Biopharmaceutical Project Manager

Ireland | Permanent full-time role & flexible working conditions

HiTech Health is a Contract Development and Manufacturing Organisation (CDMO) for advanced medicines including cell and gene therapies. 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.

We have an opportunity for a highly motivated team-player to join our growing organisation,working as a Biopharmaceutical Project Manager. The role will involve supporting a diverse range of clients as they progress new medicines from development through to supply of these new therapies to patients. The focus area of the role is the CMC development and manufacture of these new medicines. Hitech Health have good business systems to support the successful candidate in the role and all appropriate training will be provided.

The candidate will lead projects within a multi-disciplinary team environment.

Responsibilities:

• Effectively lead projects, particularly in the area of advanced medicines, from initial client briefing through to execution and completion within a highly regulated environment.
• Ensure that project tasks are controlled and executed, as well as project goals are delivered on time, within budget, to specification and meeting the highest standards of quality.
• Supporting clients with supply chain and logistics requirements in line with Good Distribution Practice (GDP) guidelines.
• Participate in cross-functional projects, working closely with other departments (QA and Regulatory etc.) for the development and scale-up of products, ensuring compliance with EU and US regulations.
• Project manage and communicate progress of projects to business and technical stakeholders. Reporting directly to the Managing Director on a regular basis to ensure client’s goals are being efficiently met in line with quality and compliance standards.
• Optimally use innovative business processes to support the launch and supply of products to patients.
• Monitor and report the project’s progress, identify and control any risks to the project’s schedule or commercial objectives.

Requirements:

• A degree in an Engineering or Science area is required at minimum (preferably Biotechnology, Bio/Chemical or Biomedical Engineering).
• Minimum 3 years of experience in the biopharmaceutical industry.
• Excellent working knowledge of Drug Substance and Drug Product processes.
• Understanding of quality systems, FDA and EU regulations, cGMP and ICH guidelines.
• Experience in people management is favourable. Ability to critically assess situations and make strategic decisions.
• Excellent time management and project management abilities. A project management Certificate is desirable.
• Outstanding written, verbal and interpersonal communication skills, presentation skills and the ability to effectively interact cross functionally.
• Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Willingness to support and contribute to other business areas as requested.
• Travel to support clients may be required.

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

Working hours: Working hours will be 9 AM-5.30 PM daily. The nature of the work may require flexibility in working times.

Start date: On completion 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: Discussed upon interview. Hitech Health provides a flexible working environment.

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

HiTech Health is an equal opportunities employer.

Ireland | Permanent full-time role & flexible working conditions

Responsibilities:

• Fulfilling the role of the Qualified Person within the company and for clients in accordance with EU Directives 2001/83/EC.

• Certifying Medicinal Products for use in the EU and outside the EU (where relevant).

• Reviewing Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorization as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU, 536/2014 and EudraLex Volume 4, Annex 13 and 16.

• Participate in Continuous Professional Development (CPD) initiatives with a view to maintaining, developing and broadening knowledge and skills as they relate to the function of Qualified Person.

• Coordinating and performing any required internal/client investigations and the issuance of follow up reports (e.g. rejected batches, deviations, CAPAs, OOS).

• Ability to generate GxP documentation which is of a high standard.

• QA review of documentation, including SOPs, protocols, batch records, validation documents and Quality Technical Agreements (QTAs) to ensure GMP compliance.

• Acting as project lead/point of primary contact for clients.

• Advising and providing input to clients’ quality management systems.

• Undertaking audits in the EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.

• Providing advice and guidance to the company’s staff and clients regarding QP requirements within the EU.

• Participating in cross-functional projects for the development and scale-up of products.

• Reporting directly to the Quality & Compliance Lead on a regular basis to ensure clients’ goals are being met in line with quality and compliance standards.

• Creating and delivering GMP training internally or externally on behalf of clients.

• Responsible for the day-to-day support of HTH QMS to ensure it is operating efficiently, effectively and in a compliant manner.

• Facilitating and/or supporting regulatory inspections.

• Undertaking departmental tasks and projects outside of the job holder’s direct area of responsibility, in line with departmental and senior management team objectives.

Requirements:

• Third level degree in Science or relevant discipline.
• Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directives 2001/83/EC and 2001/20/EC//536/2014 respectively.
• Minimum 3 years of experience in the pharmaceutical industry in a Quality role, with at least 5 year experience as a releasing QP.
• Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
• GMP auditing experience of suppliers in pharmaceutical industry.
• Collaborative team player with a positive attitude and the ability to think and act quickly to identify creative solutions to complex problems.
• Strong judgment and decision-making skills.
• Experience in aseptic processing, sterile manufacturing or cell and gene therapy manufacturing is desirable.
• Direct experience in participation in regulatory audits.
• Direct experience in development and oversight of Quality Management Systems.
• Excellent time management and project management abilities.
• Excellent written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
• Ability to handle and prioritise multiple assignments, changing priorities and meet deadlines.
• Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Some travel is required to support this role e.g., GMP audits. Approximately 10% of time.

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

Working hours: Working hours will be 9-5.30 daily. The nature of the work may require flexibility in working times. Hitech Health provides flexible working options for employees.

Start date: On completion of recruitment process.

To Apply: Please apply via jobs@hitech-health.com and indicate the position title in the email subject line.

Applications to include a cover letter & CV. References should be made available upon request.

Location:

The role will preferably be based in the greater Dublin area, however other locations will be considered as remote work is possible. The QP will be expected to be present on site in HTH’s Dublin office when performing batch certification duties.

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

HiTech Health is an equal opportunities employer.