Downstream Manufacturing Scientist Laboratory Middlesex County, NJ, US + Added - 11/11/2024 Apply for Job Seeking a Downstream Manufacturing Scientist for our client - a leading biopharmaceutical company! **Type:** Contract-to-hire **Location:** Middlesex County, NJ **Primary Responsibilities:** + Execute downstream processing at various scales in a cGMP environment, including column packing, troubleshooting processes, and data interpretation. + Provide technical leadership for the development and implementation of purification processes. + Utilize software applications to gather and analyze operational data, making on-the-fly adjustments to products, equipment, or instruments as needed. + Ensure that engineering and clinical batches are completed on time. + Create and maintain equipment specifications and enhance manufacturing procedures. + Partner with internal teams and external vendors to address technical issues and manage production equipment upkeep. + Follow GMP protocols within the production area and set an example in adhering to environmental health and safety regulations. + Coordinate and conduct investigations and corrective actions for issues found during batch execution. + Carry out other duties as needed or assigned. + Maintain compliance with all company policies and procedures. **Qualifications:** **Education:** + Bachelor’s degree in chemical, biological, or biochemical sciences, with a minimum of 4-5 years of relevant experience in the biopharmaceutical industry. + Proven experience in GMP-compliant and aseptic manufacturing techniques. + Hands-on experience with AKTA Process skids or similar systems, along with knowledge of single-use consumables like bags, tubing sets, columns, and process manifolds. + Proficiency in executing engineering and clinical batches, with a strong background in GMP documentation. **Special Skills:** + Strong teamwork and independent work skills, with solid interpersonal abilities. + Effective verbal and written communication, strong organizational skills, attention to detail, and basic computer literacy. + Proficient in using Word, Excel, and spreadsheet applications. + In-depth knowledge of GMP batch manufacturing and packaging documentation, including auditing and reviewing. + Understanding of cleaning verification and validation practices. INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.