Artios Pharma is currently recruiting a Head of Pharmaceutical Development to join our expanding team. This is an excellent opportunity to join a world class research team in a dynamic, expanding biotech company based south of Cambridge, UK. Artios is focused on identifying and developing cancer treatments by exploiting novel targets within the DNA damage response (DDR), a scientific area of high expectation following the success of PARP inhibitors in the clinic.
The company is actively working on an exciting portfolio of unique DNA repair projects. We currently have two programmes in early phases of clinical development. These phase 1/2a studies are evaluating the small-molecule ATR inhibitor ART0380 and the first-in-class Pol -Theta inhibitor ART4215 in patients with advanced or metastatic solid tumours.
Outline of the role
The Head of Pharmaceutical Development (HPD) will be responsible for activities relating to Drug Product formulation/process development and cGMP production across the portfolio of Artios development compounds, supporting projects from pre-clinical and clinical stages. The HPD should have hands-on experience in the field and a track record of developing new formulations and processes in support of clinical production of oral dosage forms, including a firm grasp of biopharmaceutics. Experience of Quality by Design as applied to Drug Product formulation and processing understand would also be advantageous. The candidate also must have experience in working in a GMP environment, and demonstrate the accompanying attention to detail to ensure products are being produced right first time in accordance with current quality and regulatory manner. Strong communication and project management skills are essential alongside the technical and quality knowledge with demonstrated experience of managing multiple internal and external international partners is essential. Experience in authoring Module 3 sections of Clinical Trial Dossiers/IMPD would be also be ideal.
The HPD will have the responsibility for the day-to-day scientific and quality management of CDMOs involved in the formulation development and production of drug product, working closely with colleagues responsible for Drug Substance and Clinical Trial Supplies packaging, labelling and distribution to ensure supply chain management
Responsibilities
- Direction, management and coordination of formulation and cGMP Drug Product manufacture activities to ensure the on-time delivery of clinical supplies.
- Primary person responsible for the management and co-ordination of external formulation and GMP Drug Product CDMOs working with external consultants (where required) as well as internal colleagues key to the success of the delivery of these products e.g. Drug Substance, analytical chemistry leads.
- Communication of project requirements to external vendors and management of those vendors to the required deliverables and ensuring the financial parameters of contracts are upheld
- Ensure production activities are conducted in compliance with Good Manufacturing Practices (GMP) and in accordance with the Quality Technical Agreement , QP agreements and relevant standard operating procedures (SOPs), and regulatory requirements.
- On-site visits to CDMOs as “person-in-plant” to oversee key activities in the production of technical and clinical batches, and ensure there is in-house knowledge of these processes. Part of audit team for Drug Product CDMO supplier selection and compliance.
- Identification and contractual set-up of new formulation and GMP Drug Product CDMOs in accordance with Supplier Selection processes, working closely with QA Team. Contributes to and reviews Quality Technical Agreements to be put in place with these CDMOs.
- Author and/or review Drug Product Sections of IMPDs and Module 3 Sections of CTDs associated with INDs and CTAs. Identify and highlight significant changes ahead of these being implemented.
- Work with and advise research and pre-clinical colleagues on biopharmaceutics and assist in identifying and developing suitable formulation for use in pre-clinical efficacy and toxicology studies.
- Work with Drug Substance colleagues to ensure APIs are adequately characterised and specifications reflect the needs on the formulations being developed and the Drug Product Manufacturing processes.
- Actively involved in change control processes especially in relation to changes in formulations and manufacturing processes and wider impact of these with respect to potential efficacy/safety (pharmacokinetic), regulatory and quality implications.
- Working closely as key member of CMC Team together with Drug Substance, Analytical and IMP Supplies colleagues as well as part of cross-functional team for study management activities. Attending relevant project development team meetings as appropriate.
- Reviewing, checking and approving CDMO vendor documentation such as formulation development protocols and reports, Master Batch Manufacturing as well as, change controls, deviations and executed batch records.
- Working closely with QA, CMC colleagues and, where appropriate, external QPs to ensure internal and external processes in accordance with QMS are followed for the release and intermediate certification of Bulk Drug Product.
- Ensure the contemporaneous management and filing of development protocols, reports and batch documentation to Artios document management system including the Product Specification File and shared external vendor document sharing sites to ensure requirement of Quality Technical Agreement are being met.
- Developing contingency planning and risk mitigation strategies to ensure successful provision of all required clinical trial supplies.
- Responsible for the creation and management of project related budgets in the areas responsible for, review and negotiation of CDMO work orders and invoice approval.
- Works with Project Co-ordinator to ensure the controlled management of material shipments of drug substance and bulk drug product, especially in relation to GxP shipments.
- Supports technical Due Diligence when requested in field of expertise
- Staying up to date with relevant cGMPs, GCPs, and other regulatory requirements/guidance and ensuring study management activities are appropriately aligned.
- Actively contributing towards the development and implementation of process improvement.
Qualifications and Experience
- Bachelor, Masters or PhD degree in Pharmacy or Pharmaceutical Science related subject
- Considerable experience in pharma, biotech or CDMO in formulation development and clinical trial production roles
- Detailed technical knowledge and experience of biopharmaceutics, oral formulation and process development (tablets, capsules, etc), including the technologies to aid in drug delivery of low solubility Drug Substances e.g. micronisation, nanomilling, amorphous solid dispersions, Hot-melt extrusion, self-emulsifying emulsion drug delivery systems, etc.
- Demonstrated current knowledge of cGMP and working in a pharmaceutical Quality Management System.
- High degree of attention to detail and accuracy
- Demonstrated experience in successfully managing projects in a proactive manner
- Demonstrated experience with multiple development projects
- Proven track record of managing external vendors to ensure optimal delivery to time, cost and quality
- Strong technical project management skills, with experience of working with project management tools e.g. MS Project, Smartsheet
- Strong interpersonal skills and experienced in presenting to senior management
- Good computing skills in MS Office suite software
- Strong team player with good motivational skills, and ability to work independently
- Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external service providers and consultants
- Ability to handle complex information
This is a permanent position, offering an attractive salary & benefits package. If you have the right background, then please apply by uploading your CV with a covering letter quoting Ref 4268.
Please apply using the link below and ensure that you click ‘upload’ before you finish your application.
https://hr.breathehr.com/v/head-of-pharmaceutical-development-28554
In order to comply with UK Employment Law, all applicants must have the Right to Work in the UK or if from the EU, subject to receiving a relevant Skilled Worker Visa to work in the UK.
Due to the high volume of applications we receive, if you do not hear from us we will not be inviting you to interview on this occasion.
No agencies, thank you.