Manager- Kilo Lab, Drug Substance Development

Req #: 1900850
Location: Summit, New Jersey, United States
Job Category: Technical Development
Work Location: 556 Morris Avenue 07901
Organization: Drug Substance Development
Employee Status: Full-time
Job Type: Regular

This position is responsible for managing a kilo-lab scale facility for drug substance process development and scale-up activities, associated with production of GMP and non-GMP drug substances and intermediates.

Responsibilities include:

• Serve as a key member of a dynamic, scientifically driven team dedicated to the discovery, development, and optimization of safe, scalable, and efficient chemical syntheses and processes for active pharmaceutical compounds.
• Lead and manage day-to-day operations of the Drug Substance Development kilo-lab facility, with responsibility for GMP and non-GMP processing activities.
  • Ensure facility/equipment operations, setup, cleaning, maintenance, and calibration are completed as required and compliant with all relevant SOPs and regulations
  • Manage all aspects of facility planning and scheduling
  • Maintain and control inventory of raw materials, intermediates, retains, and finished APIs associated with the kilo lab facility
  • Ensure that activities performed in the kilo lab facility meet all requirements for process safety and maintain compliance with all applicable safety and environmental standards and regulations.
  • Oversee and maintain all quality systems for the kilo lab area (SOPs, training, documentation, etc.) to ensure cGMP compliance with standards and regulations.
  • Develop and track performance metrics for kilo lab operations.
• Remaining current with required GMP training and qualifications.
• Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements.
• Drive strategic plans for the kilo lab area, including operational enhancements, new equipment/capability purchase and installation, capacity expansion, etc.. Assist in development of appropriate business case justification.
• Manage annual and multi-year capital and expense planning and budgets for kilo lab area.
• Provide guidance and oversight to all chemist and engineering staff who utilize the kilo lab area, establishing and driving best practices for all unit operations and activities. Serve as a resource of scientific and technical expertise regarding scale-up and kilo-lab operations.
• Apply fundamental chemistry and engineering principles to solve challenges in process development moving from bench to kilo-lab.
• Integrate DSD kilo-lab systems and operations with partner areas, including Drug Product Development scale-up facility, Laboratory Systems Management, Facilities group, EHS, etc.
• Prepare technical reports, publications and oral presentations.
• Supervise DSD technical staff and/or kilo lab operations staff under a matrix organization.
• Enhance the scientific and business capabilities of the department.

Skills/Knowledge Required:

• BS in Chemistry, Chemical Engineering, or a related field with relevant industry experience. MS/PhD preferred.
• Minimum of 10 yrs experience in the pharmaceutical industry in small molecule drug substance development and operations.
• Understanding and application of cGMPs and current regulatory standards in drug substance manufacturing for global clinical programs.
• Experience in pharmaceutical development as it relates to drug substance process development, scale-up, technology transfer and process safety.
• Proven track record in scale-up and implementation of innovative, safe, and effective processes for the manufacture of chemical intermediates and drug substances. Demonstrated record of implementing creative solutions to overcome synthetic and manufacturing obstacles.
• Demonstrated ability to balance technical needs, resource requirements, and other business considerations across multiple assigned projects.
• Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work with a sense of urgency, independently or in leading a team under deadline.
• Verbal and written communication skills are essential. Demonstrated proficientcy with standard and custom software programs / applications.
• Experience with broad CMC issues encountered in drug development, and experience with regulatory filings (IND/NDA) are highly desirable.
• Direct or indirect supervisory experience.
• Experience in operations involving highly potent compounds a plus.

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COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.