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Scientist, MTS

Date: Nov 5, 2020

Location: Miramar, FL, US, 33025

Company: Apotex

 

Aveva Drug Delivery Systems is a global leader offering a full range of research, development, and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage, and compliance rates for patients.

 

Job Summary

The Scientist applies expert knowledge across the portfolio of projects to ensure root causes of failures are identified: recommends resolution helps to solicit critical technical information from external sources and provides key inputs into Apotex Knowledge Management.Develops knowledge and risk-based approaches including QbD, state-of-the art process understanding and Process Analytical Technology and sets standards for technical product lifecycle management.  Responsible for expanding and continuously updating a scientific knowledge base on process understanding within Mfg Technical Services.Scientist, MTS serves as a technical expert role within the Mfg Technical Services department and provides scientific advice, guidance, training and coaching to Mfg Technical Services personnel limited to their expertise.Supports bio-studies, reformulations, remediation, investigations, response to regulatory quarries from agencies and any other relevant aspect of advancing product robustness and quality.Provides guidance to departments interfacing with Mfg Technical Services as a Subject Matter Expert (SME). Activities such as quality investigations, CAPAs, APRs, IRCs, DLs are mainly the Senior Scientist responsibility and will be jointly dealt with the Mfg Technical Services Leadership Team.
 

Job Responsibilities

1.Acts as a resource to the Mfg Technical Services department.
2.Serves as a scientific technical expert role within the department.
3.In conjunction with TO Directors, Associate Directors, Managers and PV Supervisors, liaises across the organization to determine current and long-term needs.
4.Investigates formulation and process deficiencies for current products being manufactured to determine the causes and to recommend and implement solutions for improvement to the Scientific Leaders.
5.Develops, recommends and provides scientific technical support to experimental trials to evaluate changes in formulations, raw materials, and manufacturing processes.
6.Writes investigational reports, project summaries, project updates, and provides recommendations as required.
7.Evaluates data (e.g. Dissolution, assay, and content uniformity) on trials, and makes recommendations for stability batches, reprocessing, rework and batch failures as required.
8.Possesses a working knowledge of the equipment used in the manufacturing processes.
9.Designs trials to develop robust manufacturing processes, and to reprocess or rework batch failures.
10.Responsible for investigation and root cause determination of Apotex Quality Reporting System, CAPA and review of draft Master Formulae issued by Mfg Technical Services. 
11.Applies strong analytical and proactive problem-solving skills and involves others in the process.
12.Uses problem-solving techniques to assess equipment and processes for optimal use, and to arrive at best practices for projects under development.
13.Supports and advises department leadership on quality investigations, CAPAs, APRs, IRCs, DLs.
14.Responsible and accountable for compliance with all aspects of the Ontario Occupational Health and Safety Act, as well as Apotex’s Health and Safety policies, Safe Work Procedures (SWPs), and Safety Charter.
15.Works in a safe manner collaborating as a team member to achieve all outcomes.
16.Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
17.Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. 
18.Performs all work in accordance with all established regulatory and compliance and safety requirements.
19.All other duties as assigned.

Job Requirements

•Education
oUniversity degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering or related science
•Knowledge, Skills and Abilities
oStrong knowledge and experience in pharmaceutical processes & equipment
oStrong verbal and written English communication skills
oExcellent organization, troubleshooting and report writing skills
oComputer literacy skills in Microsoft Office (Word, Excel, PowerPoint and Outlook)
oWell-developed interpersonal and team skills  
oMulti-tasking and project management skills
oAbility to work independently 
oCapable of issuing and investigating of Quality Notifications and CCFs in SAP (Master Formulae, SAP Recipes and Certificates of Analyses)
oThorough understanding and knowledge of cGMPs, GLP, SODs, SWPs, USP, BP, EP SUPAC, FDA and HPFBI.
•Experience
oMinimum of 5 years of working experience in the pharmaceutical industry with related experience in formulations, development of solid dosage forms, scale up and technology transfer
 

At Aveva Drug Delivery Systems, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Aveva Drug Delivery Systems offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami