Bioprocess Subject Matter Expert ( SME )

PM Group

$120K — $150K *
Apex, NC 27502In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • 15+ years of experience in design, operations, or process development
  • Strong Biologics and Advanced Therapies expertise
  • Engagement history with industry institutions like ISPE
  • Understanding of facility layout and design principles
  • Familiarity with regulatory frameworks
  • Excellent client presentation and workshop facilitation skills
  • Proven problem-solving and innovation capabilities

Responsibilities

  • Lead technology initiatives in Biologics and Advanced Therapeutics
  • Inspire confidence in clients through the project lifecycle
  • Support business development and secure new client relationships
  • Participate in proposal preparations and risk assessments
  • Collaborate with senior leadership for strategic client solutions
  • Train and mentor next-generation Subject Matter Experts
  • Engage in technical reviews and guide project teams

Benefits

  • Opportunity to work on cutting-edge projects in a dynamic environment
  • Engagement with industry-leading clients and technologies
  • Access to a global network of subject matter experts
  • Support for professional development through workshops and training
  • Flexible work arrangements including travel opportunities
Full Job Description
Overview

The Bioprocess SME position is an exciting opportunity to join PM Group's Raleigh-Durham area team out of Apex, NC and support our ongoing expansion across the United States. The offices are delivering cutting-edge projects for the Pharmaceutical, Biologics, and Cell & Gene Therapy manufacturing facilities, supporting clients from feasibility and conceptual design through qualification and operational readiness. Together with our clients and partners, we deliver projects that improve lives around the world.

As a subject matter expert (SME) position within PM Group we are looking for a Bioprocess SME who enjoys client interaction as well as the technical aspects of the work we deliver to our clients. The SME will provide technical leadership on Biologics and Advanced Therapeutics projects group wide and have a strong track record of developing and maintaining business with Biotechnology clients in the Raleigh-Durham area and across the US. As a client facing SME position the ability to inspire confidence in staff and clients from first contact through proposal preparation and project execution is important.

Project assignments will vary in size and complexity and may require periodic travel to client sites.

Responsibilities

  • Act as a technology leader in the following areas:
    • Biologics and Advanced Therapeutics
    • Current in technical and subject knowledge
    • Aware of upcoming technology changes, developments and innovations
    • Write papers, present at industry conferences
    • Involved with industry bodies such as the ISPE and BioPhorum
    • Promote knowledge exchange within the company using appropriate forums, COPs and clusters
  • The ability to inspire confidence in staff and clients from first contact through proposal preparation and project execution
  • Support BD with prospecting, identifying, securing RFP's and business with new and existing clients
  • Support BD as required; this may include client visits, client pitches, proposal writing, and preparation of appropriate supporting materials
  • Prioritize Biologics and Advanced Therapies prospects in consultation with BD, operations, and sector leaders
  • Attend bid/no bid discussions and proposal risk reviews
  • Participate in client interviews and presentations
  • Liaison with global key accounts as appropriate
  • Collaborate with the PM Group USA senior leadership, the sector heads, & operations teams to develop distinctive value propositions that enhance our clients' competitive position
  • Leverage corporate networks to identify existing capabilities that respond to client requirements and objectives as well as create a distinct competitive advantage
  • Engage with an existing global network of Subject Matter Experts and assist in the training and mentoring of next generation of PM Group Subject Matter Experts
  • Represent PM Group at networking events and conferences
  • Present and interface with clients and facilitate workshops
  • Act as an SME in early project phases (i.e. ideally site master planning, feasibility, concept and basic design phases)
  • Once a project is acquired, deploy process SME knowledge and expertise to help develop solutions for client's business and project needs
  • Produce and/or check early phase project deliverables appropriate to the discipline speciality including scoping and philosophy documents, production throughput analysis, block flow diagrams, process flow diagrams, equipment requirements, mass balances, bioprocess simulation models, P&ID's, adjacency diagrams, and layout philosophies
  • Technically assist project teams, particularly in the early project phases, with site master planning, feasibility and concept studies and basic of design
  • Break problems down to their essence, demonstrate problem solving skills and innovate
  • Travel to Project meetings / workshops as required
  • Technically assist project teams as required
  • Participate in Peer Reviews of work performed by others and other companies
  • Perform, when appropriate, SME reviews of client sites
  • Participate and/or chair technical design reviews as appropriate
  • Actively support and participate in the Tech Team and the associated development and innovation activities
  • Other special projects as assigned

Qualifications

  • 15+ years of appropriate experience in design and/or operations and/or process development
  • A history of industry engagement with institutions (such as the ISPE) and an awareness of key industry technology initiatives
  • Superior proven Biologics and Advanced Therapies knowledge
  • Demonstrated understanding of the appropriate principles of facility layout and design
  • Proven knowledge of appropriate Regulatory framework
  • Good presentation skills and comfortable interfacing with clients, facilitating workshops and technically assisting project teams
  • The ability to narrow problems down to their essence; demonstrated problem solving abilities
  • Ability to innovate
  • Self-driven, result-oriented, positive outlook and a clear focus on business
  • Comfortable representing PM Group and dealing with multi-national clients
  • Ability to work flexibility and travel as necessary for the business and client needs
  • Strong internal and external relationship building skills
  • Ability to work as a member of team as well as independently
  • Experience working in local and international business with the added complexity of new markets, extended communications and cultural factors

All of your information is confidential according to EEO guidelines.

RECRUITMENT AGENCIES NEED NOT APPLY

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