Summary of Position

The Director, Cell Culture Sciences in the BioPharmaceutical Development (BPD) department is a strategic and technical leader. He/She is responsible for early-phase cell culture process development and optimization, late-phase process characterization and process validation of cell culture unit operations, and Cell Line Development activities. This individual is responsible for designing and executing studies to develop process control strategies for the pipeline molecules. He/she will work closely with other functions, including Purification, Analytical, and Drug Product Development, and collaborate with Manufacturing, Quality and Regulatory Affairs functions to support development of molecules leading to commercialization. This role will drive talent management processes and develop and mentor team members. This individual will be a member of the BPD Leadership team.

Responsibilities and Job Duties

• Lead cell culture and harvest process development, scale-up, toxicology supply production, technology transfer, supporting clinical batch production, and IND submissions, to support development of early-phase pipeline programs. Oversee Cell Line Development function.
• Define and lead strategies toward commercialization for late-phase programs, including design, coordination, and execution of process characterization and small-scale and manufacturing-scale process validation studies.
• Oversee the technology transfer of developed cell culture processes to GMP manufacturing sites.
• Establish and qualify scale-down models of bioreactors to support Process Characterization studies and GMP manufacturing.
• Oversee Cell Line Development and protein expression activities including creation of stable pools, clonal cell banks. Support Master Cell Bank and Working Cell Bank production in collaboration with CDMOs.
• Oversee authoring of upstream process development and cell line development sections of IND, BLA, and other regulatory dossiers.
• Serve as a subject matter expert on upstream process and cell line development, including process and manufacturing related activities, risk assessments, characterization, investigations, regulatory interactions, and project team requirements.
• Manage resource and equipment utilization in Cell Culture Sciences team.
• Recruit, motivate, retain and develop team members. Create a high-performing team that emphasizes strength-based execution, accountability, open communication, and people development.
• Champion and implement Continuous Improvement on technical and business processes at Cell Culture Sciences and within BPD. Actively engage in the identification, sharing and adaptation of best practices cross-functionally.
• Present scientific findings at internal and external meetings, and champion scientific journal publications. Represent MacroGenics at industry consortia and meetings with collaborators.

Qualifications

Education/ Experience

• Bachelor’s degree in Cell Biology, Biochemistry, Chemical Engineering, Biochemical Engineering, or relevant life science field, and a minimum of 20 years of experience in biopharm industry, working on mammalian cell culture and/or cell line development,
• Master’s degree in the relevant fields with a minimum of 15 years of experience in biopharm industry,
• PhD in the relevant fields with a minimum of 10 years of experience in biopharm industry.

Knowledge, Skills, and Abilities

• Hands on experience in mammalian cell culture at bench scale and pilot scale, and in harvest process.
• Knowledge and in-depth understanding of mammalian cell culture, bioreactor scale-up, and harvest process operations.
• Demonstrated capability on set-up, maintenance of cell culture and harvest equipment. Experience in root cause analysis and troubleshooting on cell culture processes or equipment.
• Experience in technology transfer to manufacturing sites.
• Strong knowledge of DOE and QbD principles, and experience in using statistical tools.
• Ability to critically analyze data. Experience in authoring technical reports and other documentation.
• Experience in defining strategies on phase-appropriate development activities.
• Proven track record of authoring, executing and reviewing Process Characterization and Process Validation study protocols and reports.
• Solid understanding of current FDA and ICH guidelines on cell culture and Drug Substance processes. Experience in authoring and reviewing regulatory dossiers (IND, BLA).
• Strong understanding of CMC functions. Experience in participating in CMC teams.
• 5+ years of direct people management experience, including performance management, coaching and mentoring team members.
• Effective communication skills, both verbal and written, and the ability to communicate effectively with internal and external stakeholders.
• Ability to collaborate with and influence other function areas, such as Purification Sciences, Analytical Sciences, Quality, senior management.
• Demonstrated capabilities of proactively taking initiatives on process improvement.
• Experience in managing budgets, project timelines, and resources.

Preferred Qualifications

• Knowledge of cell lines and expression systems used in mammalian cell culture
• Experience in Cell Line Development and clone selection
• Experience in Master Cell Bank and Working Cell Bank production and testing
• Experience in cell culture media development
• Experience in developing high titer cell culture processes
• Experience in perfusion cell culture process development
• Knowledge related to the use of AI and data management in process development

Additional Information

The annual rate of pay for the Director, Cell Culture Sciences position ranges from $187,700-286,300. 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.**