Sr. Manager, Large Molecule Analytical Development

Job description

Nombre del sítio: USA - Massachusetts - Waltham, Upper Providence
Fecha de publicación: Feb 21 2024

JD – Senior Manager, Analytical Development, SED

As a Senior Manager of Analytical Development, you will join a team of scientists responsible for managing analytical activities throughout development and registration of pre-clinical and development-stage biologic candidates within the Strategic External Development (SED) organization. The successful candidate will serve as a project and/or technical lead in a broad analytical area and manage the collaboration with appointed CDMOs to directly support GSK’s biologics pipeline.

The scope of the role spans from overseeing release- and stability-indicating method development and validation to characterization and comparability studies, as well as reference standard qualification. Under minimal guidance, the successful candidate 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 concepts, 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.

Why you?

Basic Qualifications:

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

·  Ph.D. or M.S. in chemistry, biochemistry, cell biology, biochemical/bioprocess engineering, or related science/engineering field with extensive biopharmaceutical industry experience.
·  6+ years (for Ph.D.) or 8+ years (for M.S.) of combined biopharmaceutical industry and postgraduate analytical experience.
·  5+ years of hands-on experience with biochemical, biophysical and/or biological methods used for biopharmaceutical characterization.
·  3+ years of CMC analytical development experience of therapeutic proteins/antibody-drug conjugates (ADCs), and preferably with analytical project leadership experience of biologics.
·  1+ years of experience in tech transfer of methods and life cycle management.

Preferred Qualifications:

·  Experience with a variety of biologic modalities (ADCs, monoclonal antibodies, bi- and multi-specifics, co-formulated drug products, etc.), and exposure to all stages of biologics drug development.
·  Hands-on experience in biochemical and/or biophysical assay development and qualification/validation.
·  Thorough knowledge of structure-function relationship of therapeutic proteins. 
·  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.

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

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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.

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.