Paragon Genomics is a fast-growing life sciences company developing advanced reagents and assay kits for next-generation sequencing (NGS). We are hiring a full-time Operations Manager to lead and grow the manufacturing team and contribute to other aspects of operations as needed. The Operations Manager is responsible for the supply chain and lab operations management. This position provides oversight and leadership to ensure on-time delivery with high quality. This role requires a science background, technical leadership, managerial competencies, laboratory experience, and a desire to support the whole needs of the organization. The ideal candidate is proactive and forward-thinking with hands-on, operational experience in molecular biology leading a small- to medium-sized team.
- Plan, coordinate, manage and control manufacturing operations to ensure adherence to production plans and GMPs.
- Ensure compliance to SOPs, Batch Records, Quality Systems (Deviations, Change Controls, Corrective Action /Preventative Action), and Protocols. Perform investigative work on production discrepancies, deviations, and other such matters relating to manufacturing.
- Plan and coordinate the production schedule for the manufacturing team to meet external and internal needs for products.
- Inventory management: timely ordering of consumables and materials used in manufacturing; implementation of new systems for improved tracking and traceability; and monthly/year-end inventory reporting of consumables and materials used in manufacturing.
- Process improvements resulting in lower costs of goods sold, better quality, and higher productivity
- Provide oversight and support in lab procurement, vendor management, and expense allocation. Control lab expenses, consumables, and lab inventory according to financial budget controls.
- Interface with the business development team to successfully incorporate custom manufacturing requests and partner agreements into the production schedule.
- Monitor suppliers to ensure that they efficiently and effectively provide needed goods or services within budgetary limits.
- Ensure the transition of new products from R&D to Manufacturing, and interface with marketing to ensure communication and milestones for new product launches are completed.
- Support business regulatory compliance and risk/liability management. Provide leadership and manage the EHS program. Develop employee training plans and manage team compliance to training requirements.
- Perform personnel functions, such as selection, training, or evaluation.
- Help out with hands-on daily activities and documentation, as needed.
- Commitment to a safety- and quality-first laboratory environment
- Additional duties as assigned
Qualifications and Background
- Four-year degree in a relevant field (e.g. Biology, Molecular Biology, Biochemistry, Chemistry); Advanced degree (MS, Ph.D.) preferred, but not required. Minimum of 3 years of leadership experience required.
- Minimum of 5 years of hands-on lab experience in molecular biology required
- Detail-oriented and highly organized with effective time management skills
- Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods
- Knowledge of business and management principles involved in strategic planning, resource allocation, leadership technique, production methods, and coordination of people and resources
- Knowledge of good manufacturing practices and good documentation practices, including generating standard operating procedures, documentation review, and inventory control
- Knowledge of quality management systems and principles, including ISO 9001/13485
- Ability to multi-task, perform under pressure, adapt to changes (e.g., priorities and timelines), and work in a fast-paced and quickly changing environment
- Highly collaborative; able to work well within multidisciplinary teams
- Excellent record-keeping skills and a high level of attention to detail are required
- Desire to improve processes and step in to help wherever needed
- Forward-thinking ability, and ability to manage up and down
- Experience working with a CMO is a plus
- Proficiency in Microsoft Word, Excel, and PowerPoint required
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.
Paragon Genomics Inc. is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.