Manufacturing Science & Technology Associate II

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Manufacturing Technology Associate II provides technical support to biopharmaceutical drug substance manufacturing operations for MacroGenics' late-stage clinical and commercial programs. The position will work in partnership with Manufacturing Operations and BioPharmaceutical Development to support technology transfers, process and equipment validations, and routine manufacturing at internal sites.

Responsibilities and Job Duties

• Leads investigations of deviations to determine root cause and product impact. Develops recommendations and implements approved corrective action plans at cGMP manufacturing facilities.

• Performs detailed data analyses and root cause analyses to identify solutions to complex problems.
• Leads continuous process monitoring efforts and applies statistical tools to identify and improve productivity, efficiency, and robustness in manufacturing.
• Actively engages in the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites.
• Supports continuous improvement and operational excellence methods and efforts to improve the overall productivity and efficiency of manufacturing operations.
• Authors change controls, supports selection of new equipment and materials, and coordinates their implementation at manufacturing facilities to improve existing and new processes.

• Supports technology transfer activities between internal and external manufacturing sites and corporate partners.

• Supports fit-to-plant projections and plans for new processes and implements processes in multiple manufacturing facilities.
• Collaborates with the Quality Assurance group to fulfill quality management goals and ensures the highest quality manufacturing processes.

Minimum Qualifications

Education & Experience

• Bachelor's degree in Biology, Chemistry, Biochemistry or related life sciences or engineering field and a minimum of two years relevant experience; or
• Master's degree in Biology, Chemistry, Biochemistry or related life sciences or engineering field

AND

• Experience with commercial scale biopharmaceutical manufacturing support for cell culture processes
• Experience with Deviation, CAPA and Change Control systems

Knowledge, Skills and Abilities

• Solid understanding of overall manufacturing process, and technical knowledge downstream unit operations
• Knowledge of current Good Manufacturing Practices and US/EU regulations
• Ability to critically analyze data for process performance to compile technical reports and other documentation
• Ability to collaborate with cross functional teams resulting in creative and positive outcomes
• Strong verbal, presentation and writing skills to communicate effectively internally and externally

• Excellent organizational skills, ability to prioritize multiple projects, and attention to detail
• Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
• Demonstrated ability to effectively present information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding
• Displays a clear willingness to listen to others
• Solid proficiency in the use of Microsoft software (Word, Excel, PowerPoint)
• Ability to adapt to frequent change and thrive in a dynamic and entrepreneurial early-stage environment
• Ability to occasionally work flexible hours, including off-hours/weekends
• Ability to travel up to 10% of time

Supervisory Responsibilities

None

Additional Information

The annual rate of pay for this position ranges from $76,200 - $116,300. 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.