Novartis Biocamp Roadshow

Career in Biotechnology Industry

What is biotechnology?

“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

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

Overview of Pharma/Biotech from Product Cycle Prespective

Communications

Quality

Clinical Research Operations

Research &

Development

Marketing Legal

Compliance

Finance

Regulatory

Government Affairs Human Resources Information Technology

Market Research

Account Management

Medical Affairs Business Development Health Economics

Sales

Roles & Positions in Pharma/Biotech

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.

RESEARCH POSITIONS

CLINICAL DEVELOPMENT & MEDICAL

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

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

Examples of Roles

CLINICAL DEVELOPMENT AND MEDICAL

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

Examples of Roles

CLINICAL DEVELOPMENT AND MEDICAL

MANUFACTURING & QUALITY ASSURANCE

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

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 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

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

MANUFACTURING AND QUALITY ASSURANCE

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

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 execution-things 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

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.

BUSINESS OPERATIONS

HUMAN RESOURCES

INFORMATION TECHNOLOGY

PROCUREMENTS

FINANCE

TRAINING

LEGAL

SUPPLY & DISTRIBUTION

BUSINESS OPERATIONS

ADMINISTRATIVE FUNCTIONS

COMPLIANCES

GOVERNMENT AFFAIRS

COMMUNICATIONS

GENERAL MANAGEMENT

Thank you for your attention