Job Reference: JO-2006-65231_1591882265
This job family is responsible for analytical operations in support of clinical programs, formulation development, quality control testing to support our GMP operations and includes a function which supports preparation of regulatory submissions.
This role resides in the overall QC function and is responsible for leading and managing the QC Technical Support team for New Product Introduction (Process & Cleaning Validation analysis), Analytical Method development, validation and transfer activities as appropriate. It also entails the provision of day to day technical support to operations for deviations, investigations, optimisation programs etc.
- Leads the QC Technical Support team and manages a broad portfolio of projects.
- Forms part of the QC Leadership team and works closely with the QC Commercial Groups.
- Interfaces with key stakeholders locally with cross functional departments and with Analytical Operations (AO) in Foster City HQ & CTLs.
- Generation of budgets, spend reviews and resource modelling.
- Deployment of functional G&Os & facilitate periodic goal review sessions.
- Performance Management : mid year and end of year reviews.
- Team & Individual Development Planning.
- Governance of all Safety, Quality, & Delivery of programs through MDI & team meetings.
- Provision of updates and risk escalation to QC Management.
- Promotes core values, behaviours and culture of continuous improvement.
- Applies advanced level of understanding of analytical methods for solid oral dosage and biological products.
- Presents QC Technical Support Reports to auditors incl method validation, investigations reports, analytical method transfers etc
- Plans and schedules activities that support day to day business and project goals.
- Collaborates within AO & contract test labs to develop & validate methods.
- Generation, review and approval of development & validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
- Collation of data and technical writing of reports.
- Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols.
- Presents results of work, interprets data, and draws conclusions.
- Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors.
- Acts as a resource for other employees within the department.
- Coaching, mentoring and knowledge transfer to junior employees.
- Manage group with multiple areas of responsibility and may lead a component of a project within the job family.
- Identifies and introduces new technology and/or methods to the organization.
- Troubleshoot instrumentation/test methods.
- Uses strong communication skills (both verbal and technical) and interpersonal skills to communicate objectives and results.
- Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
- Working knowledge of GMPs, pharmacopoeias, regulatory requirements for analytical testing, phase appropriate standards for method validation.
- Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
- Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & HPLC proficient in LIMS & Empower, trackwise etc.
- 5S, Lean & Six Sigma Skills
- Extensive years of experience with BA or BS degree in Chemistry or Biology or significant experience with MS degree in Chemistry or Biology.
- PhD with no post-doctoral assignment.
- Resilient & dynamic profile with the ability to deliver in an ambiguous environment
- Ability to engage and manage multiple stakeholders to achieve the objective
- Curious with learning agility
- Operationally excellent
- Organised with systematic approach to prioritisation
- Process orientated to achieve the business objective
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