Senior Manager - Analytical Development
Site Name: USA - Massachusetts - Waltham
Posted Date: Apr 6 2023
As a Senior Manager of Analytical Development, you will be a part of a team for development and registration of pre-clinical and development-stage candidates of biologics modalities within the Strategic External Development (SED) organization. This successful candidate will serve as a technical lead and/or project lead in a broad analytical area and manage the collaboration with appointed CDMOs in order to directly support GSK biologics pipeline.
The scope of the role spans from release- and stability-indicating method development, qualification and validation, to characterization and comparability studies as well as reference standard qualification. Under minimal guidance, the incumbent will be responsible for overseeing, developing, and executing aligned CDMO and GSK goals for large molecule analytical development. It will further extend to investigations and preparation of CMC content for regulatory submissions, method transfer and troubleshooting.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Lead and manage analytical development activities performed at CROs/CDMOs associated with method development, qualification/validation, transfer and characterization of drug substance, drug product, in-process testing and reference standards qualification.
- Develop and execute strategies for product and process characterization with a focus on CQA assessment, specification, release, stability and comparability studies.
- Facilitate tech transfer of methods to GMP testing facility, commercial groups and to CMO's.
- Collaborate with process and quality functions to ensure strong cross functional collaborations and integrated process and product development and characterization.
- Author, review and/or approve key source documents for relevant sections of regulatory filings (IND, IMPD, BLA, etc.).
- Lead and track analytical development commitments to support all CMC filing activities for pre-INDs, INDs, IMPDs, CTAs and BLAs, draft and review of regulatory filings, and address RTQs.
- Assure all documentation and other regulatory compliance systems are maintained according to GSK corporate standards.
- Establish and implement processes, technical concept and methodologies to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.
- Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards.
- Provide clear communication to partners and functional line management regarding progress against technical and project objectives/milestones.
We are looking for professionals with these required skills to achieve our goals:
- Ph.D. or Master’s degree in chemistry, biochemistry, cell biology, biochemical/bioprocess engineering, or a science/engineering discipline
- 6+ years (for Ph.D.) or 8+ years (for M.S.) of analytical experience.
- 3+ years of experience in late-stage product and process development of therapeutic proteins/mAbs, and preferably with 2+ years of analytical project leadership experience of biologics.
- 5+ years of hands-on experience with biochemical, biophysical and/or biological methods used for biopharmaceutical characterization.
- 1+ years of experience in tech transfer of methods and life cycle management.
If you have the following characteristics, it would be a plus:
- Experience with recombinant biologic modalities and exposure to all stages of biologics drug development.
- Hands-on experience in biochemical and/or biophysical assay development, qualification/validation, tech transfer and lifecycle management of methods.
- Thorough knowledge of structure-function relationship of therapeutic proteins.
- Experience with antibody-drug conjugates (ADCs), bi- and multi-specifics, or co-formulated drug products.
- Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.
- Ability to work in a fast-paced, multi-disciplinary and dynamic environment with potential for changing priorities, with flexibility to support multiple development programs simultaneously.
- Ability to lead innovation, change and drive for results.
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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