Manufacturing Supervisor, Formulation Filling
Site Name: USA - Montana - Hamilton
Posted Date: Oct 14 2019
Are you looking for an opportunity to lead the production planning delivery within the safety, quality, planning and budget in a complex and highly regulated environment? If so, this is the role for you.
As a Manufacturing Supervisor, you will:
Leadership of a team providing, timely cost-effective delivery of MPL to their customer.
Supervise the team to meet required quality, compliance and delivery targets of our commercial product.
Ensure manufacturing operations are executed in cGMP compliant manner and meet company standards.
Manage the training and qualification of the staff to ensure all operating procedures are followed.
Develop skills, supervise, lead and motivate a multi-discipline team.
As a member of the Value Stream team, be responsible for the value stream and site results and develop and maintain a customer focus.
This role will give YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Responsible for application of approved EHS and Process Safety standards and regulatory compliance. Accountable for EHS performance within their area of responsibility. Promotes a highly safety conscious culture and EHS focused workforce. Core competency regarding process safety management program within area of responsibility and assistance with the development of processes and procedures to ensure sustainability.
- Ensure all activities are executed following quality and regulatory standards. Promote a quality mindset and quality excellence approach to all activities. Implement and monitor quality systems to achieve inspection readiness at all times. Promote and drive an effective risk management process. Adhere to all GSK Quality Management System policies and procedures as applicable for functional area.
- Assists with production planning to achieve the Value Stream and site objectives. Will be responsible for setting, monitoring, and achieving the objectives, metrics, and targets within area of responsibility. Will work in conjunction with other Value Stream supervisors to establish, monitor, and achieve yearly manufacturing and delivery plan.
- Ensure all relevant information and activities relating to production are tracked, captured, completed, and as needed, forwarded to management. Too include: Effective management of discretionary spend, coordination with TS to ensure equipment preventive and predictive maintenance and calibrations are appropriate and executed on schedule an in a cost-effective manner, and VS personnel coordinate, cooperate, and participate with QC in environmental monitoring and production processes.
- Drive and embed the use of operational excellence tools and techniques to realize ever increasing levels of value from operations. Additionally, the Supervisor will follow these key behavioral characteristics for this job role: Set direction & inspire, Work across boundaries, Release energy, Develop capability & talent, Drive performance, and Live our values.
- Responsibility for supporting and developing others as a coach and mentor. Allocate important projects and challenging responsibilities to others for the purpose of their development. Ensure compliance with relevant policies, including but not limited to EHS, HR, Quality, and Financial policies. Ensure all direct reports have clear written performance and development plans and their performance is regularly appraised. Hold team members accountable for supporting the value stream ways of working at GSK Hamilton. Express the following GSK expectations, Set direction & inspire, Work across boundaries, Release energy, Develop capability & talent, Drive performance, and Live our values.
- Act as a change agent by having personal responsibility for supporting the Value Stream and site way of working at GSK Hamilton. Deal positively with change, demonstrating the ability to maintain high personal performance levels as the organization evolves. Positively influence others to adapt to change.
- Hold employees accountable for supporting the Value Stream and site way of working. Guide staff through the change process and hold them accountable for moving through the process in a positive way. Support cross-functional communication. In addition, the supervisor will instill pride and ownership within the organization.
- Participate in the Validation Master Plan for production operations in partnership with the Validation team. Drive the PQ Master Plan and manage PQ activities for area of responsibility, including development, writing, and executing, protocols and completion of final reports
- Duties may also include minimal handling of hazardous waste from production activities to satellite storage areas. Annual training on area-specific hazardous waste handling is required. This training satisfies annual RCRA training requirement for large quantity generators and is part of the site's RCRA compliance program.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in a technical/scientific field
- Strong interpersonal, written and oral communication skills
- Minimum of 5 years practical experience related to manufacturing, process development, and/or quality assurance in a biopharmaceutical environment
- Experience in cGMP environment focused on design, qualification, and troubleshooting of processes and equipment
- Regulatory inspection experience
- Knowledge of biological/vaccines manufacturing and its management, including relevant regulations governing the manufacture and supply of pharmaceutical products
- Demonstrate ability to instill a proactive, "can do" attitude within a team
- Good organizational and leadership skills; ability to lead a team and make critical decisions
- Demonstrate ability at working both as an individual and groups in a dynamic multi-tasking environment.
If you have the following characteristics, it would be a plus:
- Experience in Formulation Filling
- Organizational and leadership skills with ability to effectively delegate work
- Ability to prioritize and flexibility to adapt to changing business schedules and deadlines
- Good communication, organizational, and team skills
- Ability to take initiative and work proactively with creative problem-solving skills
- Experience in Quality Risk Management
- Root cause analysis: experience with investigation and troubleshooting automation and control
- Strong technical writing skills
- Influence, persuasion, and or change management
- LEAN, OE, or similar continuous improvement methodologies
- Strong interpersonal communication skills and ability to thrive in a dynamic team environment
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritisation, execution, delivering performance.
- Setting strategic direction and leading on-going organisational transformation.
- Building a resilient organisation.
- Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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