Career Opportunities

We have the following positions open:

Quality Control Supervisor - Newburyport

Requirements:

Minimum of a Bachelor’s degree. Five (5) years minimum supervising a cGMP quality control or analytical laboratory, and thorough knowledge of GMP principles is required. Excellent written and verbal communication skills; strong ability to prioritize in a dynamic environment; proficient with Microsoft Office software; self motivated and able to work independently when necessary, set goals, organize and follow project plans; thorough, detail oriented and willing to follow through on all aspects of a task required for successful completion.

Responsibilities:

• Proactively perform Quality Control function in full compliance with current Good Manufacturing Practices. • Schedules work flow and supervise QC analysts. • Oversee and lend support to laboratory personnel in testing Raw materials, In-Process samples, Finished product, and Stability samples. • Setup and maintain Statistical Process Control (SPC) system in the QC Laboratory. • Maintain electronic data base and perform trend analysis on batch and raw material data. • Participate as an active member on the various cross functional improvement teams. • Review and approve analytical method: development reports, validation protocols and validation reports. • Conduct Lab Out Of Specification (OOS) investigations. • Transfer of validated methods from method development to quality control. • Improve existing standards/specifications by recommending changes to Director. • Conduct hands-on-training for all QC Chemists and Technicians. • Maintain the laboratory in compliance with the company’s cGMP and EH&S procedures.

Research Scientist/Senior Research Scientist - Devens

Requirements:

• A Ph.D in Organic Chemistry. • 0-7 years experience, preferably in Process R&D, with scale up experience in pharmaceutical, fine or specialty chemicals. • Demonstrated success in finding and developing efficient chemical syntheses of complex organic targets. • Experience demonstrating effective mentoring and career development of scientific staff. Skills in performance management of scientists through goal setting, feedback and coaching. • Demonstrated ability to commit to and manage aggressive timelines and deliver on time. • Excellent written and verbal communication skills.

Responsibilities:

• Discover, develop and execute multi-step syntheses for Active Pharmaceutical Ingredients (API) and assist in their DMF filings. • Supervise and mentor junior scientists who are carrying out the same type of work. • Actively manage chemical development work on one or more projects and represent chemical development on cross-functional teams. • Prepare process descriptions and reports for technology transfer and for the creation of regulatory documents. • Assist in development and communication of department goals and strategy.

Laboratory Technician - Newburyport

Requirements:

• High School diploma or equivalent, technical coursework or experience working in a laboratory or technical setting a plus. • Must pass annual physical requirement associated with material handling and PPE usage.

Responsibilities:

• Responsible for housekeeping and basic maintenance of the lab and associated areas and equipment. • Responsible for preparation of reagent solutions, aiding scientists in the set up and execution of experiments • Responsible for tracking and maintaining an inventory of laboratory chemicals • 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. • Clean laboratory equipment and glassware using established procedures • Maintain the general appearance and cleanliness of the laboratories • Set up equipment and assist scientists executing experiments • Prepare standard reagent solutions for use by scientists • Maintain an inventory of routine laboratory chemicals and reagents, order additional items when inventory levels are low

Operations Assistant - Newburyport

Requirements:

The Operations Assistant supports production as needed to maintain production schedule. Complete other assignments/tasks as directed by management. • Outside work in adverse weather required at times. • Use of Personal Protective Equipment (PPE) as required. • Interpersonal skills necessary to listen and understand oral and written instructions. • Physical ability to stand, walk, lift and carry items weighing less than 50 pounds for 25 to 30 percent of work time. • Ability to meet deadlines. • Ability to multi-task and prioritize as needed.

Responsibilities:

• Execute and complete daily cleaning work sheet for Production. • Report and write near misses when observed. • Remove, label, and log in waste drums for Production. • Maintain logs of all work performed. • Assist Production on projects as needed. • Follow all General Manufacturing Practices (cGMP) guidelines. Salary Range: $10-$12/Hour

Maintenance Electrician / Mechanic - Newburyport

Requirements:

• High School diploma or equivalent. • Licensed electrician in Massachusetts. • Must pass physical requirement associated with equipment handling, maintenance, repair and personal protection equipment usage. • Thorough understanding of equipment operation and troubleshooting and diagnosing problems. • Reliable, prompt, and must work overtime as needed. • Ability to work well with others, good verbal and written communication skills. • Strong mechanical skills. Prior maintenance experience and/or chemical operations preferred. HVAC, welding, pipe fitting, electrical, electronic, control systems, calibrations, rebuilding equipment (i.e. pumps, vacuums, filters, glass lined parts) • Must be able to interpret and follow directions with minimal supervision, (FDA, GMP, PM). • Perform work at Devens site occasionally. • Good house keeping practices.

Responsibilities:

The Maintenance Electrician/Mechanic performs routine and preventative maintenance, ensuring that the facilities and operations are fully functional on a daily basis. • Perform routine and preventative electrical work/maintenance on facilities and production equipment. • Compliance with company policies and procedures. • Report all feedback including non-compliant activities to supervisor. • Train new staff on equipment and duties. • Coordinate electrical/maintenance work activities with operations ensuring a safe and effective manufacturing operation. • Participate in developing and implementing an electrical maintenance program. • Participate in writing electrical maintenance SOP’s. • Assist with the development of an electrical spare parts inventory and maintain inventory and area. • Run conduit, and disconnect and reconnect wiring from motors, thermocouples, and digital read outs. • Coordinate and execute required maintenance of manufacturing, laboratory, warehouse, and facility needs. • Participate in and facilitate training as required. • Identify areas for improvement and recommend optimal operating and cleaning procedures. • Participate in developing and implementing equipment improvements or new products. • Complete housekeeping duties as Maintenance when there are no mechanical activities. • Perform preventive maintenance and calibrations. • Assist with work as required by maintenance manager when needed.

Receptionist/Administrative Assistant - Devens

Requirements:

This is an entry-level position in a fast-paced, professional environment. The receptionist must be organized, flexible, team oriented and proficient in Microsoft Office and Outlook. Ability to learn programs and systems quickly is a plus, and willingness to help others is a necessity.

Responsibilities:

• Phones (answer, maintain system/tech support) • Greet visitors (provide safety policy/orientation when necessary) and facilitate connection with employee(s) • Purchasing (search for best price, create a Purchase Order request, get approval and purchase when necessary) • Maintain employee daily in/out log, extension list • Coordinate meetings (maintain conference room tidiness, order and facilitate catering when necessary, etc.) • Filing (Purchase Orders, Training Records, etc.) • Mail (distribute mail and maintain mail area) • Maintain adequate supplies for the office, kitchen and bathrooms • Meeting and travel coordination • Printer/copier issues • Support A/P – send receivers and invoices to Newburyport in a timely fashion • Send Thank You gift cards to customers • Prepare customer packets • Maintain PCI shared calendar • Uniforms/lab coats – order and maintain stock • Assist Human Resources as necessary (post notices, set-up and break down work stations for new hires/termed employees, etc.) • Other tasks to be determined

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.