Associate Director, Drug Substance Tech Transfer

MSD; North Carolina; On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co. in Durham, NC is seeking an Associate Director, Technical Operations to lead the end-to-end drug substance and drug product processing at a new start-up facility.

You will guide technical transfer, risk management, and SOP/master record development to ensure high-quality manufacturing. You will manage a diverse team of engineers and scientists, drive cross-functional collaboration, and support regulatory inspections with a focus on GMP compliance and safe, efficient operations in a

Qualifications

• Bachelor’s, Master’s, or Doctorate in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or related life science or engineering discipline.
• Minimum of four (4) years (Doctorate), six (6) years (Master’s), or seven (7) years (Bachelor’s) experience in pharmaceutical operations, technical services, and/or quality operations including prior people management experience.
• Aseptic manufacturing and GMP manufacturing experience, preferably with biological drug substance.

Responsibilities

• Reporting to the Director, Technical Operations, the incumbent will assist in strategy development and will independently manage project assignments.
• Effectively manage a team of engineers and scientists supporting drug substance technical transfer by developing a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members.
• Provide end-to-end technical support to assigned areas of focus throughout the project lifecycle including but not limited to quality risk management, strategy development, development of standard operating procedures and master batch records, process development, and process performance qualification.
• Lead, facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones.
• Review and approve project documents as necessary including drug substance and process support and media technical documents, documents pertaining to utilities, manufacturing equipment and other processes, change controls, batch records, standard operating procedures, corrective and preventative actions among others.
• Act as a subject matter expert in support of quality risk assessments and regulatory inspections.
• Supports team safety, environmental, and compliance objectives.
• Escalates and consults on an as-needed basis with next level manager on more complex decisions impacting critical project milestones.

Skills

Biologics

API Manufacturing

Aseptic Processing

Regulatory Inspections

Process Transfer

Quality Operations

GMP Manufacturing

Capital Project Experience

Lean Six Sigma

Problem Solving

Education

Bachelor’s/Master’s/Doctorate in chemical/biochemical/biological sciences or related engineering field

Job description

Merck & Co. in Durham, NC is seeking an Associate Director, Technical Operations to lead the end-to-end drug substance and drug product processing at a new start-up facility.

You will guide technical transfer, risk management, and SOP/master record development to ensure high-quality manufacturing. You will manage a diverse team of engineers and scientists, drive cross-functional collaboration, and support regulatory inspections with a focus on GMP compliance and safe, efficient operations in a