Supervisor, Manufacturing Support

The Supervisor, Manufacturing Support is a managerial position responsible for planning and executing activities in the Support area of a cGMP manufacturing facility which includes weigh and dispense, buffer preparation, media preparation, facility cleaning, equipment cleaning, and material ordering. This individual will forecast monthly activities, plan daily activities and ensure staff are focused on these activities. The individual will drive actions to ensure adherence to the overall production and lot release schedules while maintaining a high level of quality and compliance. This is a hands-on role where the supervisor will frequently work directly with the team to ensure that work is done accurately and on time.

Responsibilities and Job Duties

• Perform duties in accordance with Site SOPs, EH&S standards and guidelines, and relevant legal requirements and ensure that their team does the same.
• Ensure that activities meet all quality standards for cGMP and other applicable regulatory agencies.
• Perform and supervise others conducting weigh and dispense, buffer preparation, media preparation, facility cleaning, equipment cleaning, and material ordering.
• Ensure successful implementation of new products and processes into the facility by creating new solution records, SOPs, change controls, procuring new equipment, and completing area changeover activities.
• Open and/or evaluate deviations for potential impact.
• Effectively troubleshoot production equipment and process problems of varying scope.
• Be accountable for Manufacturing Associate development and/or performance management through activities such as assignments and associated technical training programs.
• Ensure all staff are adequately trained on all cGMP manufacturing operations and documentation.
• Work on problems of advanced scope, potentially cross-functional, where analysis of situation or data requires a review of identifiable and unknown factors.
• Participate in and implement continuous improvement and operational excellence methods and tools to improve the overall efficiency of production operations.
• Schedule and coordinate activities with other departments such as Quality Assurance, Quality Control, Facilities and Engineering, Supply Chain and Materials Management, and Validation.

Qualifications

Education & Experience

• High school diploma or equivalent and a minimum of 9 years of related experience in a cGMP and/or bioprocessing environment

OR

• Associate's degree in a related discipline and a minimum of 7 years of related experience in a cGMP and/or bioprocessing environment

OR

• Bachelor's degree in a related discipline and a minimum of 5 years of related experience in a cGMP and/or bioprocessing environment

Knowledge, Skills and Abilities

• Excellent interpersonal and people management skills with a demonstrated ability to engage, influence, and lead a team
• Ability to influence others without direct authority
• Excellent organizational skills and attention to detail
• Results driven with demonstrated successful outcomes
• Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
• Ability to handle multiple priorities in a fast-paced environment
• Excellent written and verbal communications skills
• Basic knowledge of chemistry
• High degree of comfort with basic arithmetic
• Proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet)
• Ability to lift at least 30 lbs
• Ability to work flexible hours, including possible overtime and weekends

Supervisory Responsibilities

The individual will manage a group of Manufacturing Associates/Technicians

Preferred Qualifications

• Lean Six Sigma / Operational Excellence training
• Ability to lead and conduct formal documented risk assessments
• Experience writing documents for Regulatory submission (INDs, BLAs, etc.)

Additional Information

The annual rate of pay for this position ranges from $99,200 - $151,300. 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.

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.