A biotechnology project manager is responsible for coordinating and procuring all federal approvals of drug submission pertaining to chemistry and manufacturing. He is in charge of assuring that activities related to the entrance of a new drug in the market are in compliant with the Food and Drugs Act and Regulations.
The biotech project manager supervises the daily operations and activities of the project and drug such as project scheduling and project budget. He/she maintains and oversees the development process of the drug or product; interviews, hires and fires appropriate staff needed for the project; prepares status reports to top management and assures that files are on schedule to meet the target filing and registration dates. The biotech project manager also identifies and evaluates critical path activities needed by the product, analyzes contingencies and comes up with alternatives to overcome them, supervises and mentors team members, and ensures that the project team is working efficiently according to project objectives, goals, specifications, deliverables and timelines. Biotech project managers may also record minutes of meetings when necessary, prepare meeting agenda; and disseminate relevant project data and information.
Education and Training Requirements
A biotech project manager must have a bachelor’s degree in courses such as chemistry, biochemistry, pharmacy or other related health science courses. Earning post graduates degrees are an advantage. Employers prefer candidates who have significant experience in the pharmaceutical businesses speficially in regulatory affairs.
Knowledge and Skills Requirements
A biotech project manager must have a good understanding when it comes to drug development processes. He must possess excellent writing and verbal skills. He must know the Food and Drugs Act and Regulations and other important rules related to drugs at heart and be able to explain them to team members. He must be an organized, strategic-thinker and a team player as well. Biotech project managers must also possess negotiation skills and have the ability to work under high levels of pressure.
Working conditions usually revolve around pleasant and non-hazardous conditions such as laboratories, manufacturing facilities, office environments and conference room meetings. Some travel may be necessary when the project requires of it especially when it comes to big time pharmaceutical companies. They are expected to sit for long periods of time in front of the computer. They work regular working hours but evenings and weekends may be necessary to meet deadlines. Self-employed project managers may opt to work in flexible hours as they choose.
A biotech project manager’s median annual salary is $85,000. This will depend on the company’s size, location as well as his educational attainment, experience and training.