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Msat Associate Director information

What are the key skills and qualifications needed to thrive as an MSAT Associate Director, and why are they important?

To thrive as an MSAT (Manufacturing Science and Technology) Associate Director, you need deep expertise in bioprocess engineering, technology transfer, and process validation, typically supported by an advanced degree in a life science or engineering discipline. Familiarity with cGMP regulations, quality management systems, statistical analysis tools, and process simulation software is essential. Strong leadership, cross-functional collaboration, and problem-solving abilities distinguish top performers in this role. These skills ensure effective oversight of manufacturing processes, regulatory compliance, and the successful introduction of new technologies or products.

What is the difference between Msat Associate Director vs Msat Manager?

AspectMsat Associate DirectorMsat Manager
ResponsibilitiesOversees multiple projects, strategic planning, and team leadershipManages daily project operations, client communication, and team coordination
Required CredentialsTypically requires advanced degrees and relevant certificationsRequires relevant experience and certifications, but often less senior
Work EnvironmentStrategic, leadership-focused, often in corporate or consulting settingsOperational, client-facing, and team management roles
Industry UsageCommon in consulting, healthcare, and technology sectorsWidely used in similar industries for mid-level management roles

The Msat Associate Director role is more strategic and leadership-oriented, overseeing broader initiatives and teams, while the Msat Manager focuses on daily project execution and client interactions. Both roles require relevant credentials and experience, but the Associate Director typically holds a higher level of responsibility and strategic influence.

How does an MSAT Associate Director typically collaborate with cross-functional teams in a pharmaceutical company?

An MSAT Associate Director frequently works with cross-functional teams such as R&D, Quality Assurance, Regulatory Affairs, and Manufacturing to ensure that processes are robust, scalable, and compliant with regulatory standards. They often serve as a bridge between technical operations and production teams, leading technology transfer initiatives and troubleshooting complex manufacturing issues. Effective communication and project management skills are crucial, as the role involves coordinating timelines, aligning objectives, and facilitating knowledge transfer between different departments to support successful product launches and ongoing manufacturing processes.

What is an MSAT Associate Director?

An MSAT Associate Director is a senior professional responsible for leading the Manufacturing Science and Technology (MSAT) team within a pharmaceutical or biotechnology company. This role oversees the development, optimization, and troubleshooting of manufacturing processes to ensure product quality and regulatory compliance. The Associate Director collaborates with cross-functional teams, manages technology transfer, and supports the scale-up of production from research to commercial manufacturing. They play a key role in driving process improvements and ensuring that manufacturing operations run efficiently and effectively.
What are popular job titles related to Msat Associate Director jobs in Indiana? For Msat Associate Director jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Msat Associate Director jobs in Indiana look for? The top searched job categories for Msat Associate Director jobs in Indiana are:
Msat Associate Director jobs near you
Associate Director of Engineering

Associate Director of Engineering

Ossium Health

Indianapolis, IN

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 11 days ago

Job description

About the Job

This is a high-impact leadership role at the center of our manufacturing and technical operations. As the Associate Director of Engineering, you will lead the engineering and maintenance function supporting GMP/GTP manufacturing, ensuring equipment, processes, and systems remain reliable, compliant, and scalable as we grow.

You will partner closely with Production, Manufacturing, Quality, Supply Chain, MSAT, and Facilities to position Engineering as both a technical problem solver and a strategic enabler of safe, high-quality, and reliable product supply. As a key member of the Site Operations Team, you will drive disciplined execution, risk-based decision-making, and continuous improvement across the site.

This role is ideal for a technical leader who thrives in complex, regulated environments, builds strong and accountable teams, and is energized by modernizing systems to support increasing production demand and new product launches. The position reports directly to the SVP of Manufacturing Operations.

Required Qualifications
  • Bachelor's degree in Engineering and 8+ years of experience in pharmaceutical or biotech manufacturing OR 12+ years of relevant engineering experience in a regulated manufacturing environment
  • 4+ years of people management experience leading engineers or technical staff
  • Strong working knowledge of CGMP/CGTP requirements and engineering support in regulated aseptic or sterile manufacturing environments
  • Experience with equipment qualification (IQ/OQ/PQ), validation, and change controls
  • Proven track record of improving equipment reliability and reducing unplanned downtime
  • Strong project management, documentation, and communication skills
  • Experience with root cause analysis, FMEA, and SOP development
  • This position is based full time onsite in our Indianapolis facility
Preferred Qualifications
  • Experience supporting commercial-scale pharmaceutical or biotech manufacturing, including tech transfers, in multiple functional areas
  • Familiarity with computerized maintenance management systems (CMMS)
  • Experience leading capital projects and facility expansions
  • Lean or Six Sigma certification
  • Experience implementing automation and digital engineering solutions
  • Experience interacting with regulatory inspectors (FDA, EMA, or equivalent)
  • Expertise in business intelligence and analytics (Tableau, Power BI, SQL)
Key Responsibilities
  • Lead, mentor, and develop a high-performing engineering team including facilities, validation, maintenance, and automation personnel
  • Be a key member of our Site Operations Team, ensuring reliable supply of product to patients
  • Own equipment lifecycle management including design input, commissioning, qualification, maintenance strategy, and retirement
  • Oversee capital projects from concept through execution, ensuring scope, budget, and timelines are achieved
  • Establish and improve preventive maintenance and reliability programs to reduce downtime and deviation risk
  • Partner with Manufacturing, QA, and MSAT to support process improvements and capacity expansion
  • Ensure engineering compliance with CGMP/CGTP, safety standards, and internal procedures
  • Lead root cause investigations related to equipment, utilities, and facility systems
  • Drive data-based reliability improvements using trend analysis and KPIs
  • Support inspection readiness and represent Engineering during regulatory audits
  • Develop long-term facility and infrastructure strategy aligned with commercial growth plans
  • Travel (domestic and international) when required (<10%) to support other sites

In your first six months some projects you'll work on include:

  • Assessing current equipment reliability, PM effectiveness, and engineering KPIs
  • Implementing a new CMMS software platform
  • Identifying and prioritizing capital investments to support production growth
  • Standardizing engineering documentation and technical standards
  • Developing a 12-24 month engineering roadmap aligned to commercial scale and regulatory readiness

We offer a full slate of employee benefits including:

  • Competitive salaries
  • Stock options
  • 401(k) matching
  • Medical, dental and vision coverage
  • Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
  • Employer paid life insurance and long term disability
  • Gym membership/recreational sports reimbursements

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