Stability Senior Associate

Stability Senior Associate

PURPOSE

The Stability Senior Associate plays a crucial role in supporting the Stability Lab at the senior level within the BCH enterprise. This position is responsible for assisting in analytical testing processes, methods, and stability studies to ensure the quality and compliance of products developed and manufactured by BCH. The position focuses on providing support in analytical testing, sample preparation, and documentation under the guidance of Stability Managers and the Stability Hub lead. As a Stability Associate, you will play a pivotal role in ensuring the quality, reliability, and compliance of all products developed and manufactured by BCH through consistent and accurate methods and stability studies. This role is ideal for individuals looking to develop their career in the pharmaceutical or biotechnology industry.

MAJOR TASKS & RESPONSIBILITIES

Assist in the analytical validation and transfer of stability testing programs, as directed by the Stability Hub Lead.

Support the execution of stability studies, including sample and reagent preparation, sampling, instrument use, data processing and documentation. Support stability testing activities to assess the shelf-life and performance characteristics of products.

Assist and perform basic calibration and maintenance of laboratory instruments and equipment, ensuring proper functionality and accuracy.

Review and record test data, and assist in the preparation of reports.

Follow standard operating procedures (SOPs) and safety protocols to maintain a safe and clean working environment. Maintain a clean and organized laboratory environment, adhering to safety guidelines.

Follow established protocols and procedures to ensure accurate and reliable results.

Stay updated with regulatory changes, the latest stability techniques and technologies through continuous learning and training opportunities.

Collaborate closely with cross-functional teams, including BCH Quality Control and CMO laboratories, R&D Centers of Excellence, R&D Innovation Centers, Quality Assurance, and IT, to drive alignment, coordination, and shared responsibility for product development, quality, and continuous improvement initiatives.

Contribute to continuous improvement initiatives within the lab, suggesting ideas and implementing best practices.

SKILLS & REQUIREMENT

Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology, Pharmacy), or international equivalent, with +5 years of prior experience in analytical development, stability testing, and laboratory management within the pharmaceutical or biotechnology industry. Master’s degree or higher, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent is a plus.

Knowledge of regulatory guidelines (e.g., FDA, EMA) and industry best practices related to analytical validation and stability testing.

Basic knowledge of laboratory safety practices and procedures.

Knowledge in analytical techniques such as HPLC, GC, dissolution testing, and spectroscopy.

Familiarity with statistical analysis softwares and data management systems.

Familiarity with regulatory requirements and quality standards related to analytical validation and stability testing is a plus.

Good communication and interpersonal skills, with the ability to work effectively in a team environment.

Good English communication skills, both written and verbal. Other languages are a plus.

Excellent organizational and time management skills, with the ability to prioritize tasks.

Strong attention to detail and the ability to follow instructions accurately.

Good computer skills, including proficiency in MS Office applications.

Enthusiasm for learning, adapt to changing priorities, and contribute to a positive and dynamic work culture.

Desire to develop a career in analytical support and lab stability.

Application Period: 04/12/2025 Reference Code: 857886

Division: Consumer Health Location: Indonesia : West Java : Cimanggis

Functional Area: Quality Position Grade: R.13

Employment Type: Regular Work Time: Standard

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