Analytical Testing

Career Opportunities

We have the following positions open:

Process Chemist
Requirements:
Minimum of a Masters Degree in Chemistry with 5 years previous experience or Ph.D. with 1-3 years experience. Kilo lab experience required.
Responsibilities:
The successful candidate will have experience in chemical process R&D, cGMP and lab-to-plant. Kilo lab experience is a must. The process chemist is expected to be able to participate in a chemical synthesis program with the objective to develop a chemical process that can be safely performed on large scale. This involves being able to design, adapt and execute synthetic procedures and purification methods on a laboratory scale to fit the requirements of the development or scale-up plant.
 

Process Engineer
Requirements:
Requirements: Minimum of a B.S. Degree in Chemistry in Chemical Engineering with 5 years previous experience in batch and fine chemical manufacturing.

Responsibilities:
Responsible for developing processing instructions for plant technicians (mostly batch records). These are the instructions used by the plant personnel to produce products in the plant. This involves gathering information from Research, Marketing, Safety and Quality groups and then interpreting and organizing the information into a standard format for technicians to use. Secondary responsibility is troubleshooting processing problems in the plant on batch processes being executed.
 

Quality Control Analyst
Requirements:
BA/BS in Chemistry or related discipline, or comparable educational and professional experience. Previous experience in a cGMP laboratory/manufacturing environment preferred.
Responsibilities:
The QC Analyst is responsible for providing accurate timely results for the samples submitted for analysis. Some of the techniques used by the Chemist to assess the quality of the samples are liquid chromatography, gas chromatography, ultra violet spectroscopy, Infrared Spectroscopy, Titrimetry and others. A thorough understanding of these techniques is essential to accurately assess the validity of the data generated. The Chemist conducts the analysis as outlined in the analytical test procedure. The resulting data is interpreted by the chemist and submitted for review. The Analytical Chemist is also responsible for ensuring that the instrumentation used for analysis is maintained in good working order and has been calibrated. Other duties include but are not limited to: writing operating procedures for the laboratory, maintaining the chemical inventory, maintenance of the reference standard program, perform the secondary data review for analyses conducted by other analytical chemists and maintain stock and inventory of laboratory supplies.
 

Analytical Method Development Chemist
Requirements:
Minimum of a Masters Degree in Chemistry , minimum of 5 years previous experience in pharmaceutical method development/validation required.
Responsibilities:
Develop and validate both compendial and noncompendial analytical methods for raw materials, inprocess materials, final product and stability testing. Conduct product degradation studies and maintain the in-house reference standard qualification system. Provide technical support for the Quality Control and R&D laboratories, including instrument troubleshooting, routine maintenance and training. Operate, maintain and calibrate analytical instrumentation including HPLC, GC, UV, IR and TOC. Write and follow analytical test methods, validation protocols and reports in compliance with current regulatory requirements and industry standards. Characterize noncompendial standard materials through a variety of testing to establish assay and purity. Maintain, follow, and update Standard Operating Procedures for the Quality Control laboratory. Maintains accurate records. Schedule method development and validation activities. Work with R&D and QC to ensure robust methods are developed and validated that serve the needs of both groups for process development as well as routine QC analysis. Participate in technical meetings with customers to address analytical development issues. Other duties may be assigned as required.
 

Production Operator
Requirements:
Reports to the Director of Manufacturing and Production Foreman, the Technical Operator is responsible for assisting in the development of Pilot Plant procedures, operating Pilot Plant batches, and assisting in the Scale-up of Pilot operations. • High School diploma or equivalent and 5 years of related batch chemical processing experience, or an Associates Degree in a related field with 2 years experience. • Must pass physical requirement associated with material handling and PPE usage. • Thorough understanding of equipment operation and troubleshooting.

Responsibilities:
Responsible for day to day organization, safety and operations of the pilot plant and associated areas in compliance with company safety, environmental and loss prevention requirements. • Responsible for housekeeping and basic maintenance of the plant and associated areas and equipment. • Responsible for compliance with company policies and procedures. • Responsible to notify the appropriate person, or take action, in case of suspected conditions that may lead to an accident, incident, equipment damage or other undesired situations. • Responsible for training other staff during pilot and scale up. • Responsible for coordinating pilot plant activities with Project Leader, Foremen and Operators ensuring safe and effective shift transfer and operations. • Responsible for providing feedback to Product Leader during pre and post pilot meetings and during pilot and production operations. Authorities: • Stop a production or pilot process. • Activate deviation and management of change systems for pilot or production batches. Regular Duties: • Execute pilot plant and production batches. Ensure completion and maintenance of batch records, equipment cleaning and status logs, deviations, temperature charts and other required documentation. • Participate in and facilitate training (safety, process and other), HAZOP, Incident review, technical teams and meetings as requested. Participate in Pre and Post pilot meetings. Prepare reports as assigned. • Coordinate with warehouse, QC, R&D, EH&S, Maintenance and other departments thus ensuring unnecessary delays or unsafe conditions. • Identify areas for improvement and recommend optimal operating and cleaning procedures when developing pilot plant and scale-up procedures. • Participate in and observe laboratory experiments for process improvements or new products. • Complete duties as Production Operator when there are no pilot activities.
 
PCI Synthesis offers a competitive compensation and benefits package that includes medical, dental, disability and life insurances, paid vacation and stock options. If you are ready to join an expanding organization in the rapidly growing life sciences industry and you possess the skills and attitude that we are looking for, please contact us.

Contact: Laurie Souliere
Office Manager
Phone: 978-463-4800