ArsenalBio's mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments. Our people are our greatest asset, they bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.
We are seeking a talented and motivated Senior Manager/Associate Director to join the ArsenalBio Technical Operations team. The individual will work closely with Process Development, Analytical Development, and Quality team members to lead the technology transfer and manufacture of ArsenalBio's clinical product. This position will report into the Director of Technical Operations and will interact cross-functionally across the organization to enable the success of ArsenalBio's clinical scale manufacturing process.
What You Will Do
- Manage and oversee technology transfer and GMP manufacturing operations at manufacturing facility; act as person in plant and manufacturing lead. Review and approve manufacturing batch records, protocols, development reports, validation reports, specifications, and deviations
- Lead manufacturing, change control, troubleshooting, investigations and resolution of deviations at manufacturing facility
- Design, implement, analyze, author protocols/reports related to optimization of manufacturing processes; collate manufacturing data to develop metrics, control charts and reports to improve manufacturing processes
- Collaborate with cross-functional Tech Ops team (Process Development, Supply Chain, Quality)
- Negotiate MSAs, SOWs, WOs
- Author relevant sections of IND amendments, NDAs
- Organize, communicate, and present data sets to key stakeholders and senior management
- Regular communication via protocols, reports, standard operating procedures, change controls, other related documents
- Position may require travel, 20-25% of the time, in the future
What You Will Bring
- Bachelor of Science degree in relevant scientific field. At least 6-10 years experience in biotechnology/pharmaceutical industry in a manufacturing role
- Expertise in process development, manufacture of cell therapy products highly desired
- In depth knowledge of US and European regulatory requirements for cGMP
- Expertise in managing external vendors, partnerships, with the ability to manage multiple technical projects successfully
- Excellent strategic thinking skills with demonstrated ability to successfully create and implement short and long range plans to support business strategy
- Strong leadership and project management skills
- Proficient in analyzing technical data and preparing written technical reports
- Excellent communication and negotiation skills
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or Arsenalbio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.