MS&T Director (Tech Transfer Director)

Website Porton

 

With over 3,000 customer-centric employees, operations and commercial offices across the US, EU and China, Porton Pharma Solutions provides global pharmaceutical companies with innovative, reliable and end-to-end process R&D and manufacturing services across small molecule APIs, dosage forms and biologics.

Our Process Technology Centers and USFDA/EMA/PDMA/NMPA/WHO-inspected Manufacturing Facilities feature state-of-the-art equipment, highly flexible cGMP-compliant production assets, plus over 700 highly skilled scientists and process engineers, all backed by a proven program management system dedicated to seamlessly delivering successful outcomes for your unique project requirements.

We are committed to be the most open, innovative and reliable pharmaceutical service platform in the world and Enabling public’s early access to good medicines. We constantly strive for excellence, and have been recognized through awards by industry forums and global pharmaceutical companies for our process innovation, supply chain performance and compliance with global Quality and EHS standards. By efficiently advancing development and enabling commercialization of multiple high-impact medicines, Porton is proud to have earned the trust of some of the world’s leading and most innovative pharmaceutical companies and many biotechnology companies across the US, EU and Asia.

Contact Us:
www.porton.cn
www.portonbio.com
API CDMO:porton@porton.cn
Drug Product CDMO:DDS.inquiry@porton.cn
Gene&Cell Therapy CDMO:BD.SZ@portonbio.com

 

MS&T Director (Tech Transfer Director)

Job Type: Full-time

Location: Chongqing, CN

 

Responsibilities

  • Provides direct coaching, mentoring and development to each member of the team both in execution of responsibilities and in personal development.
  • Leading tech transfer from internal or external process development. Develop and translate process knowledge and understanding into manufacturing controls strategy (product, process, materials, environment etc.) to ensure successful tech transfer and manufacturing, resolve complex process/product issues.
  • In support of setting up manufacturing strategies and trouble shootings for clinical manufacturing and commercial manufacturing. Technical support & training on the shop floor.
  • Characterize manufacturing process by using State of Art technology such as scale down models to support product registration and life cycle management.
  • Translate GMP manufacturing expertise into risk assessment based decisions for process design and operations, to improve the probability of success, time and cost.
  • Ensure high quality of technical reports, process description, manufacturing instructions, and process validation documents delivered in the team. Portions of regulatory submissions at existing and new manufacturing sites, for new pipeline products or process changes.

Requirements

  • MS/PhD in Chemistry / Pharmacy related major with at least 10+ years of API experience in process development, manufacturing and Process Validation.
  • In depth knowledge of current Good Manufacturing Practices and China/US/EU regulations. Prior experience in either design, qualification, start-up or initial Mfg. facilities preferred.
  • Strong communication, technical writing, organizational and interpersonal skills.  Demonstrates critical thinking skills in problem solving and decision making.  Attention to detail and high level of accuracy.  The capacity to inspire and motivate the team in the achievement of specific objectives, and ultimate responsibility.
  • Demonstrated ability to drive change within organizations. Motivated and able to work independently as well as in teams. Excellent organization and communication skills in Chinese and English.

 

Contact

Sami

sami.Sun@porton.cn

86-18725794296

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