Senior Manager / Associate Director, Analytical Development - Oligonucleotide

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#GSKBiopharm_Development

Are you looking for an impactful role that leverages your technical expertise and ability to build exceptional relationships with trusted global partners to develop an increased number of transformative medicines for our patients? If so, this Senior Manager/ Associate Director, Analytical Development role in a rapidly growing, empowered, innovative and agile Strategic External Development organization developing transformative medicines within a vibrant GSK hub could be an ideal opportunity to explore.

As a Senior Manager/ Associate Director, Analytical Development, you will contribute to internal and external development of the company's specialty drug product s.

We are seeking an experienced Senior manager/SME supporting development and registration of GSK's pipeline of preclinical and development-stage candidates. Develop analytical strategies for integrated early and late stage development activities in support of new product commercialization. Will be a part of a team for the generation of high-quality, on-time, and right-the-first-time data that comprise a critical component of regulatory submissions required to enable the clinical and/or commercial use of GSK product s. The analytical data generated by these methods ultimately ensure the safe and effective use of our drug product s in healthy volunteers and/or patients and ensure the continuity of supply of these drugs to patients.

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

• Manage and oversee analytical activities performed at CROs/CDMOs associated with method development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards.
  
• Execute the strategies for product characterization with a focus on CQA assessment, and lead characterization activities at CROs/CDMOs.
  
• Author, review and/or approve key documents such as: comparability protocols and reports, and relevant sections of regulatory filings (IND, IMPD, NDA, BLA, etc.).
  
• Assure all lab oratory documentation and other regulatory compliance systems are maintained according to corporate standards.
  
• Implement process es to enable effective col lab oration with CRO/CDMO business partners to ensure efficiency and high quality of results.
  
• Partner with GMP /GDP Quality Assurance and Regulatory Affairs- CMC to ensure completion of appropriate documentation and maintenance of high-quality standards.
  

Why you?

Basic Qualifications:

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

• B.S. in chemistry, biology, biochemistry, or related technical discipline
  
• Minimum of 8 years of biopharmaceutical analytical experience with small molecule, oligonucleotide
  
• Experience with analytical method development, validation and transfer
  
• Experience in the biopharmaceutical industry with relevant experience in late stage product, CQA assessment
  
• Approximately 10-15% domestic and international travel is anticipated
  

Preferred Qualifications:

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

• Ph.D. or M.S. in chemistry, biology, biochemistry, or related technical discipline
  
• Strong understanding of product development disciplines and relationship of analytical testing to drug development
  
• Theoretical and hands-on knowledge and experience with characterization methodologies for drug substance and drug product
  
• Experience authoring regulatory files (IND, IMPD, BLA, MAA, etc.).
  
• Experience with antibody-drug conjugates (ADCs), bispecifics, mRNA, etc.
  
• Experience collaborating with third parties (CROs/CDMOs)
  
• Ability to work in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities; must be able to work well in “gray space”
  

Why GSK?

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

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is  ambitious for patients  - so we deliver what matters better and faster;  accountable for impact  - with clear ownership of goals and support to succeed; and where we do the right thing . So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

*LI-GSK

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