Description

Your Role:

The Senior Director, Manufacturing Science & Technology (MSAT) is the technical authority for commercial manufacturing processes within a biotech/CDMO environment. This role owns process performance and lifecycle management from technology transfer through routine commercial manufacturing and ensures processes remain in a validated and controlled state. The position provides strategic and operational leadership for MSAT functions, partnering closely with Manufacturing, Quality, Process Development, Validation, and Supply Chain to enable reliable, compliant, and scalable operations.

Key Responsibilities

• Process Lifecycle Ownership

Serve as technical owner for commercial manufacturing processes across the product lifecycle.

Establish and maintain process knowledge, control strategies, and acceptance criteria.

Own Continued Process Verification (CPV) strategy, execution, and scientific interpretation.

• Technology Transfer & Scale-Up

Lead technical transfer of processes from Process Development into GMP manufacturing.

Support site-to-site and client technology transfers within the CDMO network.

Define technical readiness criteria for PPQ and commercial launch.

• GMP Operations Support

Provide expert technical support for manufacturing deviations, investigations, and CAPAs.

Lead root cause analysis for process-related issues and implement sustainable technical solutions.

Partner with Manufacturing to improve robustness, yield, and throughput.

• Validation & Change Management

Partner with CQV/Validation to define PPQ strategies, process qualifications, and ongoing validation activities.

Assess technical impact of process and material changes and support change control decisions.

Ensure process changes are supported by data, risk assessment, and regulatory rationale.

• Regulatory & Inspection Support

Act as MSAT subject-matter expert during FDA, EMA, and client regulatory inspections.

Support regulatory submissions and responses related to manufacturing processes and control strategies.

Defend technical decisions using science- and risk-based justifications.

• Leadership & Strategy

Lead and develop MSAT managers and technical staff.

Define MSAT operating model, governance, and priorities aligned with business growth.

Drive cross-functional alignment across Manufacturing, Quality, PD, Engineering, and Supply Chain.

Minimum Qualifications:

• Bachelor's degree in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline; advanced degree preferred.
• 12-15+ years of experience in biologics or pharmaceutical manufacturing, MSAT, or process development.
• Demonstrated experience supporting commercial GMP manufacturing and regulatory inspections.
• Strong knowledge of process validation, PPQ, CPV, and lifecycle management expectations.
• Proven leadership experience in cross-functional, matrixed environments, preferably within a CDMO.

Core Competencies

• Scientific and technical leadership
• Regulatory and GMP judgment
• Strategic thinking and decision-making
• Structured problem solving and root cause analysis
• Change management and execution excellence
• Influence without authority

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $208,800-$261,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.