Project Manager – Chromatography Resin Products

Project Manager – Chromatography Resin Products

Job Title:

Job Code: 21255

Job Description:
To support the detailed design, construction, CQV activities, and start-up of a new facility, seeking an experienced Project Manager to join our highly skilled team. Must have proven senior management experience in a highly dynamic setting. Skills of organization, communication, and leadership will help develop solutions that push innovative boundaries along with working closely with executives to strategize and develop long-term plans that usher in new levels of productivity and success at Sepax. This is a full-time exempt position to be located in Middletown, Delaware.

Requirements:

• Bachelor’s degree or higher in a science discipline
• 5-10 years of project management experience in a fine chemical manufacturing operation, chromatography resin products manufacturing operation including chemical and fermentation & DSP processes, and GMP fill/finish operation
• Demonstrate Safety First through own proactive action/commitment across business areas, and expect and coach subordinates to do likewise.
• Working knowledge of manufacturing and R&D operation
• Good knowledge of GMP/FDA/ICH and implementation
• Strong teamwork spirit
• Strong communication and partnering skills
• Extreme attention to detail, accuracy, and confidentiality
• Mandarin experience is a plus

Responsibilities:

• To build and manage project teams, ensure team collaboration and competitiveness, and drive the team to complete project execution.
• Ensuring compliance and legality of project execution in accordance with company policies, state and federal regulations and laws.
• Establish and manage project team communication strategies, facilitating and encouraging multi-level project meetings.
• Implement a project management plan that outlines processes to include at minimum budget management, schedule management, construction management, safety management, change & deviation management.
• Manage the project change process as per the Project Change Management Plan. Track changes in project scope impacting the cost and schedule.
• Monitoring costs and progress, and providing guidance when necessary.
• Manage problems in project implementation and report them in a timely manner.
• Implement a sound project management process (PEP) including budget management, schedule management, construction management, safety management, verification management, change and deviation management, etc.
• Manage the project change process and review/approve changes involving project scope, cost and schedule.
• Host cross-functional meeting with internal and external teams to solve project problems.
• Support client project deliverables.
• Manage and organize the facility.
• Customer centric approach to day-to-day activities.
• Manage the site investment processes for assets (planning, prioritizing, resourcing, project management, capital accounting and reporting).
• Manage by the company values of Integrity, Excellence and Respect for People.
• Manage resources according to site priorities and anticipate future business needs.
• Promote continuous improvement culture across site (strive for excellence).
• Have external focus, benchmark best practices across network and external.

Company Overview:
Sepax is a fast growing technology company and has emerged as a leader in the biological separation industry. Sepax has been developing a wide range of intellectual properties in the areas of particle synthesis, surface modification, LC column packing, bulk media production, and purification process development. Sepax Technologies, Inc. focuses on three business areas: 1) bioanalytical solutions, 2) solution based process purification and 3) medical diagnostics. Sepax Quality Management System is ISO 9001:2015 certified.

Sepax Technologies Inc. is an Equal Opportunity Employer.

To Apply: Please submit your cover letter and resume to hr@sepax-tech.com