GSK
Director, Analytical Development (Small Molecule/Oligonucleotide)
GSK, Collegeville, Pennsylvania, United States, 19426
Site Name:
USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date:
Nov 1 2024
The
Director of Analytical Development
(Small Molecule/Oligonucleotide) will join the Analytical Operations Leadership Team and will lead a team of analytical scientists responsible for the development, validation and transfer of analytical methods and characterization of drug substances, drug products and process intermediates of multiple therapeutic modalities (small molecule, oligonucleotides, biologics, inc. mAbs, bispecifics, ADCs, etc.) within the Strategic External Development (SED) organization.
The Director will be responsible for people and project leadership with an emphasis on small molecules and oligonucleotides and will provide oversight of analytical project leads and technical leads within the team in a broad analytical development role that spans from managing collaboration with appointed CDMOs to overseeing, developing and executing aligned GSK and CDMO drug development goals. The Director will provide leadership and support to develop the team to their full potential and will contribute to creating an inclusive department culture which embraces diversity.
This role will provide YOU the opportunity to lead a team and key activities to progress YOUR career, these responsibilities include some of the following…
Provide leadership to the team in the development of scientific capability and analytical strategies. Build and maintain strong relationships with internal and external partners to ensure successful analytical strategies are positioned and implemented for the pipeline molecules in the Strategic External Development organization.
Provide leadership, guidance, and strategic direction to a group of analytical scientists on all aspects of analytics for all projects residing within the group and ensure staff are developed to their fullest potential by providing coaching, mentoring, and appropriate learning opportunities to optimize leading analytical sciences in a virtual setting.
Collaborate with Drug Substance, Drug Product and Quality functions to ensure strong cross functional collaborations and integrated process and product development and characterization. Provide clear communication to team and partners as well as functional line and matrix management regarding progress against technical / project milestones as well as organizational objectives.
Ensure efficient and effective development, utilization, and transfer of high-quality and optimized analytical methods and associated specifications for drug substances and/or drug products that meet or exceed the expectations of internal partners and external regulators and that ensure the high and consistent quality and performance of drug substances and/or products.
Ensure on-time delivery of high-quality CMC packages for submissions that meet or exceed the expectations of external regulators and lead to first-cycle approvals. Provide leadership and guidance to the team in the preparation of CMC content for regulatory submission and responses to regulatory agencies as well as conducting review/approval, as required.
Ensure the work conducted by external partners and the group is performed in accordance with GSK and external regulatory quality standards in the markets of interest and is also conducted in accordance with GSK and local EH&S standards
Embrace inclusion and diversity to create a modern and dynamic working environment across the function.
Ensure the team meets agreed performance, throughput and quality targets and that resourcing is aligned to R&D priorities.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
B.S., M.S., or Ph.D. degree in analytical chemistry, chemistry, or biochemistry. or related science/engineering degree with the following pharmaceutical industry experience
15+ years with a B.S degree
12+ years with a M.S. degree
10+ years with a Ph.D. degree
Experience in managing, coaching, mentoring and developing analytical scientists.
Experience working with small molecules and oligonucleotides methodologies and strategies with experience in a specification setting.
Experience with analytical method development including characterization methodologies for drug substance and drug product, validation and transfer.
Experience in building and managing relationships with 3rd parties and leading virtual CMC teams to deliver analytical control strategies for drug substances and drug products.
Experience in late-stage drug development including authoring and reviewing regulatory files (IND, IMPD, BLA, NDA, MAA, etc.).
Experience of non-regulated, GLP and GMP processes to develop a medicine ready for commercial release and supply to the clinic.
Experience analyzing trend data to drive continuous improvement.
Experienced handling and escalating issues based on risk.
Experience in drug product development disciplines and relationship of analytical testing to drug development
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Strong understanding of product development disciplines and relationship of analytical testing to drug development
Experience in managing and developing leaders
Exposure to all stages of drug development.
Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.
Experience across multiple therapeutic modalities (small molecules, oligonucleotides and large molecules (mAbs, bispecifics, ADCs, etc.))
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 and drive for results.
#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 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.
#J-18808-Ljbffr
USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date:
Nov 1 2024
The
Director of Analytical Development
(Small Molecule/Oligonucleotide) will join the Analytical Operations Leadership Team and will lead a team of analytical scientists responsible for the development, validation and transfer of analytical methods and characterization of drug substances, drug products and process intermediates of multiple therapeutic modalities (small molecule, oligonucleotides, biologics, inc. mAbs, bispecifics, ADCs, etc.) within the Strategic External Development (SED) organization.
The Director will be responsible for people and project leadership with an emphasis on small molecules and oligonucleotides and will provide oversight of analytical project leads and technical leads within the team in a broad analytical development role that spans from managing collaboration with appointed CDMOs to overseeing, developing and executing aligned GSK and CDMO drug development goals. The Director will provide leadership and support to develop the team to their full potential and will contribute to creating an inclusive department culture which embraces diversity.
This role will provide YOU the opportunity to lead a team and key activities to progress YOUR career, these responsibilities include some of the following…
Provide leadership to the team in the development of scientific capability and analytical strategies. Build and maintain strong relationships with internal and external partners to ensure successful analytical strategies are positioned and implemented for the pipeline molecules in the Strategic External Development organization.
Provide leadership, guidance, and strategic direction to a group of analytical scientists on all aspects of analytics for all projects residing within the group and ensure staff are developed to their fullest potential by providing coaching, mentoring, and appropriate learning opportunities to optimize leading analytical sciences in a virtual setting.
Collaborate with Drug Substance, Drug Product and Quality functions to ensure strong cross functional collaborations and integrated process and product development and characterization. Provide clear communication to team and partners as well as functional line and matrix management regarding progress against technical / project milestones as well as organizational objectives.
Ensure efficient and effective development, utilization, and transfer of high-quality and optimized analytical methods and associated specifications for drug substances and/or drug products that meet or exceed the expectations of internal partners and external regulators and that ensure the high and consistent quality and performance of drug substances and/or products.
Ensure on-time delivery of high-quality CMC packages for submissions that meet or exceed the expectations of external regulators and lead to first-cycle approvals. Provide leadership and guidance to the team in the preparation of CMC content for regulatory submission and responses to regulatory agencies as well as conducting review/approval, as required.
Ensure the work conducted by external partners and the group is performed in accordance with GSK and external regulatory quality standards in the markets of interest and is also conducted in accordance with GSK and local EH&S standards
Embrace inclusion and diversity to create a modern and dynamic working environment across the function.
Ensure the team meets agreed performance, throughput and quality targets and that resourcing is aligned to R&D priorities.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
B.S., M.S., or Ph.D. degree in analytical chemistry, chemistry, or biochemistry. or related science/engineering degree with the following pharmaceutical industry experience
15+ years with a B.S degree
12+ years with a M.S. degree
10+ years with a Ph.D. degree
Experience in managing, coaching, mentoring and developing analytical scientists.
Experience working with small molecules and oligonucleotides methodologies and strategies with experience in a specification setting.
Experience with analytical method development including characterization methodologies for drug substance and drug product, validation and transfer.
Experience in building and managing relationships with 3rd parties and leading virtual CMC teams to deliver analytical control strategies for drug substances and drug products.
Experience in late-stage drug development including authoring and reviewing regulatory files (IND, IMPD, BLA, NDA, MAA, etc.).
Experience of non-regulated, GLP and GMP processes to develop a medicine ready for commercial release and supply to the clinic.
Experience analyzing trend data to drive continuous improvement.
Experienced handling and escalating issues based on risk.
Experience in drug product development disciplines and relationship of analytical testing to drug development
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Strong understanding of product development disciplines and relationship of analytical testing to drug development
Experience in managing and developing leaders
Exposure to all stages of drug development.
Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.
Experience across multiple therapeutic modalities (small molecules, oligonucleotides and large molecules (mAbs, bispecifics, ADCs, etc.))
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 and drive for results.
#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 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.
#J-18808-Ljbffr