Senior Group Leader Biopharma

On behalf of our client, we are currently recruiting for a Senior Group Leader Biopharma.

The role of Senior Group Leader is to provide support to the 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 tiered organizational structure comprised of supervisors and analysts

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

· Review and approval of study protocols, project status reports, final study reports and other project-related technical documents.

· Reviewing data for technical quality and compliance to protocols, methods and SOPs. Approve laboratory investigations, deviations, QA facility and data audits. Leads client and regulatory authority audits.

· Responding to client questions and needs; leads client technical meetings. Provides recommendations to clients on analytical and compliance issues.

· Prepares and approves proposals, project definition and pricing. Participates in project definition and negotiations with clients on timelines and budgets.

· Preparing and implementing SOPs and company operational policies Ensuring adherence and making recommendations for quality system improvements.

· Collaborates with business development as technical representative for client visits/discussions. Identifies business opportunities through client interactions, within community, at conferences/workshops. Participates in technical sales and marketing.

· Participates in bi-annual SOP review and change management. Ownership of changes needed to comply with SOPs.

· Regularly communicates to staff quality related issues and items for staff development, and implements quality 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 8+ years) or equivalent and relevant combination of education, training, & experience.

· 2+ years of management 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, including mentoring/coaching

· Ability to cultivate a collaborative work environment with a team and across business units; including the ability to identify and implement common efficiencies across the teams/units, as well as projects/programs

· 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, such as HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.

· Understanding of basic financial terms and definitions as it applies to the business

· Ability to independently develop project proposals/plans. Utilizes expertise of others to develop programs to meet client needs.

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