WuXi AppTec

Senior Process Research and Development Scientist

Job Locations US-CA-San Diego
Job ID
2020-6930

Overview

STA Pharmaceuticals, a WuXi AppTec Company, has an exciting oppertunity for a Senior Process Research and Development Scientist, Development Chemistry in our San Diego site.

 

This position works within a team of process R&D scientists in conjunction with the Analytical Chemistry Department and be co-responsible for developing safe, efficient and easily scalable processes for producing starting materials, intermediates and active pharmaceutical ingredients (API’s). In addition, the incumbent assists in tech transferring projects to kilo lab and pilot plant scales and contributes to the safe and cGMP compliant execution of API manufacturing processes.

 

The incumbent may also work with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process development and scale-up documentation including batch production records (BPR’s) are completed in a timely manner, and that standard operating procedures (SOP’s) are written and followed. Hands-on synthetic organic chemistry and the ability to solve process and scale-up problems through laboratory-scale investigations of organic synthesis reactions and separations is required.

Responsibilities

  • Researches and develops novel and cost-effective processes using innovative approaches such as chemoenzymatic synthesis, biocatalysis, and green chemistry principles.
  • Reports project progress to PR&D Associate Director (or Site Head) to ensure that client timelines and expectations are delivered.
  • Plans, executes, and documents cGMP and Non-GMP/GLP laboratory work supporting regulatory submissions.
  • Evaluates chemical reactivity hazards using techniques such as reaction calorimetry, online analytics, and batch process modeling tools.
  • Collaborates with other functional groups as needed.
  • Responsible for the coordination and completion of specific project tasks with other departments.
  • Actively communicates, consults and collaborates with colleagues and clients to ensure optimal execution and record of PR&D activities.
  • May be responsible for supervision and guidance for other Scientists and Associate Scientists in the PR&D group.
  • Other duties as assigned.

Qualifications

Experience / Education:    

  • PhD in synthetic organic chemistry or related field with 5+ years of relevant experience, or equivalent combination of education and industry experience.
  • Experience managing PR&D Associate Scientists is preferred.
  • CMO/CRO experience is highly desirable. 

Knowledge / Skills / Abilities:

  • Significant experience in pharmaceutical process R&D work.
  • Demonstrated in-depth understanding of cGMP manufacturing for biopharmaceutical products.
  • Demonstrated success working effectively outside defined scope of responsibility, when required.
  • Ability to function with a sense of urgency.
  • Ability to provide technical and trouble-shooting support for all Process R&D activities.
  • Ability to supervise, mentor, and guide direct reports (PR&D Scientists/Associate Scientists) to enable them to be productive contributors and facilitate their scientific and career growth.
  • Provide regular updates, documentation and communication of PR&D results to development team/clients.
  • Communicates directly with clients as required.
  • Collate and present results in various forms, such as weekly/monthly reports, technical reports, and oral presentations for internal review and to clients.
  • Strong background in organic chemistry, as well as thorough knowledge of analytical techniques.
  • Supervise, mentor, and guide direct reports (PR&D Scientists and Associate Scientists) to enable them to be productive contributors and facilitate their scientific and career growth.

Physical Requirements:

  • Must be able to work in an office environment with minimal noise conditions.
  • Must be able to work in Lab setting with exposure to hazardous materials (i.e. Chemicals).
  • Must be able to wear appropriate PPE (i.e. lab coat, safety glasses, and gloves).
  • Must be able to work in environment with variable noise levels.
  • Ability to stand/sit/walk for long periods of time.
  • Ability to Lift 20 lbs routinely.
  • Ability to crouch, bend, twist, and reach.
  • Ability to push/pull 20 lbs routinely/ often / occasionally.
  • Clarity of Vision.
  • Ability to identify and distinguish colors.
  • Must be able to perform activities with repetitive motions.
  • Ability to climb Ladders/Stairs/Scaffolding.
  • Ability to work in variable temperatures high to freezing.
  • Inside working conditions.

 An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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