Overview

Reference Number: JO-2008-453276
CMC Director – Regulatory Affairs
Rate: Negotiable
Job Type: Permanent
Location: Oxford

Role: CMC Director (Regulatory Affairs)
Location: Oxford
Salary: highly competitive + benefits
Employment: full time, permanent

Regulatory Professionals are collaborating with a biopharmaceutical company who identify and develop new mechanism antibiotics for the treatment of serious infections. Our client is looking for an experienced Director of CMC Product Development. You will have proven leadership experience (10+ years) in the biotechnology or pharmaceutical industry with demonstrated expertise of formulation development and drug product manufacturing for small molecules in a wide range of dosage forms (oral solid, solution, suspensions, sterile etc.)

Other duties will include:

Delivery and execution of the drug product formulation strategy across the drug product life cycle and with emphasis in late development stages, registration and validation
Fully accountable for all product development activities aspects related to the dosage form whilst working in partnership with external (CDMOs) and internal (chemistry and analytical SMEs etc.) stakeholders
Builds product development and supply capabilities utilising science-driven, phase-appropriate, and risk-based development activities and support the delivery of appropriate control strategies for the associated products.
Manages third-party partnership (CDMOs) and collaborations for drug product development cultivating strong working relationships and a commitment to quality.
Identifies and recommends the best contract development and manufacturing partner for each project.
Serves as a subject matter expert and author and/or reviewer for relevant sections of CMC documentation in support of CTA/INDs, IMPDs and e-CTD submissions as well as regulatory amendments, and scientific briefing documents.
Studies data and provides scientific explanations and insight for project work
Ensures that the projects are being run on-budget according to agreed timelines and that ap-propriate robust decisions are made at each stage of the project.
Collaborates cross-functionally on the broader technical development strategy and leadership decisions with the wider CMC group and, where necessary, the Summit Project Team.
Supports the strategic decisions made in consultation with the SVP CMC and Supply Chain and other key senior leaders to advance Summit drug product manufacturing and pipeline projects.
Presents regularly to the internal senior leadership team and provides timely provision of data and documentation reports to support intellectual property filings and regulatory submissions

Requirements:
Right to work in the UK
PhD in a relevant scientific discipline or equivalent hands on experience
Proven leadership experience (10+ years) in the biotechnology or pharmaceutical industry with demonstrated expertise of formulation development and drug product manufacturing for small molecules in a wide range of dosage forms (oral solid, solution, suspensions, sterile etc.).
Proven experience in working in an outsourcing business model and success in development drug products via leading CDMO relationships
Experience in pharmaceutical drug product formulation, pre-formulation and process devel-opment
Experience in pharmaceutical development concepts as outlined in ICH Q8 (R2) as well as other applicable ICH and regulatory guidelines
Significant experience with scaling up, process characterisation, process validation and transfer of manufacturing processes to GMP manufacturing sites.
Will have an entrepreneurial and collaborative attitude and be self-motivated with a high level of attention to detail.
Possesses excellent communication & interpersonal skills with experience of managing and presenting complex scientific data.

If you would like to apply for this position, please contact Amani via amani@regulatoryprofessionals.com.

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