Therakind Limited
CMC Lead
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CMC Lead
Therakind is a private pharmaceutical company based in London. We are a small team with a mission to identify unmet needs for off-patent products for specific populations such as children and the elderly. We develop new formulations or routes of delivery of existing medicines to create novel products, collaborating in partner or co-development projects with other biotech and pharma companies.
We believe in finding the right therapeutic solution for patients, that’s why our products are designed specifically to take into account patients’ needs.
Job Description
The CMC Lead will work closely with the CEO and COO to 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.
The successful candidate will have CMC and specifically dry powder formulation experience and 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 key external parties including development partners.
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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.
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Requirements:
- MSc 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.
- Exceptional organisational skills. Detail oriented. Proven ability to excel in a matrix environment.
- Experience of LNPs and mRNA would be an advantage.
- Ability to multi-task and handle multiple projects simultaneously and to appreciate the details without losing sight of the larger goals.
- Proven ability to effectively participate on multi-disciplinary project teams.
- Strong initiative and ability to work in a fast paced, team-oriented dynamic environment.
- Entitlement to work in UK.
This will be a permanent full or part-time position, based out of the North London office.
Location: London
Start date: Immediate
Salary: Competitive
Please send a CV and cover letter to vacancies@therakind.com
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