Manufacturing Specialist, Senior (MF0607)
Company Information
Take charge of your career and grow in new directions by exploring opportunities within a growing Life Sciences Company...
Cambrex Bio Science Baltimore, a Cambrex Corporation, is a rapidly growing biotech company, dedicated to providing superior contract biopharmaceutical manufacturing services in our state-of-the-art facilities (Baltimore, MD and Hopkinton, MA). Our core competency is the production and purification of a variety of therapeutic and diagnostic products for clients in clinical trials and for commercial production. Cambrex Corporation (NYSE: CBM), is a $522 million innovative, global service leader supplying products and services to the life sciences industry. Headquartered in East Rutherford, NJ, Cambrex employs over 1,900 people located throughout the U.S., Europe, and Asia
Cambrex Bio Science, located in Baltimore, MD is seeking a Senior Manufacturing Specialist who shares the values and principles that characterize who we are - and how we work. It's time to join our world-class team, if the following attributes reflect your desire to contribute:
Innovation -Cambrex employees have a strong desire to excel and apply their skills in innovative ways to meet the demands of an ever-changing business environment.
Experience - Cambrex employees provide knowledge-based solutions, are empowered to make appropriate decisions, and demonstrate a commitment to quality in everything they do.
Performance - Cambrex is an organization that appreciates and rewards, efficient, reliable performance, meets goals and objectives, and delivers the Cambrex promise to bring value to our customers and investors with uncompromising integrity and ethics.
Job Description
The Sr. Manufacturing Specialist is responsible for performing all phases of operation in mammalian cell culture, microbial fermentation, and/or purification in a biopharma manufacturing facility. This work is performed under GMPs.
Job Responsibilities
Responsibilities include, but are not limited to:
Will operate large scale biopharma manufacturing equipment such as: fermentors, centrifuges, TFF skids, microfluidizers, CIP skids, chromatography skids/columns, formulation equipment, etc. Preparation of various types of media, buffers and cleaning reagents. Participate in all phases of support work for GMP bulk manufacturing such as: suite changeovers/activations, light maintenance on process equipment, cleaning, supplies ordering, and maintaining suite inventory. Participate in ongoing development, writing and revision of SOPs, SMPs and Batch Records. Accurate and timely execution of all GMP documentation such as: batch records, SMPs and logbooks. Will be the shift leader of all operations for that particular manufacturing shift. The Sr. Manufacturing Specialist is the main (responsible) point of contact for the supervisor. Will work with the process development scientists in the tech transfer of projects from that area to manufacturing. Provide assistance to validation engineers in the validation of manufacturing equipment and processes. The Sr. Manufacturing Specialist is the point of contact on the floor, for the validation engineers. Will interact with the clients on the floor in a professional manner. Close interaction with Manufacturing Process Engineers for process trouble-shooting and/or optimization is required. Will demonstrate an understanding and adherence to CBSB policies, GMP standards and safety procedures. Takes the lead in providing support to management for the training of new employees. Works with the supervisor and manager to maintain a safe work environment for all employees. Provide support to CBSB QA for audits and regulatory inspections. REQUIREMENTS
Job Qualifications Bachelor’s degree and minimum 3 years of industrial experience in large-scale fermentation, cell culture and/or purification, or an equivalent combination of education and experience. Must be able to provide technical support for all phases of cGMP bulk biologics manufacturing. Experience in a GMP environment is preferred. Must be computer literate (Word, Excel). A good working knowledge of mammalian cell culture, microbial fermentation and/or purification processes is required. Will be required to work flexible schedules (shiftwork) and holidays as needed.
Must be able to lift a minimum of 50 lbs and to work on ladders. Clear verbal and written communication between the immediate supervisor and/or manager and other staff is required. Must be able to work effectively as part of a team, in a very dynamic environment.
Will need to develop and maintain good working relationships with the clients and other CBSB departments.
Cambrex Bio Science offers a competitive salary and a comprehensive benefits package including medical (PPO), dental, vision, disability, life insurance and AD&D, in addition to tuition reimbursement, flexible spending accounts, a generous Paid Time Off package, and a matching 401(k) plan. Relocation assistance will not be offered for this position.
Please visit our web sites at www.cambrex.com for more exciting information about Cambrex Bio Science!
Equal Opportunity Employer M/F/D/V.
Thank you for your interest in Cambrex Corporation!
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