Pharmaceutical -Remote - Principal Scientist:
Germer International - Pharmaceutical Recruiting

1579683312
Germer International - Pharmaceutical Recruiting
Cleveland Ohio
Pharmaceutical
Apply
Description
Scientist / Senior Scientist / Principal Scientist - Pharmaceutical Manufacturing - Remote

The Senior Scientist will be responsible for drug development activities related to process design, optimization, scale up of the manufacturing processes and will be supporting commercialization and commercial manufacturing. The role will also cover other stages of drug development such as formulation design of new prescription drug products and manufacture of clinical trial materials in support of clinical studies and regulatory submissions. Work is performed in a virtual pharmaceutical development setting in cooperation with contract manufacturing organizations.

Company

A publicly traded branded pharmaceutical company since 1995, our client continues to be a global leader in developing and commercializing key pharmaceutical products for women. They are focused on providing products to allow women to lead a long and healthy life.

Essential Duties and Responsibilities

Lead process development studies, process optimization and scale-up, process validation, and cGMP manufacturing at various contract development and / or manufacturing sites
Author, review and approve GMP documents (e.g., MBRs, SOPs, specifications, protocols, annual reports, change controls)
Closely interact with contract manufacturers for commercial manufacturing, drug product formulation and development
Work in the CMC team and other cross-functional teams to ensure development and manufacturing of the drug products in a timely, compliant, and cost-effective manner
Support and enable CMC regulatory filings
Responsible for execution of commercial product support projects in the areas of product technical transfer, troubleshooting and investigation
Implementation of key elements of quality by design
Support formulation design of new prescription drug products to achieve scalable commercial manufacturing processes
Perform data trending
Experience with pharmaceutical oral solid dosage form and topical dosage form product development and manufacturing
Experience with process scale-up, clinical manufacturing and technology transfer
Experience in drug product IND/NDA regulatory filing
Experience in managing CROs/CMOs for drug product formulation development and manufacturing
Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and strategy
Strong interpersonal skills, ability to communicate clearly, concisely, and effectively in both written and oral context
Preferred Qualifications

Familiarity and hands on experience with quality by design in drug product development
Knowledge and experience with analytical method development
Flexibility in problem solving including the ability to independently devise and implement practical solutions to resolve complex issues in a virtual environment, providing direction and work hours to meet business objectives
Ability to effectively assess project timelines and assess resource requirements and provide recommendations to management
Proficiency in using electronic document management system
Proficiency in analysis of data using statistical evaluation
Project management skills
Education

Required Education: BS degree in pharmaceutical science or related scientific discipline (with extensive industry experience, 5+ years).
Preferred Education: M.S in pharmaceutical science or related scientific discipline (with 3+ years industry experience).
This position requires up to 25% travel. Frequently requires travel out of the area and overnight.