Senior Director-Molecule Steward Lead
GlaxoSmithKline, Waltham, MA, United States
Key responsibilities
Manage a group of Molecule Stewards (5-10) accountable for end‑to‑end technical leadership of various pipeline and in‑line programs. Recruit and develop a world‑class team.
Serve on Molecule Steward leadership team to drive and improve portfolio and organizational excellence.
Responsible for defining and owning the technical strategy through a product’s lifecycle including product transfers R&D to GSK sites/External manufacturing sites & Site to Site (both GSK sites and external manufacturing sites), Product Performance Qualification and Ongoing Continuous Process Verification, leading Product Technical Lifecycle Team (PTLT) and yearly Manufacturing Robustness Review Board meetings (MRRB) to ensure risks are identified, escalated, mitigated and resolved ensuring alignment and consistency across supply nodes.
Accountable for developing and delivering the Technical Lifecycle Plan (TLCP) including major geographical expansion requiring additional CMC activities on top of wave 1, new technologies and second‑generation programs impacting the manufacturing process, analytical process, pack, device, and associated specifications.
Ensure that product history and knowledge from development through the product’s lifecycle is maintained and aligns with knowledge management standards for the product or dose form within the Global Supply Chain network. Molecule steward is contributing as key inputter for process history file (PHF) reviewer and approver (if applicable).
Provide technical leadership and subject matter expertise for multi‑site investigations and/or critical deviations, troubleshooting, and major change programmes across supply nodes.
Stay current and maintain solid knowledge and understanding of complex scientific subject matter as well as evolving regulatory policies and guidelines and industry best practices.
Responsible for coordinating the technical review of regulatory submissions and responses to technical questions across MSAT, ensuring review by appropriate SME’s and sites (if required).
Represent MSAT, providing an MSAT single point accountable decision maker for GSC strategic team, CMC team, for established and new products, ensuring that a product control strategy is defined and maintained to drive a robust product that meets manufacturability criteria.
Develop and manage strong collaborations with technical staff across the Supply Chain sites, MSAT & R&D, and maintain and develop technical talent through mentoring across the network; with effective and clear communication on highly technical topics.
Manage stakeholders effectively.
Demonstrate knowledge of risk management approaches.
Basic Qualifications
Bachelor's degree in life sciences, pharmaceutical sciences, biochemical engineering, or a related field.
Experience in biopharmaceutical development, or a related scientific area.
Experience supporting molecule program management across preclinical and/or clinical stages.
Experience working within cross‑functional, matrixed development teams.
Experience working within external regulatory frameworks (e.g., FDA, EMA, MHRA, PMDA) in a pharmaceutical or biologics development environment.
Experience supporting technology transfer activities within a product development environment.
Preferred Qualifications
Ph.D. or Master’s degree is preferred.
Strong communication skills in English and experience presenting technical information to diverse audiences.
Experience using risk‑based approaches and project management tools.
Knowledge of global regulatory pathways for clinical development.
Comfort working in matrixed and cross‑cultural teams.
Work Location
This role is based in Upper Providence PA, Waltham MA, Durham NC, United Kingdom (GSK HQ, London or Ware), Wavre, Belgium, Aranda, Spain, Evreux, France and offers a hybrid working model, combining on‑site and remote work.
If you are based in Cambridge, MA, Waltham, MA, Rockville, MD, or San Francisco, CA, the annual base salary for new hires in this position ranges $220,275 to $367,125. The US salary ranges take into account work location within the US market, candidate’s skills, experience, education level and the market rate for the role. This position also offers an annual bonus and eligibility to participate in our share‑based long‑term incentive program, which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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 the Centers for Medicare and Medicaid Services (CMS) website.
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Manage a group of Molecule Stewards (5-10) accountable for end‑to‑end technical leadership of various pipeline and in‑line programs. Recruit and develop a world‑class team.
Serve on Molecule Steward leadership team to drive and improve portfolio and organizational excellence.
Responsible for defining and owning the technical strategy through a product’s lifecycle including product transfers R&D to GSK sites/External manufacturing sites & Site to Site (both GSK sites and external manufacturing sites), Product Performance Qualification and Ongoing Continuous Process Verification, leading Product Technical Lifecycle Team (PTLT) and yearly Manufacturing Robustness Review Board meetings (MRRB) to ensure risks are identified, escalated, mitigated and resolved ensuring alignment and consistency across supply nodes.
Accountable for developing and delivering the Technical Lifecycle Plan (TLCP) including major geographical expansion requiring additional CMC activities on top of wave 1, new technologies and second‑generation programs impacting the manufacturing process, analytical process, pack, device, and associated specifications.
Ensure that product history and knowledge from development through the product’s lifecycle is maintained and aligns with knowledge management standards for the product or dose form within the Global Supply Chain network. Molecule steward is contributing as key inputter for process history file (PHF) reviewer and approver (if applicable).
Provide technical leadership and subject matter expertise for multi‑site investigations and/or critical deviations, troubleshooting, and major change programmes across supply nodes.
Stay current and maintain solid knowledge and understanding of complex scientific subject matter as well as evolving regulatory policies and guidelines and industry best practices.
Responsible for coordinating the technical review of regulatory submissions and responses to technical questions across MSAT, ensuring review by appropriate SME’s and sites (if required).
Represent MSAT, providing an MSAT single point accountable decision maker for GSC strategic team, CMC team, for established and new products, ensuring that a product control strategy is defined and maintained to drive a robust product that meets manufacturability criteria.
Develop and manage strong collaborations with technical staff across the Supply Chain sites, MSAT & R&D, and maintain and develop technical talent through mentoring across the network; with effective and clear communication on highly technical topics.
Manage stakeholders effectively.
Demonstrate knowledge of risk management approaches.
Basic Qualifications
Bachelor's degree in life sciences, pharmaceutical sciences, biochemical engineering, or a related field.
Experience in biopharmaceutical development, or a related scientific area.
Experience supporting molecule program management across preclinical and/or clinical stages.
Experience working within cross‑functional, matrixed development teams.
Experience working within external regulatory frameworks (e.g., FDA, EMA, MHRA, PMDA) in a pharmaceutical or biologics development environment.
Experience supporting technology transfer activities within a product development environment.
Preferred Qualifications
Ph.D. or Master’s degree is preferred.
Strong communication skills in English and experience presenting technical information to diverse audiences.
Experience using risk‑based approaches and project management tools.
Knowledge of global regulatory pathways for clinical development.
Comfort working in matrixed and cross‑cultural teams.
Work Location
This role is based in Upper Providence PA, Waltham MA, Durham NC, United Kingdom (GSK HQ, London or Ware), Wavre, Belgium, Aranda, Spain, Evreux, France and offers a hybrid working model, combining on‑site and remote work.
If you are based in Cambridge, MA, Waltham, MA, Rockville, MD, or San Francisco, CA, the annual base salary for new hires in this position ranges $220,275 to $367,125. The US salary ranges take into account work location within the US market, candidate’s skills, experience, education level and the market rate for the role. This position also offers an annual bonus and eligibility to participate in our share‑based long‑term incentive program, which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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 the Centers for Medicare and Medicaid Services (CMS) website.
#J-18808-Ljbffr