Senior Manager, Quality ControlIreland - CorkQualityRegular
This QC Sr Manager role requires significant expertise/specialisation in Biological Product testing. You will be responsible for start-up and development of a Biologics potency laboratory, equipment purchase and qualification of lab equipment and will include Analytical Method Transfers, New Product Introductions, technical investigations and quality control testing to support our GMP operations.
Specific Job Responsibilities:
- Technical leadership of Analytical Method Validation/transfer for Biological Products as appropriate.
- Provision of technical support to Operations for investigations and optimisation projects.
- Deliver new technologies and continuous improvement initiatives to meet business requirements.
- Lead QC Micro investigations/troubleshooting and technical projects within the function.
- Support the procurement and qualification of new equipment for new product technology transfers.
- Demonstrates skills in data analysis and ability to critically evaluate data quality.
- Proficiently executes biological laboratory techniques such as Bio-Assays with experience in performing Cell Binding and Cell Cytotoxicity Assays
- Reviews data and results of testing to ensure compliance to appropriate specifications and protocols.
- Writes and executes protocols and reports.
- Onboarding and training of QC staff.
- Writes and revises methods, specifications, and SOP’s as needed.
- May develop methods for performing cleaning validations.
- Demonstrates and applies an advanced level of understanding of project goals and methods
- Knowledge of current Good Manufacturing Practices
- Excellent communication skills (both verbal and technical) and strong interpersonal skills
- Executes analysis efficiently, consistently, and with high quality and suggests improvements.
- Acts as a resource for other employees within the department.
- 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.
- Interfaces with key cross functional stakeholders locally, CTLs and across the Gilead network including Foster City, New Jersey, Edmonton and Oceanside.
Skills & Expertise:
- Experience in test methods for biologic and biopharmaceutical products
- Project management of laboratory set up
- Strong knowledge and understanding of cGMP, quality control (QC), and regulatory requirements for GMP laboratories in pharmaceutical industry.
- Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).
- Hands-on experience with equipment qualification and analytical techniques such as UPLC/HPLC, CE, SE and potency assay is an advantage.
- Knowledge of software such as Empower and LIMS.
- Critical thinking skills and ability to solve moderately complex problems and good judgement in making recommendations
- Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience
- Ability to work independently and as part of a team with internal and external partners, self-motivation and adaptability
Typical Education & Experience
- Significant years of relevant experience with BA or BSc degree in Biopharmaceutical Science or equivalent.
- Prior experience in a Biologics testing laboratory a distinct advantage.
- 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
Gilead Core Values
- Integrity (always doing the right thing),
- Teamwork (collaborating in good faith),
- Excellence (working at a high level of commitment and capability)
- Accountability (taking personal responsibility).
- Inclusion (encouraging diversity)