Job Summary:
We are seeking a highly skilled and experienced professional to lead our team in the development of manufacturing processes, ensuring world-class quality and operational excellence.
Key Responsibilities:
* Team Development: Mentor and develop team members, fostering a collaborative and inclusive work environment. Encourage a robust workflow, contribute to successful manufacturing campaigns, and implement effective succession planning.
* Cross-functional Collaboration: Work closely with Quality Assurance, Quality Control, Manufacturing Science and Technology, Engineering, Validation, and other relevant departments to define and implement robust process parameters, ensuring world-class manufacturing quality.
* Technology Transfer & Operational Readiness: Support Technology Transfer and operational readiness activities by implementing new production processes and lines, playing a crucial role in our growth and industry leadership.
* Process Validation: Oversee CVQ, PQ, and Process Validation, ensuring meticulous adherence to quality standards and GMP rules. Drive continuous quality improvement and timely reporting and follow-up on deviations.
Requirements:
* Education: Bachelor's or Master's degree in Chemistry, Biochemistry, Biology, Food Science, or equivalent experience in the field.
* Experience: 5-7 years of experience in pharmaceutical operations in a GMP-relevant environment. Expertise in biotech or pharma processes, including Media and Buffer preparations, weigh and dispensing, CIP/SIP, and sterile processes is an advantage. Strong knowledge and competence in automated processes.
* Leadership: Previous experience successfully leading teams.
Leadership Qualities:
* Integrity: Set an example for your team by upholding ethical standards and personal accountability.
* Customer Focus: Champion a strong focus on customer satisfaction, seeking ways to improve operational efficiency and drive our ambition to be a world-class organization.
* Talent Development: Attract and develop exceptional talent, removing barriers to success and creating a motivating work environment.
* Strategic Leadership: Develop strategic objectives, prioritize work and resources, and cultivate a culture of excellence to inspire your team to continuously strive for success.
Additional Requirements:
* Shift Rotation: Work on a shift rotation model, including weekends, nights, and public holidays. Availability for on-call duties as per the schedule.
* GMP Safety Standards: Strict adherence to all Good Manufacturing Practices (GMP) Safety Standards is required.
* Cleanroom Environment: Maintain personal grooming and protective measures, including not using hair products, jewelry, makeup, nail polish, perfume, or exposed piercings. Facial hair and eye contacts are not allowed.
* PPE Requirements: Personal Protective Equipment (PPE) is required, including safety glasses, gowning, gloves, lab coat, and ear plugs.
* Physical Demands: Ability to stand for a full shift.