Job Description
Bioprocess Upstream Development Scientist 2
APC Ltd is an award-winning science and technology driven biopharmaceutical process research company. In the space of 5 years, we have pioneered innovation in the sector and we now partner with 8 of the top 10 pharma and 5 of the top 10 biotech firms in the world, and we continue to grow.
From our world-class facility, we offer specialised bioprocess engineering solutions. Powered by novel technology and world-class scientific research, we help companies accelerate the development & launch of their medicines.
Our rapid growth has come from a commitment to excellence, a drive to innovate and the desire to develop a challenging, creative and rewarding environment for our team. If you are interested in a career focused on technical innovation, process design and impact, we would love to hear from you.
About the team
Department: Technical Operations
Reports to: UPS Biologics Functional Lead
Our biologics team comprises of highly qualified, dynamic and welcoming colleagues. We support our clients by delivering world class bioprocess development to accelerate the delivery of quality, life-changing medicines to the patient across a wide range of therapeutic areas from oncolytic vaccines to rare genetic diseases.
Our team vision is to enhance the bioprocess development experience for our clients in a dynamic and cross-collaborative environment (APC Engineering, APC Biologics, APC Analytical, APC Quality & VLE GMP Manufacturing)
If you are looking to start your career in a dynamic, creative and patient focused environment then APC is for you.
General Job Requirements
· Adopt and maintain the Medicine Accelerator workflows and their incorporation into the day-to-day execution of commercial research programs, supporting the completion of the program to an exemplary high standard. Organize, evaluate and present data in an effective manner.
· Demonstrate the use of problem-solving skills requiring the application of scientific/engineering principles, calculations and computational methods in approaching technical challenges.
· Deliver across all elements of the Medicine Accelerator’s platform programs, including but not limited to BioACHIEVE®, ACHIEVE® and iACHIEVE®.
· Organize, evaluate and present data in an effective manner.
· Technically represent the organisation to clients and at conference events.
· Support continuous improvement and best practise. Collaborate cross-functionally on the maturation and commercial deployment of new technologies, processes, techniques and ways-of-working for medicines development.
· Continue to develop diverse technical capabilities in multiple specialities.
· Support on-boarding within the commercial and internal projects landscape. Support upskilling, coaching, and training of colleagues across the Medicine Accelerator.
· Support laboratory and day-to-day operations and lead by example w.r.t. equipment/software/area ownership, equipment maintenance and scheduling.
· Support scoping and prospecting activities, where required.
Delivery of Technical Programs
· Responsible for executing the research activity in the laboratory (for lab-based programs) and managing the experimental workplan to uphold the Medicine Accelerator technical workflows, maintaining ‘excellence in execution’ and meeting program objectives.
· Support or own (for PC roles) the analysis of experimental data and technical findings from RD&I programs. In collaboration with the technical team, PC and PTL formulate hypotheses, conclusions, and research strategies for delivering on technical objectives.
· Author, review, edit and approve content on iACHIEVE®. Accountable for the delivery of clear technical reports and/or Executive Summaries with sound conclusions.
· In all phases of the program, collaborate with the Project Manager to ensure all issues (technical and otherwise) are highlighted and resolved.
· During program initialisation, collaborate with the PC to ensure document review, risk assessment, process establishment and analytical method establishment are all completed (own the task if in a PC role).
· During program execution, develop and manage the experimental workplan to ensure appropriate technical data is delivered (PC role).
· Contribute to or inform (for PC roles) the technical direction and technical execution on programs, resolve technical issues, ensure experimental writeup, data collection and review, daily tasks are all performed under complete adherence to safety and quality standards.
· Support or be responsible (PC role) for the delivery of technical updates and discussions with clients/internal stakeholders and agree technical paths forward.
· Post program, ensure technical closeout activities are completed in compliance with program closeout process (PC role).
Safety & Quality Compliance
· Promote a compliant culture of Safety and Quality through strong leadership and demonstration through day-to-day tasks.
· Consistent adherence to procedure, support continuous improvement and thorough problem solving – for all works including audit and investigations processes.
· Actively engage with and promote Safety & Quality reporting, e.g., safety adverse events and quality non-conformances.
· Where Safety & Quality tasks are assigned, ensure action ownership is assigned and tasks tracked to completion.
· Ensure Safety & Quality requirements for any site visitors/vendors are clearly communicated and are in place to support.
Qualifications
· PhD in biochemistry/biotechnology or process engineering or related area; or
· Masters in biochemistry/biotechnology or process engineering or related area; or
· Bachelors in biochemistry/biotechnology or process engineering or related area
· *Appropriate qualification level for role is experience dependent
Experience
· Minimum of 1-2 + years industry experience in pharmaceutical process research and development (if PhD qualified); or
· Minimum of 3-4 + years industry experience (if Masters qualified); or
· Minimum of 4 + years industry experience (if Bachelors qualified)
Skills & Knowledge
· Good maths skills
· Experienced in the use of Microsoft Office
· Aseptic techniques
· Experience in performing bioreactor processing and/or chromatography or filtration
· Ability to perform scale-up & scale-down calculations
· Interpretation of process data and translation into technical presentations and summary reports
· Understanding/Upskilling in DoE and QbD for process development
· Experience with scale-up techniques from laboratory to pilot/manufacturing scale.
Desirable Skills
· Demonstrated experience in adherent cell culturing
How to apply
Suitable candidates should submit a CV and a Cover Letter by close of business 31st January 2025
APC is committed to the principle of equal opportunity for all employees. All employment decisions at APC are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and/or expression, marital status, or any other status protected by Irish law.
Similar vacancies arising in the coming 6 months may be filled from this group of applicants.