CM&C Peptide Process Manufacturing Consultant

Pintail SolutionsFishers, IN

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Overview

Career level

Senior-level

Remote

Job Description

Job DescriptionConsultant, Process Manufacturing

Job Title	Position Type	Contractor
Location	Remote		Travel Required	Travel may be required
External Posting URL
Applications Accepted By
Jason C. Borkjason.bork@pintailsolutions.netor (317) 694-0232 (mobile)		Mail:Jason C. BorkPintail Solutions, Suite 10412172 Visionary WayFishers, IN 46038
Job Description
OverviewPintail 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 NotesTravel will be required to Indianapolis.

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FAQs About CM&C Peptide Process Manufacturing Consultant Jobs at Pintail Solutions

What is the work location for this position at Pintail Solutions?

This job at Pintail Solutions is located in Fishers, IN, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Pintail Solutions?

Employer has not shared pay details for this role.

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What experience level is required for this role at Pintail Solutions?

Pintail Solutions is looking for a candidate with "Senior-level" experience level.

Does Pintail Solutions allow remote work for this role?

Yes, this position at Pintail Solutions supports remote work, giving candidates the flexibility to work outside the primary office location.

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