Biopharm Product Technology Manager

Glaxosmithkline Conshohocken , PA 19428

Posted 6 days ago

Your Responsibilities:

Job Purpose:

  • Manage certain elements (such as upstream or downstream etc.) of the transfer of primary(drug substance) biopharmaceutical production technologies from R&D, third party clients or Contract Manufacturing Organizations to GMS Biopharm and from GMS Biopharm to other biopharmaceutical manufacturing sites.

  • Support delivery of new biopharmaceutical applications and technologies as well as on delivering improvements to the existing supply chains supported by GMS Biopharm and technology transfers between GMS Biopharm & R&D.

  • Support efforts to continuously reduce product COGS while improving product quality for products supplied by GMS Biopharm.

Key Responsibilities:

  • Support the introduction and possible scale-up of primary(drug substance) processes transferred from R&D or third party clients for specific products new within GMS Biopharm. Support establishing resource requirements necessary to implement approved projects.

  • Act as technical GMS Biopharm representative on the technology transfer teams and product development project team for specific products. Responsible for managing the relationship between R&D or third party clients and GMS Biopharm for specific products and if needed influence decision makers within R&D or third party clients.

  • Propose strategies and priorities in planning technical transfer/process validation activities within area of expertise.

  • Responsible for process trend analysis and assurance that processes remain within control parameters. Responsible for resolving process issues/ problems in a manner and timeframe consistent with production and quality goals for specific products.

  • Provide technical training to production staff for new equipment and process technologies as required.

  • Evaluate new technologies for GSK and define technology introduction strategies. Define long-term and near-term process improvements within area of expertise.

  • Ensure technical accuracy of process documentation and related documentation for specific products. Responsible for ensuring that new technologies are properly validated in GMS Biopharm and that related regulatory documents to support licensing of specific products are prepared.

  • May need to contribute to technical oversight of manufacturing operations, facility changes or coordinating technical activities for specific products at GMS Biopharm.

  • Contribute to evaluations of potential fit of prospective new products into GMS Biopharm (e.g. SIA's RFI responses)

  • Demonstrate the use of OE/GPS tools and philosophies.

Why You?Basic qualifications:

  • BSc/BA in either biological or chemical science or engineering or equivalent technical discipline.

  • 5 years' experience in the Biopharmaceutical/pharmaceutical industry or medical device with significant emphases on technology development and/or process technology transfer.

  • Biopharmaceutical industry experience

  • Knowledge of current GMP's, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required.

Preferred qualifications:

  • Ph.D. in either biological or chemical science or engineering or equivalent technical discipline. MSc in discipline if sufficient scientific and technical depth has been achieved from professional experience.

Why GSK?:

Why GSK? Because GSK's BioPharm business vision is to leverage its experience and technical capabilities to launch, supply, and manage Biopharmaceutical products around the world. It will fulfill GSK's Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance Being accountable for quality and safety.

Contact information:

You may apply for this position online by selecting the Apply now button.

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

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Biopharm Product Technology Manager

Glaxosmithkline