Landos Biopharma Operations Manager
Reports to CEO. See Landos Org Chart.
Location: 1800 Kraft Dr., Suite 216, Blacksburg, VA, 24060, US
Job Type: Full Time
Education: Bachelor’s degree
Experience: 3+ years management experience, Biotech or related industry strongly preferred
Travel Required: Limited
Landos Biopharma is a clinical-stage biotech company looking for dynamic and passionate individuals with demonstrated expertise in managing biotech and biopharma operations. This position will contribute the shaping the growth of Landos by managing operations and will be responsible for operational processes such as HR, IT, accounting, clinical operations, corporate communications and regulatory compliance. The Operations Manager will operate using agile, lean and efficient management systems and embed regulatory compliant continuous improvement principles across the Landos organization consisting of multiple global CMO, CRO partners and multiple clinical sites.
A successful candidate will be a motivated, self-starter with passion to accelerate the path to cures and proven ability to follow through. Familiarity with a variety of the field’s concepts, practices and procedures including clinical trials, research and development, and working in a fast-paced, dynamically growing environment are all essential. Must be able to rely on extensive experience and judgment to accomplish goals and enhance operational efficiencies.
The candidate will be aligned with four fundamental pillars of Landos’ corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
- Oversees lean, agile and efficient operational aspects in a way that enable a global reach to fulfill the mission of accelerating the path to developing new pharmaceuticals for autoimmune disease.
- Managing onboarding procedures for new personnel, plan and review compensation actions and benefits packages as directed by CEO; enforcing policies and procedures. Monitors and reviews performance of direct reports, and provide prompt and objective coaching, mentoring and counseling.
- Develops Operations strategy and budget. Responsible for ensuring the quality and quantity of work produced, staffing requirements, and personnel management for the immediate team.
- Provides a direct, consistent interaction with global vendors, reviewing and executing various types of contracts, CDAs, work orders, POs, developing RFPs, interfacing with R&D and clinical teams and meeting aggressive deadlines or any other tasks delegated by upper management in a fast-paced and value accruing environment.
- Contribute operations information and recommendations to strategic plans and reviews; prepare and complete action plans; implement production, productivity, quality and customer-service standards; resolve problems; complete audits; identify emerging business trends.
- Solicits, prioritizes, and identifies projects related to operations, consistent with the company’s goals and objectives and necessary to maintain the organizations business competitiveness in the marketplace. Provides leadership to implement identified projects based on short- and long-range goals within scope and within budget.
- Develop, implement, enforce and evaluate policies and procedures; develop processes for receiving product, equipment utilization, inventory management and shipping.
- Works closely with the CEO to manage IPO readiness planning and the transition from private to public company and develops the necessary policies, procedures, systems and SOPs.
- Analyze process workflow; implement operational changes in coordination with CEO.
- Maintain productive work environment by establishing, following and enforcing standards and procedures; complying with regulations.
- Review and approve all operational invoices, cross-check against PO, obtain approval, and ensure they are submitted for payment on a timely manner.
- Communicate all operating policies and/or issues at department meetings.
- Manage regulatory compliance functions for R&D and clinical.
- Creates and maintains operational and financial metrics dashboards and reports that accurately measure performance (CMC, financial, clinical ops).
- Establishes communication channels for sharing continuous improvement initiatives within Landos operational network and ensures alignment between sites.
- Works closely with other business operations leaders to ensure support and alignment with global processes per regulatory approval.
- Works and communicates effectively and professionally in a cross-functional team environment with minimal supervision.
- Other duties as assigned by CEO.
Education and Experience
- Biotechnology and BioPharma Enterprise with 5+ years of related experience spanning R&D, production, facilities, clinical, and business operations.
- Experience in an operations and manufacturing role with expanded responsibilities for ensuring efficient resource utilization, scheduling, unit production and supply chain management.
- Experience interacting with internal and external stakeholders.
- Experience participating in resource planning and IPO planning initiatives.
- Strong strategic and tactical decision-maker who handles unforeseen issues.
Knowledge, skills & proficiencies:
- Biotech and biopharma clinical experience.
- In-depth knowledge of process manufacturing operations.
- Understanding of powders and tableting processes and similar manufacturing processes, Standard Operating Procedures (SOPs) and Current Good Manufacturing Processes (cGMP)
- Ability to communicate clear, concise and professionally with clients and internal staff both verbally and in written format.
- Adaptability to a dynamically growing environment.
- Demonstrated leadership experience.
- Business Negotiation.
- Organization skills.
- People Management.
- Reporting Skills.
- Critical Thinking and Problem-Solving Skills.
- Planning, prioritizing, and Organizing.
- Communication Skills.
- Team Work.
- Follow through.
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off
- Flexible schedule
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