About the Role
This is a 1099 independent contractor engagement, not a W-2 position. Consultants on the Nexus bench are engaged project-by-project under an Independent Consultant Agreement, with individual Project Fee Addenda defining scope, deliverables, and fees. Work is performed remotely through your own business entity.
We are looking for consultants who can independently own a CMC workstream end-to-end — strategy, authoring, CRO/CDMO oversight, and direct sponsor interaction — without senior Nexus review of day-to-day execution. to cmc-consultant@nexus-cmc-advisors.odoo.com
Requirements
Qualifications:
Education: Minimum of a Master’s degree in a scientific discipline (Ph.D. preferred).
Experience: At least 10 years (with a Ph.D.) or 12 years (with a Master’s) of hands-on experience in CMC regulatory affairs, with a focus on small molecules, peptides and/or oligonucleotides.
Demonstrated ability to lead — not contribute to — CMC workstreams independently
Authorship or substantial contribution to at least two INDs
Direct U.S. FDA interaction experience (pre-IND, Type B, Type C meetings, responses to Information Requests)
Fluent written English suitable for client-facing regulatory deliverables
U.S. work authorization (no sponsorship offered)
Qualifications — Preferred:
Prior hands-on QC/R&D or manufacturing process development experience
Familiarity with eCTD Module 3 authoring
Experience with traditional and/or continuous manufacturing processes
Program experience through NDA submission
Engagement Terms — Please Review Before Applying
By applying, you confirm willingness to work under the following terms if selected:
Sign the Nexus Independent Consultant Agreement (Virginia governing law)
Represent yourself as part of the Nexus team using a Nexus-branded email address during client engagements
Perform all client work exclusively within the Nexus SharePoint environment (no downloads, syncing, or transfer of client files to personal devices or accounts)
Carry Professional Liability / E&O insurance of at least $1,000,000 per claim
Accept a 12-month post-engagement non-solicitation and non-circumvention obligation on Nexus clients
Assign all work product and intellectual property to Nexus upon payment
Standard hourly rate expectation in the $100–$200/hr range, or fixed project fees; final rate agreed per engagement
Who This Is Not For:
W-2 job seekers or those seeking full-time employment
Junior consultants or those requiring senior oversight to complete deliverables
Agencies or firms seeking to sub-contract
Consultants focused on biologics, cell/gene therapy, or oligonucleotides
Consultants unwilling to work exclusively within a client’s document environment
How to Apply:
Applying to the Nexus consultant bench is a two-step process:
1. Complete the Nexus Consultant Qualification Questionnaire (copy link to new browser window if it doesn't automatically open in a new window): https://forms.gle/rYQhPmT7U3Pwetiw7
2. Send your current CV to cmc-consultant@nexus-cmc-advisors.odoo.com (note: this requirement is also mentioned within the Questionnaire so only submit one time)
Both steps are required for your application to be reviewed (i.e., submitting through LinkedIn apply is not the application). If you carry Professional Liability / E&O insurance, please also attach a current Certificate of Insurance (COI) to the same email.
Do not send inquiries through LinkedIn messages or to Nexus personnel directly — those will not be reviewed.
We review completed submissions on a rolling basis. If your profile matches an upcoming engagement, we will contact you within 60 days. If you do not hear from us within 60 days, we do not currently have a client fit — we retain qualified submissions for future opportunities and may reach out later.
About the Company
Nexus CMC Advisors provides regulatory CMC strategy to emerging and lean pharmaceutical sponsors, with a focus on U.S. FDA submissions from pre-IND through Phase 2 (occasional later-phase work). We specialize in small-molecule, synthetic-peptide, and synthetic oligonucleotide therapeutics.
We are expanding our curated bench of senior independent CMC consultants to support on-demand client engagements.
We specialize in strategic CMC guidance for lean or emerging pharmaceutical companies—so we’re looking for consultants who thrive in ambiguous environments, communicate clearly, and deliver top-tier regulatory insights.