WuXi AppTec

Scientific Director - Analytical Development

Job Locations US-PA-Philadelphia
Job ID
2021-8399

Overview

Oversees the key, core assay development groups within Analytical Development. Responsible for overseeing new method development, assay qualifications and validations, as well as internal and external assay transfers. Partners with Testing Operations management to transfer methods from Analytical Development to Testing Operations. Provides high-level technical support as needed. Manages assay functional leads and supervisors and is responsible for strategical
planning, project timelines, appropriate resourcing, setting appropriate goals, and personnel development. Possesses rigorous scientific skills in biologics testing and a strong working knowledge of Good Manufacturing Practice (cGMP) compliance requirements for biologics testing. Remains current regarding regulatory testing requirements and
develops / modifies assays in accordance. Remains current in the scientific areas of their respective functional areas and serves as a key subject matter expert to the organization. Engages clients and auditors regularly.

Responsibilities

  • Responsible for the strategical planning, vision and growth of their team.
  • Responsible for equipment planning and appropriate resourcing of their team.
  • Presents to headcount committee, as needed.
  • Serves as an analytical lead on Manufacturing Core Teams, as needed. May serve on Joint Steering Committees for testing and manufacturing teams.
  • Appoints analytical lead for manufacturing core teams, as needed. Provides appropriate analytical resources to core teams and technical oversight/support when needed.
  • Leads and/or participates in complex, cross-functional investigations that have potential for high impact.
  • Assumes responsibility for direct reports and team. Directs and leads team to stay on track to meet project deadlines.
  • Communicates progress to manager regularly.
  • Supervises team of senior scientific personnel, including mostly supervisors.
  • Conducts regular team/staff meetings and one on one meetings with each direct report.
  • Assists Senior/Executive Director or VP with the department strategical planning and growth of their team.
  • Provides appropriate resourcing and reduces barriers for assay transfers between
  • Analytical Development and Testing Operations. Ensures compliance to transfer policies.
  • Serves as analytical lead representing Analytical Development and Laboratory Operations on multiple manufacturing core teams for highly complex programs.
  • May serve on Joint Steering Committees for Testing and Manufacturing strategic programs.
  • Interfaces with BD and Sales team regularly. Authors custom testing quotes and the analytical portions of manufacturing quotes.
  • Authors technical documents, procedures, policies, SOPs, & risk assessments, as needed
  • Implement innovative solutions and propose new technologies in support of multiple projects
  • Lead cross-functional teams in effort to solve organizational and process problems
  • Leading expert in field of expertise and broad knowledge across technical areas.
  • Lead cross-functional investigations.
  • Lab equipment owner. Responsible for determining departmental equipment needs and justifying CapEx.
  • Responsible for ensuring departmental compliance to REES/ELPRO monitoring and response procedures. Provides appropriate resources and expectations to team for responding to alarms.
  • Complies with all internal and external regulations, policies, and procedures.
  • Ensures safety and compliance of laboratory and team.
  • Assess team-resourcing needs. Present to headcount committee.
  • Tracks progress of department's change controls.
  • Ensures project goals are met and change controls are closed out in a timely manner.
  • Represents the company in key client meetings and outside conferences
  • Travels with other WuXi AppTec staff to visit clients as appropriate.
  • May be required to work Holidays and weekends
  • May be required to assist in other departments

Qualifications

  • 9 or more years of relevant experience or equivalent.
  • Previous management experience required.
  • PhD in Biological Science or science related field or equivalent experience
  • Knowledge of cGMP guidelines is required.

 

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.

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