Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
To perform Analytical Development laboratory data review and interpretation in support of
ongoing method development, method validation, in process testing, Pharmaceutical
development support testing and development stability analysis as directed by Analytical
Development Team Leaders.
To maintain a thorough understanding of regulatory analytical development requirements and
ensure that all work carried out complies with departmental procedures and is cGMP
compliant.
To review analytical laboratory data for accuracy, completeness and in compliance with
documented procedures.
To communicate effectively with others on site and to assist with departmental and site wide
problem solving as required.
To be organised and responsible for management of data packs passing through the
department that require technical check, proactively chasing for review or completion of
corrections and delivery of pack to QA data reviewers following completion of technical check.
To plan and prioritise own day-to-day workload in line with client requirements and adapt this
where necessary in line with client needs and expectations.
To work effectively alongside Development Analysts, Team leaders and QA data checkers to
progress data packs through to completion.
To ensure that all personal lead times are complied with, subject to the absence of attenuating
circumstances.
To determine and champion best practice for the department in the areas of data generation,
documentation and review to maintain regulatory and industry best practice.
To train other members of staff within the department, as required.
To assist in the performance of improvement project work within the team, as required.
To ensure that all health and safety procedures are adhered to with respect to personal duties
and the duties of others.
To undertake such tasks and to manage specific internal or ad hoc projects as and when
required to meet department and business needs and within the scope of the job-holder’s
capabilities and responsibilities.
Self-motivated to gain additional Analytical Development and Pharmaceutical Development
knowledge.
Identify self-development needs for future performance and own development needs and
ensure personal training record is maintained and kept up to date.
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Top Skills
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
