Process Development Manager

Hyper Recruitment Solutions; Greater Lincolnshire; On-site; GBP 70,000 - 110,000; Full time

Job summary

Hyper Recruitment Solutions Ltd is seeking a Process Development Manager to lead the transfer of complex development processes into GMP manufacturing within the MSAT framework, supporting risk assessment and documentation.

You will provide hands-on technical leadership across GMP operations, bioengineering, QA, QC and R&D, ensuring regulatory compliance, data integrity, and successful project delivery with cross-functional collaboration and focus on continuous improvement.

Qualifications

• Degree in a relevant scientific or engineering field.
• Proven experience transferring bioprocessing to GMP manufacturing.
• Strong knowledge of GMP, Data Integrity and process validation.

Responsibilities

• Provide high-level technical leadership for transferring complex processes into GMP manufacturing.
• Act as the primary technical contact for technology transfers and liaise with internal/external partners.
• Coordinate cross-functional activities across GMP operations, QA, QC, procurement and R&D.
• Lead investigations into deviations, CAPA and impact assessments in line with PQS and regulatory requirements.
• Develop, review and approve process descriptions, SOPs, risk assessments and batch records.

Skills

Process development

Biopharmaceutical manufacturing

Regulatory compliance

Education

Bachelor's degree in Bioprocess Engineering or related

Job description

Role Overview

We are currently looking for a Process Development Manager to join a leading biopharmaceutical manufacturing organisation within their Manufacturing, Science and Technology / MSAT team. This exciting opportunity is based internally and offers a pivotal role in supporting the transfer of development processes into GMP manufacturing. The successful candidate will act as a technical expert, leading complex projects, collaborating across departments, and ensuring seamless, compliant technology transfers that meet regulatory standards and customer expectations. This role provides an excellent platform for experienced professionals looking to make an impact in innovative bioprocessing environments.

This position is ideal for a hands-on leader with proven expertise in biopharmaceutical manufacturing, process development, and GMP compliance. You'll be working in a dynamic environment that values continuous improvement, technical excellence, and strategic thinking, with the opportunity to influence future projects and support the growth of our client’s state-of-the-art manufacturing capabilities.

Key Duties And Responsibilities

• Provide high-level technical leadership for the transfer of complex development processes into GMP manufacturing, ensuring regulatory compliance and operational excellence.
• Act as the primary technical point of contact for technology transfers, liaising with internal teams and external partners or clients to facilitate seamless project delivery.
• Manage and coordinate cross-functional activities across GMP operations, bioengineering, QA, QC, procurement, and R&D to support successful process transfer and continuous improvement initiatives.
• Lead investigation into process deviations, impact assessments, and CAPA activities, ensuring alignment with the Pharmaceutical Quality System and regulatory requirements.
• As the Process Development Manager, you will develop, review, and approve key documentation including process descriptions, SOPs, risk assessments, and batch records.

Role Requirements

• A Degree or higher level in a relevant scientific or engineering field (e.g., Bioprocess Engineering / Pharmaceutical Science / Chemical Engineering).
• Proven experience in transferring bioprocessing techniques into GMP manufacturing, with a strong understanding of USP, DSP, and analytical testing related to biopharmaceuticals.
• Extensive knowledge of GMP regulations, Data Integrity principles, and process validation within a regulated manufacturing environment.

WHAT’S IN IT FOR YOU?

Joining our client means becoming part of a forward-thinking organisation dedicated to innovation and excellence in biopharmaceutical development. You will have the opportunity to lead impactful projects, work with cutting-edge technology, and further develop your leadership skills within a supportive environment that values your expertise.

Key Words: biopharmaceuticals / GMP / process transfer / regulatory compliance / TEC transfer management / data integrity / bioengineering / project leadership / process validation / continuous improvement / RNA manufacturing

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career