Job Title: Sr Executive – Formulation Development
Company: Apotex Inc.
Location: Bangalore, Karnataka, India – 560099
Job Type: Full-Time
Experience Required: 6–8 Years
Education: Diploma or degree in Chemistry, Pharmaceutical Technology, Engineering, or a related scientific discipline
About Apotex
Apotex Inc. is a Canadian-based global healthcare company committed to improving access to affordable and innovative medicines worldwide. The company develops and manufactures a broad range of pharmaceutical products including generic medicines, biosimilars, innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, Canada, Apotex operates globally with regional offices in the United States, Mexico, India, and other international markets. The organization is recognized as the largest Canadian-based pharmaceutical company and a trusted partner for pharmaceutical licensing and product acquisition.
Job Summary
Apotex is seeking an experienced professional for the position of Sr Executive – Formulation Development to support pharmaceutical product development activities. The role involves designing experimental approaches, analyzing scientific results, and generating reliable development data to support formulation and process optimization.
The selected candidate will be responsible for formulation optimization, scale-up activities, and process evaluation using scientific principles such as Quality Target Product Profile (QTPP), Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs). The role also supports development, stability, and submission batches while ensuring compliance with Good Manufacturing Practices and regulatory requirements.
Key Responsibilities
Execute formulation development experiments, process evaluation trials, and scale-up batches as per project requirements.
Conduct formulation optimization studies and experimental trials to support development of pharmaceutical products.
Perform weighing, mixing, screening, and blending of raw materials to produce experimental, pilot, and small-scale batches of tablets, capsules, pellets, powders, and liquid formulations.
Support manufacturing of immediate release, delayed release, and controlled release solid oral dosage forms.
Assist in early-stage product development, stability studies, and submission batches for regulatory filings.
Ensure formulation development laboratories and equipment are dismantled, cleaned, sanitized, and assembled according to established SOPs and technical manuals.
Perform in-process quality checks such as weight variation, hardness, thickness, friability, and disintegration testing during trials and batches.
Maintain in-process testing laboratories and ensure timely delivery of samples to analytical teams.
Prepare and complete batch documentation and process records accurately during execution of development activities.
Identify and troubleshoot process deviations, analyze root causes, and recommend corrective actions where necessary.
Suggest improvements to experimental methodologies and optimization strategies to enhance development processes.
Review trial and batch documentation for completeness and accuracy before submission to supervisors.
Coordinate with procurement teams to ensure timely availability of APIs, excipients, and tooling for development activities.
Collaborate with plant operations and scheduling teams to ensure timely execution of experimental trials and registration batches.
Work with documentation teams to prepare and manage early development trial documents, process evaluation reports, and optimization records.
Coordinate with analytical laboratories for sample testing requirements and timelines.
Support preparation of manufacturing and packaging documentation for regulatory submissions.
Conduct literature reviews and patent searches to support formulation development strategies.
Participate in training programs, scientific seminars, and technical discussions to maintain expertise in pharmaceutical formulation development.
Investigate formulation and process-related issues using scientific approaches and advanced troubleshooting techniques.
Ensure all development activities are conducted in compliance with GMP, GLP, GDP, safety regulations, and company policies.
Promote teamwork and collaboration while demonstrating organizational values of Collaboration, Courage, Perseverance, and Passion.
Required Skills and Competencies
Strong theoretical and practical knowledge of solid oral dosage forms including immediate release, delayed release, and controlled release formulations.
Good understanding of pharmaceutical manufacturing processes and related equipment.
Knowledge of Quality by Design (QbD) concepts including QTPP, CMAs, CPPs, and CQAs.
Strong documentation and analytical skills.
Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.
Excellent verbal and written communication skills in English.
Ability to work effectively in cross-functional teams within a pharmaceutical research and development environment.
Knowledge of regulatory requirements including GMP, GLP, GDP, and international regulatory guidelines.
Experience Required
Candidates should possess 6–8 years of experience in a pharmaceutical research and development environment, particularly in formulation development of solid oral dosage forms for regulated markets. Experience in scale-up, technology transfer, and product development activities will be highly preferred.
Equal Opportunity Statement
Apotex is committed to fostering an inclusive and accessible workplace where employees feel respected, valued, and supported. The company provides accommodations for applicants with disabilities throughout the recruitment process. Candidates who require assistance during interviews or assessments are encouraged to inform the recruitment team.
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