Scientist IV, Product Support (Biotherapeutics)

Location: Hybrid, United States — Andover, Massachusetts. First-shift Monday–Friday schedule; occasional night, weekend, or holiday support may be required. Permanent U.S. work authorization is required; U.S. visa sponsorship is not available. Relocation assistance may be available based on business needs and eligibility.

Annual base salary: $82,700–$137,900, plus eligibility for a 10% bonus target.

Company

hirify.global develops biopharmaceutical products and operates quality control and manufacturing activities across its biotech network.

What you will do

• Provide technical and analytical support for biotherapeutic products throughout their lifecycles.
• Author and review GMP documents, technical reports, periodic method validation reviews, and annual product reviews.
• Manage reference material qualifications, period-of-use assessments, extensions, change controls, reagent studies, and instrument validation.
• Facilitate and perform method qualifications, validations, verifications, transfers, and comparability studies.
• Support audits, regulatory submissions and responses, investigations, root-cause analyses, and resolution of analytical issues.
• Collaborate with cross-functional teams and hirify.global Biotech Network sites to meet manufacturing timelines and identify continuous-improvement opportunities.

Requirements

• BA/BS with at least 6 years of experience, MBA/MS with at least 4 years, or PhD/JD with any years of experience.
• In-depth understanding of protein characterization and production processes.
• Extensive experience with protein analysis techniques, including HPLC/UPLC, peptide mapping, CE/gel, carbohydrate analysis, ICE, and UV.
• Experience improving analytical methods and designing studies to enhance method robustness.
• Understanding of U.S., EU, and ROW cGMP and GLP requirements and auditing procedures.
• Strong written and verbal communication, interpersonal, organizational, and problem-solving skills.

Nice to have

• Experience with ELISA, bioassays, validation, laboratory automation, and project management tools.
• Knowledge of ICH standards, validation and lifecycle-management guidelines, regulatory requirements, and quality standards.
• Laboratory leadership experience and the ability to mentor junior team members.
• Experience using generative AI tools such as ChatGPT or Microsoft Copilot responsibly to improve productivity and problem solving.

Culture & Benefits

• Hybrid work arrangement with on-site support for laboratory, suite, office, and manufacturing operations.
• 401(k) plan with company matching and an additional retirement savings contribution.
• Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Participation in hirify.global’s Global Performance Plan with a 10% bonus target.