Manufacturing Technical Transfer Specialist

Biocomposites; Keele; On-site; GBP 40,000 - 70,000; Full time

Job description

Job Description

Biocomposites, Ltd. is an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue. Based in Keele in Staffordshire, UK, it has global operations across Europe, USA, Canada, Argentina, China and India, and helps more than 1 million patients worldwide every year!

We are distinct in that our team of specialists is singularly focused on the development of innovative calcium compounds and all research, manufacture and distribution takes place at our headquarters in Keele, England. In 2022, Her Majesty the Queen honoured us with two Queen’s Awards for Enterprise in Innovation and International Trade in recognition of the impact of STIMULAN in infection cases and our outstanding continuous growth in overseas sales of more than 200% over six years. Biocomposites products are now used in over 120,000 procedures every year and sold in more than 40 countries around the world.

The Technical Transfer Specialist will be responsible for facilitating the successful transfer of technologies, processes, and products between different stages of the product lifecycle. This includes ensuring seamless handover from research and development (R&D) to manufacturing or scaling production processes while ensuring compliance with industry regulations. The role involves close collaboration with cross-functional teams to ensure that all necessary documentation, training, and validation activities are completed.

Responsibilities:

1. Manage the transfer of intellectual property, design specifications, manufacturing processes, products, and technologies from R&D to manufacturing and between facilities or departments.
2. Plan and manage internal projects involving intellectual property, design specifications modifications, upgrades, technology transfer of manufacturing processes within the organisation.
3. Collaborate with R&D, quality assurance, manufacturing, and regulatory teams to ensure successful technical transfers.
4. Ensure that product development and manufacturing processes meet regulatory and quality standards.
5. Coordinate and support process development, scale-up activities, and troubleshooting.
6. Lead and participate in process design reviews, risk assessments, and process validation activities.
7. Develop, review, and approve technical documents, including protocols, reports, and standard operating procedures (SOPs).
8. Provide training to manufacturing staff on new technologies and processes.
9. Track and report progress, timelines, and any issues related to technical transfer projects.
10. Troubleshoot technical issues during the transition and ensure solutions are implemented to meet production goals.
11. Work with regulatory teams to ensure all required filings and approvals are obtained.
12. Ensure that all process data, documentation, and reporting are maintained according to company standards.
13. Occasional travel may be required to various sites, vendors or partner organisations.

Person Specification:

1. Level 6 in Engineering, Chemistry, Biotech, Pharmaceutical Sciences, or related field.
2. 5 years of experience in technical transfer, process development, or manufacturing operations.
3. Familiarity with industry-specific regulations ISO13485 and GMP.
4. Strong problem-solving and troubleshooting skills.
5. Excellent communication and project management skills.
6. Ability to work in cross-functional teams and manage multiple projects simultaneously.
7. Experience with process scale-up, validation, and optimization techniques.
8. Attention to detail and strong organizational skills.
9. Familiarity with risk management and quality assurance processes.
10. Project management certification desirable.

What do we offer?

Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.

We grow talent. At Biocomposites we create opportunities to thrive and grow.

One Biocomposites - team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.

Who do we look for?

People Who Are Passionate About What We Do.

People who are open minded to evolving the way we work.

People who can work together to transform outcomes and change lives.

Benefits:

1. Company events
2. Company pension
3. Employee discount
4. Free or subsidised travel
5. Free parking