Job Description

Dual role managing both Drug substance at KBI and Drug product Fill and Finish services with KBI and Fill site. Ensures the appropriate development and control of BDS development, and production to DP-related processes and systems. Provides leadership in managing the KBI- PMO business and with establishing client relationships and managing program schedules with the Integrated programs involving Drug substance production at KBI and managing the Fill/Finish partner. The role holder will be key client account manager for KBI PMO DP business, driving delivery and exemplary client service to maximum benefit for the company in a sustainable manner. Represents or deputizes for PM senior staff as required, and in this capacity may directly lead or support the management of the Program Management department. The incumbent may participate in a panel or independent interview of PM candidates.

Client/BDS Program Management:

• Manages project timelines through all phases of development, from project award and kick-off through close-out.

• Ensures that projects are conducted on time, within scope and budget, and meet Client agreed- upon quality standards and expectations through cross- functional project team alignment.

• Develops, manages, and updates project plans in a timely manner. Communicates project status, progress, timelines, changes in schedule, scope changes, technical and/or quality issues to all relevant personnel in the company, and with the Client.

• Schedules, facilitates and documents program related client team meetings, including issuance of agenda, action items, meeting minutes, client communications, etc.

• Leads cross-functional teams without direct authority by casting a clear vision of project objectives/priorities and motivate the team to achieve them. Able to resolve conflict and foster collaborative partnerships with others to achieve peak performance with minimal assistance from manager or delegate.

• Analyzes risk, establishes contingency plans and identifies trigger events and responsibility for initiating mitigating action. Gathers stakeholder input and ranks the top project risks in terms of total impact.

• Facilitates discussion regarding portfolio priorities (resolving resource conflicts).

• Participates in strategic initiatives for PMO and Clients. Able to suggest and champion the implementation of improvements to systems and processes.

• Promotes KBI capabilities and manages business discussions.

Client/DP Fill Finish Vendor Management:

• Oversees Drug product program portfolio of increased complexity, such as government-supported programs, high profile clients of strategic importance.

• Responsible for program management for assigned clients/portfolios plus oversight of projects managed by direct reports.

• Provides sound judgments and technical / regulatory recommendations on drug development from BDS to DP Fill/Finish to clients.

• Cultivates Client relationship. Provides timely and appropriate reporting of Issues/Risks to leadership.

• Manages client expectations efficiently. Maintains strong working relationships with all client representatives. Able to mend and/or develop client relationships.

• Manage client escalations as first line, engaging functional leadership as support. Ensures timeline and appropriate reporting to Leadership.

• Primary point of contact for all Client communications and coordination between DP Fill/Finish vendor and project needs.

• Supports PM-VOC process; recommends and/or implements initiatives to identify and address opportunities to improve client service.

Staff Management:

• May have up to 6 direct reports (combined entry, mid and senior level positions), which may include leadership levels that also have direct reports.

• Responsible for staff compliance to PMO project delivery processes, and business monitoring tools (current MS-Project plans, forecasting, client deliverable tracking etc).

• Support appropriate development of staff members providing training and mentoring in line with their role and experience.

• Accurately evaluate the performance levels of direct reports and communicate openly with constructive feedback to develop potential.

• Provides technical direction and leadership to staff in connection with current projects; within the team, authority to make recommendations in terms of staff to ensure projects run smoothly. May recommend project team member or role changes as necessary.

• May participate in panel or individual interviews of Program Manager candidates.

Business/Financial Management:

• Hosts clients or represent KBI at the client site including Executive Steering Committee meetings as required.

• Manages the technical and strategic development of the program drawing on relevant Technical leadership from across the organization. This process includes generating and presenting resulting proposals and change orders to the client as appropriate.

• Drive delivery of existing business, negotiating internally to meet project timelines.

• Manages all contractual and financial aspects of the project, including finalization of change order and subsequent amendments, monthly budget reviews, forecasting, materials review, assessment of work performed and appropriate Client invoicing and vendor payments.

• Negotiates existing business opportunities as well as change orders (including facilitating / supporting terms and conditions negotiations).

• Estimates monthly revenues for departments and ensures delivery.

• Timely revenue management and forecasting; high level capacity forecasting to support incoming business planning.

• Inform finance of contractual details; work closely with finance to ensure team compliance and accuracy of invoices; prepare and include progress summaries to go with client invoices, program changes, change orders and/or amendments. Ensures team accurately recognizes revenue for each project.

• Assists Business Development Department in development of proposals as needed.

PMO Support:

• Acts as a contributing member of Program Management Organization

• Suggests, designs and/or implements improvements to systems and processes.

• Leads or contributes to departmental initiatives as appropriate, including procedure development and improvement.

• Cross-site portfolio leadership OR process ownership; work with PMO and local team to continuously improve PM and project delivery practices. May own a PMO process, responsible for training tools and associated change management.

• Participate in department strategic planning, including annual forecasting and headcount projections.

• Owns, manages and provides regular status reporting on the site goals and objectives (Balanced Score Card) for self and team.

• Represent or deputize for PMO senior staff as required.

• Other duties as required

MINIMUM REQUIREMENTS:

• MBA, M.Sc or Ph.D. required. Bachelor’s degree (B.Sc) in science or related discipline with >15 years relevant industry experience accepted in lieu of advanced degree.

• PMP certification (current or planned in the immediate future).

• Minimum 15 years industry experience, with 8 years or more direct project management experience.

• Prior experience effectively managing projects in pharmaceutical or biotech company, CDMO, CRO or related experience required.

• Experience with client contract negotiations required Previous personnel management (>5 years) is essential.

• Demonstrated experience in building project management tools/templates, improving project systems and implementing best practices.

• Adaptability and flexibility including the ability to manage deadline pressure, ambiguity and change Ability to build teams and generate a spirit of collaboration while coordinating diverse activities and groups.

• Occasionally may be requested to travel to client’s site to support strategic project discussions and/or attend industry conferences, seminars and/or tradeshows.

Posting Range: $176,544 – $242,748

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.