Safely execute, develop new approaches, and perform support operations in a cGMP regulated environment for the support of API (Active Pharmaceutical Ingredients) manufacturing teams, including maintaining equipment, preparation of solutions, staging of equipment and supplies, and other various manufacturing support activities.
Compensation
Pay Range for this position: $24.00 - $41.00
Responsibilities
Clean manufacturing equipment and facilities before, during and after operations
Support functions of the facility (e.g., maintain equipment, prepare cleaning solutions, and restock supplies, waste disposal)
Safely perform operations to meet quality expectations
Maintain required training to perform tasks/assignments
Support functions of the facility (e.g., maintain equipment, prepare reagents, and restock supplies, waste disposal)
Experienced Parenteral Manufacturing Technician responsible for executing routine and critical parenteral drug product manufacturing operations for highly sensitive pharmaceutical and biologic products in a controlled environment.
Responsibilities
Perform equipment setup, changeover, cleaning, and line clearance following approved SOPs, safety guidelines, and contamination-control standards.
Operate formulation, preparation, and filling equipment; handle and weigh excipients; execute formulation processes including pH adjustment, yield calculations, and volume adjustments per batch record instructions.
Clean, sanitize, and sterilize classified manufacturing areas and equipment; operate autoclaves, execute CIP/SIP operations, and perform pre- and post-use filter integrity testing.
Collect required in-process samples following strict aseptic sampling techniques and interact with automated/PLC-controlled equipment.
Complete all production records, logbooks, and electronic system transactions accurately, legibly, and in real time following Good Documentation Practices (GDP) and data integrity principles.
Requirements
High school diploma or equivalent
Associate Degree in Science, Industrial Technology, or related technical field
Supports manufacturing of medical devices by operating equipment, packing finished products, loading hoppers, and resolving basic equipment faults through HMI screens while adhering to GMP, GDP, and cleanroom standards.
Responsibilities
Follow safety procedures and use PPE
Report hazards, malfunctions, and incidents
Adhere to cleanroom protocols and gowning requirements
Maintain accurate documentation
Perform in-process checks
Requirements
High school diploma or equivalent
Nice to have: Prior manufacturing or production experience
Perform laboratory analysis and sampling of raw materials, intermediates, finished products, cleaning verification samples, stability samples and other miscellaneous samples following relevant SOP’s while adhering to current Good Manufacturing Practices (cGMP) to ensure they meet the required quality standards and specifications.
Compensation
The salary range for this role is $60,000–$70,000.
Responsibilities
Perform laboratory analysis and sampling of raw materials, intermediates, finished products, cleaning verification samples, stability samples and other miscellaneous samples following relevant SOP’s while adhering to current Good Manufacturing Practices (cGMP) to ensure they meet the required quality standards and specifications.
Perform basic maintenance of technical equipment, use of basic troubleshooting techniques and laboratory stock management
Deliver experimental output with a high degree of scientific integrity, both on time and on target, with a focus on quality.
Actively demonstrate strict compliance with current Good Manufacturing Practices and Good Documentation Practices (cGMP and GDP), Environment, Health and Safety (EH&S) and other relevant standards in all aspects of work.
Manages data by following established procedures, standards and processes. Uses the concepts of ALCOA+ to maintain Data Integrity.
Support manufacturing operations by developing, optimizing and implementing production processes while ensuring compliance with quality standards, collaborating with cross-functional teams to manufacture critical products for diagnostics, research, and therapeutic applications.
Compensation
The hourly pay range estimated for this position based in Massachusetts is $26.39–$39.59.
Responsibilities
Support manufacturing operations by developing, optimizing and implementing production processes
Collaborate with cross-functional teams to manufacture critical products
Contribute to raw material second-sourcing projects, including conducting characterization studies and bench builds
Perform characterization studies and analyze organic or inorganic compounds, raw materials, and finished products
Operate general laboratory instrumentation, including GC/MS, GC/FID, UV-Vis, FTIR, IR, Rotavap, and fluorescence spectrophotometers
The Manufacturing Associate I/II is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment.
Responsibilities
Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations.
Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
Document each task involving manufacturing procedures (i.e. SR’s, EPR’s and BR’s) following GDP at the time of execution.
Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR)
Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities.
Requirements
Bachelor’s degree in a related scientific or engineering discipline