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R&D Analytical Development Scientist II

On-site in León·Full-time·Added 23 days ago (last checked 23 Oct)

PCI Services

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Our summary

Work mode: On-site, León
Contract: Full-time
English: Required
Education: University degree

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Skills

Nice to have

This job advert was originally written in Spanish.

Requirements

What we're looking for

University degree in Chemistry, Pharmacy, Biotechnology, or similar
Familiarity with GMP regulations
Advanced knowledge in development, optimization, validation, and transfer of analytical methods (U/HPLC, ELISA, CE )
Good organizational and communication skills, technical rigor, and quality orientation
Spoken and written proficiency in Spanish and English

Nice to have

Previous experience in Analytical Development within the pharmaceutical industry or regulated environments (preferred)

The role

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.

We are looking for a person to join the Analytical Development area, who will actively participate in the development, optimization, validation, and transfer of analytical methods, providing support for the studies necessary for the development, registration, and manufacturing of pharmaceutical products.

What you'll do

Development and/or optimization of new or existing analytical methods (small molecules)
Development of bioanalytical methods such as CE (CE-SDS, CIEF), H/UPLC (SEC, RP, HILIC, IEX), ELISA, and Western blot for the analysis of biological products.
Preparation of transfer and validation protocols of analytical methods as well as the corresponding reports
Preparation of protocols, reports, and relevant investigations framed within the studies necessary for the development and registration phase of pharmaceutical products
Management, organization, and supervision of the Analytical Development Analysts assigned to the execution of experimental activities, as well as technical support for them and for personnel in training
Review of documentation generated by the Analytical Development Analysts and evaluation of data, trend study
Communication with the client
Verification of new USP, EP monographs
Participation and support in quality events, as well as preparation and/or review of Specifications, Analysis Procedures, special requirements, and other Laboratory or related procedures
Analytical support for the preparation of technical product documentation
Collaboration with the Galenic Development and/or Production department for the analysis of samples coming from different points of the pharmaceutical product manufacturing process,
Collaboration with the Quality Control department in the management, organization, and cleaning of the laboratory
Participation in internal and external audits (from clients or competent health authorities)

About PCI Services

In their own words

Additional information

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, Equity and Inclusion 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.

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