Staff External Manufacturing Specialist (Drug Product)

Location: Rensselaer, New York, United States; onsite, Monday–Friday, with domestic and international travel of 25% or more

Salary: $108,000–$176,000 annually

Company

hirify.global is a biotechnology company that invents, develops, and commercializes medicines for serious diseases.

What you will do

• Lead clinical drug product filling operations at contract manufacturing and business partner sites.
• Own end-to-end technology transfer, gap assessments, risk evaluations, facility readiness, engineering runs, qualification, and validation.
• Manage active clinical batches, including in-process data, batch status, lot disposition, cycle times, yields, and reject rates.
• Lead deviation investigations, CAPA closure, change-control assessments, and continuous improvement initiatives.
• Review technical requirements, master batch records, validation reports, CMC submission sections, and related manufacturing documentation.
• Coordinate with Quality, Supply Chain, Operations, Legal, Regulatory, Strategic Sourcing, and external manufacturers.

Requirements

• Bachelor’s or advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related discipline; proven experience may substitute for education.
• 10+ years of pharmaceutical or biopharmaceutical drug product manufacturing experience with direct sterile filling and CMO oversight experience.
• Hands-on experience with aseptic filling, lyophilization, container closure integrity, inspection, and GMP operations.
• Experience leading technology transfer to CMO sites, including master batch record and technical requirements document approval, PPQ, and process validation.
• Experience leading deviation investigations and CAPA development for sterile filling operations.
• Ability to mentor technical staff, lead cross-functional work, communicate effectively, and make decisions in ambiguous situations.

Culture & Benefits

• Inclusive workplace and equal employment opportunity environment.
• Comprehensive rewards may include bonuses, equity awards, retirement benefits, 401(k) matching, insurance, paid time off, and family support benefits.
• Background checks may verify identity, right to work, and educational qualifications where required by law.