Role Overview

The Vial Aseptic Filling Team Lead (Senior Manager) will play a key role in starting up a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Department Head of Commercial DP, this leader will serve as the operational end-user and primary point of contact for the vial filling area, including equipment, facilities, supporting systems, and utilities, as the site prepares for aseptic manufacturing.

You will build and lead high-performing manufacturing teams and oversee safe, efficient, compliant day-to-day operations. The role has a strong focus on critical aseptic processes, including isolator preparation, cleaning and decontamination, aseptic filling, stoppering, lyophilization, and capping. You will also lead operational readiness and New Product Introduction (NPI) activities for multiple products, supporting successful technology transfer, process validation, and commercial batch execution.

Key Responsibilities

1. Support installation, commissioning, and qualification of new manufacturing equipment; own or oversee key equipment packages for the vial filling area.
2. Develop, review, and implement operational documentation, including SOPs, master batch records, and work instructions.
3. Recruit, train, coach, and manage manufacturing personnel, including supervisors, to support validation activities and routine batch execution.
4. Lead compliant execution of aseptic operations, including part washing and packaging, sterilization, isolator preparation and decontamination, filling, stoppering, lyophilization, and capping, as applicable.
5. Ensure the manufacturing area and specified cleanroom environment meet applicable quality, safety, client, and regulatory requirements.
6. Partner with Engineering and Maintenance to coordinate timely calibration, maintenance, and validation of production equipment and supporting systems.
7. Collaborate with MSAT, Validation, Quality, and QC to develop procedures, prepare personnel, and deliver NPI, technology transfer, and process validation activities.
8. Interface with clients on technology transfer, NPI projects, and process validation, ensuring clear communication and effective execution.
9. Maintain current knowledge of cGMP and global regulatory expectations for aseptic manufacturing, including FDA, EMA, PIC/S, and ICH requirements.
10. Use and support production-related Quality Management System processes, including Change Control, Deviation, CAPA, and SAP transactions.
11. Provide operational oversight during off-hours when required to support manufacturing, validation, or site-startup needs.
12. Travel as needed for project oversight, site visits, and training, and be available for extended overseas training periods.

Qualifications and Experience

1. Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences, or a related discipline.
2. At least 12 years of experience in drug product manufacturing, including hands-on experience with aseptic processing.
3. At least 3 years of people-management experience, ideally leading manufacturing teams in a regulated production environment.
4. Direct experience with drug product manufacturing processes such as component preparation, formulation, sterilization, or related manufacturing operations.
5. Experience supporting equipment installation, qualification, operational readiness, process validation, or product introduction is highly relevant.
6. Experience in a fast-paced Contract Development and Manufacturing Organization (CDMO) environment is desirable.

Skills and Competencies

1. Strong knowledge of aseptic manufacturing principles, cGMP, cleanroom practices, and relevant regulatory expectations.
2. Demonstrated ability to develop and implement controlled procedures and maintain compliant production documentation.
3. Working knowledge of production QMS processes, including Change Control, Deviation, and CAPA; familiarity with SAP is expected.
4. Strong leadership, communication, and interpersonal skills, with the ability to develop teams and work effectively across functions.
5. Confident client-facing skills and the ability to contribute effectively to client and regulatory audits; direct audit experience is an advantage.
6. Fluent written and verbal English communication skills.
7. Comfortable working in multicultural and multinational environments; experience in such settings is preferred.
8. Flexible to support off-hours operations, business travel, and extended overseas training when required.