Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Primary function is to perform chemical and physical testing of pharmaceutical starting materials, components and finished products to client supplied and Pharmacopoeial methodology in accordance with regulatory standards with a high level of accuracy and minimal personal error.

The ability to successfully interpret and execute technically challenging methodology. Testing is performed using techniques such as FTIR, UV, Karl Fisher, HPLC, GC, TOC and Dissolution with calibration, maintenance and troubleshooting of this equipment.

Perform method development, validation and method transfers including authoring protocols and final reports. Training of analysts in techniques for which competency has been demonstrated. Authoring on-time investigations, OOS investigations and determination of root cause, including working with internal and external customers to resolve issues.

Development and implementation of corrective and preventative actions. Review and approval of technical data. Introduction of new equipment, including authoring and executing URS/IQ/OQ/PQ documentation. Write, review, and revise work practices, and test methods.

Project management. Generation of quotations for projects in area of technical expertise. Co-ordinate and schedule service engineers to ensure that equipment down time is kept to a minimal. Assist/lead customer audits. Maintain metrics with respect to area of responsibility.

Maintain and administer the stability database, including the set down and removal of samples at pre-determined timeframes. Drive on time completion of testing and data correction activities of all personnel performing testing in area of responsibility.

Allocation of testing to subordinates including collaboration with other department supervisors to ensure on time testing for other services. This role has supervisory responsibilities.

Essential Duties and Responsibilities:

• Receipt and logging of samples into LIMS including setting up new product/test and specifications

• Works in an efficient manner to a high level of accuracy with minimal personal error in: Manual/automated titrations, UV, FTIR, Karl Fisher, Water activity, Incoming component testing, Pharmacopoeial testing i.e. LOD, RI, ID, Limit tests, Water testing, HPLC, Dissolution, GC, TOC, Cleaning verification, Method transfer and Method development and validation.

• Generation and documentation of raw data in accordance with ALCOA principles Ability to interpret different customer method requirements without supervision High level of competency in technically challenging methodology Knowledge of ICH Guidelines which pertain to services trained in

• Knowledge of USP general chapters which pertain to techniques trained in Training of other analysts in techniques for which expertise has been demonstrated Participate in Product OOS investigations and assist in the determination of root cause Write calibration OOS investigations including RIT's and potential product impact assessments

• Develop and implementation of corrective and preventative actions Write and investigate deviations from defined procedures

• Work with internal and external customers to resolve issues associated with deviations and out of specification results.

• On time investigations including raising extensions prior to the due date if required Attendance at huddles including leading on a rotating basis On time completion of assigned training in ComplianceWire

• Participate in internal Health and Safety audits including developing actions and follow up Participates in internal and regulatory audits Participate in customer audits by assisting/leading the tour and answering questions

• Prepares, discuss and present analytical data to internal and external customers and auditors Retains product on completion of testing and raw data upon issuance of analytical report/certificate of analysis

• Maintains a high level of good housekeeping including ensuring that all glassware is disposed of and cleaned in a timely manner once analysis is complete and checked for compliance to specification

• Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence Ensure that all waste materials/solvents are disposed of in a safe and timely manner.

• Equipment calibration, maintenance and troubleshooting Develop Excel and Chromeleon templates and spreadsheets for validation to reduce manual activities Data review Gathering of data for use in APR's and authoring of APR's for various customers.

• Authors method transfer and validation protocols and reports Initiate change controls Participate in the introduction of new equipment, including authoring and executing URS/IQ/OQ/PQ documentation Write/Revise WP's/Test Methods Mentoring/coaching Provide technical advice to internal and external customers Review of customer updated methods and the initiation of any transfer/validation activities in accordance with defined procedures

• Project management Generate quotations for projects in area of technical expertise Submit change request in Pilgrim and route in Pilgrim.

• Hosting and attendance at weekly project management calls with PCI customers. Co-ordinate and schedule service engineers to ensure that equipment down time is kept to a minimal Generation and review of stability protocols Maintain and administer the stability database, including the set down and removal of samples at pre-determined timeframes

• Drive on time completion of testing and data correction activities of all personnel performing testing in area of responsibility

• Maintain metrics with respect to area of responsibility Collaborate with other department supervisors to ensure on time testing for other services Maintain stability storage areas

• Recruitment and selection of personnel Approval of time off requests in line with company policy ensuring that adequate cover is available to maintain service levels Development and recognition of direct reports Holds direct reports accountable for performance and behavior, administering disciplinary action per company policies where required

• Assess change controls for lab impact and sign in the absence of the Lab Management.

• Monthly invoicing in the absence of the Lab Management. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.

Special Demands:

• Stationary Position: Under a 1/4 of the day.

• Move, Traverse: From 1/2 to 3/4 of the day.

• Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day.

• Install, place, adjust, apply, measure, use, or signal: From 1/2 to 3/4 of the day.

• Ascend/Descend or Work Atop: Up to 1/4 of the day.

• Position self (to) or Move (about or to): From 1/2 to 3/4 of the day.

• Communicate or exchange information: 3/4 of the day and up.

• Detect, distinguish, or determine: 3/4 of the day and up.

On an average day, the individual can expect to move and/or transport up to 25 pounds

between 1/4 and 1/2 of the day.

This position may have the following special vision requirements.

• Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception

• Ability to focus No Special Vision Requirements

Work Environment:

• PAPR Gowning may be required for to of the day dependent on the nature of some compounds.

• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 3/4 of the day and up.

• Fumes or airborne particles for 1/4 to 1/2 of the day.

• Toxic or caustic chemicals for 1/4 to 1/2 of the day.

• Work near moving mechanical parts for up to 1/4 of the day.

• The noise level in the work environment is typically, moderate.

Qualifications:

Required:

• Bachelor's Degree in a related field and/or 4-6 years related experience and/or training.

• Statistical and Advanced Mathematical Skills

• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

• High standard of report writing.

Preferred:

• Ability to display a willingness to make decisions.

• Ability to effectively present information to various people as the job requires.

• Ability to identify and resolve problems in a timely manner.

• Ability to adapt to changing work environments.

• Ability to set and achieve challenging goals.

• Ability to how success in managing employees

• Ability to exhibit sound and accurate judgement

• Ability to take ownership of issues and works towards resolution

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.