1+ months

Investigator, Downstream Process Development

GSK
King of Prussia, PA 19406
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Sep 23 2020

Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals?If so, this Investigator, Biopharm Downstream Process Development role could be an exciting opportunity to explore.

Biopharm Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life-cycle of asset development from Discovery through commercialization. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development.We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.

Within Biopharm Process Development, the Downstream Process Development department is responsible for the development of purification processes for the manufacture of GSKs Biopharm assets.The Department is also responsible for the scale-up and tech transfer of the processes to manufacturing facilities all over the world.Our aim is to integrate innovative process platforms, automation and advanced data analytics into the downstream process development workflow.In our mission, we follow the science and are committed to the design, development, and transfer of the most robust, well-understood, and well-characterized downstream manufacturing processes and platforms that will ensure quality and reliable supply of medicines for the patient.

As an Investigator in Downstream Process Development, you will be a member of a highly skilled team of scientists and engineers responsible for the evaluation and optimization of purification processes. As a member of the Virus Clearance team, your primary focus will be on virus clearance validation for therapeutic proteins including monoclonal antibodies. Responsibilities include study design, management of contract laboratory studies, data analysis and reporting. The role involves verbal and written communication and requires good organisation as well as a broader scientific knowledge. Both individual and team work are required and therefore the role will suit a scientist with good interpersonal skills, self-motivation and an open mindset..

This role will provide YOU the opportunity to lead key activities to progress YOUR career. The responsibilities include some of the following:

  • Designing, executing and interpreting virus clearance experiments

  • Writing and reviewing technical documents, authoring of CMC sections for regulatory filings

  • Working with matrix teams to progress multiple projects in the Biopharm pipeline

  • Applying Quality by Design principles to process design

  • Evaluating and integrating innovative technologies

  • Mentoring junior scientists

  • Presenting data and status reports to senior management

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • PhD or equivalent experience in Chemical/Biochemical Engineering, Biochemistry, Chemistry; or related Biological Science

  • Experience with regulatory standards (viral safety, process validation, GxP, etc.)

  • Experience with the principles, methods, experimental approaches, and regulatory requirements of virus clearance validation for biopharmaceuticals

Preferred Qualifications:

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

  • Expert in protein purification and process development

  • Extensive theoretical understanding and practical experience of virus clearance validation for biopharmaceuticals

  • Demonstrated record of scientific achievement and a broad and integrated knowledge of the field

  • Knowledge of continuous processing

  • Knowledge of Quality by Design and control strategy development

  • Demonstrated ability to manage external contract research organization activity.

  • Ability to apply expertise to identify and evaluate new technologies for virus clearance

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

GSKBiopharm_Development

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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 GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.

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Posted: 2020-09-25 Expires: 2020-12-25

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Investigator, Downstream Process Development

GSK
King of Prussia, PA 19406

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