Senior Program Design Manager - Drug Product

Job content

FUJIFILM Diosynth Biotechnologies

Trusted for generations, we are a CDMO partner for life. Here at FUJIFILM Diosynth Biotechnologies (FDB), passion – what we call Genki – lives inside everything we do. This is your opportunity to push the boundaries of your potential to impact where we know it matters most: human lives.

Whilst working as a Senior Program Design Manager / Director, Program Design – Drug Product and Finished Goods Specialist in the Process Development team, we want you to embrace your individuality, discover your purpose, and follow what energizes, fulfills, and inspires you every day.

About Us

We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines.

We are growing and we are growing fast. With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility.

Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together.

Role & Responsibilities

• 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.
  
  

Qualifications And Experience

• The job holder must possess at least a scientific degree or equivalent (e.g. BSc) and possibly also a higher degree (e.g. MSc, PhD) and have 7 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, gene therapy, cell therapy and viral vectors and products.
• Job holder must maintain an up to date knowledge of the CDMO industry, the market and be able to offer advice to customers on matters of a scientific, regulatory and technical nature.
• Must be able to quickly and efficiently develop a deep understanding of new markets and technical areas of business, for example Finished Goods (assembly, label and pack) and cell and
  gene therapies in order to successfully develop key selling tools and lead the rollout of knowledge for new manufacturing sites.
• Excellent written communication skills, accurate and concise and able to strike the balance between sales and technical writing.
• The ability to analyse complex technical problems and present clear solutions.
• Strong influencing skills that will enable the job holder to help define new areas of business, ways of working and proposal practices. Ability to influence customers and colleagues at all levels
  (inclusive of CEO/President).
• 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.
  
  

Why work with us?

At FDB, your passion – your Genki – is your power and we empower you to define what Genki means to you.

In Addition To This, We Offer

When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training.

• Competitive salary plus company bonus scheme
• Up to 35 days of holiday, plus bank holidays.
• Salary Sacrifice scheme offering, healthcare, bikes, dental etc.
• Generous pension scheme
• Free parking
  

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