WuXi AppTec

Director, Process Research and Development Chemistry

Job Locations US-CA-San Diego
Job ID
2020-7177

Overview

This position is responsible for management of the Process Research and Development Department at STA Pharmaceutical US LLC. STA Pharmaceutical US LLC, a WuXi AppTec Company, is a contract development and manufacturing organization focused on providing high quality process development, R&D, GLP Tox lots and up to P1/P2 GMP small molecule manufacturing and early phase CTM services to the biopharmaceutical industry, including both API and Drug Product (DIC).

 

The position is responsible for managing all PR&D and related activities for all the above phases of development. The incumbent will work with a team of PR&D scientists in conjunction with the Analytical Chemistry department and assist in developing safe, efficient and easily scalable processes for producing starting materials, intermediates and active pharmaceutical ingredients (API’s). In addition, the incumbent will be the primary liaison with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process development and scale-up reports including batch production records (BPR’s) are completed in a timely manner and that standard operating procedures (SOP’s) are written and followed.

Responsibilities

  • Manages and directs PR&D projects to ensure that client timelines and expectations are delivered.
  • Manages PR&D team to develop easily scalable chemical processes for the production of starting materials, intermediates and API.
  • Responsible as the Project Leader (or to designate the project leader) for all PR&D/Production projects, which includes client interaction/update on a regular basis and coordination with other departments as needed.
  • Ensures that scientists are evaluating chemical reactivity hazards using techniques such as reaction calorimetry, online analytics, and batch process modeling tools.
  • Contributes to the approval, execution, and documentation of cGMP and Non-GMP/GLP laboratory work which supports regulatory submissions and patent prosecutions.
  • Completes hands-on work as needed, which may include lab experiments and Analytical tests (HPLC, NMR, etc.), although this is only expected to be needed if PR&D team is tied up with other activities.
  • Collaborates with other functional groups as needed.
  • Authors/reviews SOP’s, technical reports and sections for regulatory filings.
  • Actively communicates, consults and collaborates with colleagues and clients to ensure optimal execution and record of PR&D activities.
  • Administrative duties: Writing project reports, writing proposals, hiring, annual budget, etc.
  • Other duties as assigned.
  • May be required to assist in other departments.

Qualifications

Experience / Education  

  • PhD in synthetic organic chemistry or related field with 12+ years of relevant experience.
  • Previous CMO/CRO experience preferred.
  • Experience managing PR&D Scientists/Senior Scientists is required.

Knowledge / Skills / Abilities:

  • Significant experience in pharmaceutical process R&D work.
  • Experience in supporting all phases of API development, ideally spanning early development to registration.
  • Demonstrated in-depth understanding of cGMP manufacturing for biopharmaceutical products.
  • Strong background in drug substance PR&D, as well as thorough knowledge of relevant equipment and cGMPs ICH and relevant FDA guidelines.
  • Experience reviewing and organizing PR&D data and leading PR&D scientists.
  • Proficiency in hands-on PR&D work and leadership.
  • Demonstrated success working effectively outside defined scope of responsibility, when required.
  • Ability to function with a sense of urgency.
  • Possess strong project management skills while maintaining high quality and efficiency standards.
  • Provides technical and trouble-shooting support for all Process R&D activities.
  • Ability to manage activities and solve high level challenges.
  • Supervise, mentor, and guide subordinates at all levels, 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.

Leadership Activities:

  • Supervise, mentor, and guide direct reports (PR&D Senior Scientists, Scientists, and Associate Scientists) to enable them to be productive contributors and facilitate their scientific and career growth.

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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