Scientist, Manufacturing Technical Support

Date: Apr 30, 2019

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

Under minimal supervision, support existing commercial products by leading continuous process improvement, qualifying alternate APIs, alternate adhesives, alternate pouches, etc., supports regulatory submission activities, preparing and executing cleaning validation protocols as necessary in  support of on-going commercial production activities, serving as investigation team leader into process failures and discrepancies to assess impact upon product quality and validation status (CCR, Deviation, CAPAs), assisting in equipment selection, process start-up, troubleshooting, etc. Lead new product launches by preparing and executing process validation protocols for new products.

Job Responsibilities

  • Carries out responsibilities in accordance with Aveva and Apotex policies, procedures, and safety rules in accordance with local, state and federal laws.
  • Lead continuous process improvement, qualification of alternate APIs, alternate adhesives, alternate pouches, etc.
  • Supports regulatory submission activities.
  • Prepares and executes cleaning validation protocols as necessary to support on-going commercial production activities.
  • Leads new product launches by preparing and executing process validation protocols.
  • Interfaces with Quality Assurance, Production, Engineering and Transdermal Research and Development departments on process requirements for new and current products.
  • Troubleshoots process problems and assists in process optimization.
  • Serves as an investigation team leader into process failures and discrepancies to assess impact upon product quality and validation status.
  • Recommends improvements in manufacturing and control systems including corrective and preventative actions (CAPA).
  • Writes and executes evaluation protocols for all processing steps.
  • Oversees and coordinates experimental manufacturing events.
  • Analyzes and interprets protocols and experimental data to establish process specifications.
  • Develops and updates FMEAs associated with Production Process.
  • Assists during pre-approval and client audits.
  • Interfaces with other departments and outside vendors to set specifications for raw materials and final products.
  • Assists manufacturing in scale-up and manufacturing processes such as equipment selection, process start-up, troubleshooting, etc.
  • Prepares protocol documents and maintains documentation of activities and findings.
  • Analyzes data to determine if it meets protocol acceptance criteria. Writes deviation reports as required upon failures to meet acceptance criteria.
  • Writes final reports and assures they are approved through proper channels.
  • Conducts presentation of data and findings to management as required.
  • Trains Production and Quality Assurance personnel as required.
  • All other duties as assigned.

 

Knowledge of:

  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA) and other regulatory requirements.
  • Knowledge and experience in the transdermal production process (i.e. blending, coating, drying, laminating, slitting, finishing and packaging of transdermal patch and or oral film drug products).
  • Familiarization / knowledge of project management.
  • Familiarization and or knowledge of transdermal and or oral film formulation.
  • Pharmaceutical quality control and manufacturing processes.
  • Techniques of sampling, testing and measuring.
  • Proficient in the use of mathematical and statistical computations.
  • Proficient in the use of Statistical Process Control, Experimental Design and statistical software.
  • Familiarization of PLC, Electro mechanical driven production equipment (Packaging machines, Blenders, Coaters, etc.)

 

Skill in:

  • Analyzing and troubleshooting problems, identifying solutions and recommending and implementing methods, procedures, systems and/or techniques for resolution.
  • Performing necessary projects, assignments to implement goals and objectives for effective, efficient and cost-effective management of allocated resources.
  • Ability to prepare all types of pharmaceutical documentation (batch records, SOPs, protocols, summary reports, etc.)

Job Requirements

A Bachelor’s degree in Engineering or Life Sciences from an accredited college or university and at least 5-8 years of experience or a Master’s degree and 3-5 years of experience in a cGMP regulated pharmaceutical manufacturing environment or an equivalent combination of training and experience is required.

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

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