Manufacturing Associate

**Monday-Friday- 6AM - 2:30PM with Saturday shifts as per business needs** DEPARTMENT DESCRIPTION: The Manufacturing Associate will perform a variety of manufacturing tasks in the production area, working with a staff of 2-7 technicians and associates. This production operation is for Biosurgery. POSITIVE OVERVIEW WITH KEY RESPONSIBILITIES: Core Responsibilities Follows standard operating procedures in a clean room cGMP environment with strict gowning requirements. Operates manufacturing equipment inside environmentally controlled areas in accordance to established SOPs and safety regulations. Formulates large and small volume solutions, weigh out liquid and solid raw materials and filter solutions. Performs routine equipment CIP and area cleaning procedures. Follows safety guidelines. Assists in Validation activities and process improvements. Troubleshoots process problems. Works independently with little supervision. Interacts with support groups. Strong attention to detail. Works on deviations and CAPAs in Phoenix. Requests batch records from QA. Orders raw materials. Enters batch information into Athena. Trains new employees. Acts as SME for Biosurgery Operates general manufacturing equipment under close supervision in accordance with current GMPs or standardized procedures and within safety guidelines. Requires good documentation skills and attention to detail. Tasks to be completed may include fermentation, protein purification, solvent extractions, tissue culture, preparation of bulk solutions, aseptic fills of buffers, filling and labeling of vials under sterile and non-sterile conditions, routine buffer and media preparation, filtration, vial preparation and sterilization. Operates general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above. Brings deviations in process protocols to supervisors' attention. Maintains all associated documentation for operations being performed. Reviews and records physical inventory of stock items. Requires very few, if any of the requisite skills to perform the required tasks of the position at this level. Receives detailed instructions on all work. All activities are closely supervised, and work is reviewed upon completion. Receives general instructions on new work, which is generally reviewed upon completion. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires physical demands of lifting up to 30-35 pounds. The work environment characteristics described here are representative of those an employee to encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May involve work with hazardous materials. LEADERSHIP QUALIFICATION: An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes: Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures. Being honest and treating people with respect and courtesy. Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products. Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs. BASIC QUALIFICATION: High School diploma/GED with 3-5 years of experience in a cGXP environment, or a Bachelor's degree with 1-3 years of experience. Must have prior experience in GMP manufacturing operations. PREFERRED QUALIFICATIONS: B.S. Degree or a biotechnology certificate with 2 years' of related cGMP large scale production operation work experience. Candidates should demonstrate good technical writing skills, good troubleshooting skills, strong attention to detail and developed communication skills. Candidates with large- or small-scale bioreactor production experience highly preferred. SPECIAL WORKING CONDITIONS Requires physical demands of lifting up to 30 pounds. Must be willing to work weekends or required to work overtime to meet production demands. Requires working with flammable or hazardous materials. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube