Senior Director, Peptide Process R&D and Scale

Position: Senior Director, Peptide Process R&D and Scale-Up
Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a Senior Director, Peptide Process R&D and Scale-Up to serve as a founding technical leader for an emerging peptide therapeutics company establishing next-generation manufacturing and drug development capabilities in Fishers, IN.

This is a high-impact, hands-on leadership role where you will own peptide process development from early-stage R&D through first cGMP batch production. You will define the technical direction, make critical scale-up decisions, and establish the foundation for the company's future CMC and process development organization.

This is not a purely strategic role-you will be deeply involved in execution, working directly on the manufacturing floor and influencing real-time decisions.

Key Responsibilities:

• Own end-to-end peptide process development and scale-up strategy and execution
• Design, develop, and scale Fmoc SPPS processes for commercial manufacturing
• Serve as the technical authority on process development, scale-up, and manufacturing readiness
• Translate uncertainty into clear, actionable decisions across:
  • Equipment selection
  • Process parameters
  • Purification strategy
  • Cleaning and validation approaches
• Lead technical CMC content development supporting DMF/ANDA filings
• Drive equipment URS definition and selection (SPPS reactors, prep HPLC, lyophilization systems)
• Partner with engineering firms and vendors to enable facility design, build, and commissioning
• Establish process controls, analytical strategies, and GMP readiness
• Lead and support scale-up campaigns, PPQ, and first cGMP batch execution
• Build and scale the process development and CMC function post-Series A

Minimum Qualifications:

• Extensive hands-on experience scaling Fmoc SPPS processes to commercial or near-commercial scale

• Direct kilo-scale manufacturing / reactor experience (on the floor, not just in the lab)
• Proven participation in GMP campaigns or late-stage scale-up programs
• Demonstrated ability to own development through GMP execution
• Strong decision-making ability in ambiguous, early-stage environments

Preferred Qualifications:

• Experience authoring technical CMC sections for DMF or ANDA submissions
• Experience with facility startup, tech transfer, and equipment qualification (CQV)
• Deep expertise in:
  • Lipidation and complex peptide chemistries
  • Disulfide bond formation
  • Impurity control strategies
  • Cleaning validation
• Experience with prep HPLC, lyophilization, and solvent systems at scale
• PhD preferred; strong MS candidates considered

Leadership & Technical Expectations:

• Ability to design and size:
  • SPPS reactor trains
  • Purification systems
  • Lyophilization capacity
• Deep understanding of scale-up risks, tradeoffs, and failure modes
• Operates with an owner mindset, balancing speed and technical rigor
• Comfortable challenging vendors, consultants, and assumptions when needed

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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