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Contribute to the successful and timely validation, transfer and implementation of BioPharm Analytical methods/technologies to and from R&D development, contract manufacturer s, testing labs, or GSK commercial manufacturing organizations.
Own and manage method life cycles applying appropriate statistical tools to assess assay capability, and participate in method qualification/validation strategies consistent with ICH requirements and current regulatory opinion.
Expanding technical knowledge beyond own area of expertise into e.g. cell culture, fermentation, protein purification, cell banking, engineering, quality, regulatory, operational excellence, secondary manufacturing and using this knowledge to streamline/ enhance Analytical Technology Transfer.

Oversee and coordinate method qualification/validation activities insuring minimum ICH/FDA requirements are met where appropriate and consistent approaches are applied across analytical methods.
Ensure alignment of testing strategies with GSK quality standards as assets progress through development stages.
Work with QA, Document Control and Validation groups to ensure quality standards are maintained and/or enhanced. Attend team meetings and participate in continuous improvement initiatives.
Collaborate with GSK Analytical Development Groups and serve as a liaison on technical issues with secondary customers. Ensure ongoing performance of analytical methods.
Contribute to product specification development for assigned projects and ensure alignment with process/method capabilities.
Responsible for authoring and revising SOPs, methods, transfer/ validation protocols/ reports, and other laboratory documentation as necessary.
Actively involved with project/matrix teams as assigned
Business travel is expected to be up to approximately 15%

Why you?

Basic Qualifications:

  • Bachelors degree in Biochemistry, Chemistry or Biology and at least 5 years relevant experience or Ph.D/MS degree in Biochemistry, Chemistry or Biology and at least 3 years relevant experience.
  • Has thorough knowledge of cGMP requirements.
  • Familiarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Testing, Validation and Methods Transfer.
  • Independently authors internal reports, protocols, policies/plans or regulatory submission content.
  • Preferred Qualifications:

    If you have the following characteristics, it would be a plus:

  • Independently applies knowledge in area of specialization to assignments that involve multiple decision points.
  • Previous Biopharmaceutical experience a plus.
  • Key responsibilities include:

  • Contribute to the implementation of business processes and best working practices to ensure Analytical CMC activities operate strategically and as efficiently as possible.
  • Presents effectively to internal R&D forums and may present results at external meetings.
  • May lead matrix or small teams.
  • Plays a significant part in the project team decision making process.
  • Consistently exhibits professionalism and courtesy and may serve as a representative of GSK to business partners and contract organizations.
  • Anticipates and recognizes potential problems, initiates actions to solve or prevent problems and communicates issues/risks to project lead and manager.
  • Responsible for the timely follow-up of internal audit findings
  • Supports department objectives in alignment with R&D objectives.
  • Effectively prioritizes activities to meet project or department objectives using demonstrable project management skills.
  • Keeps manager and matrix team leaders informed of progress and activities.
  • Develops networks with both internal and external contacts relative to projects and/or processes.
  • May assist in the training and the recruitment of staff.
  • Represents Analytical Technical Transfer in multi-departmental meetings.
  • Participates in Deviations/Investigations and SOP/Analytical Method/Change Control authoring.
  • Why GSK?

    Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.

    We want to help people do more, feel better, live longer

    We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

    Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time. Find out more about how we are doing more across the US

    As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.

    *This is a job description to aide in the job posting, but does not include all job evaluation details.

    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-###-#### (US Toll Free) or +1 801 ### #### (outside US).

    GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

    Important notice to Employment businesses/ Agencies

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK s compliance to all federal and state US Transparency requirements. For more information, please visit GSK s Transparency Reporting For the Record site.

    * 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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