University College Cork

Bio Pharma Processing

The Postgraduate Diploma in (Bio) Pharma Processing is designed to facilitate science or engineering graduates who hold sufficient educational or professional experience to transition into the BioPharma and PharmaChem sector nationally. Development and delivery of this level 9 course in the Munster area, where comparatively high numbers of BioPharma and PharmaChem companies are situated, will provide participants with experience in the manufacture of active pharmaceutical ingredients (both small organic molecule and biopharmaceuticals) and their formulations. The programme has a key focus on upstream/ downstream processing; sterile working environment; practical training; industrial standards and regulation; collection and analysis of data; validation; novel and personalized therapies; formulation and delivery of biological drugs. This combination of modules, which spans both the drug development and drug manufacturing processes, and has been designed to meet the existing and projected needs of the industry, will help produce confident graduates that are technically competent for employment in the BioPharma and PharmaChem sectors. It will improve the skillsets of those already employed in the industry, and provide a much needed increase in the talent pool available for employment.

Why Choose This Course

This NFQ level 9 part-time course has been developed with input from world-leading companies based in Munster, and has been designed to meet the expected shortage of appropriately skilled employees in the sector in the coming years. It combines flexible on-campus and blended on-line teaching methods to deliver workshops, lectures and practicals to students from a range of disciplines and circumstantial backgrounds. The course features significant engagement with local industry through the provision of site visits, off-campus training opportunities and guest speaker lectures. Students will have the opportunity to avail of Career Services at UCC and take a non-credit bearing module that aims to assist them in transitioning to the workplace and facilitating a placement in a local company.

Entry requirements

A candidate must have obtained at least a Second Class Honours primary degree in a relevant Pharmacy, Science or Engineering discipline (NFQ level 8). Consideration will be given to other applicants with sufficient equivalent professional qualifications and significant industrial experience.

Duration

12 months

Lectures/workshops will be scheduled on Fridays (09:30-17.30pm) from mid-September 2019 to end July 2020. The programme will be assessed through a variety of formal written examinations, and continuous assessment (written assignments, practical reports, MCQs).

Careers or further progression

Skills and Careers Information

Graduates will develop knowledge and critical skills relating to GMP, aseptic and sterile manufacturing, upstream/downstream processing, cell culture, bioreactors, chromatography, filtration, viral clearance, media and buffer preparation, formulation, validation, bioanalytics, facility management, clean utilities, calibration, automation, equipment maintenance, environmental health and safety, continuous improvement, documentation management, quality person duties, batch release, regulatory filings, new product improvement and modifications. Graduates will be in a position to apply for a variety of positions including, but not limited to, Process Technician, Production Supervisor, Quality Assurance Specialist, Technical Services Scientist, Validation Science, Scientist (BioPharma), BioProcess Engineer and Process Scientist (Manufacturing Support).

Placement or Study Abroad Information

Suitable students will be provided with an optional 5 credit module PF6615 focused on transitioning to the workplace which, where possible, will include a placement in a local company.

Further enquiries

Rachel O Farrell

rachel.ofarrell@ucc.ie

+353 (0)21 490 4706

https://www.ucc.ie/en/ace/

Dr. Eoin Fleming

j.fleming@ucc.ie

021-490-1679

Subjects taught

MODULES

Students will complete 60 credits as follows:

PF6603 Introduction to the Principles of Formulation and Dosage Form Design (5 credits)

PF6605 Microbiology and Sterile (Bio) Pharmaceutical Processes (5 credits)

PF6607 Pharmaceutical Process Design and Verification (5 credits)

PF6609 GxP - Regulatory and Best Practice Standards in the (Bio) Pharmaceutical Industry (5 credits)

PF6610 Biopharmaceutical Technology and Processes (10 credits) PF6612 Research Methods in (Bio) Pharma Processes and in the Development of Novel Biotherapeutics (10 credits)

PF6611 Biologics: Formulation and Dosage Form Design (5 credits)

PF6612 Research Methods in (Bio) Pharma Processes and in the Development of Novel BioTherapeutics (10 credits)

PF6613 Introductory Statistics for the (Bio) Pharma Industry (5 credits)

PF6614 Advanced (Bio) Pharma Technology and Data Analysis (10 credits)

Optional Module: PF6615 Transitioning into the Workplace and Placement (5 credits)

This optional module will be offered to students (subject to approval of the programme director) looking to transition into the workplace (i.e. those classified as jobseekers or returners). PF6615 is assessed on a pass/fail basis and is not counted toward the final award. The result obtained in PF6615 will be recorded on the student's transcript.

Assessment method

Assessment methods vary across the programme modules. The Placement and 'Transitioning into the workplace' modules are assessed by 100% continuous assessment. The placement is assessed on a Pass/Fail basis. For these modules continuous assessment examples include a Career development plan, Group project, Placement Portfolio (Placement Plan, Placement Journal, Review of Placement and Supervisor's Report). All other modules will be assessed by a combination of continuous assessment and end of semester written paper (1.5 hours). Continuous assessments examples include practical and site visit reports, written assignments and group projects.