Description

Associate Group Leader, Biopharma On behalf of our client, we are currently recruiting for an Associate Group Leader, Biopharma.

Discover Impactful Work:

The role of Associate Group Leader is to provide support to our Biopharma department by providing management and direction to a group of laboratory staff and resources for project activities and needs, overseeing daily operations to monitor quality and project timeliness, and assist in preparation and implementation of company policies, quality systems and training programs.

Responsibilities:

• Management of a team of analysts

• Allocation, scheduling and managing laboratory resources for group's project activities and updates LIMS for project status. Reviews timesheet reports for billing accuracy.

• Preparation, review and approval of study protocols, project status reports, final study reports and other project-related technical documents.

• Designing experimental study and participates in technical troubleshooting.

• Reviewing data for technical quality and compliance to protocols, methods and SOPs. Review and approve laboratory investigations, deviations, QA facility and data audits. Assists in client and regulatory authority audits.

• Responding to client questions and needs; leads client technical meetings.

• Assisting in preparation of proposals, project definition and pricing.

• Coordinating and prioritizing project activities with internal functional groups (physical testing, analytical development, etc.) and support functions (QA, sample management, etc.)

• Assisting senior group leaders and/or managers in their responsibilities.

• Preparation and implementing SOPs and company operational policies. Ensuring adherence and making recommendations for quality system improvements.

Education and Experience

• Educated to a bachelor's degree level in a relevant area, ie chemistry, biochemistry

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.

• 1+ year of leadership responsibility

Knowledge, Skills, Abilities

• Management experience in the pharmaceutical, biotech or analytical contract laboratory industries

• Stability/QC/analytical R&D/project and program management.

• Direct supervision of technical staff.

• Full understanding of GMP requirements, client SOPs, ICH guidelines, EP and USP requirements, EMA and FDA guidance's.

• Knowledge and experience of a wide range of techniques, HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.

For full details contact Linda at or email your CV to Thornshaw Scientific is a division of the CPL Group