Severn, MD, 21144, USA
2 days ago
Manufacturing Associate
Our client, one of the largest pharmaceutical companies in USA is looking for Manufacturing Associate in Severn, MD. Our client is looking for someone who has experience with with **upstream (fermentation/bioreactor) biologic production** processes under GMP compliance. **Job title:** Manufacturing Associate **Work Location:** Severn MD 21077 **SHIFT 12pm - 12am (2-2-3 rotation) -** Lifting to 40 lbs., unassisted may be required at times. Frequent standing and walking is required, as this role requires presence on the manufacturing floor. Shift work and weekend work is required. **KEY RESPONSIBILITIES:** + Collaborate with MST and development groups to assist with tech-transfer, scale-up, and translation activities. + Will lead for one or more areas in upstream manufacturing as directed by the supervisor. + Interface with engineering group to source new production equipment. + Interface with Quality Assurance department to execute corrective actions / preventative actions. + Represent the department to clients and on cross-functional project teams. + Work with manufacturing manager and supervisors to develop and maintain training materials and curricula. + Ability to work with bioreactor operation and cell culture including aseptic technique + Execute and monitor critical processes supporting mammalian, microbial, and fill finish production facilities + Solid experience with the following:  large-scale centrifuges, washers, autoclaves + Performs the weighing, dispensing of raw materials for media and buffers + Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product. + Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc. + Dispensing, labeling, transfer/staging of raw materials and parts + Assembly/disassembly, cleaning and sterilization of components, parts and equipment + Ability to contribute to the development of new concepts, techniques, and standards + Assist Facilities and Engineering personnel as necessary on equipment maintenance and calibration + Interface with Quality Control department to submit in-process samples and coordinate environmental monitoring during key process steps. + Provide support to cross-functional teams to meet production or timeline demands. + Demonstrate understanding in scientific concepts, technical operations, safety, and Good Manufacturing Practice. + Adhere to Quality standards and learn and comply with regulatory requirements. + Provide suggestions for process optimization and efficiency, where applicable. + Operate manufacturing equipment in assigned area + Write standard operating procedures (SOP’s) and other documents as necessary + Complete manufacturing documents such as batch records, logbooks + Assist in the execution of validation protocols + Ability to accurately analyzes and processes scientific data + Ensure the completeness and accuracy of manufacturing documentation per approved procedures + Identify and support the implementation of process efficiencies and areas for improvement + Ensures solutions are consistent with organization's objectives + Demonstrate ability to perform all process steps upstream and/or support production operations + Ability to generate SOPs for equipment and procedures used in the manufacture of biological products + Train new staff in scientific concepts, technical operations, safety, and Good Manufacturing Practice. + Eligible to apply for the Qualified Trainer (QT) Program. **POSITION REQUIREMENTS:** **Bachelor’s degree** in a Scientific, Engineering or Biotech field with 4 years’ experience with **upstream (fermentation/bioreactor) biologic production** processes under GMP compliance. OR HS Diploma or Associate’s Degree with 5– 6 years’ experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance. If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you! **About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells** _ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent. ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. 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