DUTIES:

• Responsible for generating workbook for costing on projects, COS or new business opportunity
• Ensure completion of all quote activities including amendments for changes of scope in a timely manner
• Work with technical team to determine approach and scope of project
• Issue 3-4 new quotes of varying degree of difficulty per week independently
• Resource Load project plans for awarded business
• Client Meetings
• Provide assistance to Senior Associates, Managers and Director 
• Provide project tracking reports to Senior Management as required (Quarterly reports)
• Other related duties as required.

QUALIFICATIONS:

• Minimum Bachelor level education, B.Sc. or B. Comm.
• Minimum 3 years pharmaceutical industry experience (preferred areas include product development, project management, manufacturing, regulatory or quality assurance)
• Working knowledge of pharmaceutical drug development processes
• Excellent written and oral communication skills
• Proficiency with the English language
• Ability to prioritize multiple tasks
• Detail-oriented

• Relationship Management - Serve as the main existing-business contact and advocate for client & the main existing-business representative for Patheon. Identify and coordinate resolution of significant issues (service, financial, operations, quality, etc.) – include Business Director as appropriate. Develop action plans for each client in order to optimize client service levels and to meet internal company objectives.  Lead client operations review meetings and support business executives in business reviews.
• Financial and Forecast Management - Ensure client’s forecasts are assimilated into 3-year planning model. Assist in development of annual commercial revenue budget. Request & implement annual pricing reviews - ensure premiums captured and communicated to client. Work with finance to collect on overdue invoices, resolve root issues, and in general understand client financial processes.
• Project Management - Work closely with PDS Project Manager to complete transition of PDS projects to Commercial Operations during validation process. Assume ownership of manufacturing projects (e.g. purchasing or pricing initiatives, task forces) and follow through to completion. Participate in monthly departmental meetings and contribute to the identification and implementation of new initiatives.
• Relationship with Business and Sales Management - Identify key client contacts and events and relay to sales management. Inform, include and, if appropriate, seek the assistance of Business Director relative to the nature and resolution of any significant account issue or event described above.  Relay all new project opportunities to sales management for their follow up and implementation.

• Degree in Science, Business, or other related field.
• 5 years experience in manufacturing, client service, or related area in a pharmaceutical or food environment. 
• Minimum 2 yrs. project management experience in pharmaceutical industry.
• Demonstrated success in the management of multiple projects. 
• Strong attention to detail and organization skills.
• Superior communication and interpersonal skills, including the ability to work effectively with internal resources.
• High level of computer skills.
• Knowledge of pharmaceutical industry, regulatory environment, and operational processes an asset.

DUTIES:

• Assist / Troubleshoot problems and participate in resolution of issues as they arise on the shift
• Daily scheduling of area personnel by referring to the master production schedule
• Monitor employee performance and provide feed back to respective manager as required
• Recommend procedural changes and efficiency improvements for the area.  Continually auditing of area to ensure GMP/safety compliant
• Provide training and guidance to manufacturing staff
• Participate in the recruitment process for new manufacturing staff
• Investigate and provide information for QIR’s
• Other related duties as assigned

QUALIFICATIONS:

• Minimum B.Sc. or equivalent
• Minimum five years manufacturing experience
• Extensive knowledge of at least one functional processing area and related equipment and procedures
• Good knowledge of GMP’s and WHMIS
• Excellent communication skills as well as proven interpersonal abilities
• Proficiency using MS Office applications
• Proficiency with the English language

• Process/manufacture products in accordance with written processing orders.
• Prepare manufacturing areas and equipment for the production of pharmaceutical products.
• Clean processing equipment and rooms in accordance with written SOP’s and established GMP’s.
• Ensure product quality meets TPP and/or FDA standards.
• Follow the required safety and GMP requirements.
• Other related duties as assigned.

• High school and/or have some post secondary education
• Minimum 1 year experience in either: powder blending/granulation, tablet compression, encapsulation, tablet printing and/or coating, with exposure in the areas of dispensing, liquids/semisolids manufacturing an asset.
• Ability to lift up to 40 lbs.
• Proficiency with the English language.
• Must be able to work well with limited supervision in a team environment.
• Must be willing to work rotational shifts (including weekends and 12hrs/shift.)
• Must have good organizational and housekeeping skills.

DUTIES:         

• Participate / Lead the design/evaluation of formulations and manufacturing processes for solid, semi-solid or liquid dosage forms.
• Participate /Lead in problem solving for formulations, equipment and processes.
• Write protocols and manufacturing cards for feasibility and clinical trial materials.
• Write development reports.
• Present interpreted results and updates to Client Services, PDS, Operations, and individual clients.
• Record results in accordance with current Good Manufacturing Practices and company standard.

• Other related duties as assigned

QUALIFICATIONS:

• Minimum B.Sc.in pharmaceutical science or technology
• Minimum 1year pharmaceutical formulation/technology experience
• Demonstrable understanding of pharmaceutical formulation science
• Basic cGMP and FDA compliance knowledge
• Computer proficiency
• Good interpersonal, communication (both oral and written), and organizational skills
• Able to work independently or in team environment
• Communicates and co-operates with others to meet project and team objectives

• Proficiency with the English language

DUTIES:    

• Co-management of the Business Management department working closely with the Business Director. Includes oversight of day-to-day work and communication to clients.
• Lead the development of infrastructures in BM to ensure efficient execution of projects.
• Develop and maintain infrastructure for setting and monitoring performance objectives and career development plans for BM staff.
• Serve as the main business contact and advocate for client for a series of key site accounts. Identify and coordinate resolution of significant issues (service, financial, operations, quality, etc.) – include Business Director as appropriate. Develop action plans for each client in order to optimize client service levels and to meet internal company objectives.  Lead client operations review meetings and support business executives in business reviews.
• Other duties as assigned.

QUALIFICATIONS:   

• University Degree in Science or other related field
• 10 years pharmaceutical industry experience with working knowledge of the complete manufacturing process
• 3 years of project management experience
• 5 years contract management experience
• Excellent interpersonal and communication skills, as well as the ability to motivate and lead
• People management experience with strong leadership and conflict resolution skills (min of 1 year  managing direct reports)
• Proven client interface experience and strong negotiating skills
• Strong attention to detail and organizing skills
• Proficiency in the English Language

• Maintain working relationship and scientific dialogue with established clients and lead scientific and technical discussions with prospective clients
• Lead the management of a PDS unit including day to day work, communication, and revenue stream
• Lead the development of infrastructures in Project Management to ensure efficient execution of projects
• Develop and maintain infrastructure for setting and monitoring performance objectives and career development plans for Project Management staff
• Assign Project Managers to appropriate projects and coach where needed
• Other related duties as assigned

• 10 years of pharmaceutical industry experience
• 5 years of pharmaceutical product development or product transfer experience
• 3 years of project management experience and 5 years of contract management experience
• Minimum B.Sc. with MBA, M.Sc., or PhD preferred
• People management experience with strong leadership and conflict resolution skills
• Well organized and detail oriented with the ability to prioritize multiple tasks across a portfolio of projects
• Excellent interpersonal and communication skills and the ability to motivate and lead a unit
• Proven client interface experience and strong negotiating skills
• Proficiency with the English language

DUTIES:       

• To participate in the development of analytical procedures in support of client pharmaceutical product development projects
• To conduct preformulation studies in order to provide data on APIs that will lead to development of suitable pharmaceutical products
• To take particular responsibility for the development of new methods or for conducting novel analytical studies or investigations
• To ensure that validation studies, analyses of experimental samples, GMP batches and stability samples are conducted strictly in accordance with cGMP  and Patheon SOPs, protocols and CTMLPs
• To participate in the training and supervision of junior chemists within the Group
• To ensure that all AD laboratory documentation is completed to the highest quality standards and that any  formal investigations e.g. Out of Specification (OOS) or Quality Incident Reports (QIR)/ Quality Deviation Reports (QDR) are conducted promptly and thoroughly
• To assist Supervisor to convey results of analytical studies and participate in project discussions with colleagues within other Departments within PDS and during teleconferences with clients
• To help Supervisor to manage the schedules for each chemist in the Group to ensure that studies are completed in accordance with project timelines and client expectations
• To help Supervisor to make recommendations to Manager for additional personnel and equipment resources that might be needed to meet our project commitments
• To keep up to date with advances in analytical, pharmaceutical and regulatory developments and to help Supervisor make recommendations to Manager for any new types of Analytical Technology that should be considered within AD
• Other duties as assigned

QUALIFICATIONS:

• Ph.D. or M.Sc. in a science related to Pharmaceutical Analysis and at least 2 years of pharmaceutical analytical development experience, or B.Sc. in a science related to Pharmaceutical Analysis and at least 5 years of pharmaceutical analytical development experience may also be considered for exceptional candidates under some circumstances
• Good understanding of analytical method validation requirements of pharmaceutical industry
• good understanding of the chemistry of pharmaceutical APIs and of analytical techniques for their characterization
• Candidates must have a good theoretical knowledge of chromatographic sciences and in addition an understanding of spectroscopic technologies e.g. UV, IR, MS, NMR, XRD
• Very positive interests in keeping up to date with new technologies and developments in analytical sciences
• Good understanding of cGMP,  ICH and FDA requirements
• Excellent written and oral communication skills
• Proficient use of English language
• Works well independently, and in team environment

Lead the design/evaluation of formulations and manufacturing processes for solid, semi-solid or liquid dosage forms.

Lead development of new formulations and scale-up procedures of solid, semi-solid or liquid dosage forms at the pre-clinical, clinical and post marketing stages of drug development.

Manage resources in their PPT work group to achieve project and team objectives.

Lead/participate in problem solving for formulations, equipment and processes.

Develop realistic proposals and timelines,  Write development reports.

Write protocols for feasibility work and manufacturing batch records and clinical trial materials. 

Write and ensure timely execution of protocols and provision of results in accordance with cGMP and company standards.

Coach people in their work group in e.g. drug development process, PDS systems

Liaise with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development and other functional areas to meet project and team objectives

Participate in relevant meetings/teleconferences with clients; may involve travel to client sites.

Maintain expert knowledge of pharmaceutical processes, equipment, instrumentation and procedures necessary to perform the tasks. Keep current with scientific literature and industry trends relating to process technologies; disseminate relevant information.  Key technical leadership role in CEI; look for opportunities for publication/external presentations

Other related duties as assigned

SKILLS/EXPERIENCE REQUIRED:

Minimum B.Sc. in pharmaceutical science or technology, M.Sc. or Ph.D. preferred

Minimum 4 years of experience in drug development.

Extensive knowledge and understanding of the drug development process.

Demonstrable organizational skills relevant to drug development.

Excellent written and oral communication skills, Computer literate.

Established leadership and organizational skills.

Experience in technical/scientific discussions with clients.

Established quality, regulatory, and production mindset including an appreciation for client service and the contract manufacturing industry.

Works independently with minimal need for intervention by more senior management.

Able to execute own work which is typically planned by others.

Proficiency with the English language.

• Perform formulation, scale up, and other manufacturing related assignments and document them appropriately.
• Participate in the maintenance of manufacturing and laboratory instruments and equipment.
• Participate in training of equipments.
• Participate in inter departmental coordination for documentation and equipment related tasks.
• Other related duties as assigned

• Minimum B.Sc. in Pharmaceutics, Engineering, or Chemistry.
• Minimum 1year pharmaceutical formulation experience or pharmaceutical manufacturing experience.
• Basic understanding of formulations and processes.
• Knowledge and familiarity with cGMP guidelines.
• Computer proficient.
• Excellent written and oral communication skills.
• Proficiency with the English language.
• Able to execute own work which is typically planned by others.