Associate Director, MSAT

Site Name: USA - Maryland - Rockville

Posted Date: Apr 29 2024

Are you energized by a scientific leadership role that allows you to enhance and improve processes across biopharmaceutical product development? If so, this Biopharmaceuticals Manager role could be an ideal opportunity to explore.

As a Biopharmaceuticals Manager, you will be responsible for providing in depth focus on due diligence evaluations for biopharmaceutical product sciences, and management and direction of Biopharmaceuticals Science staff across Biopharmaceutical Product Development (BPD) departments.

PURPOSE OF JOB ROLE:

Serve as the technical lead and site product owner for a biopharmaceutical product or value stream. This individual will lead a team to support technology transfer of new products, product lifecycle management of existing commercial products, campaign readiness, and technical support for manufacturing. This individual will help develop strategy for biopharmaceutical products with Rockville, aligning with central teams and technical brand leads.

KEY RESPONSIBILITIES: (10 bullet points maximum)

• Manage and lead the technical program for a biopharmaceutical asset or value stream, including product Lifecycle Management (Technical Risk Assessment, Product Control Strategies, Continued Process Verification, Process Robustness Assessment), New Product Introduction and Technical Transfer to other sites/third party manufacturers.
• Oversee product technical lifecycle management with regards to process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registered detail. Ensure technical documentation is accurate and updated appropriately.
• Manage and facilitate the Continued Process Verification (CPV) programs for products manufactured at the Rockville site.
• Provide technical leadership for the rapid resolution of technical issues impacting supply through and product performance investigations through use of root cause analysis (RCA) tools and appropriate Corrective and Preventative Actions (CAPA) and escalate key site technical issues to the wider GMS technical community for timely resolution.
• Act was the primary technical representative on the technology transfer team for the transfer of DS biopharmaceutical production processes and technologies from R&D, third party clients, or MSAT labs to/from Rockville Biopharm.
• Serve as part of the GSK technical community, providing input to technical discussions and cross-site collaborations.

Why you?

Basic Qualifications:

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

• Bachelor of Science in Biochemistry, Chemistry, Biology, Pharmaceutics Engineering or related scientific filed
• 5+ years industrial experience in technology/biopharmaceutical process development, technical project management and process transfer to production in a biopharmaceutical/biotechnology manufacturing environment
• Experience in biopharmaceutical technologies including large scale Cell Culture technologies, bioseparation technologies, and pharmaceutical manufacturing of proteins
• Experience with GMP's, ICH Guidelines and FDA/EU validation practices for biopharmaceutical processes
• Experienced in the manufacturing of biopharmaceutical products for clinical use.

Preferred Qualifications:

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

• Masters Degree in Chemical, Biochemistry, Chomical Engineering
• Successful management of scientific matrixed teams
• Strong interpersonal and leadership skills. Committed team player prepared to work in and embrace a team-based culture.
• Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines
• Strong verbal and written communication skills which emphasize teamwork with a strong quality orientation.

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:

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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