Category Manager - Raw Materials & CMO

Location
Durham, NC, United States
Posted
Sep 27, 2019
Ref
1145835
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
The Category Manager/Senior Manager - Raw Materials and CMO will be a key member of a growing Supply Chain team which is currently building a supply chain function including all aspects of Plan-Source-Make-Deliver as well as launch readiness, product security and packaging. The focus of this role will be to secure supply, guarantee access to proprietary materials and technology, improve spend under contract by executing MSA/SOW agreements and maintain price security for select group of manufacturing critical suppliers.

The Category Manager is expected to develop and lead the core pillar of Source within the Supply Chain and become a central part of the Make decision team regarding CMO selection and make vs. buy analytics. The Category Manager will take ownership of strategic sourcing, Supplier Relationship Management (SRM) and developing a formalized sourcing process at Precision BioSciences for Direct Material Sourcing Categories, third-party logistics providers and CMO/CDMO selection. This team member will be a part of the broader CMC organization which aims to drive operational excellence for the successful development of Precision BioSciences Cell and Gene Therapy Products.

The ideal candidate will have extensive experience Sourcing and Managing third-party supplier networks with a focus on quality, reliability, sustainability, speed and cost. Skills in operational risk analysis, financial and operational modeling, and decision analysis are highly advantageous.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
  • Build Precision BioSciences strategic sourcing and supplier management capabilities to support multiple early phase cell and gene therapy clinical programs through to commercial launch
  • Manage and coordinate strategic sourcing for internal or outsourced activities to ensure timely supplier selection and on-going delivery of supplier KPIs, products and services
  • Develop and implement standard strategic sourcing, supplier management tools, and technology including spend analytics and e-sourcing
  • Lead cross-functional interactions with key stakeholders (e.g. Development Program Leads, Clinical, Manufacturing, Quality, Finance) to support supplier evaluation and selection
  • Identify, vet and manage a complex network of third-party vendors including contract negotiations, establishing supply agreements, and supporting audits and quality agreements in partnership with Quality Assurance
  • Develop a project portfolio and prioritize appropriately
  • Perform spend analytics to fully understand the category and opportunities available
  • Present category analytics in a clear and concise manner with visual analytics where possible
  • Negotiate with internal stakeholders to understand the true needs of the business

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Education/Experience:

Required:
  • Bachelor's degree in business, engineering or life sciences with a preference for a multi-faceted business-science or engineering background, or equivalent combination of education and experience
  • Minimum of 8 years' experience in operational roles in the Biopharmaceutical industry including GMP strategic sourcing across all product lifecycle phases and multiple geographies including North America and Europe
  • Demonstrated strength in Direct Material Category management within the cGMP biotechnology space and the standard 5-7 step sourcing process including Developing the Statement of work SOW with the technical team, coordinating Market Research as appropriate, Developing and recommending a Sourcing Strategy, Conducting the Sourcing Process (RFX, RFI, RFP, Negotiating contract terms and pricing)
  • Experience in on-going Supplier Relationship Management (SRM) and QBR processes
  • Excellent working knowledge of cGMP's and pharmaceutical industry procedures and regulations as it relates to strategic sourcing, cGMP suppliers and SOW development
  • Experience in supplier negotiations within a proprietary, single source technology environment
  • Expertise in MSA/SOW development and negotiation within the cGMP biotechnology direct materials space
  • Experience with e-sourcing (ScoutRFP, Ariba, Coupa, GEP, etc), Spend Analytics, Microsoft Office Suite, ERP systems such as SAP, Sage, and NetSuite, and Visual Supply analysis and analytics
  • Excellent communication skills, both verbal and written and the ability to interface effectively with all levels of the organization;strong communication skills with outside contract organizations

Preferred:
  • Experience leveraging supplier innovation for continuous improvement preferred
  • Understanding of Quality Systems and demonstrated proficiency in application of QA principles, concepts, industry practices and standards
  • Strong conceptual, strategic, analytical, problem solving and organizational skills
  • Strong personal alignment with Precisions values, mission and vision

Work Environment

The work environment characteristics described here are representative of those an employee could potentially encounter while performing the essential functions of this job.
  • While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals and risk of electrical shock
  • The noise level in the work environment is usually moderate

Physical Demands

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.
  • The employee must occasionally lift and/or move up to 25 pounds
  • Specific vision abilities required by this job include close vision, color vision, peripheral vision and ability to adjust focus
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to handle or feel and talk or hear
  • The employee is occasionally required to reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell

Travel Requirements
  • This position will require travel (up to 20%)

Location
  • This is an office-based position located at the main headquarters in downtown Durham, NC.


Precision BioSciences is dedicated to improving life through its proprietary genome editing platform, ARCUS. Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food.

Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.