Analytical Chemistry

About PSC BiotechWho are we? 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 point 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 though 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. This role provides analytical testing support for all late stage clinical and marketed drug product manufactured at the Ballydine site. Following MMD approved methods or pharmacopoeia methods testing will cover raw materials, intermediates and finished product associated with the Drug Product facility. Responsibilities will also include, documenting all work in a compliant manner, participating in laboratory investigations, training staff, reviewing analytical results to ensure accuracy and compliance to test methods, preparation of all laboratory documentation and participate in continuous improvement programs. Principal Accountabilities:

• To adhere and comply with department high performance behaviours during execution of all work.
• Comply with all safety and GMP requirements within the Laboratory.
• Perform Laboratory testing to the Pharmacopoeia or MMD approved methods.
• Plan daily schedule to meet testing release plans
• Operation of laboratory equipment including daily up-keep and maintenance and assist in trouble-shooting when required
• Preparation and revision of laboratory protocols, reports, procedures, etc.
• Participate in the training of analytical chemists.
• Participate in or lead laboratory investigations, utilising technical knowledge to identify

assignable cause and corrective/preventative actions.

• Document all testing activities to current and regulatory standards. Input of data into

computerised laboratory systems.

• Review analytical results to ensure accuracy and compliance to both test methods and

registered specifications.

• Participate in and facilitate improvement programs within the laboratory.
• Participate in or lead introduction of new method, analytical techniques to the Pharm Ops

Laboratory area.

• Participate in multi-functional teams to support project assignments.
• Complete additional tasks considered necessary to meet customer requirements.
• Must be able to work effectively in a mutli-functional team environment

Requirements Core Competencies Technical: This position requires a B.Sc. (or equivalent experience) in analytical chemistry, pharmaceutical science or a related science discipline. The incumbent must have demonstrated problem solving, and communication skills. Strong scientific understanding of analytical methodology and knowledge of relevant regulatory requirements, including cGMPs, is important. Business:

• The ability to work in partnership with all plant departments in areas related to analytical chemistry
• and related validation. Must be able to demonstrate the ability:
• Identify the Business competencies required of the role.
• To perform precise and constant analyses in support of various projects.
• To communicate technical information both verbally and written in a concise manner
• To analytically evaluate projects, suggest appropriate options, solutions and timelines.
• To complete assignments in a timely manner and communicate progress at internals

Leadership:

• Must be able to demonstrate skills in the following areas:
• Expertise in analytical laboratory techniques
• Team work skills
• Skills in leading defined projects
• Computer skills - excel, word, outlook, scheduler,
• Project Management Skills
• Interpersonal Skills
• Customer Service skills
• Written & verbal presentation and communication skills
• Time Management

Educational Requirements:

• Minimum of BSc in Chemistry or related discipline.