Job Description
About PSC Biotech Who we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA. We operate globally in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment, giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting. Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech. We provide unparalleled empowering career development through Learning & Development, in-house training, and mentorship with constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations with regards to the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Description: Process Engineer/Scientist required to work within the Process Development Commercial Support team based at the client site. The team is responsible for providing process and product support to drug product formulation and fill-finish operations at the client site as drug product process SMEs. Requirements Key responsibilities listed below, but primarily the Hiring Manager can foresee support will be needed for the following: Act as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in drug product formulation, vial filling, pre-filled syringe filling, lyophilization, and vial capping. Key contributor to product and process investigations, responsible for assessing product and process impacts. Leads continuous improvement projects to improve process performance and productivity. The chosen candidate would typically be involved in activities such as (but not exclusively): Assess product impact associated with proposed changes to commercial processes under the change control process. Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation. Support new product introduction team as a process subject matter expert; this includes, but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support. Review and approve changes to operating procedures, electronic batch records, and product documentation. Identify and implement operational opportunities for current and new sterile operations risk assessments and mitigation projects relating to line performance. Perform process gap analysis and develop strategies to close gaps. Data trend analysis for all performance aspects of the area. Troubleshooting performance trends. The chosen candidate will work in a collaborative manner within the process team's structure and contribute as a member of cross-functional teams within the local organization and functional team globally. Basic Qualifications: Bachelor’s or Masters degree in Engineering, Science or related discipline with 6 years experience in a similar role OR PhD and 3 years of directly related experience. Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external. Preferred Qualifications: Typically 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling, or lyophilization. Qualification in Lean and 6-sigma methodologies would be an advantage. New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous. #J-18808-Ljbffr