Technical Transfer Manager - KSA

دوام كامل في Aspen Holdings في Saudi Arabia

نُشرت يوم November 10, 2024

تفاصيل الوظيفة

ROLE PURPOSE: The Technical Transfer Manager is responsible for leading the successful transfer of pharmaceutical processes, technologies, and products from R&D or external partners to manufacturing. This role ensures seamless communication between stakeholders, adherence to regulatory requirements, and the execution of manufacturing processes while maintaining product quality and timelines. The ideal candidate will have a strong technical background, proven leadership skills, and extensive experience in pharmaceutical manufacturing and process development. RESPONSIBILITIES:

Technical Transfer Leadership: Oversee the end-to-end process of transferring technologies and products from R&D, third parties, or other sites to manufacturing. Manage and coordinate cross-functional teams, including R&D, quality, engineering, and regulatory, to ensure smooth technical transfer processes. Ensure compliance with all GMP (Good Manufacturing Practices) and regulatory standards during the transfer process.
Process Development & Optimization: Lead process design and optimization efforts to ensure efficient and scalable manufacturing processes. Work closely with manufacturing teams to troubleshoot any issues related to process transfers and ensure product quality and process efficiency. Develop process validation protocols and execute validation plans to meet regulatory and company standards.
Documentation & Reporting: Prepare and review technical documents, including protocols, reports, batch records, and change controls related to technical transfers. Ensure all technical transfer activities are fully documented, and knowledge transfer is accurately captured.
Regulatory Compliance & Quality Assurance: Ensure all technical transfer activities comply with FDA, EMA, and other global regulatory requirements. Work closely with the quality team to ensure adherence to internal and external quality standards and support regulatory filings when necessary. Address any regulatory queries or issues related to process transfers.
Continuous Improvement: Drive continuous improvement initiatives in technical transfer processes to enhance efficiency, reduce costs, and improve product quality. Stay current on industry trends and advancements in technology transfer methodologies.

Level of Education required:

Bachelor’s degree - In Chemical/Biochemical Engineering, Pharmaceutical Science, Pharmacy, Chemistry/Biology, or other related science or engineering field.
Master’s Degree - Preferred

Years of experience required:

5 years total,
3 years in a technical transfer or related role,
Experience working in the Saudi market.

Field of Experience:

Proven track record in leading technology transfers in a cGMP manufacturing environment.
Experience with process development, scale-up, and validation in pharmaceutical or biotech manufacturing.

Technical Skills:

Strong technical understanding of pharmaceutical manufacturing processes, equipment, and technologies.
Excellent written and verbal communication skills, with the ability to work cross-functionally and interact with various stakeholders.
Problem-solving mindset with strong attention to detail.

Professional Knowledge and Key Competencies:

In-depth knowledge of regulatory requirements (FDA, EMA, ICH guidelines) and cGMP standards.
Must-Have Drug Product Technical Transfer Experience for this role (minimum 5 Years preferred).
Proven expertise in finished product manufacturing, analytical testing, process development and tech transfer.
Demonstrated ability to manage projects/work to schedule/deadlines independently.
Mathematics/Statistics experience (including Process Analysis and Continuous Process Verification).
Experience in QMS activities - deviation management, CAPA and change control.
Strong communication skills in English and Arabic (preferred)

Aspen Competencies: BUSINESS

Foster Consumer & Customer Commitment
Makes Good Decision

PEOPLE

Communicate Effectively
Dealing with ambiguity/Embrace change

SELF

Continuously Grow & Develop
Contribute Special Expertise

Key Attributes:

Market Knowledge
Consumer relevancy
Problem-solving
Information seeking
Flexibility and tolerance for ambiguity
Capacity for and resistance to stress
Active listening
Informal communication skills
Technical /Professional skills
Industry knowledge
Curiosity/learning agility

Work Level: Management Job Type: Permanent Salary: Market Related EE Position: No Location: Riyadh #J-18808-Ljbffr

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