Technical Support Manager

Technical Support Manager

Job Descriptions:

• Oversee technology transfer and scale-up activities from development to commercial manufacturing, ensuring process consistency, product quality, and compliance with Good Manufacturing Practices (GMP).
• Lead formulation trials for product diversification, reformulation, raw material source changes, equipment changes, and batch size adjustments to ensure product quality and process reliability.
• Supervise the development, evaluation, validation, and transfer of analytical methods, including dissolution testing and cleaning validation, to ensure compliance with approved specifications and regulatory requirements.
• Oversee accelerated and real-time stability studies, establish and review raw material and finished product specifications, and ensure the availability of technical data to support product registration, renewal, and variation submissions.
• Review and approve technical documentation, including trial reports, analytical results, master batch manufacturing and packaging records, standard operating procedures, validation reports, and product development documents, ensuring accuracy and compliance with GMP requirements.
• Manage Technical Support laboratory and formulation trial facility operations, including equipment qualification and calibration, personnel training, performance evaluation, workplace safety, hygiene, and resource allocation.
• Collaborate with Quality Assurance, Quality Control, Regulatory Affairs, Production, R&D, Business Development, Packaging Development, and Purchasing to support product development and commercialization. Manage departmental budgets, performance reports, continuous improvement initiatives, and technical support for regulatory inspections.

Job Qualifications:

• Bachelor's degree in Pharmacy with a professional Pharmacist qualification (Apoteker).
• Minimum of 5 years of practical experience in pharmaceutical Research and Development, preferably in formulation development, technical support, analytical development, or pharmaceutical manufacturing.
• Strong knowledge of pharmaceutical formulation development, reformulation, product diversification, scale-up and scale-down processes, technology transfer, and commercial manufacturing trials.
• Extensive knowledge of analytical method development, method validation and transfer, dissolution testing, comparative dissolution testing, cleaning validation, and pharmaceutical stability studies.
• Good understanding of GMP (CPOB), pharmaceutical manufacturing processes, quality assurance principles, regulatory documentation, product specifications, and applicable pharmaceutical regulatory requirements.
• Familiarity with laboratory and pharmaceutical production equipment, equipment qualification and calibration, technical report preparation, validation documentation, and standard operating procedures. Proficiency in written and spoken English.
• Strong leadership, people management, analytical thinking, problem-solving, planning, budgeting, and cross-functional coordination skills, with the ability to manage multiple technical projects and ensure timely delivery of departmental objectives.

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