GSK

Manager Analytical Lifecycle Management

Employer
GSK
Location
King of Prussia, PA
Salary
Competitive
Posted
April 27 2021
Ref
287614
Organization Type
Pharma
Job Type
Manager
This role oversees and implements the GMP analytical life cycle from mid phase (pre-Commit to Medicinal Development) through commercialization of Biopharmaceutical products. Develop analytical method transfer/qualification/validation strategies between R&D, PSC and external contract testing laboratories. Oversee the implementation of the analytical contracts and relationships with external contract testing laboratories. Contribute to product specification development and ensure alignment with process/method capabilities, implement and manage the GMP specification. Reviews and/or approves regulatory submissions. Recruit, train and develop direct reports.

  • Develop a phase appropriate analytical integrated strategy for method verification/qualification/validation and technology transfer between R&D, PSC and external contract laboratories/manufacturers.
  • Accountable for setting the strategy of GMP analytical work and overseeing the transition of Biopharmaceutical assets from mid phase development into the GMP testing laboratory, through licensure and post-marketing requirements.
  • Work to establish and oversee the external contract laboratory testing capability to support the Biopharmaceutical pipeline.
  • Approve product specifications, certificates of analysis, analytical methods, method transfer/validation protocols and reports to ensure alignment with phase appropriate project requirements.
  • Author or review/approve templates, guidelines, SOPs, policies or project plans.
  • Review and/or approve regulatory submissions and associated RTQs.
  • Represent the GMP analytical strategy in internal/external project meetings.
  • Support regulatory inspections such as Product Approval Inspections, post-marketing commitments such as new method implementation, and new product formulations or DP presentations beyond licensure.
  • Recruit new employees and ensure direct reports are trained to perform their job.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • B.S. Biotechnology, Chemistry, Biology or other scientific or technical field
  • 10+ years of experience with B.S., or 8+ years of experience with M.S., or 5+ years of experience with Ph.D. in industrial biotechnology/product process development/Quality Control.
  • Experience with analytical life cycle and operations across GSK biopharmaceutical products


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Significant knowledge of cGMP and Regulatory requirements for the development and commercialization of Biopharmaceuticals. Familiarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Testing. .
  • Extensive knowledge of analytical method development, technical transfer and validation.
  • Oversee several projects at different stages of development and may include commercial projects.
  • Excellent written/verbal communication, presentation and influencing skills.
  • Effective project management skills.
  • Applies technical knowledge to form new ideas, anticipates and recognizes potential problems whilst providing workable solutions and make decisions based on complex information or expertise from multiple specialty areas.
  • Acts as an internal subject matter expert in area of expertise.
  • Provide analytical information to support the project team decision making process.
  • Act as a QMS ambassador where required.
  • Ensures change management is followed for analytical methods and specifications.
  • Present at internal meetings and may present information at external meetings.
  • As a manager of direct reports:
  • Coach/mentor to achieve full potential
  • Sets goals and assigns tasks
  • Manages performance and develops performance plans
  • Conducts performance appraisals and makes recommendations for advancement and development


Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.


*LI-GSK

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