Unither Virology

Date:

December 12, 2011

Title:

Manager of Manufacturing

Job Type:

Full-Time Position

Job Category:

Manufacturing

Location:

Washington, DC

Experience Required:

5+ years experience in a leadership role involving process development or manufacturing or other relevant experience; or equivalent

Education Level:

Advanced degree (M.S., Ph.D.) in chemistry, chemical engineering or related field preferred

Role Purpose/Position Overview

This is an exciting opportunity to join our team at an early stage to help develop a small molecule, broad-spectrum antiviral therapeutic within one of the world’s leading biotechnology companies.  The Manager of Manufacturing will oversee the production, scale-up and formulation of our investigational drug.  This is a hands-on position involving management of manufacturing via an outsourced subcontractor.

This position will initially be based in Washington D.C.  Within 3 to 12 months this position will permanently move to Silver Spring, Maryland.

Key Accountabilities/Responsibilities

• Assists in developing, planning, implementing and maintaining  both development and GMP manufacturing methods, processes and operations for our investigational drug, via outsourced resources
• Works closely with quality groups to ensure strict compliance with all applicable specifications, Standard Operating Procedures, FDA regulations and investigational drug guidelines
• Works with outsourced resources to develop production through pilot, small-scale, and intermediate-scale to deliver drug material to meet project needs
• Troubleshoots manufacturing issues
• Accountable for drug storage and shipment logistics and assists quality with product reconciliation 

Requirements

• 5+ years experience in a leadership role involving process development or manufacturing or other relevant experience; or equivalent
• Technical/scientific knowledge of biopharmaceutical processes, at both process development and manufacturing scales of operation; expertise with a variety of analytical methods and techniques to support process development and product characterization
• Direct industry experience with small molecule drug development, including oversight of subcontract manufacturers
• Experience with manufacture of intermediates, bulk drug and final formulations 
• Expertise with GMP systems to support the creation, implementation of and regulatory defense of new technology introductions as well as process changes for a commercially licensed process
• Ability to travel up to 20%

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

December 15, 2011

Title:

Manager, Quality Assurance

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Washington, DC

Experience Required:

6 plus years experience in quality management in the biotech/pharmaceutical industry, 3 of which in a leadership role; or equivalent

Education Level:

Undergraduate or advanced degree in a scientific discipline or related area

Role Purpose/Position Overview

This is an exciting opportunity to join our team at an early stage to help develop a small molecule, broad-spectrum antiviral therapeutic within one of the world’s leading biotechnology companies.  The Manager, Quality Assurance will be responsible for implementing and maintaining the activities of the company’s quality systems. This is a hands-on position.

Key Accountabilities/Responsibilities

• Build and manage quality systems across all the activities of the drug development program
• Ensures compliance with the company’s quality systems and standards, applying methods and procedures to audit, inspect, test and evaluate all aspects of the development effort
• Reviews company and subcontractor documentation used to establish compliance with GMP, GLP, GCP and other quality standards and practices
• Performs and/or manages internal and external GxP compliance audits according to audit plans to support manufacturing, non-clinical, clinical and other project activities
• Investigates potential product quality issues
• Makes recommendations for corrective action necessary to ensure conformity with quality specifications.  Ensures finished products conform to government and company standards and satisfy GxP standards and regulations
• Interacts with vendors. Reviews company and subcontractor documentation used to establish compliance with GMP, GLP, GCP and other quality standards and practices
• Interacts with various departments. Plans, performs and/or manages internal and external GxP compliance audits according to audit plans to support manufacturing, non-clinical, clinical and other project activities

Requirements

• 6+ years of experience in quality management in the biotech/pharmaceutical industry, 3 of which in a leadership role; or equivalent
• Extensive experience in managing quality systems and assurance, including GMP, GLP, GCP document management and hands-on experience working with electronic document management systems
• Experience overseeing quality compliance of vendors supplying GxP services.
• Thorough knowledge of FDA, EU and global GxP and related standards and regulations
• Working knowledge and experience with pharmaceutical manufacturing and regulatory requirements for drug approval
• Undergraduate or advanced degree in a scientific discipline or related area
• Must be able to communicate effectively, both written and orally with colleagues, management and senior management - cross-functionally.
• Strong problem solving skills
• Ability to plan, organize, prioritize and manage multiple priorities; detail oriented
• Computer proficiency, including experience with quality management applications

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V

Date:

October 06, 2011

Title:

Senior Document Management Specialist

Job Type:

Full-Time Position

Job Category:

Research & Development

Location:

Washington, DC

Experience Required:

8+ years of experience working with document management systems in a life science organization; or equivalent

Education Level:

BA in life sciences or a related area

Role Purpose/Position Overview

Key Accountabilities/Responsibilities

• Collaborates with team leaders to develop, implement and maintain multiple systems including accounting, contract administration, and scientific data management (support of manufacturing (GMP), preclinical (GLP), clinical (GCP), quality, regulatory and other functions)
• Establishes document management systems and central repositories
• Maintains and supports systems, including document and data entry, recordkeeping, reporting and associated processes as necessary to comply with company, client and government regulatory requirements
• Interfaces with project teams to develop systems, procedures and documentation
• Trains team staff in document creation, management, control and reporting

Requirements

• 8+ years of experience working with document management systems in a life science organization; or equivalent
• Extensive knowledge of electronic documentation systems, document management software applications, data entry, and electronic files
• Strong background and demonstrated effectiveness in implementing and managing documentation control systems for compliance with government standards and FDA regulations
• Strong verbal and written communication skills and effective interpersonal skills
• Proficiency in Microsoft Office and relevant software applications
• Ability to multitask, prioritize and meet deadlines
• Able to work independently and as part of a team
• Excellent organizational skills and detail orientation

United Therapeutics Competency Profile:

The ideal candidate will possess the following core competencies: Ethical, Accountable, Creative, Nimble and Collaborative.

At United Therapeutics, we:

• Commit to doing the right thing the right way
• Are unwavering in our adherence to regulatory, scientific and company policies and procedures
• Set high standards for ourselves and others and strive to meet them
• Take full ownership of our area of responsibility
• Plan ahead, focus and prioritize to ensure deliverables are met
• Think outside the box to devise non-traditional and novel approaches to business and scientific issues
• Act with a sense of urgency and purpose to fulfill UT’s mission
• Adapt quickly to change and new direction
• Treat everyone with respect
• Share information and expertise within and across functions, and partner with others to achieve goals

Qualified candidates please click here to apply!

EOE M/F/D/V