Manufacturing Associate II/III - Cell Culture

The Manufacturing Associate II/III participates in the manufacturing of biopharmaceutical drug product to support MacroGenics' multiple clinical programs in the Cell Culture area. This position will work in the manufacturing suite under GMP (Good Manufacturing Practices) to ensure that materials manufactured meet required specifications and regulatory requirements.

Responsibilities and Job Duties:

• Perform cell expansion in shake flasks, rockers and SUB production reactors and conduct harvest operations.
• Perform SAP consumption of raw materials and components.
• Operate bioprocess equipment under strict adherence to cGMP, OSHA and required policies and regulations.
• Assist in the preparation and maintenance of reports and other documentation as applicable to the scope of operations in the manufacturing facility.
• Collaborate with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes.
• Perform room changeover of manufacturing suites and coordinate with QA/QC to release the room for manufacturing activities.
• Coordinate sample testing and equipment release with QC following equipment changeover.
• Assist with technical issues and problems.
• Assist with scale-up and basic trouble-shooting of technical issues and other problems encountered within the manufacturing process.
• Monitor, maintain and calibrate NovaFlex and Vi-Cell equipment as needed.
• Monitor and audit work processes to ensure compliance and completion of targets.
• Author and revise batch records and SOPs, as well as drafting of technical reports.
• Write deviation/incident reports as needed.
• Identify areas for improvement in manufacturing efficiencies and compliance.
• Assist with technology transfer from Process Development to manufacturing environment.
• Participate in the training of junior team members.
• Capture data using PIMPS, Excel, Word, PowerPoint and a document control system.
• Keep the GMP suite safe, clean and organized.
• Request and review Audit Trails / alarms for comments, accuracy and completeness.

Qualifications

Manufacturing Associate II

Education & Experience

• High School Diploma or equivalent and a minimum of three years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Associate's degree in a related discipline and a minimum of two years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Bachelor's degree in a related discipline and a minimum of one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
• Prior experience following GMP rules and procedures

Manufacturing Associate III

Education & Experience

• High School Diploma or equivalent and a minimum of five years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Associate's degree in a related discipline and a minimum of four years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Bachelor's degree in a related discipline and a minimum of three years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
• Prior experience following GMP rules and procedures

Knowledge, Skills and Abilities

• Knowledge of cell culture techniques
• Ability to write and revise technical documents
• Critical thinker who can analyze date and respond quickly to manage manufacturing projects
• Ability to mentor and train others
• Ability to manage multiple projects.
• Strong organizational skills
• Engaged and committed team professional who is committed to generating quality products
• Professional work ethic driven by manufacturing time-lines
• Passion for continuous improvement
• Independent thinker and self-learner
• Manual dexterity and attention to detail are required
• Technical accuracy and ability to perform mathematical calculations
• Strong interpersonal skills and the ability to work effectively and efficiently in a team environment.
• Ability to work flexible hours, including possible overtime and weekends
• Ability to lift up to 30 lbs

Supervisory Responsibilities

None

Additional Information

The annual rate of pay for this position ranges from $67,200 - $102,500 (Manufacturing Associate II) and $76,200 - $116,300 (Manufacturing Associate III). 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.