MSAT Product Owner

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee and manage the portfolio of solid oral, liquid, sterile, and topical dosage products.

• Provide technical leadership for specific products or product families at both local and global levels.

• Act as the Technical Product Owner throughout the entire product lifecycle.

• Direct the introduction of new products, technology transfers, scale-up processes, validation, and the transition to manufacturing sites and contract partners.

• Maintain in-depth technical knowledge of products, monitor performance, ensure process capability, robustness, and facilitate continuous process verification.

• Evaluate and authorize technical changes utilizing risk management tools.

• Uphold current product control strategies and risk mitigation plans.

• Lead investigations and root-cause analyses for deviations, complaints, CAPAs, audit findings, and intricate product performance challenges.

• Prepare and assess risk evaluations, specifications, validation documentation, qualification papers, and periodic product reviews.

• Assist the PLM lead in implementation and sustainability efforts.

• Aid in statistical analysis and the development of statistical capabilities in ES India.

• Collaborate with Quality, Operations, Engineering, R&D, suppliers, and global sites.

• Mentor teams to enhance technical and statistical expertise.

⛳️ Requirements

• M. Pharm. (Pharmaceutics) with a maximum of 5 years of experience.

• Specialization in pharmaceutical manufacturing, technical operations, MSAT, or product ownership.

• Experience in new product introductions, technology transfers, or lifecycle management.

• Proven experience in leading technical investigations, root cause analysis, and corrective actions.

• Experience managing the technical aspects of the product lifecycle, including technology transfers, technical risk assessments, product control strategies, process capability/robustness, QbD, validation, and change control.

• Understanding of Good Manufacturing Practices (GMP) and product quality standards.

• Ability to lead line and matrix teams in a technical capacity.

• Familiarity with external regulatory requirements, including MHRA and FDA.

• Knowledge of various product dosage forms and manufacturing processes.

• Proficient in data analysis, statistical tools, or digital product lifecycle management tools.

• Experience collaborating in a matrix organization across diverse geographies and cultures.

• Strong project management and resource management skills.

• Ability to utilize and interpret data for both tactical and strategic decision-making.

• Familiarity with operational excellence tools such as FMEA and MSA.

• Background in packaging components, primary containers, or device qualification.

• Experience with sterile, liquid, solid, or topical dosage forms.

• Knowledge of validation protocols, qualification activities, and risk assessments.

• Experience in process validation, scale-up, and technical transfer.

• Understanding of dosage-form unit operations, formulation-material functionality and criticality, plant equipment, and analytical testing.

• Level 1 Practitioner for TRAs, or familiarity with PLM toolsets and their site advantages.

• Knowledge of regulatory frameworks within product markets.

• Proven track record in product/process improvement and conducting technical trials and validation activities.

• Comprehensive understanding of GMP and EHS standards.

• Ability to analyze and interpret statistical data, including process capability, control charts, DoE, and MSA.

• Excellent English communication skills and proficient technical report writing capabilities.

🏝️ Benefits

• Inclusion and adjustments to the recruitment process available upon request.

• Opportunity to work for a global biopharmaceutical company that specializes in medicines and vaccines.

• Environment designed to foster employee growth and wellbeing.