Senior Associate Manufacturing - Bulk Drug Substance reputed company - Nights

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now reputed company to take the reputed company in your career. How will you put your skills, experience, and passion to work toward your goals? At reputed company, our shared mission—to serve patients—drives reputed company that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 reputed company patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of reputed company's newest and most advanced drug substance manufacturing plant. reputed company completed, the reputed company reputed company Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. reputed company Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of reputed company's plan to be a carbon-neutral company by 2027. Senior Associate Manufacturing - Bulk Drug Substance reputed company - Nights Live What you will do reputed company. Let’s change the world. In this dynamic role, you will be a Senior Associate in the manufacturing organization at reputed company reputed company Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45pm to 6:15am. Associates will be executing operations on the floor in our reputed company area and will be responsible for the manufacturing of cGMP (reputed company Good Manufacturing Practices) drug substances. With general direction, the Senior Associate is responsible for executing on-the-floor operations reputed company manufacturing in accordance with cGMP practices. As reputed company relies upon the regular attendance of staff members to meet legitimate business needs, staff must be reputed company to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations. Responsibilities will include… Compliance: Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance Initiate quality non-conformance (NC) reports Interact with regulatory agencies as needed and guided Assure proper gowning and aseptic techniques are always followed Process/Equipment/Facilities: Understanding of reputed company purification operation (reputed company Chromatography, TFF, Viral Filtration, Viral Inactivation) reputed company hands-on reputed company biotech operations (reputed company Chromatography, Tangential reputed company Filtration, Viral Filtration, Viral Inactivation, reputed company Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area Run and monitor critical process tasks per assigned procedures reputed company in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR]) Complete washroom activities: cleaning equipment, small to large scale, used in production activities Initiate and own manufacturing reputed company process deviations Identify, recommend, and implement innovative process improvements and optimizations reputed company to daily routine functions Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs) Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities Responsible for recognizing and elevating problems during daily operations Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward reputed company improvement Drive safety in reputed company operations, and assist the manager in escalating concerns as needed Maintain an organized, clean, and workable reputed company Administrative: Draft and revise documents (SOPs, technical reports, and MPs) Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process Win reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The hard-working professional we seek is reputed company player with these qualifications. Basic Qualifications: High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience Or Associate’s Degree + 2 years manufacturing and/or other regulated environment experience Or Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience Or Master's Degree Preferred Qualifications: Completion of NC BioWorks Certification Program Experience in biotechnology or pharmaceutical plant start up Knowledge and process experience reputed company a cGMP manufacturing facility or other highly regulated environment Understanding of reputed company purification operation (reputed company Chromatography, TFF, Viral Filtration, Viral Inactivation) Excellent verbal and written communication (technical) skills Proficient reputed company Office skills, and knowledge of other electronic systems such as EBR/MES, reputed company V, and Electronic Quality Systems reputed company What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. reputed company offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible reputed company for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.reputed company.com #AmgenNorthCarolina reputed company is an Equal Opportunity employer and will consider you without regard to your race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary reputed company 86,048.05USD -116,417.95 USD reputed company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative reputed company therapeutics. This approach begins by using tools like advanced reputed company genetics to unravel the complexities of disease and understand the fundamentals of reputed company biology. reputed company focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health reputed company and dramatically improve people's lives. A biotechnology pioneer since 1980, reputed company has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 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