Associate Director, MSAT Downstream
Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Associate Director, MSAT Downstream will lead technical strategy and execution for the scale up and commercial manufacturing of recombinant proteins produced in mammalian cells. This role will own technology transfers and scale up execution in GMP suites, quality compliance, continuous process improvement, and stakeholder engagement with clients and internal functions.
Key Responsibilities:
- Team leadership: Lead, mentor, and develop a technical team of 6–8 engineers and scientists; set performance goals and conduct reviews to foster a safety‑first, high‑performance culture.
- Technology transfer: Drive and enable successful technology transfers from Process Development or client teams into Avid manufacturing operations.
- Scale up and manufacturing: Ensure robust scale‑up strategies and successful manufacture of batches in Avid’s GMP suites, including planning, execution, and troubleshooting.
- Quality management: Lead or support timely and complete resolution of Quality Events; ensure product quality, adherence to safety procedures, and compliance with company and regulatory guidelines.
- Process risk and improvements: Identify process risks, lead root cause investigations, launch corrective and preventive actions, and champion continuous‑improvement initiatives.
- Innovation and technology adoption: Monitor emerging downstream technologies, evaluate fit for purpose, and propose implementation and qualification plans.
- Cross‑functional partnership: Build and maintain strong relationships with Process Development, Manufacturing, Quality Assurance, Supply Chain, and other key stakeholders to enable seamless handoffs and problem resolution.
- Operational excellence: Promote lean practices and a continuous‑improvement mindset to optimize quality, delivery, cost, and productivity.
- Reporting and governance: Provide regular and ad‑hoc updates to senior management and participate in technical reviews and governance forums.
- Direct management: Supervise a team of six to eight technical staff; provide coaching, performance management, career development, and hiring support.
- Culture: Maintain a safety, quality, and compliance culture while encouraging scientific rigor and operational accountability.
Minimum Qualifications:
- Master’s or Doctorate in science or engineering plus 6–8 years’ experience or a bachelor’s degree in science or engineering plus minimum 10 years’ experience in a GMP pharmaceutical manufacturing environment, preferably biologics.
- 5+ years leading technical teams and managing complex datasets.
- Hands-on knowledge of large-scale chromatography columns, ÄKTA systems, tangential flow filtration systems, and depth filtration.
- Proven experience resolving quality events, writing technical reports, and supporting regulatory submissions.
- Comfortable handling large datasets, performing basic statistical analyses, and creating clear graphical presentations of results.
- Strong written and verbal communication skills for drafting technical reports and presenting to senior management, clients, and external committees.
- Proficient with Microsoft Office (Excel, Word, PowerPoint), electronic record keeping, and laboratory/manufacturing databases.
Preferred Qualifications:
- Lean Six Sigma Green Belt or Black Belt preferred.
Position Type/Expected Hours of Work:
This role is a full-time position. Days of work are Monday through Friday, unless otherwise stated by Supervisor. The employee must also, if instructed, 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 $138,900 - $185,000 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 20 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.