Career in Biotechnology Industry. Novartis Biocamp Roadshow

Transcription

1 Career in Biotechnology Industry Novartis Biocamp Roadshow

2 What is biotechnology?

3 Biotechnology, often referred to as biotech, is the application of biological research techniques to create new processes and products while using biological systems, living organisms, and/or derivatives of organisms. Although biotech processes have been used for thousands of years, scientists began to use components of microorganisms to solve human problems within spheres such as agriculture, medicine/healthcare, food processing and industry in the 1970s

4 Consideration Questions Before Starting Career at Pharma/Biotech Industry Do I like thinking about living things? What sectors of the economy can I see myself operating in? As you think about a career in biotechnology, it can be useful to identify the general areas where your aptitude and interests lie

5 Overview of Pharma/Biotech from Product Cycle Prespective Business Development Medical Affairs Market Research Finance Health Economics Marketing Sales Legal Clinical Research Operations Information Technology Human Resources Government Affairs Research & Compliance Communications Development Quality Account Management Regulatory

6 Roles & Positions in Pharma/Biotech

7 RESEARCH POSITIONS

8 RESEARCH POSITIONS Research positions deal with the process of drug discovery and testing. The entry-level job title in most pharmaceutical companies is lab technician. The work can be somewhat tedious, but a lab tech position can be an excellent way into the industry Some examples of Research Positions Are : LAB TECHNICIAN Lab techs perform the routine maintenance tasks- cleaning and maintaining glassware, working with animal colonies, operating lab equipment, and so on-that are needed to keep labs functioning RESEARCH ASSOCIATE A degree in biochemistry or a related discipline and experience working in a lab are typically required to land this job. Associates work at the bench, conducting experiments under the guidance of scientists. If you're coming out of school with some lab experience but no PhD and you want to work in R&D, this is the job for you RESEARCH SCIENTIST A scientist can get a job as a research scientist (sometimes the initial title is "associate scientist"), designing and conducting experiments and writing up results for publication when appropriate.

9 CLINICAL DEVELOPMENT & MEDICAL

10 CLINICAL DEVELOPMENT AND MEDICAL Clinical development offers several career options, A variety of medical and scientific specialists at pharma companies perform the numerous studies required to take clinical compounds from the lab bench to the pharmacy shelf and ends up into regulatory documents for Drug Approval Some of Medical Function are responsible for building product's clinical development plan, creating that lays out & guidelines of the studies a company intends to perform. also write or contribute to clinical trial protocols, the instructions for an investigator describing the objectives, design, and methodology of a clinical trial If you work in clinical development within Big Pharma, interacting with CROs will be an important part of the job

11 CLINICAL DEVELOPMENT AND MEDICAL Examples of Roles CLINICAL RESEARCH Clinical Research develop and implement plans for ushering experimental drugs through preapproval clinical trials. They get involved in designing protocols, enlisting physician investigators, training clinic personnel, and evaluating data. The job can require travel, sometimes as much as 80 percent of the time REGULATORY AFFAIRS Regulatory affairs specialists complete the paperwork required by regulatory agencies worldwide and communicate directly with the agencies to ask questions and resolve issues. Depending on their level of industry experience, they may also set regulatory strategy for a pharma company. BIO STATISTICIAN Statisticians in clinical development prepare analysis plans for clinical studies, design tables and figures that display information clearly, interpret final study data, and write the statistical sections of clinical study reports. CLINICAL DATA MANAGER Clinical data managers supervise all aspects of clinical data. They specify how metrics will be collected and assist in standardizing data management procedures for internal operations and external reporting

12 CLINICAL DEVELOPMENT AND MEDICAL Examples of Roles MEDICAL SCIENCE LIAISON Medical Science Liasons (MSLs) are field-based MDs, PhDs, or PharmDs with therapeutic area specialties. They interact with physicians and scientists in the health care community-especially those doing prominent academic research-to maximize the acceptance and proper use of company products MEDICAL ADVISOR Medical Advisor are MDs and/or PhDs or PharmDs that responsible for drawing up a particular product's overall clinical development plan, which is a strategic and tactical document that lays out the studies a company intends to perform before it applies for marketing approval

13 MANUFACTURING & QUALITY ASSURANCE

14 MANUFACTURING AND QUALITY ASSURANCE Roles include designing the manufacturing processes for drugs, ensuring the integrity of finished product, creating product packaging, and planning specialized workspaces One area that gets a lot of attention in pharmaceuticals is called quality assurance and control, often shortened to QA/QC. Quality experts ensure that medicines are manufactured and studied in compliance with federal standards Like scientists on the pure research side, many employees in manufacturing and QA/QC encounter a dual ladder in Big Pharma. Engineers and scientists can get promoted doing technical work or, if they have the aptitude and inclination, can shift over and become part of the management team that coordinates the work of the technical team

15 MANUFACTURING AND QUALITY ASSURANCE PROCESS ENGINEER In most cases, process engineers work on project teams with more senior engineers. Job responsibilities may include designing chemical or biological methods for mass-producing compounds, designing equipment, and designing and overseeing the construction of various elements of manufacturing plants from pilot to commercial scale QUALITY ASSURANCE SPECIALIST Quality assurance (QA) specialists ensure that a company's testing, reporting, and manufacturing are in compliance with regulatory requirements. They conduct site audits and review and analyze data and documentation QUALITY CONTROL ANALYST Quality Control (QC) analysts are responsible for the biological and chemical evaluation of products, materials, and facilities. They perform assays and establish and write specifications and standard operating procedures

16 BUSINESS OPERATIONS

17 BUSINESS OPERATIONS Business operations encompasses the diverse array of commercially oriented positions within a pharma company, plus the standard corporate positions in areas such as Finance, Legal, Compliances, HR, and purchasing MARKET RESEARCH ANALYST Market research analysts collect and analyze data to support the marketing of medicines during every stage of the product life cycle, including pre-launch, launch, and when the products become established. They design and conduct market research studies, analyze accumulated data, and communicate findings to management to support business recommendations

18 BUSINESS OPERATIONS ASSOCIATE PRODUCT MANAGER/PRODUCT EXECUTIVE primarily responsible for coordinating and implementing campaigns for specific drugs, audiences, or both. This involves a little strategy and a lot of executionthings like developing collateral pieces, working as a liaison to advertising agencies, and establishing a company presence at conventions PRODUCT MANAGER This job requires managing a team of people and working to determine price, distribution, brand image, forecasting, and overall strategy for one or more drugs. On a micro level, the job can be claustrophobic: Imagine spending 13 months of six-day weeks learning every aspect of a single drug, then having the company decide that it would be best simply to let the product die STRATEGY DIRECTOR Strategy directors develop plans for maximizing the commercial potential of a particular product or therapeutic area. They perform quantitative and qualitative analyses of disease and treatments trends, as well as assess opportunities for expanding market share and competitive positioning. These individuals typically work closely with colleagues in marketing analytics, business development, and finance

19 BUSINESS OPERATIONS BUSINESS DEVELOPMENT MANAGER Employees in business development evaluate new business opportunities aligned with a pharma company's therapeutic product divisions and strategic goals. They examine in- and out-licensing opportunities, collaborative development deals, and joint ventures. SALES JOBS Sales reps are categorized according to the particular customer base they serve : primary care physicians (PCPs), specialty physicians, hospital physicians, and managed care companies. Some sales reps visit pharmacies as well. From their expertise & experiences, sales jobs can be defined into two main roles: Field reps service territories that are typically defined by specialty and geography, and operate under a prescribed call cycle that determines how often they visit doctors in their territory District/Area managers usually are in charge of 10 to 14 field reps, hiring, training, and supervising them; regional managers oversee the district managers. Some sales positions require extensive travel; others don't. Virtually all positions come with generous perks such as a company car, computer, and expense account, plus attractive bonuses based on sales.

20 BUSINESS OPERATIONS HUMAN RESOURCES INFORMATION TECHNOLOGY PROCUREMENTS FINANCE TRAINING LEGAL ADMINISTRATIVE FUNCTIONS COMPLIANCES GOVERNMENT AFFAIRS COMMUNICATIONS GENERAL MANAGEMENT SUPPLY & DISTRIBUTION

21 Thank you for your attention