Technology Manager - Biopharmaceutical Tech Transfer

Rockville, Maryland
Feb 09, 2021
Feb 27, 2021
Jobseeker Type
Organization Type
Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Technology Manager - Biopharmaceutical Tech Transfer role could be an exciting opportunity to explore.

As a Technology Manager - Biopharmaceutical Tech Transfer, you will 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 Organisations 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; and support efforts to continuously reduce product COGS while improving product quality for products supplied by GMS Biopharm.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
  • 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 or co-ordinating technical activities for specific products at Third Party sites for 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 tools and philosophies.
  • As necessary will be required to supervise laboratory based biopharmaceutical process development/investigational activities.
  • Independently design lab experiments and interpret complex data/results.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS/BA in either biological or chemical science or engineering or equivalent technical discipline.
  • A minimum of 5 years post-graduate experience in the Biopharmaceutical/pharmaceutical industry or equivalent with significant emphases on technology development and/or process technology transfer.
  • Experience with current GMP's, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Preferably has at least 2 years of experience in the development of biopharmaceutical drug substance manufacturing processes.
  • Expert knowledge in biopharmaceutical technologies including large scale cell culture/microbial technology, biopseparations technologies, and pharmaceutical manufacturing of proteins. Understanding of analytical technologies related to the above.
  • Strong interpersonal and leadership skills.
  • Strong verbal and written communication skills.
  • Strong Analytical and critical thinking skills.
  • Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
  • Able to provide leadership to generate options to resolve problems, prioritise, and decide appropriate courses of actions. Effective at implementing decisions.
  • Committed team player prepared to work in and embrace a team-based culture.
  • Leadership potential.

Why GSK?

Our values and expectations are 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.

*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 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.

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