Director of Compliance

Director of Compliance: Responsible Official for Federal Select Agent Program

The Location: This position is located at Object Pharma’s laboratory in Madison, Wisconsin.

The Company: Object Pharma is a biotech company with laboratory facilities in Madison, Wisconsin and headquarters in Aliso Viejo, CA.  Object creates and sells Metabiologics neurotoxin reagents for laboratory use.  The products are used by laboratories studying pharmaceuticals, food safety, and bioterrorism world-wide.  Object is also developing a novel therapeutic for human use.  The neurotoxins are regulated by the US Federal Select Agent Program. 

We offer our employees competitive compensation, a flexible, fast-paced environment, and the opportunity to learn a diverse skill set in a growing company.

• 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: We are looking for a Director to serve as Object’s Responsible Official for the Federal Select Agent Program. The Responsible Official (RO) is the designated, federally registered, and security-cleared individual responsible for ensuring that all company activities involving select agents and toxins are conducted in compliance with U.S. Select Agent regulations, biosafety requirements, and applicable federal, state, and local laws. The Director will also oversee laboratory production activities, safety, dangerous goods shipments, and chemical hygiene.

Responsibilities

• Regulatory Compliance
  • Maintain and oversee the company’s CDC Select Agent Program registration.
  • Serve as the primary point of contact with federal regulators, inspectors, and law enforcement (eg CDC, APHIS, DOJ/FBI).
  • Ensure timely submission of required documents, incident reports, and amendments.
• Security & Access Control
  • Oversee personnel suitability assessments, ensuring that only reviewed, approved, and cleared individuals access regulated materials or facilities.
  • Develop and enforce strict access control and inventory tracking procedures for Select Agents.
  • Oversee Dangerous Goods shipping.
• Safety & Security
  • Lead the development, implementation, and auditing of the Biosafety, Biosecurity, and Incident Response Plans in line with current standards (e.g., BMBL, Federal Select Agent Program guidelines).
  • Coordinate emergency preparedness and response measures for potential release, exposure, or security incidents.
  • Oversee lab safety measures and compliance including Chemical Hygiene.
• Training & Oversight
  • Ensure all authorized employees receive initial and recurrent training in biosafety, security, incident response, and regulatory compliance.
  • Monitor and evaluate facility practices, correcting deficiencies and enforcing standards.
• Recordkeeping & Reporting
  • Maintain complete and auditable records of agent inventories, facility access, transfers, training, and incident reports.
  • Submit annual reports and incident notifications as required by law.
• Leadership Role
  • Lead personnel and laboratory activities in the production and testing of botulinum neurotoxins.
  • Serve as the ethical and regulatory anchor of the company’s select agent and toxin operations.
  • Advise senior leadership on compliance, risk management, and continuous improvement strategies.
• Additional duties as assigned.

Requirements

• U.S. citizen or lawful permanent resident eligible for DOJ/FBI Security Risk Assessment (mandatory for Select Agent access).
• Bachelor’s degree or higher in biology, microbiology, biochemistry, biomedical sciences, or related field.
• Minimum 5 years of experience in biosafety, biosecurity, regulatory compliance, or select agent program management.
• Strong knowledge of 42 CFR Part 73, BMBL guidelines, federal select agent regulations, and dangerous goods shipping regulations.
• Demonstrated experience interacting with regulatory agencies.
• Proven leadership, organizational, and communication skills.

Preferred

• Advanced degree (M.S., Ph.D., or M.P.H.) in life sciences or public health.
• Certification such as Certified Biosafety Professional (CBSP) or Registered Biosafety Professional (RBP).
• Prior designation as an RO or Alternate Responsible Official under the Select Agent Program.
• Experience with quality systems in a small biotechnology company.
• Experience managing inventory systems.

Employment Conditions

• Must pass DOJ/FBI Security Risk Assessment.
• Subject to ongoing suitability evaluation for access to Select Agents.
• Flexible availability for regulatory inspections and emergency response.

Equal Employment Opportunity

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.