About Us
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.
Job Responsibilities
1. 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.
2. Maintain a thorough understanding of regulatory analytical development requirements and ensure that all work carried out complies with departmental procedures and is cGMP compliant.
3. Review analytical laboratory data for accuracy, completeness and in compliance with documented procedures.
4. Communicate effectively with others on site and assist with departmental and site-wide problem solving as required.
5. Manage data packs passing through the department that require technical check, proactively chase for review or completion of corrections, and deliver pack to QA data reviewers following completion of technical check.
6. Plan and prioritise day-to-day workload in line with client requirements and adapt as necessary.
7. Work effectively alongside Development Analysts, Team leaders and QA data checkers to progress data packs through to completion.
8. Ensure compliance with personal lead times, subject to the absence of attenuating circumstances.
9. Champion best practice for the department in data generation, documentation and review to maintain regulatory and industry best practice.
10. Train other members of staff within the department as required.
11. Assist in the performance of improvement project work within the team as required.
12. Adhere to all health and safety procedures in respect to personal duties and the duties of others.
13. Manage specific internal or ad hoc projects as required to meet department and business needs.
14. Self-motivate to gain additional Analytical Development and Pharmaceutical Development knowledge.
15. Identify self-development needs for future performance and maintain personal training record.
Join Us
Join us and be part of building the bridge between life changing therapies and patients.
Equal Employment Opportunity
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.
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