Manufacturing Associate I - Production Support

Responsibilities and Job Duties:

• Performs support tasks that enable the manufacturing of material for clinical trials in a GMP manufacturing environment, including planning, communicating daily material needs, weighing materials, preparing and testing solutions, coordinating sample collection and submission, facility cleaning, equipment cleaning, material ordering, and routine consumption of raw materials and component transactions within our electronic management system.
• Creates and revises Solution Records, Work Instructions, Standard Operating Procedures and other GMP documents related to the support work.
• Reviews cleaning logbook forms for accuracy.
• Cleans and disinfect materials that enter the manufacturing suite.
• Prepares solutions, completes solution records, and reviews solution records under GMP regulations and related SOPs. Documents all manufacturing activities clearly and accurately, including preparation records, testing records, and equipment use records.
• Works in collaboration with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes.
• Maintains chemical and supplies inventory and performs routine equipment maintenance and housekeeping ensuring that equipment and materials are available and adequate to set the manufacturing team up for success.
• Participates in a variety of projects, as assigned, designed to improve the service, quality, and efficiency of the production support team.
• Operates bioprocess equipment (Single Use Mixers, TOTE Tanks, Mixers, Scales) under strict adherence to cGMP, OSHA and required policies and regulations.
• Follows all related safety rules and procedures when working with hazardous materials to maintain a clean and safe plant environment.
• Organizes projects and data using Excel, Word, Powerpoint and a document control system.
• Requests Master Batch Records from Quality Assurance Document Control
• Performs other activities assigned by area supervisor

Qualifications

Education & Experience

• High School Diploma or equivalent with exposure to science and math coursework and a minimum of two years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Associate's degree with one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Bachelor's degree in a related discipline with no experience

Knowledge, Skills and Abilities

• Knowledge of basic chemistry
• Ability to write and revise technical documents concisely and clearly
• Technical accuracy and ability to perform mathematical calculations
• Ability to follow detailed instructions and to maintain accurate records and notes
• Strong organizational skills and attention to detail
• Ability to work effectively in a team environment while demonstrating a commitment to generating quality products
• Professional work ethic driven by manufacturing timelines and passion for continuous improvement
• Ability to think critically, analyze data and respond quickly to manage multiple manufacturing projects
• Skilled in problem solving and troubleshooting
• Ability to safely operate production equipment in accordance with established practices
• Ability to lift up to 30 lbs.
• Ability to work occasional weekends or overtime as needed

Supervisory Responsibilities

None

Additional Information

The annual equivalent of pay for the Manufacturing Associate I position ranges from $47,250 - $78,750. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.