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Manager / Sr. Manager, External Manufacturing

About IGM Biosciences, Inc.IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases, and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology, and inflammation targets. For more information, please visit www.igmbio.com.IgM Antibodies and Autoimmune and Inflammatory DiseasesAntibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases, and IgMs are the first antibody defense against a pathogen infection. We are committed to exploring how the unique structure and binding properties of our IgM platform can improve outcomes for patients with these serious conditions.IgM Antibodies and OncologyIGM Biosciences has a T cell engager program, a receptor cross-linking agonist program and a targeted cytokine program in clinical studies for the treatment of patients with solid tumors and hematological malignancies. Position SummaryThe Manager/Sr. Manager of External Manufacturing candidate will manage and support the daily external Manufacturing operations; review complex documents, non-routine equipment, or process events; analyze and assess deviations, review batch records, and author supporting documents. The successful candidate will have established experience managing 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 Director, External Manufacturing.\n Responsibilities:Work with Director, External Manufacturing to 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.Manage scale-up cell culture and downstream processes to optimize contract manufacturing capabilities and production yield to support clinical studies.Provide Manufacturing oversight to all cGMP external activities, including Drug Substance and Drug Product manufacturing, secondary packaging and assembly, and clinical packaging operations.Manage and support 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.Enhance external contract manufacturing upstream and downstream process understanding and participate in platform optimization efforts, as needed.Coordinate and help review contract manufacturing documents in collaboration with external Quality and Manufacturing teams in order to release lots per the production schedule.Ability to author/review/approve clear and concise Standard Operating Procedures (SOP’s), Production Documents, and forms/addenda to facilitate GMP manufacturing.Manage and support Key Process Indicators (KPIs) for external contract manufacturing to support internal information for presentations, process improvements, and production alignment.Contribute to GMP campaign summary reports, relevant CMC sections in regulatory filings and technical development reports.Support contract manufacturing to evaluate supply chain constraints and support procuring raw materials as needed to ensure production run timelines are met.Support the Request for Proposal (RFP), Scope of Work, and Master Services Agreements (MSA) and diligence process for all external manufacturing contracts.Travel approximately 50% of the time.Requirements:Bachelor of Science degree in the Life Sciences/Engineering, or equivalent.8+ years experience in the Pharmaceutical/Biotech industry or an equivalent combination of education and experience.3+ years of management experience with 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 products supporting equipment preferred but not required.Extremely well organized with great attention to detail and the ability to multitask.Effective oral, written, and interpersonal communication skills.Travel approximately 50% of the time.The typical annual salary range for this full-time position is $XXX - $XXX, plus eligibility for cash and equity incentives. This range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location. Actual individual pay is determined by demonstrated experience and internal equity alignment.\nWe offer a fast-paced, collaborative, team-based, work environment. One of our top priorities is to maintain the health and well-being of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options: · Medical, dental and vision insurance.· The full premium amount for our employees and their dependents is covered by IGM· FSA (Flexible Spending Account)· 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.

Job Type
Full Time
Salary
N/A
Experience
N/A
Posted
5 days ago

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