Biologics Drug Substance Leader

2 weeks ago

King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time

Site Name:
USA - Pennsylvania - King of Prussia

Posted Date:
May

Are you energized by a impactful role that allows you to drive technology transfer, process performance qualification and commercialization for the drug substance manufacturing process for our innovative large molecule portfolio? If so, our MSAT drug substance lead role could be an excellent opportunity to explore


As a MSAT drug substance lead, you will engage with our process development groups, global MSAT and the new product introduction sites, and ensure that our transfer, control strategies and technical support targets are met.

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

  • Ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug substance: Technical Risk Assessment, Product Control Strategy, Process Performance Qualification, Continued Process Verification and Process Robustness Assessment. Ensure risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g., CAPAs or governance boards.
  • Ensure QbD principles are applied, and a robust and well understood process and product control strategy underpin technical transfer, full scale clinical development and commercialisation for new products from R&D, and lifecycle transfers to other commercial sites.
  • Assess the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of Technical Risk Assessment and Product Control Strategy.
  • Lead the initial technology transfer if new processes from R&D or from the MSAT process sciences groups and then to other manufacturing sites, internally and externally. Responsible for developing DS technology transfer and PPQ strategies aligned to the new product industrialization strategy.
  • Further to the TT, work with internal or external site partners to deliver manufacturing campaigns aligned to strategy. Provide leadership and subject matter expertise required to deliver successful PPQ campaign outcomes.
  • Lead cross functional improvement projects with a clear demonstration of value created.
  • Provide technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
  • Respond to technical questions during regulatory submission and inspections. Recommend technical readiness to launch, including ensuring technical aspects of Transfer Acceptance Criteria are achieved.
  • Provide leadership and subject matter expertise where required to support the investigation and resolution of product complaints and deviations, in-particular complex investigations.
  • Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate.
  • Provide technical leadership and establishes key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and with R&D.
Why you?

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

  • Bachelor's Degree in a scientific discipline
  • 5+ years of experience in late stage process development or MSAT roles supporting industrialization & commercialization.

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

  • Experience delivering a late stage drug substance technology transfer, with an understanding of the product development process.
  • Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
  • Track record of improving products, processes and troubleshooting, execution of technical activities including validation activities.
  • Proven problem-solving skills and ability to think and work creatively.
  • Demonstrated experience in the pharmaceutical industry in leading the technical aspects of Product Lifecycle Management.
  • Demonstrated knowledge of Quality by Design and risk management approaches.
  • 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.
  • Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO), process validation and BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, Change and Deviation Management), and knowledge management.
  • Knowledge of regulatory requirements for biopharmaceutical production, including principles of quality by design.
  • Ability to support due diligence activities.
#LI-GSK

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

Why GSK?

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


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.

We prevent and treat disease with vaccines, specialty and general medicines.

We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be.

A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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.

  • Director, Clinical Portfolio Execution

    4 weeks ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job DescriptionCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and 30,000 employees worldwide, CSL is inspired to develop...

  • Director, Clinical Portfolio Execution

    2 weeks ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job DescriptionJob DescriptionCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is...

  • Investigator, Advanced Data Analytics

    4 weeks ago

    King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: Upper MerionPosted Date: May 7 2024GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do...

  • Warehouse Manager

    1 week ago

    King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - King of PrussiaPosted Date: Jun We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at...

  • Microbiologist I

    4 weeks ago

    King of Prussia, Pennsylvania, United States Eurofins Full time

    Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest...

  • Senior Manager/Associate Director

    2 weeks ago

    King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - King of Prussia, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: Jun 5 2024 The Senior Manager/Associate Director, Biologic Services, Strategic External Development will be a subject matter expert, who has established a deep understanding of the modality of antibody-drug conjugates (ADCs),...

  • Senior Manager/Associate Director

    4 weeks ago

    King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time

    Site Name: USA - Pennsylvania - King of Prussia, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: Jun 5 2024 The Senior Manager/Associate Director, Biologic Services, Strategic External Development will be a subject matter expert, who has established a deep understanding of the modality of antibody-drug conjugates (ADCs),...

  • GMP Quality Analyst

    2 weeks ago

    King of Prussia, Pennsylvania, United States Eurofins USA PSS Insourcing Solutions Full time

    Job DescriptionJob DescriptionCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on,...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Nom du site: USA - Pennsylvania - King of PrussiaDate de publication: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and maintenance of...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Nazwa biura: USA - Pennsylvania - King of PrussiaPosted Date: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and maintenance of SOPs and...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Standort: USA - Pennsylvania - King of PrussiaDatum: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and maintenance of SOPs and quality...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Nombre del sítio: USA - Pennsylvania - King of PrussiaFecha de publicación: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Tên địa điểm: USA - Pennsylvania - King of PrussiaNgày đăng tuyển: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Nama Site: USA - Pennsylvania - King of PrussiaTanggal Posting: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and maintenance of SOPs and...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Munkavégzés helye: USA - Pennsylvania - King of PrussiaKihirdetett időpont: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Locație: USA - Pennsylvania - King of PrussiaData postării: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and maintenance of SOPs and...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Site Name: USA - Pennsylvania - King of PrussiaPosted Date: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and maintenance of SOPs and...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Nome della sede: USA - Pennsylvania - King of PrussiaData di apertura: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and maintenance of...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Pobočka: USA - Pennsylvania - King of PrussiaDatum zveřejnění: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and maintenance of SOPs...

  • Archivist (Biobanking, Human Sample Management)

    4 weeks ago

    King of Prussia, Pennsylvania, United States GSK Full time

    Nome do Local: USA - Pennsylvania - King of PrussiaData da Publicação: Apr We are looking to recruit an archivist who will be responsible for the day-to-day operation of human sample bank including receiving, inspecting, accessioning, archiving, shipping of human samples, as well as management of equipment in the sample bank, development and maintenance of...