CM&C Peptide Process Manufacturing Consultant

Fishers, IN
Contracted
Executive
Job Description
Job TitleConsultant, Process ManufacturingPosition TypeContractor
LocationRemoteTravel RequiredTravel may be required
External Posting URL
Applications Accepted By
Jason C. Bork
[email protected]
or (317) 694-0232 (mobile)
Mail:
Jason C. Bork
Pintail Solutions, Suite 104
12172 Visionary Way
Fishers, IN  46038
Job Description
Overview
Pintail Solutions is a trusted life science partner improving global health. We work with a variety of clients including CDMO's, biotechs and pharmaceutical companies, CROs, academic institutions, and philanthropic organizations. Clients work with Pintail because of our breadth of experience, our ability to deliver outcomes, and our passion for every project we work on. We focus on the greater good of the client and are fearless about informing clients about what they need instead of what they may ask for. We expect everyone in the company to act like an owner and be insatiable about looking for ways to improve. We value excellence, integrity, and collaboration, and we believe we will make a greater difference in our work when we are having fun doing it. 

A company is building a commercial-scale peptide Active Pharmaceutical Ingredient (API) manufacturing facility and is seeking a Senior Peptide Manufacturing Consultant to guide process scale-up, facility design, validation, and regulatory readiness for cGMP production.

We are seeking an experienced process manufacturing consultant, preferably with peptide manufacturing and continuous flow experience.  This engagement is expected to last 9-18 months or longer.  
 
This individual will need an entrepreneurial spirit, deep clinical trial experience, preferably from a pharma/sponsor perspective, and a mature business presence to successfully engage with internal and external business partners.   Experience is oligos and brain shuttle technology is preferred.  

The following roles and responsibilities entail most of what this role may be asked to do, but will expand based on the individual’s and organization’s needs.  

Roles and Responsibilities
  • Commercial Process Scale-Up

    • Translate laboratory/pilot peptide processes to multi-kilogram production batches

    • Optimize synthesis steps (coupling, deprotection, cleavage, yields)

    • Develop impurity control and solvent usage strategies

    • Produce a commercial scale-up strategy report

  • Equipment & Production Capacity Planning

    • Determine appropriate sizing and throughput for:

      • Peptide synthesizers

      • Cleavage reactors

      • Preparative HPLC systems

      • Lyophilization equipment

      • Solvent storage/recovery and waste systems

    • Build a production capacity model capable of >100 kg/yr output 

  • Facility Design & cGMP Compliance

    • Review facility layout and workflows

    • Ensure proper segregation for solvent, resin, cleavage, chromatography, and lyophilization areas

    • Assess safety and contamination risks

    • Provide facility design recommendations including utilities

  • Process Validation & Regulatory Readiness

    • Help develop:

      • Process Validation Master Plan (PVMP)

      • Process Performance Qualification (PPQ) strategy

      • Cleaning validation for solvent-heavy processes

      • Continued Process Verification (CPV)

    • Support preparation for FDA and international inspections

  • Technology Transfer & Commercial Launch

    • Create technology transfer packages

    • Conduct risk assessments (FMEA)

    • Review batch records

    • Support commissioning activities including:

      • FAT/SAT

      • Engineering runs

      • PPQ campaigns


Qualifications and Education Requirements
  • 10+ years in peptide API manufacturing

  • Commercial-scale SPPS/LPPS experience

  • Regulatory inspection support experience

  • Large-scale preparative chromatography

  • Hands-on plant operations experience

Preferred Skills
  • Experience designing or commissioning peptide facilities

  • Complex/long-chain peptide synthesis

  • Greenfield facility projects


Additional Notes
Travel will be required to Indianapolis. 
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