Object Pharma is a biotech company located in Aliso Viejo, California, with GMP facilities in Madison, Wisconsin. Object is developing novel neurotoxin products for aesthetic and therapeutic applications. We offer our employees competitive compensation, a flexible, fast-paced environment, and the opportunity to learn a diverse skill set in an expanding company. We are an equal opportunity employer.
The Company: Object Pharma owns Clostridium botulinum serotypes A through G and has a pipeline of neurotoxin candidates that will expand the clinical application of neurotoxins.
- Our employees have the unique opportunity to develop broad expertise in a small, inclusive company.
- We believe that every member is critical to building a strong company and generating superior products.
The Position: Object is searching for a Quality Manager who will be responsible for QA/QC and regulatory compliance of Object’s Madison site. The position will be based in Madison, WI and will report to the Site Head. The Quality Manager will work closely with corporate Quality, Regulatory, and related functions located in California.
- Be an integral Quality partner in Object’s drug development activities and reagent manufacturing
- Establish and maintain a phase-appropriate Quality Management System
- Implement a document control process to draft, review, approve, issue, maintain, and archive GMP documents and records
- Proactively identify and communicate issues and risks; work together with management and SMEs to develop plans to address and/or mitigate
- Coordinate and manage the handling of change controls, deviations, investigations, complaints, CAPAs, etc.
- Host and/or participate in regulatory inspections and quality audits of the site
- Ensure inspection & audit findings are adequately addressed and closed per agreed timeframes
- Qualify and maintain quality oversight of vendors, suppliers, and contract partners
- Review and negotiate quality agreements
- Work with manufacturing and site leadership to plan and coordinate batch production and testing activities
- Perform Person-in-Plant activities as necessary
- Review batch production records, including test results, and identify any discrepancies
- Perform batch disposition activities in support of lot release
- Review and approve stability protocols, data, and reports
- Prepare Annual Product Reviews (APR) as required
- Identify opportunities for continuous improvement and support site or corporate initiatives to enhance systems
- Maintain awareness of new or evolving regulatory-compliance requirements and develop plans to address gaps
- Identify country or region-specific Quality requirements in support of Object’s product development plans
- Represent Object Pharma in a professional manner with internal and external team members, business associates, and regulatory authorities
- Ability to operate under pressure, manage multiple ongoing tasks while consistently delivering timely and quality results
- Strong problem-solving and analytical skills
- Ability to lead projects involving multiple stakeholders, collaborate and communicate effectively, and balance divergent inputs while continuing to move forward
- Ability to operate in a growing company with site, functional, and executive leadership
- Ability to travel +/- 10% to external sites
- Bachelor’s degree in a scientific discipline.
- Prior experience in a Quality or Manufacturing role in an FDA-regulated environment.
- Thorough understanding of cGMP regulations and expectations
- Team player with demonstrated willingness to learn new skills across relevant specialties to fit the broad needs of a small biotech
- Physical ability to work regularly in a laboratory environment, including walking/standing for long periods of time, using standard laboratory equipment, using standard office equipment, and occasionally lifting up to 40 pounds
- Employees must pass a background check and receive CDC approval to work with select agents and toxins. Previous CDC approval is a plus
The Location: This position is located at Metabiologics in Madison, Wisconsin.
Object Pharma is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to any legally protected characteristic in compliance with U.S. and State of Wisconsin employment laws.