Job DescriptionAbout PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations 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 of working in top pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition Employees are the "heartbeat" of PSC Biotech; we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Job Summary: An exciting and rare opportunity has presented for an Aseptic Process Owner Lead. This is a senior role in the organization and requires in-depth technical and operational knowledge of aseptic drug product manufacturing processes; parts/components preparation, formulation, syringe filling, vial filling, lyophilization, and capping.The Site Aseptic Process Owner Lead will continue to build on the site and network aseptic processing knowledge and represent the client site at a global level across the client manufacturing network.As the Site Aseptic Process Lead, you will be an established professional who is a self-starter, capable of applying advanced process knowledge and creativity to complete complex assignments related to aseptic operations. You are someone who contributes to the development of new principles and concepts, who wants to be challenged and can lead change from an aseptic operations perspective.
RequirementsPrimary Responsibilities: Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance aseptic operations.Lead and/or provide input to strategic initiatives that will improve and develop manufacturing processes for the future including contamination control and aseptic process simulations (APS).Contribute in a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required.Remain current on state-of-the-art for systems and processes and advise on the appropriate adoption and use of new techniques and technology.Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends (Personnel and Environmental Monitoring), including business performance metrics. Identify actions that will enable the process, and the manufacturing areas better achieve and surpass metrics in the future.Lead and/or support investigations that impact safety, quality, and/or compliance of the processes, ensuring thorough investigations are conducted and actionable CAPAs, to prevent future reoccurrence, are implemented within agreed timelines.What You Need to Apply: Bachelor's degree in microbiology or a related discipline with 10+ years' experience in the pharmaceutical industry.Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products.Proven ability to work in a high-paced matrix organization and effectively influence change and escalate issues professionally and in a timely manner.Excellent decision-making skills and confidence to challenge others respectfully and professionally on decisions that impact the manufacturing area.Proactive and works well with others in a collaborative, fast-paced goal-driven environment.Interacts well with diverse groups (Manufacturing, Validation, Engineering, Quality, etc.) and maintains strong working relationships with internal and external collaborators.Demonstrated ability to coach, mentor, and/or cross-train colleagues within core technical areas.Excellent verbal and written communication skills: Strong technical writing skills for cGxP documentation (e.g. investigations, procedures, change controls) and good presentation skills.
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