To provide big picture context at the start of the training, this module introduces the biotech industry in Massachusetts and explains the role that biotech companies play within the broader healthcare ecosystem and to patients. Students will learn basic terminology and how it is applied in industry. They will learn the difference between biotech and pharmaceutical companies while discovering the steps involved in drug development and approval process. There will be a review of the various functional departments across the industry. The role of regulatory agencies will be explained in relation to lab and occupational safety, as well as confidentiality/privacy. There will be exposure to the different personality traits and skills that make someone successful in biotech. Students will participate in a group activity where they will research and present information on a selected company, providing an opportunity to practice teamwork, communication, and delivery and receipt of feedback.

Learning Objectives

• Understand what biotech and pharmaceutical companies do from a product, process, and stakeholder perspective
• Describe the therapeutic discovery process
• Learn about the various departments within biotech companies
• Summarize the various regulations found within most biotech and pharmaceutical companies. This includes safety regulations, such as occupational safety, hazardous waste, biohazardous waste, bloodborne pathogens, as well as drug/patient safety regulations from the FDA, and privacy regulations like HIPPA and internal confidentiality and trade secret restrictions.
• Awareness that audits can happen (internally or from external agencies) and how to be best prepared
• List the unique characteristics of and career opportunities within the biotech industry in Massachusetts
• Start practicing communication skills

Topics Covered/Activities

• Purpose of biotech/pharma and the types of companies that exist
• The regulations placed on these companies and how that impacts work with them (special emphasis on safety, documentation practices, and confidentiality)
• Overview of the different functional areas and skills needed within biotech/pharma companies to enter the industry and to be promoted

Assessments

• Development and delivery of group mini-presentation using PowerPoint/Google Slides
• Knowledge check questions throughout the presentation
• Summative assessment quiz with multiple-choice and short answer questions

This module comprises the majority of the training program. In the classroom, students will learn key fundamental and foundational biology and chemistry concepts with an aim to allow the most seamless transition into the lab environment. Subsequently, students will spend the bulk of their time in the training lab completing hands-on practice to gain important occupational skills, from both scientific and operations standpoints. For example, students will learn how to clean, monitor, and maintain equipment. They will practice critical safety concepts including proper PPE and common hazards. Important mathematical and measurement concepts will be covered including the difference between accuracy and precision, significant figures, and stoichiometry. Students will use real-world standard operation procedures (SOPs) from employer partners to ensure alignment with what they will likely see in the work environment. With site visits to area companies, students will connect what they have practiced in the training lab to how it takes place in the real-world environment.  Employees working in lab industry roles will speak about their experience.

Learning Objectives

Scientific

• Recognize basic science concepts associated with lab work
• Use lab equipment to perform common lab activities
• Apply appropriate safety standards in a lab
• Explain Good Documentation Practice (GDP) and lab notebooks

Operations

• Understand the basics of working safely in a lab setting
• Perform facility cleaning and hazardous waste management
• Learn the use of secondary containers, satellite storage, and appropriate labeling standards
• Understand basic chemical storage principles
• Explain the basic use and safety concerns of high- and low-pressure tanks, including the use of regulators

Topics Covered/Activities

General Lab Skills

• Mathematical and measurement concepts including the difference between accuracy and precision, significant figures, and stoichiometry, volumetric, and mass measurement
• Proper use and safety techniques of lab equipment like centrifuges, balances, pipettes, graduated cylinders, biosafety cabinets, fume hoods, incubators, cold storage, etc.
• Sterilization, autoclaves, aliquoting, and pipetting
• Analysis of data, checking for expected patterns

Protocols and Procedures

• Standard Operating Procedures (SOPs) and protocols (and their differences)
• Good Documentation Practice (GDP) and recording of data in written and electronic lab notebooks
• Safety Data Sheets and common lab signage
• What to do when things go wrong, problem-solving, asking questions, and continuous learning

Clean Room/Environment Regulations

• PPE and gowning techniques and why they are important for safety and lab integrity
• Signage
• Clean room standards
• Common health and safety codes, standards, and environmental regulations
• Safety related to flammables, liquid nitrogen, and dry ice
• Tank safety, exchange, and the installation and use of pressure gauges
• Waste management (i.e., general RCRA guidelines, collection of biowaste, chemical waste and sharps containers)

Other

• Site visits to company labs
• “Day in the Life” from industry speakers
• Communication to peers on their activities
• Microsoft Excel and common software

Assessments

• Complete bloodborne pathogen training
• Within the classroom students will be assessed on the material they have learned
• In the laboratory, hands-on skills will be evaluated. These will be done by observing students in real-time and examining final laboratory report submissions.
  • Properly preparing buffers/solutions and pH-ing
  • Serial dilutions
  • Vacuum trap installation, removal, disposal (in a BSC)
  • Creating and disposing of hazardous waste bins/autoclaving
  • Mock spill cleanup
  • High pressure CO2 tank transport within the lab, install and setting of pressure regulator (matching incubator spec)
  • Exchanging low-pressure Liq-N supply on cryo storage tank
  • Documentation practices

While much of the safety and cleaning skills will be practiced in the Science and Lab Module, the program will have sessions specific to procurement and inventory management including speakers and exposure to procurement issues that commonly arise.

Learning Objectives

• Identify common stock items and consumables and the expected turnover of them
• Describe process of ordering and receiving consumables and raw materials from external suppliers, processing for storage and quality checking items upon arrival
• Practice maintenance of consumables documentation, organization, and labeling
• Understand inventory and storage best practices and incorporation of EHS best practices

Topics Covered Activities

• Inventory management practices, lot/batch numbers, expiration dates, incoming and outgoing inventories (e.g., FIFO, Kanban)
• Vendor management, contacting customer service
• Common points of confusion with labeling and types of supplies that look the same at first glance
• Shipping and receiving practices, including knowledge of laws around domestic and international shipping, verification of packing lists to invoices, POs, etc.
• Microsoft Excel and common software (Prendio/Bioprocure, Vendor Websites, Excel/Smartsheet)

Assessments

• Conduct stock inventorying, lot identification, and examples of high v low turnover consumables
• Complete DOT HazMat Certification
• Summative assessment quiz with multiple-choice and short answer questions

Participants will learn the critical aspects of good job performance in the lab, embark on a journey of discovery, exploring operational and strategic roles within the industry, understanding the unique career opportunities available to non-degree individuals, and developing essential transferable skills for success.  The goal is to empower students to make informed career decisions and build a clear pathway toward a rewarding and fulfilling career in the biotech industry.  At the end of the program, participants will create a personalized career exploration template to update as their work experiences grows.

Learning Objectives

• Understand important aspects of job readiness for lab work including appropriate attire, reliability, and communication with supervisors and co-workers
• Explore operational and strategic career opportunities, responsibilities, and advancement opportunities of entry-level scientific operations roles.
• Discover roles across the biotech industry spectrum (facilities, research and development, instrument specialists, biomanufacturing, etc.)

Topics Covered/Activities

• What good job performance looks like according to supervisors and HR
• Real-world examples of individuals who have built successful careers in non-degree roles within the biopharma industry
• The breadth of career opportunities in biotech, along with experience and education requirements
• Current and emerging trends in biopharma industry and how these trends may impact job roles and opportunities
• Create a list of transferable skills (adaptability, teamwork, leadership, problem-solving, communication, creativity…) and learn to apply it for your success
• Strategies for continuous learning (e.g., pursue college degree, additional certifications)

Assessment:

• Preparation process for meetings with industry professionals (research background, develop questions)
• Practice and receive feedback on interpersonal skills
• Self-assessment and reflection activities
• Personalized career pathway plan based on individual interests, skills, and industry knowledge
• Problem solving common work scenarios (e.g., missing work, handling feedback, communicating errors)

Students will first develop a polished LinkedIn profile and professionalize their public social media channels. Next, using Microsoft Office software, students will draft tailored cover letters and resumes. As part of that process, students will work together to review their peers’ documents, practicing the skill of giving constructive feedback.  Next, students will receive individualized coaching and feedback from program staff on their resumes and cover letters and apply for jobs of interest. Program staff will also work with students to develop their professional “story” to best position their experience and skills during interviews (and in cover letters).  During the program, students will complete a series of mock interviews with program staff, followed by industry professionals with hiring responsibilities. Bioversity will assist students and graduates with employer engagement, job applications, and interview prep as soon as feasible, even pre-graduation, to shorten the job search duration.

Learning Objectives

• Cultivate a professional presence
• Practice job application and interview skills (in-person and virtual)
• Create customized cover letters and resumes
• Practice effective communication

Topics Covered/Activities

• List the various hiring avenues and the differences between apprenticeships, internships, direct company hire, and staffing agencies
• Articulate “Dos and Don’ts” from talent acquisition leads and hiring managers
• Practice creating a positive first impression (posture, eye contact, handshake, dress)
• Create a professional LinkedIn Profile and sanitize personal social media that is publicly available
• Draft, workshop and perfect a resume geared toward lab administration/operation roles
• Draft effective cover letters tailored to specific jobs and companies
• Using company websites to get background info and access career pages
• Practice interviewing, incorporating examples and storytelling from your program and work experience
• Interview attire
• Thank you emails and cards
• Effective in-person, email, and phone/webinar communication
• Professional writing
• Give and receive feedback
• Emotional intelligence

Assessments

• Completed resume
• Completed cover letter
• Submission of job application
• Performance in mock interviews and follow-up communication to interviewer