Scientist III - Product Development

Recro Pharma Gainesville , GA 30501

Posted 2 months ago

This position's key function is to support Product Development by conducting research directed toward development of new formulations and/or formulation platforms for a significant PD project or a number of small projects with many complex features under minimal supervision using established and novel technology. This role is responsible for the formulation development and evaluation of complex pharmaceutical products such as controlled release solid oral dosage forms, liquids, or parenterals.

Major Duties/Responsibilities

  • Performs literature and patent searches to provide background basis for development plans.

  • Executes, and assists in the evaluation of formulation development, scale-up and process transfer activities. May lead initiatives within the Product Development group.

  • Writes, reviews, and approves cGMP documentation including batch records, protocols, SOPS, pharmaceutical development reports, investigation plans, and outcomes for development problems, etc.

  • Ensures training for self and other PD personnel, as requested. May identify and develop specific training content to support ongoing development efforts.

  • Attend cGMP training sessions and comply with site-wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security.

  • Maintains and expands knowledge of current and new formulation development technologies and manufacturing processes (ours and competitive).

  • Advances process technologies and supports the patent (intellectual property) development.

  • Provides mentoring to less senior Scientists.

  • Assist department management on various project activities.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Director Product Development

Recro Pharma

Posted 1 week ago

VIEW JOBS 5/15/2019 12:00:00 AM 2019-08-13T00:00 Primary Objective of Position The Director, Product Development, leads the formulation, process development, and analytical development teams, and directs all aspects of Product Development at the Recro Gainesville LLC site (Gould Drive). The function includes scientific, project management and engineering support for technology transfer projects, development of formulations, methods, and processes for new product candidates, and scale-up activities. The function will also support existing commercial processes where appropriate. The position will also assist in assessing new business development opportunities for the site. The position requires close cooperation with other relevant site disciplines to ensure corporate and site objectives are met. Major Duties/Responsibilities * Direct and lead the effective development and/or transfer of products, methods, processes, and technology to the Gainesville site. * Support senior management and Business Development in due diligence, selection and commercialization of new products and technologies from external partners * Interact directly with internal and external clients in relation to tech transfers, new product introductions, technology enhancements and process improvements where appropriate. * Provide scientific leadership for the site in the areas of manufacturing technology, processes, and regulatory requirements. * Operational management of the Product Development group in the areas of * cGMP and Training * EHS&S * Budget preparation and monitoring * Project Management * Objective setting and Performance Reviews * Responsible for hiring all members of the Product Development team and ensuring they are adequately trained to perform all necessary tasks of their roles * Responsible for documentation generation, review, and approval as required, particularly, but not exclusively in the areas of Product Development, CMC, Tech Transfer and Validation. Lead or Supervisory Responsibilities: Supervises work of others, including planning, assigning, scheduling and reviewing work, ensuring quality standards. Is responsible for hiring, terminating, training and developing, reviewing performance and administering corrective action for staff (may be subject to final approval by leadership). Plans organizational structure, position content and staffing. Directly Supervises 6 - 10; Indirectly Supervises 4 - 6 Recro Pharma Gainesville GA

Scientist III - Product Development

Recro Pharma