Associate Director, Technical Operations Drug Substance
About The Position
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state-of-the-art laboratories, manufacturing plants, and offices designed to inspire our employees as we learn, develop, and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development. We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of sterile products, making accessible our company's next generation of vaccines and biologics. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. We have an exciting opportunity for an Associate Director to join the technical operations team supporting a start-up of Human Health at our facilities in Durham, North Carolina. This new facility will include end-to-end processing of both drug substance and drug product and quality control laboratories. The Associate Director, Technical Operations will be responsible for providing technical leadership to the drug substance manufacturing area as part of the Technical Operations team.
Requirements
- Bachelor's, Master’s, or Doctorate degree 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.
- Effective decision-making, problem-solving, and communication skills.
- Ability to manage multiple priorities and complex problems in a fast-paced environment.
- Aseptic manufacturing and GMP manufacturing experience, preferably with biological drug substance.
Nice To Haves
- Capital project experience.
- Experience using Lean/Six Sigma tools.
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.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Manager
