Senior Manager, Drug Substance Development Kilo Lab
4 days left
- Full Time
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
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.
- Develop and drive strategic plans for the kilo lab area, including operational enhancements, new equipment/capability purchase and installation, capacity expansion, etc., including development of appropriate business case justification.
- Develop and 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 chemical engineering principles to solve challenges in synthesis and process development moving from bench to kilo-lab and from kilo-lab to pilot plant manufacture.
- Integrate DSD kilo-lab systems and operations with partner areas, including Drug Product Development scale-up facility, Laboratory Systems Management, Facilities group, EHS, etc.
- Assist in the preparation of CMC regulatory documents. 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.
Ph.D. + 6 years, M.S. + 9 years, or B.S. +12 years in Organic Chemistry, Chemical Engineering, or a related field.
- Ph.D. + 6 years, M.S. + 9 years, or B.S. +12 years in Organic Chemistry, Chemical Engineering, or a related field with relevant industry experience.
- 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 developing and scaling-up 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.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.