Aseptic Manufacturing Supervisor – Chicago
Global Life Science Hub is proud to partner with a specialised Biopharmaceutical company leading the charge of next-generation drug delivery technologies and oral//biosimilar drug development.
Having gathered 2 recent FDA approvals, they’re in the process of gearing up for exponential growth. With brand new in-house Manufacturing capabilities set to triple production in 2024, this is an exciting time to join the train that is about to leave the station.
The Supervisor, Aseptic Manufacturing Operations, is a shift leader for the manufacturing operation and is responsible for producing high quality products in accordance with regulatory requirements to achieve the operations production plan. This employee must maintain effective employee relationships, compliance to cGMP and other regulatory and SOP requirements, as well as environmental, health and safety obligations and company policies.
- Provides daily supervision on the floor to personnel in the efficient use of equipment and materials to produce quality products under cGMP in accordance with the production plan.
- Provides coaching, counseling, development, discipline and recognition of direct staff, including performing annual performance reviews.
- Responsible for maintaining alignment with department direction, goals and objectives.
- Promotes the use of safe work practices during all production and ensures all external and company policies and EHS standards are met daily.
- Responsible for training personnel on equipment, processes and Standard Operating Procedures (SOPs).
- Trains and develops personnel, develops and maintains packaging schedules, and manages within the department budget.
- Ensures that projects are completed on schedule per established procedures.
- Participate in execution of qualification and validation activities.
- Participate in process related investigation(s) and implement CAPA derived from investigation outcome in timely manner.
- Author and reviews SOPs and other documents to ensure integration of cGMPs and improve process efficiency.
- Works collaboratively to ensure flow of product, sharing of best practices and lean behaviors.
- Performs process monitoring, including use of databases, documents and/or spreadsheets to support business reporting requirements.
- Performs ongoing operational tasks of organization unit, actively assists, or provides direction to subordinates as required.
- Responsible for final review of completed documentation per compliance standards and establish timelines.
- Investigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management.
- Participation and/or leadership role in multi-functional project teams as necessary.
- Other tasks as requested by management.
- Bachelor’s degree, in a life science field is a must, preferably in engineering
- Aseptic Processing experience preferred
- PFS and Vials manual visual inspection experience
- Finished Product packaging experience with Serialization preferred
- Prior aseptic process execution and supervisory experience is strongly preferred
- Previous biotechnology experience in a pharmaceutical environment is preferred
- Knowledge of FDA cGMPs
- Strong communication and leadership skills
- Strong problem-solving skills
- Strong technical writing skills with ability to author SOPs and deviations
- Proven ability to lead operational teams
- Ability to lead/participate in cross-functional teams
- Competent with MS Office Applications
- Leadership and professional development of others
- Knowledge of current Code of the Federal Regulations (CFRs) and current Good Manufacturing Practices (cGMPs)
- Problem solving
- Planning and documentation
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com