Program Manager

SUMMARY                                                                                     

Ascential Medical & Life Sciences is a contract manufacturer for medical and combination devices. We work side-by-side with our customers in the development of the manufacturing process of new products.  We increase manufacturability by implementing continuous improvement, (processes, fixtures, tooling and custom automation), produce batches, and ensure compliance with all regulatory bodies required for the production of Medical Devices, Combination Devices, and Pharmaceutics. 

Candidates with previous experience manufacturing pharmaceuticals, who are familiar with FDA 21CFR parts 210 and 211 are preferred. Experience with FDA 21CFR part 820 for medical device is also applicable.

As a Program Manager you must have a strong organizational and project-based background. You will serve as a direct contact for both internal employees and our customers, and be responsible for coordinating program activities, timelines, program budgets, compliance, etc.

The ability to communicate technically and manage the details of these production lines is critical. A strong desire to provide a high level of customer service and develop key customer relationships is needed.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Create and manage project activities, schedules, and financial budgets.
• Identify and manage risk in projects and corresponding activities.
• Organize and prioritize general action items.
• Communicate with project members, management, customers, and key stakeholders.
• Manage customer communications, requests, concerns, and priorities.
• Execute project activities including document writing, quality system setup, part inspections, labeling, etc.
• Hold project meetings, document meeting minutes, capture and communicate action items.
• Generate meeting minutes and project records; maintain customer communication throughout project duration.
• Assemble necessary documentation sets for internal/external manufacturing.
• Participate in weekly project status meetings.
• Monitor and track project costs..
• Generate customer change request and obtain appropriate approvals, document correspondence.
• Monitor and track project schedules, staying on schedule.
• Coordinate shipping and delivery issues, verify internal signoffs, documentation needed to ship a product.
• Retrieve manufacturing documentation, update as needed.
• Archive project notes, data, folders, etc.
• Generate additional opportunities with existing customers.
• Facilitate and mediate issues.
• Work with management to accomplish program goals as needed.
• Provide continual updates and status to management.
• Bring customer feedback and/or concerns to management.
• Participate in existing and future business development and strategic planning.
• Be willing to accept varying assignments when economic conditions warrant.

OTHER DUTIES AND RESPONSIBILITIES

• Maintain a high personal level of quality.
• Help assure compliance to regulatory and customer quality requirements.
• Create and improve company processes and procedures.
• Participate in team building, training, and departmental communications.
• Manage corporate risk by evaluating projects and making recommendations.
• Work as a team player with management and co-workers to develop a win-win partnership through positive relationships and excellent interpersonal skills.
• The goal of each team member - and the team as a whole - is to create effective communications that help all employees clearly understand overall company objectives and the role they play in helping meet those objectives.

 

QUALIFICATIONS

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must have several years of experience as a Program Manager, Project Manager, Manufacturing Engineer, or other related field.
• Must have experience in a Manufacturing Industry, Medical/Combination Device or Pharmaceutics is preferred. IT, Tech, Finance, or other industries are not applicable.
• Must have a bachelor’s degree.
• Must be PMP certified.
• Must have very strong organizational skills.
• Must be a strong team leader and member.
• Must have knowledge of MS Windows operating system and products.
• Must have knowledge in applying basic mathematics, and algebra skills.
• Must have strong written and verbal communication skills in the English language.
• Must have reliable transportation.