MANUFACTURING SUITE POINT OF CONTACT (CT)

United States, Portsmouth (New Hampshire)

Manufacturing Suite Point of Contact

Role Purpose

The role of the Manufacturing Suite Point of Contact is to act as a controller, providing essential duties to support the respective production suite, Supervisor and Manager. This position allows both the Supervisor(s) and the Manager to be present on the floor; to oversee critical operations, coach and develop their teams, and

ensure systems and activities are set up and working to deliver expected results under minimal direction. On a daily basis, the POC is expected to have a full understanding of the schedule and the process; promoting adequate assessment and response of any production needs. The POC will be responsible for fulfillment of

immediate requests from the Mfg. support departments including, but not limited to, approval for WO commencement for calibration and facilities/suite maintenance, QA tag out placement and removal, and response to customer or MSAT process related inquiries. Outside of daily requests, the Suite Point of Contact will own the suite specific planning schedule and Mfg. activities including, Engineering/validation testing, PMOP’s, changeover, and column packs and unpacks, as applicable. The Purification POC will also be responsible for resin, mesh and membrane management. To further support the daily operation of the suite, the POC will assist the Supervisor and Manager with immediate triage response; aide in trouble shooting, attend cross-functional meetings to determine and plan for

a path forward, own immediate follow-up actions, communicate path forward to all shifts and provide necessary input into the deviation investigation.

Primary Accountabilities, Duties and Responsibilities

• Provide on the floor support for respective area, Supervisor(s) and Manager
• Work cross-functionally with Scheduling to identify and plan for any non-routine suite and equipment windows needed o Engineering work, validation, etc.
• Coordinate and approve Mfg. support department requests for work in suite o Calibration, facilities/suite maintenance, elastomer team, etc.
• Provide response to MSAT/Customer process related inquiries
• Resin, mesh and membrane management o Cycle counts, scrap form completion, disposal
• MFG process specific change controls, CAPA’s, Laboratory Investigation Reports (LIR), Validation activities.
• Own suite specific planning schedule
• Plan changeover, packing/unpacking activities, restores (as applicable for area)
• Coordinate PMOP work across shifts
• Collaborate with area leaders to ensure the resources are available to support above deliverables at requested times.
• Support immediate triage response
• Aide in troubleshooting
• Attend cross-functional meetings to provide input into path forward
• Own immediate Mfg. follow-up actions (ie. batch record redlines)
• Provide detailed communication to suite and provide input into deviation investigation.
• Supported by the manager, own and drive major investigations (contaminations, CPP failures, etc)
• Perform risk assessments and/or justifications for forward processing, when applicable
• Administrative tasks –attending shift exchange and daily production meetings, sending/receiving emails, training, etc.

Business Acumen

• Able to make unbiased, accurate and timely decisions utilizing vast operational and process knowledge and experience.
• Considers the width and depth of the respective issue, the potential impact to the product, business, customer (internal and external) and schedule; considers all options for solutions including risks, pros and cons and full impact before making a decision.
• Is engaged in identifying, promoting and implementing operational improvements; focused on key business drivers meant to create efficiencies, consistency, quality, right first time and reduce costs.

Driving Results

• Able to plan, prioritize and deliver to schedule; understands standard times required to complete tasks and is able to create realistic timelines to deliver to.
• Utilizes organizational tools to ensure milestones and associated deadlines are being met; escalates or ensures risk mitigation is in place if not met.
• Able to understand the big picture and creates schedules that support it Works directly with the Supervisor to ensure planning schedule workload is appropriate and can be managed with the available resources, and other production needs.
• Focused on right first time, creating systems and implementing improvements that meet high quality standards to deliver excellence during execution

Agility

• Maintains an open mindset, treating change as an opportunity for learning and growth; in respective area
• Challenges what has been done in the past and seeks to identify and implement a new and more efficient way of working.
• Avoids short term fixes and focuses on removing barriers to create long term solutions.
• Engages with cross-functional teams to influence decisions, ensuring the best decision is made for Mfg., the process and the business.
• Able to quickly identify and resolve potential setbacks associated with new systems, schedules and the triage of events; understands the bigger picture outside of area of expertise.
• Takes personal responsibility for change; embraces new initiatives, speaks positively of them and manages the message to communicate the benefit.

Collaboration

• Works as member of various teams, across shifts, and with all support departments; actively participates and is committed to the team and the success of the team.
• Seeks to transfer knowledge across shifts and support functions; educates individuals on the “why’s” to promote a deeper understanding.
• Actively seeks different perspectives through a broad network of team members, peers and support departments.
• Acts as a champion of Manufacturing and business core values; influencing behaviors, attitudes and actions.
• Able to be convincing and influential when presenting ideas and solutions to achieve the best result for Mfg. and the business; drives to get resolution and support from peers, Management and support functions

Leadership

• Takes accountability for own actions and decisions; avoids placing blame or making excuses and learns from experience to avoid future recurrence.
• Leads by example in all core values and beliefs; demonstrates high integrity, strong GMP principles, safe and engaging working environment.
• Promotes a positive work environment, even in the face of adversity; remains focused on solutions instead of roadblocks, and works to instill this mindset into others.

Actively seeks feedback to enhance self-awareness; open to performance and behavioral feedback to further improve relationships and interactions.

Reference: R61406