Senior Associate, External Operations

Tonix Pharmaceuticals; North Dartmouth (MA); In loco; USD 90.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive compensation package

Medical, dental, and vision insurance

Retirement savings plan

Paid time off

Descrizione del lavoro

A biotechnology company in North Dartmouth is seeking a Senior Talent Acquisition Partner to oversee manufacturing operations. The role involves managing relationships with external partners and ensuring compliance with quality processes. Candidates should possess a relevant degree and at least 8 years of experience in the pharmaceutical or biotechnology industry, with a strong knowledge of regulatory requirements. A comprehensive benefits package is provided.

Competenze

• Minimum of 8 years of experience in pharmaceutical or biotechnology.
• Ability to work effectively in a cross-functional team environment.

Mansioni

• Manage product life cycle activities across the product portfolio.
• Author and revise process documentation for GMP products.
• Lead continuous process verification activities to ensure product quality.
• Analyze process data and implement improvements with partners.
• Perform risk assessments related to process performance.

Conoscenze

Strong knowledge of regulatory requirements

Hands-on experience with manufacturing operations

Experience with quality systems

Formazione

BS, MS, or Ph.D. in a relevant scientific field

Descrizione del lavoro

Tonix Pharmaceuticals is seeking a Senior Talent Acquisition Partner. The company is a fully-integrated biotechnology company, publicly traded on NASDAQ, with marketed products and a pipeline of development candidates.

Tonix is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya, a first-in-class, non-opioid treatment for fibromyalgia.

Position Overview

The Senior External Operations Associate will play a critical role in overseeing the manufacturing across Tonix’s product portfolio. This position will manage relationships with external partners, drive operational excellence, and oversee development, manufacturing, and quality systems related to manufacturing supply.

Responsibilities

• Manage product life cycle activities across Tonix product portfolio.
• Author and revise process documentation for GMP products.
• Lead continuous process verification activities to ensure product consistency and quality.
• Analyze process data and implement improvements in collaboration with external partners.
• Perform risk assessments and manage mitigations related to process performance, supply continuity, and change management activities.

Contract Manufacturing Oversight

• Oversee CMOs to ensure compliance with Tonix manufacturing processes and testing.
• Maintain routine meetings with external supply partners and manage agendas.
• Conduct visits to CMOs and supply partner sites to ensure adherence to contractual agreements.

Requirements

• Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
• Hands-on experience with manufacturing operations and documentation.
• Experience as an owner of quality systems such as change control, deviation, CAPA, and validation activities.
• Ability to work effectively in a cross-functional team environment.

Education and Experience

• BS, MS, or Ph.D. in a relevant scientific field (e.g., chemistry, biology, engineering) or equivalent work experience.
• Minimum of 8 years of experience in pharmaceutical or biotechnology.

Tonix provides a comprehensive compensation and benefits package, including medical, dental, and vision insurance, retirement savings, and paid time off. Tonix is an equal employment opportunity employer and welcomes applications from diverse candidates.