Technical Project Leader II - PPT

pbuJob Description/u/b/pp/pdivdivpbspanSummary:/spanspan /span/bspan /span/p/divdivpspanspanLead the design and evaluation of formulations and manufacturing processes as well as problem solves for solid, semi-solid or liquid dosage forms. Engage in the management of clientele, processes and equipment design for clinical, scale up and registration batches including tech transfer of projects to and from clients. Manage resources in the Pharmaceutics and Process Technology (PPT) work group to achieve project and team objectives and coach/spanspan associates/spanspan in their work group in areas such as the drug development process and Pharmaceutical Development Services (PDS) systems. Liaise with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development and other functional areas to meet project and team objectives./span/spanspan /span/p/divdivpspan /span/p/divdivpbspanEssential Functions:/spanspan /span/bspan /span/p/divdivullipspanspanLead the design/evaluation of formulations and manufacturing processes for solid, semi-solid, or liquid dosage forms. /span/spanspan /span/p/lilipspanspanLead 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. /span/spanspan /span/p/lilipspanspanManage resources in their PPT work group to achieve project and team objectives./span/spanspan /span/p/lilipspanspanLead/participate in problem solving for formulations, equipment and processes. /span/spanspan /span/p/lilipspanspanParticipate in relevant meetings/teleconferences with clients. /span/spanspan /span/p/lilipspanspanWrite protocols for feasibility work and manufacturing batch records and clinical trial materials. /span/spanspan /span/p/li/ul/divdivpspanspanWrite and ensure timely execution of protocols and provision of results in accordance with current Good Manufacturing Practices and company standards. /span/spanspan /span/p/divdivullipspanspanWrite development reports./span/spanspan /span/p/lilipspanspanDevelop realistic proposals and timelines./span/spanspan /span/p/li/ul/div/divdivdivullipspanspanCoach /spanspanassociates/spanspan in their work group in areas such as the drug development process and PDS systems./span/spanspan /span/p/lilipspanspanLiaise with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development and other functional areas to meet project and team objectives. /span/spanspan /span/p/lilipspanspanMaintain expert knowledge of pharmaceutical processes, equipment, instrumentation and procedures necessary to perform the tasks. /span/spanspan /span/p/lilipspanspanKeep current with scientific literature and industry trends relating to process technologies; disseminate relevant information. /span/spanspan /span/p/lilipspanspanAs the key technical leadership role in /spanspanCentre/spanspan of Excellence Initiative; look for opportunities for publication/external presentations. /span/spanspan /span/p/lilipspanspanPromote a safe working environment, report potential hazards and ensure all direct reports follow Environmental Health and Safety procedures./span/spanspan /span/p/lilipspanspanSelect, develop (goal setting/spanspan)/spanspan and evaluate staff to ensure the efficient operation of the function. Work with and /spanspanadvises/spanspan staff on administrative policies and procedures (if applicable)./span/spanspan /span/p/lilipspanspanP/spanspanerform alternating or rotating shift work (as /spanspanrequired/spanspan)./span/spanspan /span/p/li/ul/divdivpspan /span/p/divdivpbspanREQUIRED QUALIFICATIONS/span/bspan /span/p/divdivpspan /span/p/divdivpbspanEducation:/spanspan /span/bspan /span/p/divdivpspanspanBachelor of Science (B.Sc.) in pharmaceutical science or technology./span/spanspan /span/p/divdivpspanspan /span/spanbr /bspanExperience:/spanspan /span/bspan /span/p/divdivpspanspanMinimum /spanspan6/spanspan years of experience drug development./span/spanspan /span/p/divdivpspanspanPrevious Project Management experience./span/spanspan /span/p/divdivpspanspanPrevious Supervision and/or leadership experience an asset./span/spanspan /span/p/divdivpspanspan /span/spanbr /bspanEquivalency/span/bispan:/spanspan /span/ispan /span/p/divdivpspanspanEquivalent combinations of education, training, and relevant work experience may be considered. /span/spanspan /span/p/divdivpspan /span/p/div/divdivpspan /span/p/divdivpbspanKnowledge, /spanspanSkills/spanspan and Abilities:/span/bspan /span/p/divdivpspanspanExtensive knowledge and understanding of the drug development process/spanspan. /spanspanDemonstrated understanding of equipment, /spanspanformulations/spanspan and processes/spanspan. /spanspanExcellent Good Manufacturing Practices, /spanspanStandard Operating Procedures/spanspan and Food and Drug Administration (FDA) compliance knowledge. /spanspanEstablished leadership skill/spanspans/spanspan. /spanspan /spanspanDemonstrable organizational skills relevant to drug development/spanspan. /spanspanExcellent written and oral communication skills. /spanspanAbility to communicate and liaise with client/spanspans/spanspan and other departments/spanspan. /spanspanGood organizational, documentation and housekeeping skills/spanspan. /spanspanAbility to work well independently /spanspanand in a team environment with limited supervision/spanspan. /spanspanExcellent written and oral communication skills/spanspan. /spanspanCommunicates and co-operates with others to meet project and team /spanspanobjectives/spanspan./spanspan Ability to meet deadlines and prioritize multiple project deliverables/spanspan. /spanspanThe ability to motivate and influence/spanspan. /spanspan /spanspanDemonstrated computer /spanspanproficiency/spanspan with Microsoft Office programs. /spanspanProficiency/spanspan with the English language/spanspan. /span/spanspan /span/p/divdivpspan /span/p/divdivpbspanStandards and Expectations: /span/bspanspan /span/spanspan /span/p/divdivpspanspanFollow all Environmental Health Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field. /spanspan /span/spanspan /span/p/divdivpspan /span/p/divdivpbspanPhysical Requirements: /span/bspan /span/p/divdivpspanspanLight physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights./spanspan /spanspanUse of Personal Protective equipment may be required and may include any of the following: s/spanspanafety glasses, safety shoes, lab coat, gloves, /spanspanhair net, beard cover, /spanspansafety apron, respirator/spanspan on occasionally/spanspan./span/spanspan /span/p/div