Job Title: QC Separations Team Lead
About Us
{company} is a world-class biologics services provider, offering discovery to commercialization services to global clients in the biopharmaceutical and healthcare industries.
We accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide.
With sites/offices in China, US, EU, Asia, and Israel, we employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Job Description
You will lead a range of technical projects and activities in the QC Separations group at {company}.
The site is focused on start-up activities involving commissioning and qualification aligned with project timelines.
As part of the project, the role will evolve based on project timelines.
Your Responsibilities
* Key member of the QC Team in Dundalk.
* Support execution of the strategy and business planning processes, ensuring cross-functional collaboration.
* From a QC functional capacity, support the design, construction, and commissioning of the new facility for the production of drug substance.
* Support the development of a Biologics QC separations product-testing team (HPLC, CE, and cIEF) including planning, recruiting/hiring, coaching/mentoring, and training.
* Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations.
* Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations.
* Team Lead and line Manager for QC Separation Scientist and Associate Scientist, providing guidance, performance management, training plan through scheduling, and direct 1-2-1 with the team.
* Serve as a technical expert supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, and CAPAs.
* Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
* Seek opportunities for continuous process improvements/improved operational excellence.
* Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.
* Support Risk Assessments for projects and business innovation initiatives from a Separations perspective.
Your Profile
Technical Competencies:
* Experience working in a QC function in a greenfield context of similar size and scale is ideal.
* Previous experience handling regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance is advantageous.
* Experience working in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field is desirable.
* Technical expertise in tech transfer, validation, and troubleshooting Biologics product-testing methods, including HPLC, CE, and cIEF to support QC release and stability testing in a GMP-environment according to USP, EP, and ChP requirements is preferred.
Qualifications:
* University degree in related science/quality discipline required.
Benefits
Bonus, Canteen, Life Assurance, Paid Holidays, Parking, Pension, VHI