. We expect individuals to be responsible and accountable, while understanding the importance of collaborating with colleagues to fuel success. We pride ourselves on our inclusive culture, based on the belief that everyone brings unique strengths and perspectives. We have an unwavering dedication to employee growth and development
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