Associate Director, Program Design - Drug Product and Finished Goods Specialist

Location
Morrisville, NC
Posted
Sep 24, 2021
Ref
2021-15505
Hotbed
Bio NC
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Associate Director, as part of the Global Program Design Team, will secure new business in line with the company vision. This team is responsible for delivering bespoke, high quality proposals to potential clients based on extensive understanding of global FDB's technical and business capabilities, and an ability to match them to client's actual needs. Proposal building requires in depth understanding of FDB program management systems, technical capabilities of Process Development, manufacturing capabilities, the quality aspects of program delivery, regulatory requirements, and program financials. Program Design directly contributes to new business acquisition and market share growth by projecting to potential clients FDB's technical competence, operational excellence, vast experience, and broad capabilities. 

External US

As part of the Global Program Design Team, secure new business in line with the company vision. This team is responsible for delivering bespoke, high quality proposals to potential clients based on extensive understanding of global FDB's technical and business capabilities, and an ability to match them to client's actual needs. Proposal building requires in depth understanding of FDB program management systems, technical capabilities of Process Development, manufacturing capabilities, the quality aspects of program delivery, regulatory requirements, and program financials. Program Design directly contributes to new business acquisition and market share growth by projecting to potential clients FDB's technical competence, operational excellence, vast experience, and broad capabilities. This is a global position that will support all four of our sites (Denmark, United Kingdom, Texas and North Carolina). This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

No of staff reporting to individual

Up to 1

Proposal workload

> 20 proposals per year pro-rata

Estimated value of proposals

Majority in excess of GBP 3.5M

Principal Accountabilities

  • Deep expertise in Drug Product and Finished Goods (Assembly, label and packing) business offering / service area. This area is large, complex and key to FDB, requiring significant development and focus. Develop key selling tools and lead the rollout of knowledge.
  • Review customer Request for Proposal (RFP) through analysis and evaluation of written documents and technical questioning of customer and commercial colleagues to ascertain detail of the request.
  • Lead technical discussions in teleconferences and face to face meetings with potential new customers. Occasionally face to face meetings will be remote to Billingham site and will require travel.
  • Perform initial Impact Assessment of molecule, expression system, process and product; review any and all new, unique and difficult aspects of the request for impact to site procedures, ways of working, staff safety, manufacturing licenses etc. Based on outcome of Impact Assessment issue an agreement to bid, or a decline to propose message to the client.
  • Accountable for the design of a customer program, from Technology Transfer to cGMP manufacture through targeted and appropriate process development and including all ancillary services deemed necessary by regulations or local policies.
  • Generate proposal documents (Proposal, Resource/Price Model and Timeline).
  • Lead technical review of the proposed scope of work with the client including timeline and pricing feedback.
  • Support the work of Program Design Scientists by reviewing RFPs and proposals and providing an orthogonal viewpoint of technical and commercial issues.
  • Relevant customer territories are worldwide.
  • Provide or collate specialist technical advice for members of the commercial team, potential or current customers.
  • Maintain and continually improve proposal templates within job holder's area of expertise. This involves keeping up to date with departments on site and translating Standard Work Elements (SWE) into customer-facing work packages and sufficiently detailed resource models.
  • Assist with the development of SWEs for PD, particularly in the job holder's area of expertise.
  • Maintain an up to date knowledge of the CDMO industry, and the biologics market. Be able to offer advice to customers on matters of a scientific, regulatory and technical nature.
  • Participate where necessary in proposal review meetings, StageGate reviews at SLT level and scope development meetings.
  • Support Programme Management by generating a First Draft Statement of Work using the final version of the proposal agreed with customer.
  • Lead the technical aspects of visits by potential new customers. Assist with the coordination of site tours for such visits.

Competencies:

Level: Manager

Assessed:  Process Management,  Customer Focus,  Relationship Building,  Achievement and Results Orientation.

 

Special Features

  • The job holder must possess at least a first scientific degree or equivalent (e.g. BSc) and possibly also a higher degree (e.g. MSc, PhD) and have 5 or more years' experience in a technical role in Fujifilm, or another similar business (e.g. CDMO) as well as significant experience working with external customers.
  • Substantial theoretical and practical knowledge in the fields of Biotechnology, Protein expression and purification, Biologic drug development. The ability to discuss these topics with internal and external customers with confidence.
  • Excellent written communication skills; accurate and concise and able to strike the balance between sales and technical writing.
  • The ability to build lasting relationships with staff across all site functions and all levels of the organisation.
  • The ability to interact with external customers in a professional and personable manner and to present a competent image of Fujifilm at all times.
  • Prioritisation of competing tasks as well as good planning and organisational skills. The ability to work independently with minimum supervision.
  • Views situations from the customer and the business perspective, to offer solutions that are attractive to the customer, and in the best interests of Fujifilm.

 

 

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FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

 

FDBT is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. 

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.