Analytical Chemist

About PSC Biotech

Who we are

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 cloudbased 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 likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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.

Role Description:

Reports To: Laboratory Systems Leader/ Laboratory Leader

Job Purpose: To execute and appropriately document testing of Raw Materials Intermediates Drug Substance & Drug Product in accordance with Analytical Standards and/or other. approved protocols. To provide analytical support to product quality investigations including the use of sophisticated analytical techniques. To undertake significant assignments and to work on own initiative and with minimum supervision e.g. technology transfer for new product demonstrations; new methods development. management of an ongoing programme such as the Intermediate Stability programme; and to provide training for other chemists and other lab staff.

Requirements

Role Functions:

The Laboratory Analyst has responsibility for Raw Material Intermediate Drug Substance & Drug Product testing to meet compliance requirements and customer targets. The Analyst may also take a leadership role in change or improvement projects in ADC or at a site level.

The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP.

The Laboratory Analyst assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as HR policies are also responsibilities of the role.

To test Raw Materials Intermediates Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols.

To comply with all GMP and analytical procedures relevant to area of work.

To adhere and comply with department High Performance Analytical Behaviours

To document all testing activities and to input results into computerised lab systems in accordance with department and client standards.

To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.

Complete the investigation of laboratory OOSs (Z1 Quality Notifications) in line with site and divisional procedures and Provide leadership in the laboratory aspects of OOS investigations.

Complete documentation checks (e.g. GCM s Quality Notifications Data Integrity) as required for test packages prior to release.

To complete testing as required on non routine samples to support process changes Request for Service Quality Notifications

Accountable for own laboratory safety practices. Follow the principles of Safe by Choice

To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.

To identify and aid resolution of analytical issues within the IPT laboratory.

To be a resource for analytical testing for the site as required.

Execute specific assignments (e.g. DI Initiatives Lab X Champion Empower/LIMS Superuser and other systems) in a comprehensive manner and under minimum supervision.

Complete training with new laboratory Analysts and Laboratory Apprentices.

Special Features:

On assignment and depending on experience participates in or leads departmental initiatives on improved compliance and quality systems. Operates as part of selfdirected team in allocating testing and assigning priorities.

Experience Knowledge & Skills:

Technical:

To have demonstrated knowledge of site quality policies procedures and guidelines which relate to finished product testing and release.

Relevant GMP standards

Lab safety standards

Business:

To perform analytical testing with a high degree of precision and accuracy

To perform instrument maintenance and troubleshooting

To maintain accurate records in compliance with ALCOA principles and GMP expectations

To understand and internalise procedures relevant to GMP operations

To communicate clearly and concisely on technical issues

On assignment to manage specific department projects

To provide training programmes to laboratory staff as assigned

To liaise effectively with external groups such as MRL RAS DI COE etc.

To act as auditee (in internal and external audits) for assigned areas of responsibility

Leadership:

Analytical chemistry demonstrated ability in all technical elements relevant to ADC IPT operation.

Technical lab skills (precision etc)

Strong aptitude for handling analytical instruments

Clear understanding of DI requirements

Mechanical and computer

Communication written oral

Team and interpersonal skills

Leadership skills

Educational Requirements:

Minimum of BSc in Chemistry or related discipline.

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