Associate Manufacturing Outsourcing Manager
Apply NowCompany: MacroGenics
Location: Rockville, MD 20850
Description:
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 Associate Manufacturing Outsourcing Manager is accountable for effective supply chain management of cell banks, drug substance and drug product sourced from external Contract Manufacturing Organizations (CMOs). The Associate Manager is responsible for project coordination with external manufacturing partners to ensure product supply for MacroGenics' portfolio. The Associate Manufacturing Outsourcing Manager collaborates cross-functionally with key MacroGenics stakeholders including CMC Project Management, BioPharmaceutical Development, Quality Control, Quality Assurance, Clinical Supply Operations and MSAT to drive external manufacturing activities.
Responsibilities and Job Duties:
Minimum Qualifications
Education
Bachelor's degree in a relevant technical or scientific discipline
Experience
At least 3 years' experience in biopharma/pharma supply chain, GMP manufacturing or process development
Knowledge, Skills and Abilities
Preferred Qualifications
Supervisory Responsibilities
None
Additional Information
The annual rate of pay for this position ranges from $80,300 - $122,500. 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.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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 Associate Manufacturing Outsourcing Manager is accountable for effective supply chain management of cell banks, drug substance and drug product sourced from external Contract Manufacturing Organizations (CMOs). The Associate Manager is responsible for project coordination with external manufacturing partners to ensure product supply for MacroGenics' portfolio. The Associate Manufacturing Outsourcing Manager collaborates cross-functionally with key MacroGenics stakeholders including CMC Project Management, BioPharmaceutical Development, Quality Control, Quality Assurance, Clinical Supply Operations and MSAT to drive external manufacturing activities.
Responsibilities and Job Duties:
- Supports external manufacturing relationships and interactions between MacroGenics teams and the CMO to ensure on-time production, release, and shipments.
- Monitors detailed project timelines for outsourcing activities and ensures transparent communication to project teams.
- Manages the internal cross-functional external production meeting by scheduling and hosting meetings, preparing agendas and meeting minutes.
- Coordinates shipments between MacroGenics and the CMO by preparing documentation and coordinating with internal and external stakeholders.
- Updates the internal cross-portfolio manufacturing outsourcing production plan.
- Updates and maintains manufacturing outsourcing team site.
- Authors and reviews supply chain maps for clinical portfolio products.
- Assists converting paper forms to electronic/fillable PDF formats.
- Performs additional responsibilities to support supply chain activities as designated by management.
Minimum Qualifications
Education
Bachelor's degree in a relevant technical or scientific discipline
Experience
At least 3 years' experience in biopharma/pharma supply chain, GMP manufacturing or process development
Knowledge, Skills and Abilities
- Excellent verbal and written communication skills
- Self-motivated and results-oriented with initiative to complete tasks proactively
- Well-organized with ability to effectively establish priorities and manage multiple responsibilities, tasks, and projects simultaneously in a fast-paced environment
- Capacity to organize assignments and work within deadlines
- Strong collaboration skills, ability to develop working relationships with colleagues at all levels of the organization
- Strong attention to detail
- Strong computer skills including versatility with Microsoft Office Suite, Adobe Acrobat
- Willing to learn new areas of expertise as required for the position
Preferred Qualifications
- Knowledge of GMP requirements
- Preference for direct experience in one or more areas of biopharmaceutical manufacturing (drug substance or aseptic fill/finish) or process development (cell culture, purification, drug product)
- Preference for related experience in project management
- Prior use of SAP or similar ERP system
- Prior use of project management tools (e.g. Microsoft Project, Smartsheet)
Supervisory Responsibilities
None
Additional Information
The annual rate of pay for this position ranges from $80,300 - $122,500. 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.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.