Operations is responsible for the day-to-day running of the business and includes a lot of activities.
Technical Operations- Can be a part of discovery or product research or a subcategory or operations. For companies without commercial products, this area oversees the day-to-day management of the company.
Clinical Operations- Clinical manufacturing and production can either be a research and development function or an operation function depending on the company.
Commercial Operations- Oversees the production of marketed products and manages budget, sales, company infrastructure, international operations, etc.
Divisions of Operations
- Manufacturing- Concerned with quality, production, packaging and distribution of products. They institute, oversee and further optimize the efficiency of the production process.
- Clinical manufacturing- Typically less strictly controlled that Commercial manufacturing. More varied and scientifically challenging because it consists of refining for scale up in the commercial manufacturing.
- Commercial manufacturing- Takes place after the product has been approved. Strict guidelines (GMP set by the FDA). Deal with cycle time reduction, process improvement and cost reduction. Small companies often outsource this to vendors.
- Engineering and Programming- Engineers manage a large variety of tasks including fluid dynamics, steam sterilization, remote control or large-scale continuous types of operations, plant design, assessments, overseeing equipment etc. Software programmers are needed for controlling and monitoring automated systems.
- Validation and Technical Services- Engineers and scientists write protocols and design studies to oversee proper operation of equipment, facilities and processes.
- Procurement- Handles purchasing of raw materials for products. Large companies may have individuals or teams that handle this.
- Supply Chain Management- Economically manage large number of raw materials used in manufacturing. Define specification and processes used to monitor and control the movement of materials.
- Logistics- Plan and schedule manufacturing operations to ensure steps of manufacturing are monitored and running smoothly.
- Shipping and Receiving- Oversees the shipping of products to customers and management of contracts with deliverers. They monitor the receipt of raw materials and other goods and services.
- Quality Control- Test products or batches to ensure they meet regulatory and customer requirements.
- Quality Assurance- Document the quality test data and provide regulatory guidance.
- Facilities and IT infrastructure- Includes security, facility leases, IT infrastructure, energy-saving initiatives, pilot plant operations, air handling, systems controls, refrigeration, equipment maintenance and other elements required to keep production running smoothly.
- Process Development- After clinical trials, engineers devise methods for large-scale manufacturing to help reduce costs and improve efficiency.
- Project Management- Assignment to cross-functional programs in a company. Make sure the right people know the right information at the right time.
- Finance- Large companies often have teams that handle budgetary controls in operations.
- Human Resource management- Due to large number of people in manufacturing, some companies have a manufacturing-specific HR in addition to the general HR group.
*These areas are all found in small and large companies as well as academic research institutions. They simple vary depending on the organization, their size and resources.
Roles and Responsibilities
Since operations consists of a lot of different functions, these are some general basic roles and responsibilities that you might expect. Keep in mind they vary by position.
- Manufacturing, product monitoring, testing and release
- Hiring and training new employees and managing people
- Capacity Utilization- Preparing enough products for future needs of research and development departments. Make sure manufacturing is at maximum capacity.
- Vendor and Alliance Management- may include obtaining and negotiating agreements pertaining to confidentiality, research collaborations and consulting.
- Ensuring total quality systems- Maintenance of good business practices. Oversee routine technical evaluations for all company departments.
- Facilities management
- Budget management
- Strategy and portfolio management
Are you a good Candidate?
People who flourish in Operations career tend to have:
- Superb organizational skills
- An outstanding ability to multitask
- A driven, self-motivated, go-getter personality
- An ability to work under pressure and with limited timelines
- The sociability to deal with a wide variety of people
- Excellent attention to detail
- An Ability to negotiate
- A flexible attitude
- Excellent, proactive problem-solving skills
- Exceptionally good communication and presentation skills
- An ability to delegate
- The ability to work in a highly regulated environment
Most people do not set out to enter operations right away. They typically enter after experience in areas such as manufacturing, quality, process development, project management, research, etc. Advanced degrees are not always required but typically senior level positions hold MS, PhD or MBA degrees. With an advanced degree, you will need some management experience before being promoted.
- Come in from manufacturing and quality for initial positions; Come in from discovery research, process development, project management, product development and technical support for higher level positions
- Consider a project management position; learn how the company operates
- Show interest in the business side of biotechnology; budgets, purchase, product reproducibility, quality. Consider taking a finance class or obtaining an MBA
- Learn about logistics of how products are made and sold and how you can use your science background to make it more robust and efficient
- Develop people management skills
- Take classes in negotiating
- Join companies that have distinct operations groups
- Consider working at a contract research organization, contract manufacturing organization or other company that provides service to biopharma companies
- Internship in operations and manufacturing