Quality Control Manager/Senior Specialist

The Opportunity

Esco Lifesciences Group is Singapore's most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.

Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017.

Esco Aster is a contract research development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products at affordable prices.

Our scientific work is in emerging and frontier biology utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.

Our first commercial breakthrough success is Esco Aster is commercially first in class being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.

We are first in the region to operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.

The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.

Join us as we redefine BioSolutions for One World and One Health for the current and future generations to come.

Esco Aster.

One World Biosolutions for One Health.

Who we're looking for

Physical/Mental Requirements/Work Environment

· Ability to understand protocols, technical reports and technology transfer documents.

· Ability to understand standard operating procedures and other related documents.

· Able to commit to weekend work when needed, off in lieu will be given for work on public holidays.

· Repetitive motions due to certain laboratory techniques.

· Good Understanding of Aseptic Techniques.

· Work performed in a clean room environment wearing PPE.

· Ability to define problems, collect data, establish facts and draw conclusions.

· Ability to focus regardless of circumstances and stress induced pressure.

· Ability to take proactive approach.

· Meticulous and systematic.

· Commitment to continuous learning and staying updated with industry best practices.

· Have a strong focus on safety, quality and timeliness.

· Have strong critical thinking skills.

Job Responsibilities

Sample and QC Process Management:

· Ensure all QC sample management, testing, including process validation, cleaning, raw materials, stability samples, water samples, etc., are planned and executed on time.

· Prioritize and plan all testing activities to support processing schedules.

· Plan QC testing on a FIFO basis to eliminate backlog and meet internal QC KPIs.

· Plan work assignments for all QC analysts based on the production plan.

· Support future setup of central QC lab for all BioSolutions within Esco Aster.

Leadership and Team Management:

· Lead the implementation of the Laboratory Information Management System (LIMS).

· Lead Quality Control SOP implementation.

· Collaborate with the Analytical Development Team and manage QC Analytical, Microbiology Team to manage the revision and/or change control of QC documents as needed.

· Ensure new Analysts and Specialists are trained appropriately.

· Supervise, develop, engage, and motivate a young and driven team of QC Team Members.

· Manage the routine operations of the QC lab, ensuring business delivery at the right quality, cost, and speed.

· Able to build and lead across functional department consisting of different QC functions and supervisors / deputies / subject matter.

Operational Oversight:

· Oversee several sub-teams such as sample management, reference management, regulatory management, and QC instrument and equipment management.

· Lead the team to comply with internal requirements in all aspects through end-to-end quality control system oversight.

· Ensure all activities in the QC team are performed in compliance with cGMP, data integrity, and EHS requirements.

· Keep up to date with the latest trends in Quality Controls Tools.

Training and Development:

· Oversee the training, evaluation, and management of staff in the QC lab, including coaching, developing, and supporting them to reach their full potential.

Regulatory Compliance:

· Manage GMP audits from regulatory authorities and clients, respond to audit reports, and create CAPAs as applicable.

· Support analytical method transfer activities.

· Author and review OOS/OOT and Deviation investigations for approval, maintaining investigation records in accordance with company policies.

Cross-Departmental Collaboration:

· Participate in Quality Risk Assessment Programs.

· Provide input and expertise on QC testing and practices for all departments.

· Serve as the QC representative for all customer and agency audits and support the audit of all 3rd party contract facilities.

· Oversee the management of Sample and Controlled Substance inventories.

· Provide technical support and advice on QC matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Developments.

· Work with Analytical Sciences and Technology (ASAT) to internal or external tech transfer from developed protocols from Analytical Development to Quality control including overseeing method verification, qualification, and validation activities.

Compliance Management:

· Participate in self-inspection and support client audits.

· Manage compliance tasks to ensure the Quality Control department is current and compliant.

· Maintain purchase orders, cost centers, and budgets for the QC department.

· Manage implementation and adherence to all applicable SHE and cGMP regulations.

· Support and oversee 3rd party test labs and ensure test labs are qualified per our QMS.

· Perform calibration and maintenance of QC laboratory equipment working with our CMMS and as per Iso 17025 standards and relevant GLP standards.

· Support/ oversee QC laboratory equipment/system qualification.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor and Management from time to time to support GMP activities.

Requirements

· Bachelor's degree in life sciences with minimum of 5 years of experience in Quality Control within highly regulated cGMP pharmaceutical industry. Experience is Biologics and ATMPs (i.e. Cell and Gene) is an added advantage.

· Candidates with experience in ATMPs (Cell & Gene) manufacturing are highly preferred but not mandatory.

· Familiar and keeping up to date with current GMP and applicable GxP regulations and standards; experience with regulatory requirements such as Singapore/HSA, US/FDA, EU/EMEA, etc.

· Good understanding of GMP requirements in release testing (Potency, Identity, Content, Impurities, Microbiological safety assays).

· Experience in HPLC, Flow Cytometry, ELISA, dPCR/PCR, Assays and method qualification.

· Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).

· Strong analytical skills and the ability to interpret data to drive decisions and improvements.

· Able to work independently, self- starter, self-motivated and task oriented.

· Good communication skills and leadership skills to effectively collaborate with cross-functional teams.

· A thorough understanding of the principles and management of cGMP compliance, and a strong quality mindset.

· Must be able to work in a team as well as independently.

· Proven leadership and team management skills.

· Excellent communication and organizational skills.

· Experience with LIMS and other laboratory management systems.

· Experience in Laboratory Equipment Qualification is an added advantage.

· Will be able to commit 5 working days per week in a fixed pattern.

Apply now by submitting a Cover Letter and CV to jobs@escoaster.com.