Job Description
Pharmaceutical Technical Transfer Specialist - Solid Dose
Salary: Competitive plus benefits
My client, a renowned player in the pharmaceutical industry, is seeking a skilled Technical Transfer Specialist to contribute to their Technical Services team. This role demands a strong technical background within solid dose scale-up and a proven ability to support new product commercialization and optimization projects.
This is an excellent opportunity to join a dynamic company and make a significant impact on product development and manufacturing.
Key Responsibilities:
* Execution of product commercialization projects for the site using product lifecycle approach, preparation and approval of GMP documentation to support such projects, scheduling, raw material acquisition, supervising engineering batch manufacture, etc.
* Identifying potential process improvements for existing commercial products including proposals for formulation/process optimization. Then support implementation of changes after management approval.
* Provide technical support to all departments to solve problems as they occur.
* Assist in new equipment evaluation by interfacing with the Engineering group.
* Assist in activities for successful transfer of new equipment to production, including training of both supervisors and operators.
* Assist in the evaluation and qualifying alternate sources of raw materials and commodities.
* Using the Product lifecycle approach and statistics, take project leadership for the technical activities involved in the commercialization of internal products during Product Development, Registration, Optimization, Validation/Launch of drug products.
* Assist in the Technical assessment of products/projects (development and commercialized products for optimization/site transfer).
* Assist in implementing the product life cycle program for the site to ensure compliance with commercialization standards and compliance with current Global Regulatory expectations.
* Proactively identify and troubleshoot formulation and process type issues of products manufactured internally to improve product quality and minimize product supply interruptions.
About You
To apply for this role you should demonstrate:
* The ability to design, develop and implement effective technical transfer and product lifecycle strategies for solid dosage forms manufactured by the site.
* A firm working knowledge of manufacturing platforms and pharmaceutical facility infrastructure.
* Strong technical knowledge, problem-solving skills, and understanding of process validation.
* Understanding of the dosage form development process, along with some knowledge of process development techniques, cGMP regulations, FDA and EMA regulations, and recent trends in product lifecycle concepts.
* Proven ability to manage multiple projects and prioritize tasks.
If you're interested in the above role then please click apply or get in touch to discuss further.
Consult will endeavor to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.
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