Careers

Purpose: Work as part of the Quality Assurance Team to ensure the highest quality product in compliance with internal procedures, cGMP’s 21 CFR 820 and ISO 13485.

General Responsibilities:

• Inspection of finished product to meet internal procedures and customer requirements
• Level 1 and 2 inspection of raw materials per applicable material specifications
• Write and revise procedures as necessary
• Assist with audits (customer, FDA, and ISO) in the knowledge area of inspection activities
• Ensure non-conforming material is handled per applicable procedure
• Ensure quarantine areas are orderly and items are properly labeled to its status, when applicable
• Ensure timely trending of inspection data
• Product label verification per applicable procedures
• Inspection of kits using ANSI/ASQZ1.4-2003 and applicable procedures
• Quality assurance review of quality records (i.e. charts, and other associated quality records)
• Other duties as assigned

Knowledge and Skill Requirements:

• Use of Microsoft Word, Excel and Microsoft Outlook
• Experience in performing quality inspections
• Slight lifting may be required

Education and Experience:

• High school diploma and two years inspection experience or the equivalent combination of experience combination of experience and/or education required

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
• Communicates well (written and verbal)
• Good listener, committed to finding solutions to problems, works well with difficult people
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner

Physical Requirements:

• Occasionally sit, constantly stand and walk, constantly use hands to finger, handle, or feel. Constantly reach with hands or arms, frequently climb or balance, occasionally stoop, kneel, crouch, or crawl. Constantly talk or listen, occasionally taste or smell. Lift 11 to 25 lbs. 1-33% of the time, carry 11 to 25 lbs, 1-33% of the time. Occasionally exposed to working near moving mechanical parts. Frequently exposed to fumes or airborne particles or toxic or caustic chemicals. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Quality Inspector Temp to Perm here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School Diploma or equivalent education?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Biotech on Cape Cod! Seeking hardworking, motivated and reliable people for positions in our Manufacturing team. Experience not necessary, we provide the training. Good attitude a must. Seeking temporary workers to collect and process blood cells from horseshoe crabs to make LAL - a test for a bacterial toxin. Applicants must be hard working, careful, team players with a positive attitude. Work will last from May until approximately November. Perfect for students or others seeking experience in the biotech field. Must be 18+ to be considered. Responsible for all functions related to Horseshoe Crab bleeding, and processing. Flexible schedules available to include full-time, part-time or mother’s hours.

General Responsibilities:

• Receiving crabs and unloading barrels of crabs from trucks
• Bleeding crabs, initial cell processing, and operation of centrifuges
• Washing and preparing all bleed related glassware
• Cleaning of labs
• Cleaning of controlled process areas
• Other duties as assigned by supervisor

Knowledge and Skill Requirements:

• Can work in a team atmosphere and with minimal supervision
• Possess a positive attitude and desire to learn
• Work on their feet in a fast-paced environment
• Read and write English
• Lift up to 50lbs
• Have restaurant, manufacturing experience, or simply want to learn something new

Education and Experience:

• High School Diploma or 1 yr. of college preferred or an equivalent combination of experience and/or education required.

Job Type: Full-time - Seasonal

To Apply:

Please submit a current resume and cover letter for Temporary Laboratory Technician here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School Diploma?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Biotech on Cape Cod! Seeking hardworking, motivated and reliable people for positions in our Manufacturing team. Experience not necessary, we provide the training. A good attitude is a must. Seeking temporary workers to assist with the preparation of glassware for sterilization. Applicants must be hard working, careful, team players with a positive attitude. Work will last from August until approximately December. Perfect for students or others seeking experience in the biotech field. Must be 18+ to be considered. Responsible for all functions related to glass washing/sanitation. Flexible schedules available to include full-time, part-time or mother's hours.

General Responsibilities:

• Assisting with preparation glassware for sterilization
• Washing, drying and wrapping glassware
• Handwashing / operation of commercial washer
• Mopping / cleaning of glass washroom
• Full time / part time/ mothers’ hours available

Knowledge and Skill Requirements:

• Can work in a team atmosphere and with minimal supervision
• Possess a positive attitude and desire to learn
• Work on their feet in a fast-paced environment
• Read and write English
• Lift up to 50lbs
• Have restaurant, manufacturing experience, or simply want to learn something new.

Job Type: Full-Time and/or Part-Time - Seasonal

To Apply:

Please submit a current resume and cover letter for Temporary Glass Washer here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School Diploma?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Maintain and monitor boiler and building systems in accordance with Massachusetts laws.

General Responsibilities:

The major responsibilities of this position will be to support the advancement of the company product development pipeline.

• Properly monitor the facilities boiler in accordance with the Code of Mass. Regulations. CMR-146. This includes standing watch in a 24/7 environment on either a fixed or rotating schedule
• Make rounds every two hours of the mechanical room and the air handling room, checking for any problems with the machinery
• Performing preventive maintenance on facility equipment and production equipment as needed and in accordance with FDA and cGMP guidelines
• Troubleshoot any problems and take corrective actions for machinery, water systems and production equipment throughout the building
• Answer and troubleshoot alarms from the Building Management System
• Take water samples of the clean steam system, DPW system, and take TOC readings on the DI and Clean Steam System
• All duties assigned by supervisor

Knowledge and Skill Requirements:

• Knowledge of High Pressure Boiler Systems
• Knowledge of DI and DPW water systems
• Knowledge of HVAC Systems
• Ability to follow written and verbal instructions
• Working knowledge of cGMP, ISO 13485 and other regulatory guidelines as appropriate

Education and Experience:

• Minimum of a High School Diploma or equivalent education and/or experience required
• Second class fireman’s license or greater (required)

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
• Information organized and accessible, maintains efficient work space, manages time well
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

• Occasionally sit. Frequently stand and walk. Frequently use hands. Occasionally reach with hands or arms, climb or balance, stoop, kneel, crouch, or crawl. Occasionally talk or listen. Lift 26-50 lbs. 1-33% of the time. Carry 26-50 lbs. 1-33% of the time.
• Frequently exposed to wet or humid conditions (non-weather). Frequently work near moving mechanical parts. Occasionally work in high places, occasionally exposed to fumes or airborne particles, occasionally exposed to toxic or caustic chemicals. Occasionally exposed to outdoor weather conditions, extreme heat (non-weather). Work environment is loud for this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Boiler Operator here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School Diploma or equivalent education?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Design and implement facility engineering projects in support of overall corporate objectives

General Responsibilities:

• Responsible for the design and implementation of facility engineering projects including HVAC, production equipment, building management system and capital expense projects
• Provide expertise in research, manufacturing, engineering, design and process design/scale-up
• Assist the manufacturing/research operations in problem solving with regard to equipment and systems
• Develop capital expenditure requirements and documentation to purchase/install new systems/equipment/processes
• Develop and recommend new processes and technologies to achieve cost effectiveness and improved product quality
• Recommend processes for the production of products
• Interface with various departments (specifically manufacturing and engineering) to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology
• Support company growth with space optimization and construction management for manufacturing, research and administrative areas
• Maintain the facility drawings and ensure that applicable drawings follow change control for any modifications
• Provide assistance with annual reporting to regulatory agencies
• Perform other duties as assigned by the supervisor

Knowledge and Skill Requirements:

• Knowledge of HVAC, chilled water systems, pure water systems
• Knowledge of production equipment including autoclaves, depyrogenation ovens, filling equipment, lyophilizers, capping and labeling equipment
• Project management/team leader skills
• cGMP and ISO requirements for clean room operations

Education and Experience:

• A minimum of a Bachelor's degree in an engineering discipline or an equivalent combination of experience and/or education required
• Minimum of 5 years' experience in a manufacturing environment
• Proficient with AutoCAD
• Hands on experience with facility and production equipment including preventive maintenance and troubleshooting and resolving equipment problems

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
• Information organized and accessible, maintains efficient work space, manages time well. Manages workload, works efficiently, and meets goals and objectives
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity

Physical Requirements:

• Frequently sit. Occasionally stand and sit. Frequently use hands. Occasionally reach with hands or arms. Frequently talk or listen. Lift 11-25 lbs. 1-33% of the time. Carry 11-25lbs. 1-33% of the time. The work environment of this job is quiet.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Facility Engineer here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor's Degree or equivalent?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Responsible for all activities in the Accounts Payable function and support for month- end close activities including JE's, accrual entries and account reconciliation.

General Responsibilities:

• Ensures timely payments of vendor invoices and expense vouchers and resolve disputes
• Matches PO's, receiving records and invoices to support payment internal controls policy
• Reviews applicable accounting reports and accounts payable register to ensure accuracy
• Reconcile AP to AP Aging, accrued expenses, sales tax payable, PPD accounts
• Identify, review and analyze expense reports and investigate/escalate those reports not in compliance with Corp. Expense policy
• Manage payments to all vendors: Cut checks, process wires and ACH transactions
• Works closely with external auditors to ensure timely and accurate reports for the yearly audit function
• Calculates and pays all sales and use taxes to appropriate states

Knowledge and Skill Requirements:

• Knowledge of Microsoft Office Software
• Knowledge of Great Plains helpful
• Great organizational skills and attention to detail
• Ability to work well with vendors and fellow employees to resolve issues
• Ability to prioritize tasks and follow up appropriately
• Must be motivated and able to work independently with minimum supervision

Education and Experience:

• A minimum of a Bachelor's of Science Degree in Accounting or equivalent combination of experience and/or education required
• A minimum of 5 years experience in Accounts Payable and General Ledger functions required
• Experience in fiscal/monthly closures, audit processes, and financial reporting

General Requirements:

• Adapts to change, open to new ideas and responsibilities
• Uses resources efficiently, strives to reduce cost, part of the budgeting process
• Communicates well (written and verbal), delivers presentations, has good listening skills
• Good listener, committed to finding solutions to problems, works well with difficult people
• Works well with internal and external customer, promotes a positive image of the company, and strives to solve issues raised by customers
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
• Honest, accountable, maintains confidentiality
• Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command
• Takes action, seeks new opportunities, and strives to see projects to completion within the boundaries of the job description
• Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks
• Strives to understand contributing factors, works to resolve complex situations
• Manages workload, works efficiently, and meets goals and objectives
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements
• Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner
• Accountable to team, works to meet established deliverables, appreciates view of team members, respectful

Physical Requirements:

• Constantly sit, frequently stand and walk. Constantly using hands to finger, handle or feel. Constantly reach with hands or arms. Occasionally stoop, kneel, crouch, and or crawl. Constantly talk or hear. Lift approximately 1-10 lbs., 1-33% of the time. Carry 1-10 lbs., 1-33% of the time. The work environment for this job is very quiet.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Senior Accountant here.

In your cover letter please answer the following:

• Have you completed the following level of education: Bachelor's Degree?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: To develop a greater scientific understanding of the ACC/SKK product line and effect changes in protocols to give greater reliability with respect to products. To develop new products revolving around the current technology and new concepts leading to new technologies.

General Responsibilities:

• Adapt and develop new technologies around the LAL system
• Develop projects that will enhance the scientific understanding of the current products with the goal of improvement and the introduction of new products
• Expand the range of products within the framework of ACC
• Provide the technical expertise to conceptualize and implement new research areas
• Provide technical support when necessary
• Supervise Research and Development staff

Knowledge and Skill Requirements:

• Protein Chemistry/Biochemistry including enzymology and purification
• The use of spectroscopic, chromatographic and molecular biological techniques
• Assay Development
• Technology transfer and scale-up
• Supervisory experience

Education and Experience:

• A minimum of a PhD in Chemistry, Biochemistry or related field or an equivalent combination of experience and/or education required
• Several years of experience in assay development, protein chemistry and protein purification. Additional expertise in Molecular Biology and supervisor/management experience is desired

General Competencies:

• Adapts to change, open to new ideas and responsibilities
• Uses resources efficiently, strives to reduce cost, part of the budgeting process
• Communicates well (written and verbal), delivers presentations, has good listening skills
• Perform task with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held
• Good listener, committed to finding solutions to problems, works well with difficult people
• Works well with internal and external customer, promotes a positive image of the company, and strives to solve issues raised by customers
• Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions

Physical Requirements:

• Frequently sit, frequently stand and walk, use hands to finger, handle or feel. Frequently reach with hands or arms, climb or balance. Occasionally stoop, kneel, crouch, or crawl. Frequently talk or listen. Occasionally taste or smell. Lift 11 – 25 lbs 34-66% of the time. Carry 11 – 25 lbs 34-66% of the time. Occasionally exposed to wet or humid conditions. Frequently work near moving mechanical parts. Occasionally work in high places. Frequently exposed to fumes or airborne particles, frequently exposed to toxic or caustic chemicals. Occasionally exposed to uneven surface and vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Sr. Research Scientist here.

In your cover letter please answer the following:

• Have you completed the following level of education: A minimum of a PhD in Chemistry, Biochemistry or related field ?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: In this role, you will work in a multidisciplinary environment where Biology and Medicine meet Engineering, Chemistry and Manufacturing to support the development of new endotoxin and glucan detection products.

General Responsibilities:

The major responsibilities of this position will be to support the advancement of the company product development pipeline.

• The major responsibilities of this position will be to support the advancement of the company product development pipeline
• Conduct laboratory experiments and studies according to approved protocols and Standard Operating Procedures (SOPs)
• Collaborate in creating SOPs, protocols for studies, verifications, and validations
• Participate in the development, improvement, verification, validation, and technology transfer of current and new products or processes
• Analyze laboratory results and prepare study reports
• Follow Design Control requirements and SOPs in a GMP environment
• Participate in cross-functional activities
• Maintain records in accordance with Quality Assurance guidelines
• Support regulatory filings for Class I and Class II in vitro diagnostic reagents and products

Knowledge and Skill Requirements:

• Experience providing analytical support for assay development activities
• Experience working as part of a cross functional team
• Experience with reagent, instrument, and software development
• Experience collaborating with external CRO/CMOs
• Experience with change management processes
• Knowledge of basic statistics
• Experience with automation and automated processes
• Understanding of protein and enzyme function

Education and Experience:

• A BS/MS in biochemistry, chemistry, analytical chemistry, or closely related field with at least two years’ experience in industry or an equivalent combination of experience and/or education required.

General Competencies:

• Excellent written and verbal communication skills required
• Strong record keeping and organizational skills with excellent attention to detail
• Ability to work independently with minimal supervision

Physical Requirements:

• Frequently sit, frequently stand, and walk, use hands to finger, handle or feel. Frequently reach with hands or arms, occasionally climb or balance. Occasionally stoop, kneel, crouch, or crawl. Frequently talk or listen. Frequently look at detailed information on computer screens and in printed form. Occasionally lift of carry 11 – 25 lbs. Occasionally exposed to wet or humid conditions. Frequently work near moving mechanical parts. Occasionally work in high places. Occasionally exposed to fumes, airborne particles, toxic or caustic chemicals. Occasionally exposed to uneven surface and vibration. Moderate noise is typical for the work environment of this job.

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Research Associate II here.

In your cover letter please answer the following:

• Have you completed the following level of education: BS/MS in biochemistry, chemistry, analytical chemistry, or closely related field?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.

Purpose: Biotech on Cape Cod! Seeking hardworking, motivated and reliable people for positions in our Manufacturing teams. Experience not necessary, we provide the training. Good attitude a must.

General Responsibilities:

• Can work in a team atmosphere and with minimal supervision
• Possess a positive attitude and desire to learn
• Work on their feet in a fast-paced environment
• Read and write English
• Have restaurant, manufacturing experience, or simply want to learn something new
• Fill and finish technicians
• Formulation of finished product
• Filling operations
• Cleaning of controlled process areas
• Glassware preparation
• Cleaning of controlled process areas
• Machine operation (crimping/filling/ Freeze dryer operation)

Knowledge and Skill Requirements:

• Experience in manufacturing is desirable
• Must be able to get along with and respect others
• Be able to lift at least 25 lbs.
• Basic computer skills needed

Education and Experience:

• A minimum of a high school diploma or equivalent and 0-2 years related industry experience Associates degree or equivalent is an advantage

Job Type: Full-Time

To Apply:

Please submit a current resume and cover letter for Production Technician here.

In your cover letter please answer the following:

• Have you completed the following level of education: High School Diploma?
• Are you authorized to work in the United States?
• Must be willing to undergo a background check after an employment offer has been made.