Director, Chemical Engineering R&D

About the role

The Director of Chemical Engineering R&D is responsible for managing a portfolio of projects from our Company's clinical pipeline, including oversight of laboratory-based process development and characterization, pilot plant scale-up and activities to support technology transfer and regulatory filings. The incumbent will be responsible for the performance and professional development of staff members within their group.

Responsibilities

• Manage a portfolio of projects from the Company's clinical pipeline, overseeing laboratory-based process development and characterization, pilot plant scale-up, and activities to support technology transfer and regulatory filings.
• Oversee the performance and professional development of approximately 15 staff members, including both scientific supervisors and R&D engineers.
• Lead cross-functional groups and demonstrate and encourage diversity and inclusion principles in problem-solving and talent development.
• Technical and strategic oversight of chemical engineering staff contributing to the development, characterization, and scale-up of various unit operations for manufacturing processes, including batch and continuous reactions, crystallizations, extractions, membrane separations, distillation, filtration, and drying.
• Ensure processes are demonstrated and validated at internal and external commercial supply sites and documented in technology transfer documents and regulatory filing submissions.
• Participate in network-wide activities within Small Molecule Process and Research & Development division for setting strategic direction on the pipeline and other priorities, as well as help prioritize resource allocation.
• Influence the strategic direction of drug development and contribute to program Line-of-Sight (LOS) plans and Integrated Development and Supply Plans (IDSPs).
• Direct technical and strategic work supporting projects and provide input and guidance on best practices and resource utilization, as well as novel ideas or innovative approaches to technical or strategic advancements of programs.
• Keep abreast of external factors, internal and external contacts, and expertise requirements needed to solve challenging technical problems.
• Oversight of department's specialty groups, such as the crystallization lab (Xlab) or Environmental Process Safety and Engineering (EPSE) teams.

Qualifications

• Education: Degree in engineering or related pharmaceutical science is required.
• Experience: 10+ years of pharmaceutical process development experience with a proven track record in small molecule commercial process development, scale-up, and technology transfer to manufacturing.
• Experience: Demonstrated ability in leading cross-functional groups.
• Experience: Track record and commitment to employee development/retention.
• Skills: Excellent interpersonal, communication, and collaboration skills.
• Skills: Strength in delivering results on firm deadlines.
• Skills: Demonstrated ability in selection and prioritization of a portfolio of projects.

Requirements

• Location: Rahway, NJ location is required.
• Skills: Chemical Engineering, Chemical Technology, Clinical Manufacturing, Collaborative Communications, Diversity and Inclusion (D&I), Drug Development, Good Manufacturing Practices (GMP), Pharmaceutical Process Development, Pharmaceutical Process Engineering, Process Manufacturing, Project Portfolio Management (PPM), Regulatory Compliance, Technical Leadership, Technology Transfer, Vaccine Manufacturing.
• Preferred Skills: Current Employees apply HERE, Current Contingent Workers apply HERE, US And Puerto Rico Residents Only, Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retail benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days

Pay

The salary range for this role is $173,200.00 - $272,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.