• WuXi AppTec
  • $72,630.00 -116,810.00/year*
  • Philadelphia , PA
  • Scientific Research
  • Full-Time
  • 1103 Market St


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Overview

Designs, supervise, and interprets research & development and GMP studies. Provides appropriate resources to team to conduct studies. Supervises team of scientific personnel with varying skill level. Directs and leads team to stay on track to meet project deadlines. Oversees assay transfers between Analytical Development and Testing Operations. Serves as analytical lead on manufacturing core teams for low complexity programs. Interfaces with Sales team regularly. Authors technical documents, procedures, policies, SOPs, & risk assessments, as needed.

Responsibilities

* Lab equipment ownership. Responsible for REES/ELPRO monitoring and response

* Designs, supervise, and interprets R&D and GMP studies.

* Provides appropriate resources to team to conduct studies.

* Supervise team of scientific personnel with varying skill level.

* Assumes responsibility for direct reports and team. Directs and leads team to stay on track to meet project deadlines.

* Communicates progress to manager regularly.

* Conducts regular staff meetings and one on one meetings with each staff member

* Oversees assay transfers between own team and Operations.

* Serves as analytical lead on manufacturing core teams for complex programs.

* Interfaces with Sales team regularly. Authors custom quote sections.

* Authors technical documents, procedures, policies, SOPs, & risk assessments, as needed.

* Participates in webinars.

* Implement innovative solutions and propose new technologies in support of multiple projects.

* Lead cross-functional teams in effort to solve organizational and process problems

* Broad knowledge in field of expertise, including the ability to interpret current literature relevant to R&D projects, and visibility outside of functional area.

* Complies with all internal and external regulations and policies and procedures. Ensures safety and compliance of laboratory and team.

* Tracks progress of team's change controls. Ensures project goals are met and change controls are closed out in a timely manner.

* Investigates, responds and/or approves equipment OOTs

* Represents the company at outside conferences, as needed.

* Maybe required to work Holidays and weekends

* Thorough understanding of Good Manufacturing Practices

* May be required to assist in other departments

Qualifications

Job Requirements:

* Bachelors' degree in Biological Sciences or science related field with 15 years of experience or

* Master's degree in Biological Sciences or science related field with 10 years of experience or

* PhD in Biological Sciences or science related field with 6 years of experience

* Deep understanding of virology and methods to assess the titer of replication competent and defective vectors.

* Experience with gene therapy vectors and/or gene mediated cell therapy highly desirable.

* Automation experience highly desirable.

* Experience in a cGMP environment is highly desirable.

* Ability to accomplish the described duties through the use of appropriate laboratory equipment (i.e. biohazard hood, centrifuge, incubator, and autoclave) and computer equipment and software. (i.e. Microsoft Word, Outlook).

* Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
Associated topics: air, air monitoring, biodiversity, ecology, environment, environmental, environmental science, sustainability, sustainable, water

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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