Program Manager

Job Location:

College Station, TX - USA

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Program Manager with mentoring and support from the Head of Program Management and/or Associate Program Director or Program Director will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to program delivery including technology transfer and taking a product/process from execution of a CSA/MSA through process development and early stage clinical supply through program closure. The Program Manager role is a lead role that ensures the organization provides services in alignment with contractual commitments to the clients and the Companys vision/mission (strategy and compliance).

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples lives.

From developing the next vaccine to advancing cell and gene therapies we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If youre ready to help transform the future of medicine join FUJIFILM Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station Texas which combines a small-town feel with vibrant culture top-notch schools and close proximity to big city life. Nestled between major hubs its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

Essential Functions:

On board new customer programs with the Sales Team to transition to become the primary liaison for program planning and execution upon confirmation that a Verbal Win/Letter of Intent has been reached.
Lead the planning and execution of programs in alignment with the FLBT Program Management business best practice (vision mission SWOT/SIPOC strategy-goals-objectives).
Oversee the general day-to-day execution of Program activities and planning to ensure on-time completion of Program tasks and deliverables as scheduled.
Identify program delivery risks and mitigations and ensure the program team the site leadership team and the customer are appropriately informed.
Lead the Program team in Stage Gate reviews as part of the program life cycle to communicate program readiness and risk profile to the site leadership team.
Attend and lead daily Tier meetings to support FLBTs communication structure for escalations and feedback in program risk items.
Serve as the lead with the functional areas to ensure the SOW elements are accurate complete and organized based on revenue generating segments of work.
Ensure financial activities and program milestones are aligned (SOW revenue recognition milestones change orders invoicing/payment activities etc.).
Ensure all Contract elements (CSA-MSA Quality Agreement Price and Payment Schedule SOW) are completed with support from Head of Program Management.
Develop and maintain the Master Program Plan (MPP) including ensuring durations and accountabilities for all revenue generating milestones are accurate through the scope of the program (contract sign PD US/DS AD Tech Transfer Clinical-Commercial Manufacturing QA QC Release Transfer in and Transfer out).
Collaborate with the Sales Team to identify additional opportunities for additional work within the current contract.
Partner with functional teams (QC QA PD Manufacturing etc.) to ensure that MPP revenue generating milestones are accurately translated into functional deliverables and all action items are completed per the committed timeline.
Work closely with Process Development Manufacturing Engineering Quality Control and Quality Assurance to reduce time to clinic or market improve ease of manufacturing and reduce costs when compared with existing platform products while achieving and maintaining full compliance (cGMP Safety and Environmental).
Accurately define timelines and resource requirements for the assigned Programs.
Maintain Program documentation (change orders Program reports timelines etc.).
Manage and lead Program team meetings including issuance of agenda action items meeting minutes client communications etc.
Communicate Program updates to the Leadership Team at predefined milestones and at defined intervals.
Organize and conduct Program team and Joint Steering team meetings with external clients including agenda meeting notes action items and follow-up of action items.
Track and report program performance (financial delivery metrics and analysis monthly reports quarterly and annual leadership reviews revenue change log etc.); ensure accurate and timely completion of financial transactions (revenue adjustments/ recognition change orders invoicing pass through) and maintain a change log capturing all financial activity per program.
Responsible for authoring Scopes of Work Change Orders Cost Models and Confidentiality Agreements. Responsible for approving Program purchase orders. Responsible for forecasting revenue and reviewing/approving monthly customer invoices.
Continuous improvement of existing systems as well as implementation of new program management systems including training of employees to ensure FLBT maintains best practices in the industry.
All other duties as assigned.

Required Skills & Abilities:

Excellent attention to detail with strong organizational and analytical skills.
Computer proficiency required including strong experience with Microsoft Office (Word Excel PowerPoint).
Excellent problem solving and conflict resolution skills and the ability to identify assess and resolve business problems issues risks and facilitate issue resolution and risk mitigation.
Ability to accurately complete required documentation.
Good written and oral communication skills and the ability to effectively interact with all levels of the organization.
Excellent time management skills with the ability to multi-task and self-manage activities.
Demonstrated effective resource and Program planning/decision making.
Demonstrated experience with problem solving and conflict resolution.
Accountable for all aspects of Program Teams data support entry and ongoing data accuracy reporting.
Knowledgeable in Quality systems tools for process improvement and cGMP guidelines.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the employee is regularly required to:

Experience prolonged sitting standing walking bending stooping and stretching.
Use hand-eye coordination and manual dexterity sufficient to operate a keyboard photocopier telephone calculator and other office equipment is required.
Attendance is mandatory.

Qualifications:

Masters Degree preferably in Business Engineering Microbiology Chemistry Biochemistry or related field with two (2) years of experience in a fast-paced environment preferably in the biotechnology pharmaceutical laboratory healthcare or related industry; OR
Bachelors Degree preferably in Business Engineering Microbiology Chemistry Biochemistry or related field with four (4) years of experience in a fast-paced environment preferably in the biotechnology pharmaceutical laboratory healthcare or related industry; OR
Associates Degree with six (6) years of experience in a fast-paced environment preferably in the biotechnology pharmaceutical laboratory healthcare or related industry; OR
Highschool Diploma or GED with eight (8) years of experience in a fast-paced environment preferably in the biotechnology pharmaceutical laboratory healthcare or related industry.
A minimum of two (2) years of experience leading cross functional teams in support of organizational programs and/or direct project/program management experience.

Preferred Qualifications:

Relevant project management experience in a biotechnology or pharmaceutical development and manufacturing environment managing one or more projects of medium to high complexity.
Degree in Business Engineering Microbiology Chemistry Biochemistry or related field.
Certifications in Project/Risk Management or Lean Six Sigma.
MBA or Masters degree.
Experience in a cGMP facility or working with FDA regulations.
Previous Accounting/Finance/Budgeting experience.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or ).

Required Experience:

Position OverviewThe Program Manager with mentoring and support from the Head of Program Management and/or Associate Program Director or Program Director will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to pr...