Career Opportunities

We have the following positions open:

Process Engineer/Senior Process Engineer

Requirements:

General Description: The Process Engineer is primarily responsible for developing processing instructions for plant operators (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 operators to use. Secondarily responsible for troubleshooting processing problems in the plant on batch processes being executed. Problems discovered in these processes should be corrected for future use by revising the batch records in a timely manner. Develop cost reduction options for existing processes to reduce production costs in order to improve plant performance and maintain product viability. The process engineer should also be able to carry out projects in the plant with maintenance and contract personnel. This includes specifying equipment, piping, and controls and developing plans to install, startup, and operate the equipment. Skills/Experience Needed: o BS in Chemical Engineering or related discipline with 3-5 years experience in a batch fine chemical manufacturing environment. o •Advanced computer skills. o •Excellent communication skills. o •Strong knowledge of process equipment and scale up. o •Organized and action driven project leadership skills. o •Process control, OSHA, and change control management. Personal Characteristics: o •Self starter who is capable of working independently. o •Task oriented and able to prioritize multiple objectives. o •Ability to communicate in a clear, concise manner with all levels of personnel. o •Quality and customer service oriented. o •Safety conscious. Process Engineer Metrics: o •Deviation count on batch records. o •Cost reduction for existing processes o •On time and on budget

Responsibilities:

o Prepare batch records in a timely fashion. o Schedule batch record review meetings. o Train operators on new batch records. o Check for major processing problems with batches. o Develop corrective measures for the problems. o Develop cost reduction options for existing processes. o Develop process equipment changes for plant equipment. o Design, plan, and coordinate execution of those plans. o Develop startup plans for new equipment, write Standard Operating Procedures (SOP), and train personnel. o Document Process summary, investigations, and corrective actions. o Facilitate Failure Mode Effects Analysis (FMEA), product improvement, and investigation teams. o Coordinate, communicate, and follow through on production plans. o Ability to efficiently use computer software (Macola, Word, Excel, Visio, AutoCAD). o Good understanding of Chemical kinetics, thermodynamics, and scale up. o Team leadership from inception through execution of scheduling Raw materials, Batch record reviews, cGMP documentation, and Quality Control (QC) testing and release of new and commercial products. o Ability to envision system requirements rather than using just what we have. o Ability to plan, construct, startup and operate new plant equipment when needed. Secondary Functions: o Act as project manager for new product introductions o Assist in the development of SOPs and work instructions. o Act as back up to Director of Engineering when required. o Other duties as required.

Quality Assurance Specialist

Requirements:

Bachelor’s degree, or equivalent formal training and experience. Three (3) years minimum in a cGMP quality, regulatory, and / or chemical manufacturing environment, and thorough knowledge of GMP principles is required. SKILLS: Excellent written and spoken communication ability; proficient with Microsoft Office software; experience building and using databases (e.g. Microsoft Access) preferred but not critical; 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 Assurance function in full compliance with current Good Manufacturing Practices. • Demonstrated working knowledge of 21 CFR 211 and ICH Q7. • Perform routine inspection tours of the facility to ensure real-time GMP compliance. • Contribute to the company’s process deviation and excursion control program. • Review recorded deviations from approved processes and procedures, conduct appropriate investigations and assign necessary corrective or preventive actions. • Perform Final Product release, including final data and batch record review. • Contribute to the site’s document control system, using Part 11 compliant quality management software. • Contribute to change control procedures, including documentation, equipment and process changes. • Contribute to the company’s Supplier Qualification program, including documentation, correspondence and external auditing required for vendor approval and ongoing compliance. • Contribute to management of the Customer Complaint system. • Contribute to training program, including training documentation, personnel training files, and quality management software training module to ensure it is adequately maintained, effectively operated, and continually improved. • Initiate, edit and perform reviews of standard operating procedures, manufacturing batch records, cleaning records, and other corporate documentation. • Contribute to the site’s CAPA (Corrective Action / Preventative Action) program, and verify implementation of corrective actions to ensure continuous improvement. • Contribute to the internal audit program to ensure continued compliance to the Quality Program and cGMPs.

Production Operator - Newburyport (2nd Shift)

Requirements:

• High School diploma or equivalent and 5 years of related batch chemical processing experience. • Must pass annual physical requirement associated with material handling and PPE usage.

Responsibilities:

General Description: The Production Operator is responsible for assisting in the development of pilot plant and production procedures, operating pilot plant and production batches, and assisting in the Scale-up of Pilot operations. Regular Duties/Responsibilities: • Adjust controls to regulate temperature, pressure, feed and flow of liquids and gases, and times of prescribed reactions, according to knowledge of equipment and processes. • Observe safety precautions to prevent fires and explosions. • Monitor gauges, recording instruments, flow meters, or products to ensure that specified conditions are maintained. • Control and operate equipment in which chemical changes or reactions take place during processing of industrial or consumer products. • Measure, weigh, and mix chemical ingredients according to specific actions. • Inspect equipment or units to detect leaks and malfunctions, and monitor operating conditions - shutting equipment down if necessary. • Draw samples of products at specified stages so that analyses can be performed. • Record operational data such as temperatures, pressures, ingredients used, processing times, or test results. • Day to day organization, safety and operations of the manufacturing areas in compliance with company safety, environmental and loss prevention requirements. • Housekeeping and basic maintenance of the plant and associated areas and equipment. • Compliance with company policies and procedures. • Notifying the appropriate person, or take action, in case of suspected conditions that may lead to an accident, incident, equipment damage or other undesired situations. • Training other staff. • Coordinate manufacturing activities with Project Leader, Supervisor and Operators ensuring safe and effective shift transfer and operations. • Providing feedback to Project Leader during pre and post pilot meetings and during pilot and production operations.

Maintenance Mechanic - Newburyport

Requirements:

Regular Duties: • Execute required and planned maintenance of manufacturing equipment, laboratory equipment, shipping equipment, and facilities needs. • Participate in and facilitate training (safety, process and other), meetings as requested. • 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. • Participate in developing and implementing equipment improvements or new products. • High School diploma or equivalent. • Must pass physical requirement associated with equipment handling, maintenance, repair and PPE usage. • Thorough understanding of equipment operation and troubleshooting and diagnosing problems. • Good housekeeping practices.

Responsibilities:

The Maintenance Mechanic is responsible for assisting manufacturing in its day to day ability to maintain a full and functional production schedule. • Responsible for the mechanical requirements, safety and operations of the plant and associated areas in compliance with company safety, environmental and loss prevention requirements. • Responsible for performing Preventative Maintenance on plant and production equipment. • Responsible for performing basic and or major maintenance of the plant equipment/buildings and associated areas. • 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 assisting in training new staff on various pieces of equipment and duties. • Responsible for coordinating maintenance work activities with Lead Operator and Operators ensuring a safe and effective manufacturing operation. • Responsible for providing feedback to Maintenance Manager and or Lead Mechanic during maintenance operations.

Facility Manager - Devens

Requirements:

o Construction trades/Maintenance experience desirable o Warehousing/Inventory/Ordering experience desirable o Shipping and Receiving experience desirable o High School education

Responsibilities:

o Maintain the facility infrastructure including routine cleaning and minor remodeling. o Participate in planning infrastructure improvements to be completed by either this position and/or maintenance contractors, and oversee scheduling thru implementation. o Maintain a clean, safe and orderly warehouse for maximum efficiency and utilization based on product placement. o Shipping: packaging, labeling and shipping of all goods to customers including the shipment of hazardous waste (mandated training will be provided). o Receiving: work with other departments to account for all ordered and received materials. o Monitor and maintain certain inventory items. o Supply chemicals for R&D and QC upon request. o Stage material for production as required and return unused materials. o Follow procedures as outlined in PCI’s Standard Operating Procedure manual. o Initiate changes to procedures as dictated by change/improvements. o Special assignments as required.

Vice President/Director of Business Development

Requirements:

This position, reporting directly to the CEO, requires a results-oriented individual who will focus on the tremendous opportunities in the emerging and specialty pharmaceutical industry. The right candidate will be a highly talented, motivated, professional person to manage our customer relationships and get through to the “C” level decision makers selling to small, middle market and large clients. This person must possess strong consultative, proven strategic selling abilities and be able to interact with the other members of the senior team.

Responsibilities:

The role of Vice President/Director of Business Development will entail identifying, qualifying and closing new manufacturing and synthesis opportunities through extensive relationship building and also to manage and grow the existing sales team to help execute the company’s aggressive near term growth plans. The appropriate candidate should have a BS degree or higher in a technical discipline and have 7-10 years of experience in direct sales/business development in either chemical, pharmaceutical, custom manufacturing, medical device, or drug product sales. Experience in contract manufacturing for drug substance and/or drug products would be a plus.

Lab Aide - Devens & 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:

• This entry-level position is 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

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.

Process Chemist - Devens & Newburyport

Requirements:

Bachelors or Masters Degree in Chemistry with 0-5 years experience. Strong verbal and written communication skills. Experience with scale up and cGMP manufacturing a plus.

Responsibilities:

The successful candidate 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. • Highly productive, results-oriented individual, who will generate and implement original ideas and solutions that contribute to improvements in processes used to synthesize valuable compounds • Support drug substance process development via laboratory development, kilo lab scale-up. Prepare and characterize molecules using appropriate analytical tools including IR, NMR, MS, GC, and HPLC. • Develop, troubleshoot, and optimize multi-step chemical syntheses at the bench and kilo-lab scales. • Transfer procedures to kilo labs or pilot plants for GMP and non-GMP manufacture. • Contribute to the writing of documentation as assigned. • Maintain lab equipment and laboratory instrumentation.

Life Sciences Sales Executive

Requirements:

Approximately six years of experience and travel to 35% required. Also, previous earnings of at least 100K+ required.

Responsibilities:

You must have prior success selling high-end custom engineered services to senior technical or scientific managers of both emerging and global companies in a long sales cycle against designed in competitors. You excel at finding and closing new business and developing advisor based relationships in a marketplace resistant to change. You are goal driven, entrepreneurial, thrive in a multi-functional team environment and excel at insuring the success of complex projects. You must be excited with being a part of the value creation stage in successful start-up. Travel to 35% required. Experience with medical devices, biotech, life sciences, pharmaceuticals, chemical sales, process-engineering, technical and strategic sourcing and or drug compound sales helpful.

Vice President/Director of Analytical Services - Newburyport & Devens

Requirements:

This position, reporting directly to the CEO, requires a well organized, results-oriented individual who will focus on the all of the companies analytical testing (raw material, in-process, and final product), as well as methods development and validation activities. The right candidate will be a knowledgeable and motivated professional with the experience and capability to actively recruit, train, manage and grow the companies analytical capabilities to match the companies overall growth. The chosen candidate will direct QC and Methods Development at two sites - Newburyport and Devens, MA. This person must possess a strong analytical chemistry background as well as strong communication skills with the ability to interact at a high level with both the company’s customers as well as the appropriate regulatory agencies when required. This individual must be able to interact and contribute along with the other members of the senior team.

Responsibilities:

The role of Vice President/Director of Analytical Services will require an innovative individual who is willing to promote and/or lead the organization to develop new analytical techniques and introduce instrumentation as required. The appropriate candidate should have a Ph.D degree or equivalent in a technical discipline and have a minimum of 10 years of experience in analytical methods development or Quality Control. Experience in a cGMP environment in the pharmaceutical, custom chemical manufacturing, medical device, or drug product industries is required.

Environmental Health and Safety Manager

Requirements:

A bachelor's degree and 5-7 years of experience.

Responsibilities:

o Manage PCI regulatory training requirements as defined by OSHA and the EPA. o Train PCI employees in all applicable EH&S related standards and regulations. o Oversee process implementation to ensure compliance with all applicable state and federal guidelines and standards. o Managing environmental processes to assure proper waste management and minimization practices in accordance with RCRA and TSCA regulatory requirements. o Managing environmental processes to assure proper surface and ground water management (i.e. permitting, treatment, etc) and spill and contingency planning are in compliance with Clean Water Act regulatory requirements. o Managing environmental processes to assure permitted facilities under the Clean Air Act operate in compliance with regulatory requirements. o Monitoring developing environmental federal, state, and local regulatory requirements and risk initiatives; analyze potential impacts on system operations; provide operations and upper management with information as appropriate. o Ensuring timely environmental technical support. This support will be provided in the areas of regulatory compliance, compliance reporting, testing, EHS data management, enforcement action response, and regulatory agency mediation. o Coordination and engagement of environmental personnel and other personnel in the identification, development and implementation of EHS goals which will positively impact and add value to the organization.

Quality Control Analytical Chemist - Newburyport

Requirements:

• BA/BS in Chemistry or related discipline plus 4-6 years experience, or comparable educational and professional experience. • Excellent verbal and written communication skills are essential. • Previous experience in a current Good Manufacturing Practices (cGMP) laboratory or manufacturing environment required. • Thorough understanding of the techniques listed above is essential to accurately assess the validity of the data generated.

Responsibilities:

Responsibilities: This analyst is responsible for providing accurate and timely results for the samples submitted for analysis to support our manufacturing and research and development departments, using liquid chromatography, gas chromatography, ultra violet spectroscopy, infrared spectroscopy, titrimetry, and other techniques to assess the quality of samples. The resulting data is calculated and interpreted by the analyst and submitted for review. It is expected that the analyst will be able to assist in troubleshooting equipment and method issues. The analyst is also responsible for ensuring that the instruments used for analysis are calibrated to industry standards. Other Duties: In addition to the above, other duties include but are not limited to: • writing operating procedures for the laboratory. • maintaining the chemical inventory. • maintenance of the reference standard program. • performing secondary data review for analyses conducted by other analysts. • ensuring appropriate levels of laboratory supplies.

Maintenance Manager

Requirements:

General Description: Maintenance manager is responsible for managing all maintenance activities for production and the facility. This responsibility includes directing the work force to facilitate production requirements and insuring that materials and or parts required to perform the tasks are available to the mechanics to insure a smooth, continuous production. The Maintenance Manager is responsible for maintaining the integrity of the Preventative Maintenance (PM), Process Safety Management (PSM), and calibration program by scheduling and planning work for the on site mechanics and all contracted maintenance contractors. Additionally, the maintenance manager assures the work force operate in compliance with cGMP, PSM, and OSHA regulations and requirements. • Minimum of five to seven years in applicable industrial setting with a BS degree in engineering or minimum of 10 years experience. • Must be hands on and familiar with rotating mechanical equipment including: HVAC, chillers, cooling towers, PM program, vacuum pumps, glass lined equipment, single and double mechanical seals, Agitator repair, general maintenance and scheduling.

Responsibilities:

• Plan and schedule all major maintenance activities for the facility to insure a fluid completion of the project and keep production operations on schedule. • Maintain a full and comprehensive PM program. • Schedule and maintain an accurate and ongoing calibration program. • Research parts, contact vendors, and order parts necessary to keep the facility in a cost efficient operational mode at all times. • Supervise maintenance activity to meet schedule requirements. • Assist mechanics with maintenance tasks as required. • Monitor activity to insure safe, healthful and environmentally sound work practices. • Supervise maintenance tasks to insure compliance to cGMP practices. • Document Environmental Health and Safety (EHS), Quality, and Maintenance related data as required by company policy. • Head up training program for all maintenance personnel. • Communicate and facilitate company human resource policies. • Set and track direct reports measurables. Primary Duties: (D) = Daily (W) = Weekly (P) = Periodically • Review and assess daily PM sheets to identify required tasks. (D) • Assign required tasks to maintenance mechanics. (D) • Monitor maintenance activity to insure that daily operating goals are met. (D) • Supervise daily maintenance activity to insure that tasks are carried out in a safe, healthful and environmentally compliant manner. (D) • Assess equipment needs to insure production availability. (D) • Interface with Manufacturing, Quality Control, EH&S, R&D, and office personnel to communicate maintenance priorities and scheduling. (D) • Monitor assigned areas to insure that housekeeping standards are maintained. (D) • Complete all required equipment and personnel paperwork and maintain a filing system. (D) • Report all employee absences. (D) • Train new employees. (P) Secondary Duties: • Complete required performance review forms. • Dispense all disciplinary actions as required.

Quality Control Supervisor (2nd Shift)

Requirements:

Requirements: Minimum of a Bachelor’s degree in chemistry or related field, plus previous experience supervising employees in a current Good Manufacturing Practices (cGMP) quality control or analytical laboratory with thorough knowledge of GMP principles and analytical Chemistry. : Technical proficiency with analytical equipment and analyses. Excellent written, verbal and interpersonal skills; strong ability to prioritize in a dynamic environment; proficient with Microsoft Office; self motivated and able to work independently when necessary; set goals, organize and follow project plans; detail oriented and willing to follow through on all aspects of a task required for successful, timely completion.

Responsibilities:

• Proactively perform Quality Control (QC) function in full compliance with cGMP. • Interface with manufacturing personnel and QC manager to schedule work for the shift and supervise QC Analysts. • Oversee and lend support to laboratory personnel in testing raw materials, in-process samples, finished product, and stability samples. • Support the company’s stability study and method transfer/validation programs. • Review and approve analytical data. Maintain electronic database on batch and raw material data. • Conduct Out Of Specification (OOS) investigations. • Assist with the transfer of validated methods from Method Development to Quality Control. • Conduct hands-on-training for all QC chemists and technicians. • Maintain the laboratory in compliance with the company’s cGMP and Environmental Health and Safety (EH&S) procedures.

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.