Careers

Supply Chain Manager

The Supply Chain Manager is responsible for material supply and control. Through sales, inventory and manufacturing analysis he/she will generate a master schedule which will in turn drive purchasing of raw materials and/or services in support of the production plan. Inventory levels will also be calculated based on replenishment lead times, expiration dating and obsolescence.

General Responsibilities:

  • Manage purchasing, planning, warehousing and inventory control in accordance with ACC's quality system
  • Generate and maintain the master production schedule
  • Lead the installation and ongoing system management of the MRP module of Great Plains
  • Direct interface with finance associated with BOM accuracy, excess and obsolete inventory and purchase price
  • Oversee warehouse operations ensuring a high degree of inventory accuracy through proper inventory transactions and consistent cycle counting
  • Develop “power user” skills associated with the Great Plains business management system
  • Communicate material needs to purchasing
  • Train warehouse personnel on proper SOPs and Great Plains transaction process
  • Organize and manage physical inventories at least once and possibly twice per year
  • Assist in the generation and overall effectiveness of the work center production plan

Knowledge and Skill Requirements:

  • Strong management and training skills
  • Business management system software and MRP experience
  • Familiar with cost accounting principles
  • Above average spread sheet skills
  • Experience with GMPs and ISO based system management

Education and Experience:

  • A minimum of a BA or BS in a business discipline or an equivalent combination of experience and/or education required
  • 5-8 years planning or purchasing experience preferable in a medical device or pharmaceutical environment
  • APICs certification a plus

General Competencies:

  • Communicates well (written and verbal), delivers presentations, has good listening skills
  • Good listener, committed to finding solutions to problems, works well with difficult people
  • Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
  • Offers feedback, coach’s employees appropriately, rewards employees wisely, takes mentoring role, challenges and develops employees, offers opportunity
  • Honest, accountable, maintains confidentiality
  • Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Provides strong leadership, sets a good example, skilled decision maker, motivator, encourager
  • Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Supply Chain Manager here.

In your cover letter please answer the following:

  • Have you completed the following level of education: BA or BS in a business discipline or equivalent combination of relevant experience and education?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Human Resources Specialist

Provide Human Resources support to the HR Generalist(s) in the areas of Benefits, HRIS, project work and other administrative responsibilities as required in support of organizational goals. Will ensure the accuracy and timeliness of tracking, analyzing and reporting trends and variances. The work is of a confidential nature requiring an understanding of ACC's policies and practices, requiring expediting critical matters and effectively interfacing with all levels of personnel.

General Responsibilities:

  • Coordinate processes and monitor a variety of information in the administration and explanation of benefits to employees
  • Assist in the administration of all types of leave of absence i.e., STD, LTD, maternity leave, FMLA, etc
  • Assist with coordinating the Flexible Spending Plan
  • Counsel and assist employees with benefits questions
  • Process termination of benefits, including notification of carriers, COBRA logs and notification of employee of portability/conversion opportunities as needed
  • Participate in the coordination of open enrollment, vaccine clinics, Medicare seminars
  • Assist employees with 401k questions
  • Validate and gather information for various insurance agencies as needed
  • Promote and coordinating Wellness initiatives
  • Coordinate and participate in audits as required
  • Provide back-up coverage for reception area
  • Other tasks as requested

Knowledge and Skill Requirements:

  • Working knowledge of applicable Federal, State and Local laws and regulations related to the Human Resources function
  • Strong knowledge and experience working in benefits
  • Must be able to interact effectively with all levels of management and employees
  • Strong verbal and written communications skills in English
  • Proven ability to maintain confidentiality and deal with sensitive information in a professional manner
  • Excellent communication, organizational and interpersonal skills required
  • Must have good project management, decision-making, critical thinking and listening skills
  • Proven problem solving and analysis experience
  • The ability to multi-task and manage time in a fast-paced environment
  • Self directed and self motivated
  • Strong PC skills (e.g. Excel, Word Powerpoint) as well as proficiency in HR database systems required
  • Biotech, Life Science or Pharmaceutical industry experience preferred
  • Maintains information, keeps it organized and accessible, maintains efficient work space, manages time well

Education and Experience:

  • An Associate degree with a concentration in Human Resources is preferred or an equivalent combination of relevant experience and education.
  • A minimum of 2-3 years human resources or similar experience working in a highly confidential environment required.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Human Resources Specialist here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associate's Degree or equivalent combination of relevant experience and education?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Facilities Mechanic

Perform a wide variety of duties in connection with the installation, repair and maintenance of building, grounds, and facility equipment.

General Responsibilities:

  • Performs scheduled and corrective maintenance of complex equipment and systems. Evaluates equipment performance and recommends improvements to the Maintenance program and system design
  • Ensure compliance with quality system procedures related to the Facility equipment and general day to day operations
  • Performs scheduled and corrective maintenance of Purified Water, Clean Steam, WFI, and Process Gasses. Maintain critical facility utilities such as boilers and steam distribution systems, air compressors and other utilities
  • Coordinates maintenance activities with manufacturing supervisors. Solicits quotations and reviews contractors’ proposals within his area of responsibilities
  • Performs periodic inspections and conducts maintenance per procedure to prevent failure of various equipment and systems
  • Performs duties with limited supervision and has the ability to work independently or in a team environment. Also has the ability to work extended hours as required
  • Troubleshoot and repair electro mechanical equipment of all types, including HVAC systems
  • Accurately and legibly document detailed description of work performed in equipment log books
  • Develop and or revise GMP and non GMP maintenance documentation (SOPs, preventative maintenance check-lists, etc.)
  • May be required to stand watch and make routine building rounds and monitor the facilities boilers in accordance with the Code of Mass. Regulations. CMR-146
  • Is required to work rotating shift and on call schedules
  • All other duties assigned by Facilities supervisor and/or manager

Knowledge and Skill Requirements:

  • Knowledge of High Pressure Boiler Systems, industrial pump/piping systems and compressed air 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:

  • Associate's Degree or equivalent from two-year College or technical trade school; and five or more year’s field experience, including electrical and mechanical troubleshooting and repair. Equivalent professional experience may be substituted in lieu of education.
  • Universal refrigeration license and experience with the life science industry are both a big plus.
  • Ability to obtain a Massachusetts Second Class Fireman’s License or Special License to Operate within 1 yr is a must.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Facilities Mechanic here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Associate's Degree or equivalent combination of experience and/or education?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Boiler Operator

To maintain and monitor boiler and building systems in accordance with Massachusetts laws.

General Responsibilities:

  • 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)

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 and related experience?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Facilities Supervisor

In this role, you will supervise the day-to-day operations of the maintenance group which includes planned maintenance activities and unplanned repairs of the facility and its equipment.

General Responsibilities:

  • Provide excellent support to the various groups within the building
  • Support the facilities maintenance team by providing leadership and technical, resource and planning assistance
  • Maintain a working knowledge of the team’s workload to efficiently delegate unscheduled work requests
  • Confirm scheduled and unscheduled work is completed by their due dates
  • Complete reviews of all maintenance work in a timely manner
  • Prioritize work while considering the maintenance team’s activities as well as the needs of the groups we support
  • Provide open lines of communication with groups we support
  • Oversee onsite contractors
  • Must be available for on-call for emergencies

Education and Experience:

  • A Bachelor's Degree in a scientific or engineering field or an equivalent combination of experience and/or education is required
  • A minimum of five years’ experience troubleshooting, repairing, and maintaining typical building systems such as steam, electrical, plumbing, pneumatic and HVAC systems preferably in cGMP manufacturing facility or other highly regulated industry. Building automation experience is a plus
  • A minimum of three years’ experience in a leadership/supervisory role
  • Previous experience in cGMP or another highly regulated industries where exceptional organizational and documentation skills, accuracy and attention to detail are paramount to the success of the company
  • Proficient with computerized maintenance management systems. Blue Mountain RAM a plus

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Facilities Supervisor here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's Degree in a scientific or engineering or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Production Technician

2nd shift, 2pm-10:30pm

To work as a member of the Production Team to manufacture products in compliance with ACC procedures.

General Responsibilities:

  • The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records
  • Execution of routine production operations
  • Record information into logbooks, forms or document records
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Perform scheduled cleaning of equipment/process areas
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Complete required training on time
  • Perform standardization of equipment
  • Receive and distribute supplies into the production area as necessary
  • Communicate issues related to safety, quality, compliance and equipment to the Production Lead Operator and Supervisor
  • Must be able to read and follow detailed written procedures
  • Support machine change over activities
  • Assist in the assembly and disassembly of process equipment
  • Must be able to work overtime as required
  • Pay attention to floor inventory levels and communicating any deficiencies to the Lead or Supervisor
  • Other duties as assigned by supervisory staff

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 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?
  • Are you authorized to work in the United States?

Systems Administrator III

The purpose of the Systems Administrator III is to ensure uptime, performance, and security of computer systems primarily focused on servers, switches, routers, firewalls, and data solutions for Associates of Cape Cod, Inc.

General Responsibilities:

  • Perform installation, configuration, qualification, maintenance and troubleshooting of information systems, applications and related hardware and firmware
  • Provide technical support for both hardware and software issues to end-users
  • Review system logs to proactively mitigate issues and maintain security
  • Maintain systems documentation
  • Assist in periodic performance/metric reporting
  • Provide basic training to end-users in operation of equipment and applications
  • Provide on-call/after-hours support for critical computerized systems, Potential weeknights, weekends and or Holiday coverage
  • Author and maintain information technology company-wide policies
  • Lead and manage IT projects to support various business functions
  • Provide guidance to less experienced team members

Knowledge and Skill Requirements:

  • Extensive knowledge in Microsoft operating systems (Windows 10 & Server 2008-2019)
  • Extensive knowledge in Microsoft Server applications including IIS, Exchange and SQL
  • Extensive knowledge of Active Directory and Group Policies
  • Extensive understanding of computer networking concepts, protocols and services
  • Extensive knowledge of batch or powershell scripting
  • Extensive knowledge of cloud computing platforms (Azure/AWS preferred)
  • Extensive knowledge of virtualization solutions (VMware ESXi, Hyper-v, Xen, and Citrix preferred)
  • Experience in Office 365
  • Experience with Microsoft System Center Configuration Manager (SCCM) and Intune
  • Experience in administering Unix/Linux operating systems
  • Experience in administering Oracle database solutions
  • Knowledge of project management best practices and methodologies
  • Ability to research and solve complex technical issues
  • Detail-oriented and excellent organizational skills
  • Ability to effectively communicate and explain detailed and/or complicated technical issues in terms that benefit users and help resolve problems and issues
  • Ability to manage multiple projects and ensure deadlines are met
  • Ability to follow rules, regulations and guidance required in FDA and ISO regulated environments

Preferred Qualifications:

  • Any current technology certification (A+, Network+, Security+, MCTS, MSCA, ITIL etc.)
  • Information Technology Service Management tool set experience
  • SOX, 21 CFR Part 11, GDPR, GxP and/or HIPAA experience

Education and Experience:

  • A minimum of a Bachelor’s degree preferably, but not required in computer science or a related field or an equivalent combination of experience and/or education required
  • Seven or more years related experience in systems administrator, hardware maintenance such as configuring, installing and troubleshooting servers, workstations, and network related equipment
  • Biotechnology, life science, pharmaceutical or healthcare industry experience is preferred

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Systems Administrator III here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor’s degree in Computer Science or equivalent combination of experience and/or education?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

LAL Production Technician

With direct supervision this individual will perform routine manufacturing operations for the manufacture of ACC and SKK commercial products. Individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records. The individual will complete required training on time, demonstrate acceptable attendance as well as respect for coworkers.

General Responsibilities:

  • The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP) and applicable records
  • Execution of routine production operations
  • Record information into logbooks, forms or document records
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Perform scheduled cleaning of equipment/process areas
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Complete required training on time
  • Perform standardization of equipment
  • Receive and distribute supplies into the production area as necessary
  • Communicate issues related to safety, quality, compliance and equipment to the Production Lead Operator and Supervisor
  • Must be able to read and follow detailed written procedures
  • Support machine change over activities
  • Assist in the assembly and disassembly of process equipment
  • Must be able to work overtime as required
  • Pay attention to floor inventory levels and communicating any deficiencies to the Lead or Supervisor
  • Other duties as assigned by supervisory staff

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 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 LAL Production Technician here.

In your cover letter please answer the following:

  • Have you completed the following level of education: High School diploma and 0-2 years related industry experience?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Production Lead Technician

Purpose: With minimal supervision this individual will deliver leadership and excellence in manufacturing ACC and SKK Products. The incumbent assists Management with scheduling to meet site demands and observes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Provide interactions with support groups/departments to ensure accurate communication and continuous flow of manufacturing processes. Provide support to integrate best practices, where appropriate, into manufacturing.

General Responsibilities:

  • Primary contact for troubleshooting and issue resolution or escalation
  • Create and follow up on work orders
  • Communicate/coordinate days scheduling and staffing plan
  • Re-allocate staff as needed during the day (breaks, lunch, training, etc.)
  • Oversight and execution of all routine and critical operations as well as commissioning and validation activities
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Ensure documentation is complete, reviewed, and meets good documentation practices
  • Update SOP's as required
  • Responsible for floor inventory and communicating deficiencies
  • Recommend/implement process changes/improvements or safety/ergonomic improvements
  • Ensure work is carried out in a safe manner, notifying management of safety issues and risks
  • Responsible for interviewing candidates
  • Provide timely feedback on staff’s performance
  • Address minor personnel issues timely
  • Escalate major personnel issues to the supervisor
  • Act as a resource/subject matter expert (SME) for staff
  • Conduct training and assess effectiveness
  • Assess staff skill sets and provide feedback to supervisor
  • Must be able to work overtime as required
  • Must be able to work weekends as required
  • Other duties as assigned by supervisory staff

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
  • Computer skills are necessary in this function
  • Act as a role model (lead by example)

Education and Experience:

  • Associates degree and 1-4 years related experience or 4-6 years industry experience or an equivalent combination of experience and/or education required
  • Bachelors of Science degree or equivalent is an advantage with 2-4 years of GMP Manufacturing experience

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: Associates degree or related field or an equivalent combination of experience?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Senior Research Scientist

Develop a greater scientific understanding of the ACC/SKK product line and effect changes in protocols to give greater reliability with respect to products. 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.

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: PhD in Chemistry, Biochemistry or related field or an equivalent combination of experience?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Sr. Software Engineer

Design and develop software to support the manufacture, sale and support of ACC’s endotoxin and glucan detection products and develop/maintain software to support company’s line of business.

General Responsibilities:

  • Analyze User Needs and develop high-quality, innovative software with operational efficiency.
  • Work closely with BAs, SMEs and Software Developers to develop software requirements specification and software design specifications
  • Design and implement software for Bio/medical devices and systems from requirements to production and commercial deployment
  • Responsible for design, debug, and integration of software C#/Java applications running in a MS Windows environment
  • Give aid and guidance to junior engineering staff.
  • Lead and direct activities on development  project
  • Contribute to the improvement of the development life cycle.
  • Be self-empowered, take ownership of, and responsibility for your work
  • Collaborate and communicate effectively with team members and with other teams
  • Work independently and know when to ask for help
  • Perform comprehensive unit and integration testing of all software produced
  • Participate in group design and code reviews
  • Review code and work with software quality assurance to ensure that all software meets company or medical device standards
  • Stay abreast of the latest technology and industry best practices
  • Understand the software development life cycle

Knowledge and Skill Requirements:

  • Must demonstrate significant proficiency in C#/Java
  • Documents and demonstrates solutions by developing documentation, flowcharts, layouts, diagrams, code comments and clear code. 
  • Ability to gather and understand User Needs/Requirements
  • Ability to work in a very fast paced environment
  • Familiarity with software configuration management tools, defect tracking tools, and peer review
  • Familiarity with relational databases
  • Any exposure or knowledge of the Bio/Medical industry is a strong plus

Nice To Have:

  • Experience implementing software for class I or II medical devices
  • Object-oriented design and development, and C#, are strongly preferred
  • Experience with Visual Studio, Git, Helix ALM and Microsoft Team Foundation Server
  • Experience with IEC-62304, ISO-13485, and ISO-14971

Education and Experience:

  • Bachelor’s Degree in Biomedical Engineering, Software Engineering, Computer Science, Applied Mathematics, Electrical Engineering or a related field or equivalent combination of education and experience.
  • 8 or more years of software development using C#/Java
  • Good written and oral communications skills, strong attention to detail and willingness to follow directions and established procedures with minimal supervision. 

Job Type: Full-time

To Apply:

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

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor's or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Production Technician

General Responsibilities:

  • The individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), and applicable records
  • Execution of routine production operations
  • Record information into logbooks, forms or document records
  • Carry out work in a safe manner, notifying management of safety issues and risks
  • Perform scheduled cleaning of equipment/process areas
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
  • Complete required training on time
  • Perform standardization of equipment
  • Receive and distribute supplies into the production area as necessary
  • Communicate issues related to safety, quality, compliance and equipment to the Production Lead Operator and Supervisor
  • Must be able to read and follow detailed written procedures
  • Support machine change over activities
  • Assist in the assembly and disassembly of process equipment
  • Must be able to work overtime as required
  • Pay attention to floor inventory levels and communicating any deficiencies to the Lead or Supervisor
  • Other duties as assigned by supervisory staff

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 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?
  • Are you authorized to work in the United States?

CTS  Analyst

General Responsibilities:

  • Perform testing using each of the three LAL (limulus amebocyte lysate) methods-gel clot, turbidimetric & chromogenic
  • Interpret results, perform pipetting
  • Report writing, interact with clients relative to sample testing
  • Database entry
  • Utilize calibrated/certified equipment & instrumentation,
  • Maintain certification in all three LAL methods

Knowledge and Skill Requirements:

  • 1 years exp. in a lab environment
  • Strong organizational skills
  • Must be detail oriented with good aseptic/laboratory technique
  • Possess the ability to work independently as well as with others in a fast paced environment
  • Excellent oral & written communication skills
  • Possess a working knowledge of cGMP, ISO 9001, ISO 13485 & internal operating procedures
  • Required to pass a pipetting proficiency training and certification course.
  • Other – Hepatitis B vaccination

Education and Experience:

  • Bachelor’s Degree in Chemistry, Biochemistry, a related scientific discipline, or an equivalent combination of experience and/or education required.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for CTS Analyst 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?

Product Development Associate

General Responsibilities:

The major responsibilities of this position will be to support the advancement of the company clinical product development pipeline while using various laboratory equipment for routine analyses (e.g., spectrophotometers, manual pipettes and automated liquid handlers etc)

  • Participate in the development, improvement and validation of new assays
  • Design, write and carryout experimental protocols.
  • Test analytical and clinical samples
  • Analyze laboratory results and prepare study reports.
  • Support regulatory filings for Class I and Class II in vitro diagnostic reagents and products.
  • Follow Design Control requirements and SOPs in a GMP environment.
  • Maintain records in accordance with Quality Assurance Guidelines.
  • Participate in cross-functional activities.

Education and Experience:

The position requires a minimum of BS/MSc in Biochemistry, Chemistry or Biology with 5 years of relevant industry experience or equivalent combination of education and/or experience. 

General Competencies:

  • Scientific creativity, critical thinking, ability to innovate, and analytical problem solving.
  • Ability to accurately follow, draft and review technical documents, including test plans, protocols and reports.
  • Ability to work independently, as well as, with others in a fast paced laboratory environment.
  • Willing and able to drive projects to completion and to meet deadlines
  • Excellent written and oral communication skills.
  • Proficiency in software applications such as Word, Excel, PowerPoint.
  • Excellent use of manual, multichannel, and repeater pipettes. Able to accurately dispense small volumes consistently.
  • Hands-on experience with the use of automated liquid handling system is a plus
  • Other – Hepatitis B vaccination to be able to test clinical samples.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Product Development Associate here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Bachelor of Science or equivalent?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Regulatory MGR / Associate Director / Director (Level Dependent Upon Experience)

Purpose: To assure regulatory compliance at Associates of Cape Cod, Inc.

Knowledge and Skill Requirements:

  • Knowledge of:
    • 21CFR, esp. Parts 210, 211, 600-610, 600's as appropriate, and 800 as appropriate
    • Canadian Medical Device Regulations, SOR/98-282
    • Directive 98/79/EC of the European Parliament and of the Council
    • FDA Guidance documents, esp. Guideline for Validation of Limulus Amebocyte Lysate Test; Changes to an Approved Application: Biological Products; Sterile Drug Products Produced by Aseptic Processing; Investigating Out-of-Specification (OOS) Test Results
    • Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice (September 2004)
    • Guidance for Industry - Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (October 2006)
    • Relevant ISO documents, esp. 13485; 14971
    • Relevant EU and JP regulations
    • Relevant USP chapters
  • Good communication and writing skills
  • Project management and risk management
  • Design control

Education:

  • At least a Master's degree and three years' experience in the regulatory field or an equivalent combination of experience and/or education required
  • RAC certification preferred
  • Experience on project teams (new product development) with submissions to regulatory bodies

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Regulatory MGR / Associate Director / Director here.

In your cover letter please answer the following:

  • Have you completed the following level of education: Master's Degree?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?

Quality Control Analyst I

Grow your career in life sciences on Cape Cod!

In this role you will perform chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with cGMP, ACC SOPs, and FDA Analyst has working knowledge of relevant QC techniques, policies and procedures to perform QC tasks and document results. Analyst receives minimal supervision on routine assignments and detailed instructions on new assignments.

Knowledge and Skill Requirements:

  • Organizational skills
  • General laboratory skills
  • Must be detailed oriented and show proficiency in aseptic and laboratory technique
  • Ability to work independently, as well as, participate on teams comprised on immediate group members or to work cross functionally, in a fast paced laboratory environment
  • Working knowledge of cGMP, ISO 13485 quality system requirements, and principles of quality control
  • Required to pass a pipetting proficiency training and certification course.

Education and Experience:
A minimum B.S. degree in a relevant scientific discipline with 0-2+ years relevant laboratory experience within a cGMP regulated environment or an equivalent combination of experience and/or education required.

Job Type: Full-time

To Apply:

Please submit a current resume and cover letter for Quality Control Analyst I here.

In your cover letter please answer the following:

  • How many years of Quality Control experience do you have?
  • Have you completed the following level of education: Bachelor's Degree?
  • Are you authorized to work in the United States?
  • Are you willing to undergo a background check, in accordance with local law/regulations?