Process Development Manager

Process Development Manager

Galway, Ireland | Permanent full-time role

HiTech Health is a Contract Development and Manufacturing Organisation (CDMO) for advanced medicines including cell and gene therapies as well as aseptic products. The company was established in 2013 in Dublin, Ireland, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports healthcare companies globally from the development to the launch and supply of products.

At HTH we care deeply about our clients and their patients, about the success of our business and every individual on the team. We have an opportunity for a highly motivated leader to join our growing organisation and to lead our process development team. Our development laboratories and GMP manufacturing facility focus on cell and gene therapies as well as aseptic (sterile) products. We offer an exciting role, responsible for supporting a diverse range of clients, in this field, by providing cost effective clinical and commercial products for their patients, while leading projects within a multi-disciplinary team environment.

Responsibilities:

• Lead a technical team who are responsible for development projects for clients.
• Technical lead at meetings and conference calls with clients.
• Responsible for technical transfer projects and technology into and out of the development laboratories and GMP manufacturing facility.
• Working with management to ensure that company strategy is implemented and goals are set and executed.
• Provide strong leadership and guidance (coaching) to the technical team, fostering a culture of delivery, collaboration, accountability, and continuous improvement.
• Drive continuous improvement and operational excellence, ensuring adherence to cGMP guidelines, regulatory requirements, and industry best practices.
• Build new technical capabilities in order to best serve our clients.
• Working with Operations and Quality, lead technology transfer activities, ensuring seamless integration into the manufacturing facility and successful execution for clients.
• Serve as a critical point of contact for clients, providing technical expertise, addressing inquiries, and ensuring alignment with project timelines and deliverables
• Deliver on & provide direction on key budgets, manpower plans and capital expenditure

Essential Requirements:

• Bachelor’s degree in a scientific discipline (Master’s or PhD is a plus).
• Proven experience in a technical role with a strong understanding of aseptic manufacturing in a clean room environment and (ideally) knowledge cell and gene therapy products.
• Leadership experience, managing and developing scientific & technical teams in a matrix environment.
• Thorough knowledge of cGMP guidelines, FDA regulations, and industry best practices.
• Experience with process optimization, scale-up, and technology transfer from development to manufacturing.
• A critical thinker, with strong analytical and problem-solving skills, and the ability to make informed decisions in a timely manner.
• Minimum 5 years of experience in the biopharmaceutical industry.
• Excellent working knowledge of Drug Substance and Drug Product processes.
• Excellent communication skills, time management skills and a commitment to the timely delivery of projects and products, within budget.
• A competent stakeholder manager who engages effectively with all key players to drive alignment or critical decisions, strategy and risk mitigations
• Travel to support clients may be required.

Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.

Start date: On competition of recruitment process.

To Apply: Please email your CV to jobs@hitech-health.com with your CV and referencing the job role in the subject line.

Location: HiTech Health operations are based in Galway.

We reserve the right to re-advertise or extend the closing date for this job post.

HiTech Health is an equal opportunities employer.