Oligonucleotide Manufacturing Consultant (Equipment URS SME)

Job Title: Oligonucleotide Manufacturing Consultant (Equipment URS SME)

Location: Harris County, TX (Remote in January; Onsite starting February)

Start Date: Week of January 1

Duration: 6 months (Potential extension to 12 months)

Schedule: 40 hrs/week

Overview

Our client is seeking a senior-level Oligonucleotide Manufacturing Consultant to support a major expansion project involving a broad suite of process equipment for oligonucleotide synthesis, upstream preparation, downstream purification, and supporting utilities. This consultant will serve as a subject matter expert (SME) responsible for developing User Requirements Specifications (URS) and providing technical guidance across a wide range of specialized equipment.

This role is ideal for an experienced engineer or technical SME with deep expertise in oligonucleotide manufacturing operations, equipment, and facility fit-out.

Required Experience

• Minimum 15 years of experience in pharma/biotech manufacturing.
• At least 7 years of direct experience in oligonucleotide manufacturing (synthesis, cleavage/deprotection, purification, TFF, enzymatic ligation, buffers, utilities, etc.).
• Demonstrated expertise in drafting URS documents and working with process equipment vendors, engineering partners, and project teams.
• Understanding of GMP, validation, automation/controls, and process engineering principles.

Equipment Categories Covered

Note: SME coverage of every item is not required; candidates with strong experience across a majority of these domains are encouraged to apply.

Synthesis & Upstream Equipment

• DCA, Activator, Oxidizer, Sulfurizer, Deblock, Cap vessels
• Amidite prep vessels
• Fluidized Bed Reactors (FBR) & Synthesizer Skids
• Synthesis UPLC patrol units
• Cleavage & deprotection vessels
• Material handling & molecular sieve systems

Purification / TFF / Chromatography

• Crude and final TFF systems (skids, feed vessels, TCUs)
• Chrom skids, columns, fractionation systems, packing equipment
• Ni-IMAC skids, columns, buffer vessels
• MCSGP systems and eluent coolers
• Enzymatic ligation reactors & buffer systems
• Annealing & concentration systems (vessels, TCUs, vacuum systems)

Buffer & Solution Prep

• Buffer prep vessels, handling equipment, heat exchangers
• Distribution systems (NaOH, ethanol, HCl, etc.)

Utilities & Distribution Systems

• Nitrogen systems (cryogenic/high purity)
• RO/WFI generation, storage, and distribution
• Clean steam, process air
• Solvent transfer/distribution systems (acetonitrile, toluene, etc.)
• HVAC/AHU for buffer prep areas

Waste, Vent, & Environmental Systems

• Process vent collection & scrubber systems
• Emergency relief vent collection
• High/low solvent waste systems
• Aqueous waste neutralization and discharge
• RTO collection header

Cleaning, Freezers, Ancillary Systems

• CIP skids & distribution
• Parts washers
• Lyophilizer (future system)
• Final product freezers
• Bulk liquid filling
• Single-use mixing systems

Preferred Background

• Experience with greenfield or brownfield facility buildouts.
• Involvement in commissioning/qualification (FAT/SAT/IOQ).
• Familiarity with automation platforms (DeltaV, PLC-based systems).
• Prior knowledge of TFF, chromatography, ligation, and FBR-based oligo systems.

Soft Skills

• Ability to interface with diverse technical teams.
• Strong documentation and communication skills.
• Ability to manage multiple equipment packages simultaneously.
• Independent, detail-oriented, and capable of rapid ramp-up in a complex project environment.