FierceBiotech and FiercePharma Jobs
Sr Manager / Assoc Director Cell Culture Operations - Discovery Solutions
Nov 13
Location: Branchburg, NJCategories: Biotherapeutic
Website: http://www.discoverysolutions.net
Position Description
Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.
Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.
Currently looking for an Associate Director, Manufacturing – Cell Culture
This position is responsible for providing effective leadership to the cell culture manufacturing operations for the commercial production of monoclonal antibody products. This position reports to the Senior Director of commercial manufacturing and interacts with engineering, maintenance, validation, quality assurance, quality control, clinical development and logistics departments. As needed, further interaction will be required with material vendors and commercial partners. Knowledge of cell culture operations and support systems, along with spreadsheets and databases is essential.
Responsibilities:
Responsible for overall management of cell culture operations and support services functions
Provides key inputs for budget projections, material and staffing forecasts and ensure strict adherence to the approved budget.
Develops production schedules to meet commercial supply goals.
Provides accurate production forecasting methods. Leads all efforts for continuous improvement through capacity optimization and cost reduction programs.
Implements and maintains personnel policies, procedures and production control systems
Ensures cGMP and EHS compliance by assuring that all production equipment is properly validated and production processes/facilities meet quality as well as all safety standards
Develops departmental goals, objectives and metrics supportive of the corporate goals and work closely with subordinates to develop and manage their individual goals/objectives.
Measures and appraises subordinates’ performance against job duties and corporate/departmental objectives. Provide accurate and timely feedback. Recommend/approve merit increases, promotions, hires and terminations.
Represents the department during regulatory and other audits as assigned.
Provides technical input to resolve process problems and champion the NCE process within the department in order to ensure timely processing of all NCEs, CAPAs etc.
Champions all technical training initiatives within the department and ensure that personnel’s training is given a high correct priority.
Champions safety/ quality initiatives within the department and perform regular audits in order to ensure and maintain full compliance.
Experience Needed:
BS/BA degree in a technical discipline or equivalent experience.
Minimum of 10 years experience in a cell culture/biologics facility with minimum 6 years supervisory experience in a GMP production environment.
Hands on experience in the day to day supervisory aspects of a cell culture facility
Has a detailed process and equipment knowledge of cell culture and support services functions.
Has a thorough understanding of GMP requirements for a commercial scale manufacturing facility.
Experience in successful facility licensure a plus.
Excellent communication skills, both oral and written.
Demonstrated leadership skills coupled with strong planning, organizational, and time management skills.
Initiative minded team player with an excellent work ethic and high personal integrity.
