CML - US

Head of Manufacturing

Plant/Facility Engineer

Process Transfer Specialist

Quality Assurance Engineer

Analytical R&D Scientists

Quality Control Chemists

Process Chemists

Plant (Chemical) Operators

Employment Application

Invitation to Identify

CML - Europe

Chemical Analyst

Junior Process Operator

Employment - US

Cambridge Major Laboratories, Inc. will only accept resumes for specific positions that have been posted.

All candidates must complete the Cambridge Major Laboratories, Inc. employment application, along with an Invitation to Identify. Also submit a resume and cover letter with salary history. Candidates failing to submit all requested information will not be considered.

Head of Manufacturing

Responsibilities:

• Lead all technical aspects of large scale manufacturing and ensure operations run smoothly and safely.
• Safety and environmental compliance, large scale plant production, process transfers from other CML development sites.
• Scheduling and coordination of large scale production, raw materials supply and staging, compliance with GMP's, modification of equipment to meet production needs, qualification and validation of systems, maintenance and repair of equipment.
• Managing the high level of profitability of the operation by ensuring timely completion of projects/campaigns.
• Close monitoring of operational expenses.
• Liaise regularly with customers.
• Participate as a management team member and provide technical and career mentorship, training, and skill improvement for technical staff.
• Responsible for technical hires and terminations within the facility with Human Resources' assistance.

Minimum Requirements:

• Education: Minimum of BS in chemistry or related field (PhD preferred).
• Must be able to work within the USA without employer sponsorship.
• 10+ years experience in managing large scale API manufacturing operations, preferably in a contract manufacturing environment.
• Ability to effectively communicate with employees, peers, customers, and the general public.
• Background check required.

Plant/Facilities Engineer

Responsibilities:

• Understand the fundamental design and operation of CML's manufacturing facilities.
• Manage all engineering projects.
• Manage CML's engineering department and maintenance staff.
• Maintain Preventive Maintenance Program.
• Coordinate outside contractors; ensure that work is done properly and in a timely manner.
• Liase with procurement on purchasing to support the facilities.
• Provide detailed maintenance and capital plans, and forecasts.
• Project manage new equipment installations and upgrades.
• Update drawings and SOPs in compliance with GMP's.
• Assist in AutoCAD drawings and updates to facility drawings.
• Assist with regulatory and quality assurance requirements.

Minimum Requirements:

• Education: Bachelors Degree in Chemical or Mechanical Engineering.
• Must be able to work within the USA without employer sponsorship.
• 5+ years experience in a Chemical / API plant manufacturing environment.
• Fundamental understanding of GMP facility design including, reactor system design, heat exchangers, and heat transfer.
• Strong understanding of PLC's and their function.
• Ability to effectively communicate with employees, peers, customers, and the general public.
• Background check required.

Chemistry Process Transfer Specialist

Responsibilities:

• Efficiently scale chemical processes from lab to pilot scale / large scale manufacturing.
• Detailed understanding of CML's production plants and ancillary equipment to ensure smooth process transfers.
• Maintain hazard evaluation and reaction calorimetry equipment.
• Perform optimization of the existing processes to improve bottom-line.
• Perform analytical tests to support the process control; ie. GC, HPLC, and NMR.
• Effectively liaise with R&D, analytical, and plant personnel to ensure project success.

Minimum Requirements:

• Education: PhD in Organic Chemistry or Chemical Engineering.
• Must be able to work within the USA without employer sponsorship.
• 5+ years industrial experience in Process R&D, both on kilo lab and plant scale.
• Fundamental knowledge of scale-up issues including heating and mass transfer, agitation, isolation/filtration, drying.
• Understanding of GMP's and working in an FDA-regulated environment.
• Must be an effective communicator; write reports, present information, and dialog with peers, managers, and clients.
• Background check required.

Quality Assurance Engineer

Responsibilities:

• Monitor and trend facilities, areas, and equipment from production and laboratories for implementation of corrective and preventative measures.
• Coordinate any investigations as they relate to facilities and/or equipment.
• Perform Quality Reviews and generate final reports for facilities and/or equipment.
• Utilize quantitative and qualitative statistical process control techniques, measurement systems, metrology, and design of experimentation to determine process capabilities, reliability, reproducibility, and risk assessment of quality and manufacturing processes.
• Generate protocols and final reports as assigned by supervisor. Interfacing with Manufacturing and Engineering to ensure compliance with SOPs, Protocols, and regulatory requirements.
• Review and support execution of qualification / validation protocols and master plans.
• Generate and maintain Standard Operating Procedure (SOP) as necessary.
• Assist with the maintenance of engineering change control.

Minimum Requirements:

• Education: Bachelors Degree Required with coursework in engineering or related field.
• Must be able to work within the USA without employer sponsorship.
• Minimum of 1 year of industrial experience required, preferably in a pharmaceutical facility.
• Ability to effectively communicate with employees, peers, customers, and the general public.
• Background check required.

Analytical R&D Scientists

Responsibilities:

• Apply scientific principles, theories and concepts to resolve analytical problems related to drug substances in compliance with appropriate Standard Operating Procedures (SOPs) and regulatory guidelines.
• Perform literature searches and extract relevant information from published protocols and journals.
• Analyze and study thermal hazardous properties of organic molecules by using techniques such as TGA and DSC.
• Correctly analyze data/results and interpret outcome of experiments.
• Calibration, maintenance and troubleshooting of analytical equipment.
• Write project documentation (Analytical test methods, developmental reports, and protocols) of medium complexity with minimal input from supervisor.
• Understand basic theories and principles of synthetic organic chemistry.
• Establish and coordinate activities at contract chemical and analytical laboratories as required.

Minimum Requirements:

• Education: Bachelors Degree Required, Master's or PhD preferred, in a scientific discipline such as analytical chemistry, organic chemistry, or related field.
• Must be able to work within the USA without employer sponsorship
• Minimum of 3 years industrial experience in working with chemical and/or pharmaceutical compounds.
• Posses skills and knowledge in chemical and physical properties of organic molecules and also hands on experience in analytical techniques such as HPLC, GC, Mass spectrometry, ICP, KF, UV, etc. to support all stages of API (Active pharmaceutical ingredient) development.

Quality Control Chemists

Responsibilities:

• Apply scientific principles, theories and concepts to resolve analytical problems related to drug substances in compliance with appropriate Standard Operating Procedures (SOPs) and regulatory guidelines.
• Testing and release of raw materials, intermediates, and final products using various analytical techniques.
• In-Process production support.
• Validate analytical methods using HPLC, GC, or LC-MS following protocols, test methods, and applicable SOPs.
• Correctly analyze data/results and interpret outcome of experiments.
• Write project documentation (Analytical test methods, reports, and protocols) of medium complexity with minimal input from supervisor.
• Understand basic theories and principles of analytical chemistry.
• Establish and coordinate activities at contract chemical and analytical laboratories as required.
• Troubleshoot analytical equipment and existing test methods.

Minimum Requirements:

• Education: Bachelors Degree Required, Master's or PhD preferred, in a scientific discipline such as analytical chemistry, organic chemistry, or related field.
• Must be able to work within the USA without employer sponsorship.
• Minimum of 3 years industrial experience in working with chemical and/or pharmaceutical compounds.
• Posses skills, knowledge, and experinece in analytical techniques such as HPLC, GC, Mass spectrometry, ICP, KF, UV, FTIR, etc. to support all stages of API (Active pharmaceutical ingredient) development.

Process Chemists

For our Germantown location we are looking for a few enthusiastic and motivated Process Chemists from entry level through 2+ years of experience.

Responsibilities:

• Carry out chemical reactions on gram to multi-kilogram scale, up to 50L equipment.
• Understand reaction mechanisms and apply them to practical execution of the given synthesis.
• Solve common synthetic problems, including optimization of conditions of proposed and designed synthetic routes including but not limited to purity, loadings, equivalents, cycle times, work up procedures, and yields.
• Perform routine analytical procedures to monitor reaction progress (i.e. TLC, GC, NMR, HPLC, KF) and interpret analytical data.
• Clearly communicate all results and procedures, including final reports and updates to supervisor and/or clients.
• Manage and track project progress including, calculating raw materials and establishing the production schedule to meet proposed timelines; and monitoring timelines, equipment availability, and yields to ensure project success.
• Project management with limited supervision including calculating required amounts of raw materials and establishing the production schedule to meet proposed timeline.
• Write project documentation (production and test records, etc.) of medium complexity with minimal input from supervisor.
• Training/Mentoring of new or less experienced chemists.

Minimum Requirements:

• Education: Bachelors Degree Required; Chemistry or related field.
• Must be able to work within the USA without employer sponsorship.
• Background check required.

Plant (Chemical) Operators

For our Germantown location we are looking for a few enthusiastic and motivated Plant Operators.

Responsibilities:

• Operate process equipment and utilities.
• Utilize proper PPE and complete weekly safety inspections of equipment per department procedures.
• Demonstrate environmental stewardship by preventing spills, correcting leaks, and utilize existing control systems such as scrubbers and spot exhaust trunks.
• Follow department cGMP procedures.
• Observe housekeeping and chemical hygiene practices to maintain a neat, safe, orderly, and clean working environment.
• Use documentation systems for inventory management and batch records.
• Use the Allen-Bradley Control System in process operations, and troubleshoot equipment problems.
• Handle small maintenance-type work (i.e. replacing small sections of pipe, tightening bolts, and replacing like for like items).

Minimum Requirements:

• Education: High School Diploma/GED Equivalent Required.
• Must be able to work within the USA without employer sponsorship.
• Minimum of 1-2 years of experience in chemical plant operations.
• Background check required.