Bio Process Design Expert
4 days ago
We are seeking a highly skilled Technical Operations Lead to join our team at Lifelancer, an innovative talent-hiring platform in Life Sciences, Pharma and IT.
Role Overview
The ideal candidate will have extensive experience in design and/or operations and/or process development, with a strong background in Bulk Bio. The successful applicant will work closely with our global network of experts to deliver cutting-edge solutions for our clients.
About the Role
- As a Technical Operations Lead, you will be responsible for providing technical leadership on Bulk Bio projects. This will involve working as a Subject Matter Expert (SME) to develop and implement best practices in the field of Bulk Bio.
- You will also be responsible for mentoring and training junior staff members, ensuring they have the necessary skills and knowledge to excel in their roles.
- An essential part of this role is staying up-to-date with industry developments and advancements, writing papers, and presenting at conferences.
- Additionally, you will participate in industry bodies such as the ISPE and ICHEME, promoting knowledge exchange within our company through forums, COPs, and teams.
Key Responsibilities
- To perform as an SME for early project phases, producing and checking deliverables, including scoping and philosophy documents, production throughput analysis, process flow diagrams, equipment requirements, PIDs, and layout philosophies.
- To assist project teams technically and undertake Peer Reviews of work performed by other companies.
- To engage with our global network of SMEs and other staff, assisting in the training and mentoring of the next generation of Subject Matter Experts.
- To participate in technical design reviews, actively supporting and participating in the PM Group's RD Team (TechTeam), and associated development and innovation activities.
Specific Knowledge Areas
- Upstream and downstream unit operations and support functions, including familiarity with equipment options available and selection criteria.
- Principles of facility layout, including area classifications, layout adjacencies, segregation approaches, and more.
- Aspects related to technologies like process closure technologies, connected and continuous processing, stainless steel and single-use systems, bulk bio automation concepts, CIP/SIP, clean utility generation and distribution, and waste systems.
- Facility operations, including operating philosophies and GMP Regulatory frameworks.
- Project delivery aspects, such as basis of design, basis of safety, simulation tools, tech transfer, commissioning and qualification.
Required Skills and Qualifications
- Bachelor's degree; Master's preferred.
- 15+ years of relevant experience in design and/or operations and/or process development.
- A history of wider industry engagement with institutions like the ISPE and awareness of key industry technology initiatives and direction.
- Excellent knowledge relating to the area of specialty.
- A good understanding of principles of facility layout and design as appropriate.
- Good appreciation of appropriate Regulatory framework.
- Good presentation skills and ability to client interface, facilitate workshops, and technically assist project teams.
Salary Estimate
$120,000 - $180,000 per annum, depending on experience and qualifications.
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