Manager, Global Technical Operations
Proclinical is currently recruiting for a Manager of Global Technical Operations with a pharmaceutical company located in Wilmington, DE. Successful candidate will be responsible for providing analytical support for assigned projects while working collaboratively with cross-functional teams in support of drug development activities.
- Contribute to drug development Analytical activities to address key issues.
- Monitor, review and guide the analytical activities at external laboratories to ensure timely delivery of quality analytical work packages.
- Contribute to and coordinate improvement initiatives within Analytical Development.
- Track stability studies across projects, collate the associated data and summarize/tabulate results.
- Contribute to implementation of data management systems.
- Ensure consistency in documentation of shelf lives and retest dates that ensure the quality and safety of drug substances and drug products.
- Ensure consistency in drug substance and drug product specifications, incorporating batch data and regulatory expectations to ensure drug substance and drug product quality.
- Write and review technical documentation for regulatory submissions.
- Author and review SOPs to ensure quality and compliance within GTO.
Skills and Requirements:
- Must have at least a BS in analytical chemistry or other relevant field.
- Experience with key analytical technology such as HPLC and GC.
- Experience with electronic lab data management systems.
- Experience in GMP, Industry and Regulatory requirements.
- Three years of pharmaceutical R&D analytical experience.
- Must have thorough knowledge of GMP, Industry and Regulatory requirements.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Phil Sawyer at (+1) 347-431-4523 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.