2nd shift Aseptic Manufacturing Supervisor
- Hunt Valley, MD
- $81,400-146,500 per year
- Permanent
- Full-time
- Lead a team of manufacturing technicians.
- Produce clinical and commercial material on an annual basis that meets the site's strategic objects and is compliant with cGMPs and safety regulations.
- Performs training with staff on the floor, as needed.
- Point person on shift to assign/distribute the work and coordinate emergency situations.
- Performs training with staff on the floor, as needed.
- Maintain aseptic qualification training.
- Support and demonstrate skill set to Manufacturing Technician I, II, and III.
- Ensure documentation (batch records and SOPs) are accurate and updated as required.
- This role is responsible for the accurate, safe, environmentally responsible, and quality compliant operations of the manufacturing process.
- Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuously improvement.
- Recommends equipment, supply purchases within the production areas.
- Exhibit safety leadership by example (e.g., utilize proper PPE when performing job functions)
- Responsible for shift schedule and summarizing shift progress at the end of the shift.
- Lead and mentor staff. Write performance reviews and annual goals, hold one-on-ones.
- Effectively communicate results of departmental work through team discussions and documentation
- Ensure cGMP compliance and all its related elements in documentation, reports, and records.
- Initiate non-conformances when identified and complete investigations to support on-time closure of deviation.
- Understand and review current regulations, industry guidance, and other applicable professional documentation.
- Additional duties, as assigned.
- B.S. in Engineering or Science discipline highly preferred
- Minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations, related technical field, or equivalent industry experience. (Some or all this experience should be in fill/finish processing), or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
- Experience with GMP fill finish operations and sound understanding of the drug development process.
- Aseptic Filling or Pharmaceutical Manufacturing experience: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices.
- Has considerable knowledge/expertise relevant to fundamental Fill/Finish manufacturing operations.
- Has sound understanding and knowledge of all fill finish operations including aseptic hand filling and automated filling of liquid vials.
- Demonstrated track record of leading or supervising hands-on cGMP manufacturing operations.
- Demonstrate skill/experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC, MC, and other manufacturing groups) to maintain internal and project schedules.
- Demonstrated ability to motivate and mentor peers, staff, and foster a culture of continuous improvement and operational excellence.
- Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
- Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
- Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
- Must be able to comprehend and follow all applicable SOPs.
- Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
- Demonstrated knowledge on current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Demonstrated thorough understanding of cGMPs, industry, and regulatory standards and guidelines.
- Demonstrate experience with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Demonstrated ability to execute a task, unit operation and/or document (forms and/or SOPs) with little to no assistance.
- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
- Demonstrate the ability to work well in a cross-functional team environment.
- Must communicate fluently in English and have legible handwriting.
- Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to lift up to 40 pounds on occasion.Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
- Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
- 401K Match
- Employee Stock Purchase Plan
- Paid Time Off
- Tuition Reimbursement
- Life, AD&D, and Disability Insurance
- Commuter Benefits
- Employee Assistance Program
- Pet Insurance
- Adoption Assistance
- Annual Merit Increases
- Community Volunteer Opportunities