Description

In this role, you will lead efforts to ensure sterility assurance for parenteral products, with a focus on compliance, process optimization, and scientific understanding. Your daily responsibilities will include evaluating risks, mentoring team members, and representing the site during audits.

Requirements

• •BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
• •In-depth knowledge and understanding of GMPs and internal standards
• •In-depth knowledge of parenteral processing
• •In-depth knowledge of microbiology and sterility assurance
• •In-depth knowledge of risk management and risk assessment tools
• •Ability to analyze complex data and solve problems
• •Strong technical writing and presentation skills
• •Teamwork and interpersonal skills to effectively influence
• •Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
• •Prior experience in multiple functions associated with manufacture of parenteral products
• •Minimum 7 years’ experience in the biopharmaceutical industry
• •Advanced Degree in Microbiology, Biology or related scientific field preferred
• •BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline

Tasks

• •Develop and implement a technical agenda for sterility assurance
• •Ensure reliable and compliant manufacturing of drug products
• •Improve process control strategies and optimize technologies
• •Enhance scientific understanding of sterility assurance
• •Maintain a safe work environment and support HSE goals
• •Understand scientific principles for manufacturing parenteral products
• •Evaluate manufacturing processes for sterility assurance risks
• •Lead complex projects related to sterility assurance programs
• •Develop and execute monitoring strategies for microbial risk
• •Conduct root cause analysis for major deviations in sterility assurance
• •Stay updated on external regulatory requirements for sterility assurance
• •Influence revisions to corporate guidance on sterility assurance
• •Identify and implement continuous improvements in sterility assurance
• •Provide design input for new processes and facilities
• •Represent sterility assurance programs during audits and inspections
• •Assist in writing regulatory submissions for sterility assurance
• •Create and approve sterility assurance training for new hires
• •Mentor less senior scientists within the TS/MS organization
• •Offer technical consultation across the Parenteral Network