Director, External Manufacturing
IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company pioneering the development of engineered IgM antibodies for the treatment of cancer, infectious diseases, and autoimmune and inflammatory diseases. IgM antibodies have inherent properties that we believe may enable them to bind more strongly to targets on the surface of cells than comparable IgG antibodies. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers.
Our lead product candidate, Imvotamab, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3 proteins, and it is currently in two Phase 2 clinical trials for the treatment of relapsed and/or refractory diffuse large B cell lymphoma and follicular lymphoma. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with relapsed and/or refractory solid and hematologic malignancies, and it is currently in a Phase 1 clinical trial. Also in our product pipeline is IGM-7354 and IGM-2644. IGM-7354 is an anti-PD-L1 IgM antibody that targets the delivery of interleukin-15 (IL-15) cytokines to the area of PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies. IGM-2644 is a bispecific T cell engaging IgM antibody targeting CD38 and CD3 proteins for the treatment of patients with multiple myeloma.
Position Summary:
The Director of External Manufacturing will establish an external manufacturing group to develop, implement, and continue driving the company’s CMC external manufacturing functions (CMOs, CROs, etc.). The successful candidate will have established experience leading Manufacturing teams responsible for oversight of external partners with emphasis on external manufacturing, packaging, storage, and distribution of Drug Substances and Drug Products. This position reports to the Sr. Director, Manufacturing.
Responsibilities
- Build an External Manufacturing organization supporting manufacturing oversight of Drug Substance and Drug Product CMOs with requisite budget and resources to support company’s eventual product commercialization
- Drive scale-up cell culture and downstream processes to optimize CMO capabilities and production yield to support clinical studies
- Collaborate with IGM’s External Quality equivalent
- Provide Manufacturing oversight to all cGMP external activities, including Drug Substance and Drug Product manufacturing, secondary packaging and assembly, and clinical packaging operations
- Drive all manufacturing activities related to the manufacturing and disposition of clinical product including resolution of investigations and technical issues
- Responsible for ensuring that all drug substances and drug products are manufactured in accordance with IGM’s specifications, in compliance with cGMP, and consistent with applicable regulatory filings
- Support regulatory filings including INDs, NDAs, amendments, etc.
- Partner with internal and external stakeholders as necessary to meet business objectives and deliver results for our patients
- Conduct risk and gap analyses of existing systems and drug products
- Coordinate and help review CMO manufacturing documents in collaboration with internal Quality and Manufacturing teams in order to release lots per the production schedule
- In collaboration with IGM’s External Quality team, support reviews and approvals of specifications for drug substances and drug products
- Drive oversight of performance tracking and reviews of contract manufacturers and suppliers
- Initiate, drive, and update Key Process Indicators (KPIs) for external CMOs to support internal information for presentations, process improvements, and production alignment
- Supports quality investigations at contract manufacturers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions
- Routinely interacts with internal and external colleagues, regulatory agencies, and auditors/inspectors
- Provide effective leadership including setting individual and department objectives, employee evaluations, leading departmental meetings, providing performance feedback, recognizing employee contributions, coaching, and developing staff
- Support contract manufacturers to evaluate supply chain constraints and support procuring raw materials as needed to ensure production run timelines are achieved
- Drive or initiate Request for Proposal (RFP), Statement/Scope of Work, and Master Services Agreements (MSA) and diligence process for all external manufacturing contracts
Requirements:
- Bachelor of Science degree in the Life Sciences/Engineering, or equivalent
- 15+ years’ experience in the Pharmaceutical/Biotech industry or an equivalent combination of education and experience
- 5+ years management experience of exempt and non-exempt employees in the Manufacturing setting
- Knowledge of GMP manufacturing requirements related to clinical production and commercial manufacturing of injectable products
- Exceptional knowledge of applicable FDA, EMA, ICH cGMP regulations and guidance documents
- Experience supporting regulatory inspections, including FDA, EMA, and Ministries of Health, etc.
- Experience providing scientific input, data analysis and written reports for failure investigations
- Experience operating multiple sized bioreactors, chromatography skids, and other production supporting equipment preferred but not required
- Extremely well organized with great attention to detail and able to multitask
- Effective oral, written, and interpersonal communication skills
- Must be able to commute to Mountain View
- Must be able to travel approximately 50% of the time
Comprehensive benefits:
- Medical, dental and vision insurance.
- The full premium amount for our employees and their dependents is covered by IGM
- STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
- 401(k) Plan
- 120 hours of Paid Time Off, 5 sick days per year, 11 holidays
- Cell phone & internet subsidy
- Employee Referral Bonus Program
- Annual training budget for professional development
- Commuter Benefit
- Annual bonus program
- New hire stock options
IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.