Project Manager

Profile

The CMC Project Manager will work closely with the Head of Pharmaceutical Development and Director of Regulatory Affairs to develop and execute the pharmaceutical development strategy for all pipeline products. This individual will have responsibility for day–to–day management of CMC activities for Therakind, including identification of drug substance manufacturers, drug product formulation development, drug product manufacture, clinical trials supply chain management and authoring the CMC sections of regulatory submissions.
The successful candidate will be a CMC subject matter expert with a strong understanding of the drug development and commercialisation process including the need to work as part of a multidisciplinary team. This position will involve management of multiple Contract Development and Manufacturing Organisations (CDMOs), contract laboratories and academic organisations. As a key team member, this individual will ensure strong technical oversight of outsourced CMC activities as well as working seamlessly with the clinical project team, product logistics team, quality team and Responsible Person for GDP, as well as key external parties including development partners.
The position reports to the Head of Pharmaceutical Development.
*Essential Duties & Responsibilities:*
* Collaborate in design of product development plans, providing expert input on analytical development, formulation development and manufacturing (including cGMP) for a portfolio of projects.
* Develop CMC plans with particular focus on drug substance procurement, drug product contract development and contract manufacturing. Facilitate cross–functional planning of CMC activities across different functions to align with project needs.
* Execute CMC activities across a portfolio of products. Develop goals, associated timelines and budgets as well as anticipating risks (technical, business, regulatory) and recommending mitigation strategies.
* Identify, select and manage CDMOs performing formulation development, analytical development, process development and optimisation, cGMP manufacturing, and supply of drug product in support of ongoing non–clinical and clinical activities.
* Provide technical expertise, and specialised knowledge in formulation development, analytical development and process development to support new drug products.
* Provide strong technical leadership and strategy development for process optimisation to support clinical manufacturing, scale–up, technology transfer, validation and regulatory filings.
* Oversight of CDMOs producing drug product for clinical trials. Ensure manufacturing and testing activities follow cGMP, regulatory requirements and project needs.
* Review documentation produced by CDMOs such as protocols, final development reports, batch documentation, and other technical reports to support product development and regulatory filings.
* As necessary, assist with writing of product development documentation, technical reports, protocols, specifications, summary of technical data or other development reports as needed.
* Prepare/review drug substance and drug product documents for regulatory filings including scientific advice, clinical trial applications, marketing authorisation applications, amendments and annual reports.
*Requirements:*
* BSc with 8–10 years or higher degree with 5 years' experience in Pharmaceutical R&D or Technical Operations environment.
* Successful track record in pharmaceutical development of small molecules, including scale–up and commercial manufacture and oversight of activities leading to regulatory filings.
* Experience in development of large molecules will be an advantage.
* Experience in managing CROs/CDMOs for the manufacture of cGMP API and DP.
* Experience with CTA, MAA, IND and NDA filings and thorough knowledge of relevant EMA and FDA regulations.
* Outstanding interpersonal skills and excellent oral and written communication skills
* Exceptional organisational skills. Detail oriented. Proven ability to excel in a matrix environment.
* Strong track record of appreciating the details without losing sight of the larger goals. Ability to multi–task and handle multiple projects simultaneously.
* Proven ability to effectively participate on multi–disciplinary project teams
* Strong initiative and ability to work in a fast paced, team–oriented dynamic environment
* Experience in supply chain management would be a plus.
* Entitlement to work in UK.
This will be a permanent position, based out of the North London office with some potential for homeworking.
Location: London
Start date: Immediate
Salary: Competitive
*Please send CV and cover letter to *

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