Reports to: Quality Control Manager

Section/Department: STORES/WAREHOUSE

Purpose

To provide scientific and technical expertise in analytical development to support the development, characterization, optimization, validation and transfer of new pharmaceutical formulations. The role will develop fit-for-purpose analytical procedures and generate reliable analytical data to support pre-formulation, formulation development, product quality, stability, regulatory requirements and successful transfer of products to manufacturing.

Key Responsibilities

• Develop, optimize and implement analytical methods for new pharmaceutical formulations, ensuring that methods are fit for purpose and suitable for use throughout the product development process.

• Conduct literature reviews to identify relevant scientific information, analytical approaches and regulatory requirements that support formulation and analytical development activities.

• Develop and draft product specifications for new formulations, using applicable pharmacopoeial monographs, regulatory requirements and appropriately developed in-house analytical methods.

• Characterize APIs, drug products and reference comparator products during pre-formulation and product development, interpret the results and prepare clear technical reports for the Formulation Development team.

• Plan and conduct comparative dissolution studies between test products and reference comparator products to support assessment of pharmaceutical equivalence and formulation performance.

• Develop and execute cleaning validation protocols for new products developed by Formulation Development and prepare the corresponding technical reports.

• Develop and perform analytical method validation and verification studies, ensuring that analytical methods are reliable, reproducible and suitable for their intended purpose, and prepare the associated validation reports.

• Support analytical method transfers when products move from Formulation Development to Manufacturing or Quality Control, ensuring that methods can be successfully and consistently implemented.

• Develop stability study protocols, coordinate and conduct stability studies, evaluate analytical results and prepare comprehensive stability reports to support product development and quality assessment.

• Conduct impurity profiling of drug substances and products, including the identification, characterization and quantification of impurities, and assess results against applicable acceptance criteria and regulatory requirements.

• Design, coordinate and execute experimental studies related to biopharmaceutical characterization, and interpret and report the results to support drug product development.

• Keep up to date with and support the evaluation of new analytical techniques, automated laboratory workflows and biorelevant testing approaches that can improve pharmaceutical development and analytical capability.

• Prepare and maintain analytical protocols, reports, specifications, study records and other technical documentation required to support product development and technology transfer.

Qualifications, Skills and Experience: 

Qualifications

Bachelor’s degree in chemistry, or a closely related scientific discipline from a recognized institution.

Experience

Minimum of 3 years working experience in a pharmaceutical laboratory environment.

Skills and Competencies 

• Strong laboratory and analytical skills, with the ability to accurately perform, interpret and document analytical testing.

• Working knowledge and hands-on experience with analytical instruments, particularly HPLC and GC.

• Strong technical report writing, scientific documentation and data interpretation skills.

• Strong problem-solving and analytical thinking abilities, with a systematic approach to investigating analytical issues.

• Ability to troubleshoot analytical methods and identify potential causes of unexpected or atypical analytical results.

• Ability to work effectively and collaboratively with cross-functional teams

• Strong communication, presentation and interpersonal skills.

• High level of attention to detail, scientific integrity and commitment to data quality and data integrity.

• Good understanding of laboratory procedures, GMP/GLP requirements and applicable analytical standards.

How to Apply

Interested persons who meet the above requirements should hand deliver or email their applications and resumes with supporting documents, with the “Role Name” as the subject to the Qcil Front Desk, or recruitment@qcil.com.

Deadline for receiving applications: Friday 25^th September 2026.

Only short-listed candidates will be contacted. Qcil is an equal opportunity employer and therefore lobbying for the above position will lead to automatic disqualification.