Job Description
Our client, a leading Biopharma company based in Dublin, now seek a Senior Process Development Chemist who will lead the delivery of manufacturing targets within quality, safety and environmental requirements and on schedule. Flexibility for hybrid work model.
The successful candidate will provide technical support and direction to manufacturing, ensuring manufacturing and facilities are operating at optimum efficiency and that changeovers of both equipment and production areas can be carried out in an efficient and effective manner.
This hire will play a leadership role in the introduction and outsourcing of chemical processes together with the preparation and execution of process validation programs.
Responsibilities:
- Subject Matter Expert in technical aspects of the process including assessment of critical parameters, establishment of bases of safety and implementation of control strategies.
- Support cleaning and process risk assessment programs to define manufacturing and cleaning procedures.
- Provide technical support and direction to manufacturing personnel in order to ensure that the manufacturing and ancillary facilities can be operated to optimum efficiency.
- Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. CI with a cross functional focus is a core activity.
- Play a leadership role in process improvement together with the preparation and execution of process validation programs.
- Be responsible for Laboratory-based investigational and development projects.
- Participate fully in any cross functional training initiatives.
- Ensure timely completion of all SOP, reading, training and assessment.
Quality Systems and GMP
- Perform development and manufacturing operations in accordance with company quality standards, cGMP and all other relevant policies, procedures, regulations and standards including HSE Legislation.
- Complete required documentation relating to development and manufacturing activities in an accurate and timely manner. Such documentation would include BMRs, Master Manufacturing Instructions and CPV documentation.
- Support investigations for any deviations from defined manufacturing processes or other established procedures.
- Generate documentation associated with their activities as required by cGMP and review SOPs, BMRs, Logbooks, Labels, In-Process Test documentation, and other regulatory documentation as required.
- PhD in Synthetic Organic Chemistry
- Minimum of 5 years working in a Process Development role in the Pharmaceutical Industry
- Ability to work independently as well as in a team environment, and the ability to cultivate and maintain positive business relationships, a well-motivated self-starter.
- Effective problem solving, analytical aptitude, learn quickly and embrace change.
- Ability to manage multiple priorities independently and simultaneously.
- Strong interpersonal and communication skills (written, verbal and visual). Ability to communicate ideas clearly and concisely to both technical and non-technical people.
- Experience with BioVia Discoverant is advantageous.
- Experience in the application of in-line PAT and DoE methodology advantageous (e.g. RAMAN, IR).
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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