The successful candidate will join a team of scientists and engineers supporting GSK’s portfolio of commercial and late stage biopharmaceutical and steriles assets (internal and/or external). As an SME in drug substance manufacturing, the candidate will possess in depth knowledge of downstream processing manufacturing requirements and expertise in the associated unit operations.
The role will include working across the supply chain network to drive progression of platforms, standards, and new technology industrialization. By identifying and focusing on the highest priority areas to drive business value and patient impact, this role will flex across the portfolio to deliver proactive and reactive solutions to complex problems. To ensure alignment across the business, shared learnings, and technical capability build, the candidate will also lead effective communities of practice, as appropriate. Engagement with suppliers and external CMOs will be required.
In partnership with R&D and Pharma Supply Chain (PSC), the person in role will work to implement standards of quality by design (QbD) into robust manufacturing operations, maintaining knowledge of latest industry trends and becoming an advocate in the external community. The position requires the ability to manage across multiple projects simultaneously, lead matrix teams, and mentor site based technical staff members. Requires excellent oral and written communication skills.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- BS/MS/PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry, or equivalent industrial experience and knowledge.
- Minimum of 10 years pharmaceutical industry experience in technical support of commercial manufacturing and/or process development.
- Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.
- Broad and integrated knowledge and experience that can impact project and workgroup direction.
- Working knowledge of regulatory requirements in the industry and drug development.
- Must have excellent verbal and written communication skills, and ability to influence, lead and drive change.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO), validation (including engineering project progression through IQ/OQ/PQ), regulatory submissions, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e. CPV, PPR, Change and Deviation Management), and knowledge management.
- Knowledge of relevant regulatory requirements, including principles of quality by design. Ability to support due diligence activities.
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.
As a global healthcare company, we take on some of the world’s biggest healthcare challenges. By delivering a sustainable business, we provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We are committed to widening access to our products, so more people can benefit, no matter where they live in the world or what they can afford to pay. Each of our three businesses benefits from GSK’s commercial infrastructure, integrated supply networks and significant global presence.
As a global company, our reward packages are designed to meet the needs of our geographically diverse workforce. They are benchmarked against industry standards and relevant to your job, no matter where you live.
Our reward package includes:
- A competitive base salary
- An annual bonus that rewards you for your individual contribution to our strategy, as well as business targets
- Benefit programs designed to support you and your family, including access to healthcare and well-being programs, pension plan membership, savings programs, time off and childcare support
- Employee recognition programs which reward exceptional achievements
- Share ownership schemes which link your reward to GSK’s longer term performance
- A performance and development program that helps you identify what you need to do, and the behaviors you need to demonstrate, to achieve success.
