Associate Director - Biopharm CQA Lead at GSK in Collegeville, PA
Are you energized by a scientific leadership role that allows you to enhance and improve processes across biopharmaceutical product development? If so, this Associate Director role could be an ideal opportunity to explore. As a Associate Director, you will be responsible for providing in depth focus on due diligence evaluations for biopharmaceutical product sciences, and management and direction of Biopharmaceuticals Science staff across Biopharmaceutical Product Development (BPD) departments. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following A scientific individual contributor role under the Team Director of Mass Spectrometry and Characterization. Provides leadership and direction to mass spec and characterization scientists, analytical workstream leads and other stakeholders on the identification and life cycle management of critical quality attributes as related to physicochemical properties, structure function relationships, analytical comparability and phase-appropriate analytical control strategies of the therapeutic protein portfolio. Sets and leads internal strategies aligning to changes in analytical technologies, regulatory expectation, and portfolio. Works with candidate selection (CS) teams to understand potential CQAs (pCQAs) and knowledge transfer at CS Interfacing and collaborating with other functional areas (e.g. Discovery, in vitro/in vivo Translation, and clinical teams) in a matrix environment, to design suitable structure-function relationship studies including in vitro and in vivo studies to mitigate any potential CQA risk. Supports continuous improvement in analytical technologies, product characterization strategies, innovation, and efficiency within the department Providing leadership through effective feedback, coaching, mentoring, and training to influence cultural change to deliver the strategic priorities. Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
PhD in Analytical Chemistry, Biochemistry, Biology, or related scientific field with greater than 8 years' experience in biopharmaceutical development. Experience in the identification and life cycle management of critical quality attributes (CQA) for protein therapeutics. Knowledge and/or experience in analytical methodologies used to characterize physiochemical properties, immunochemical and biological activity of protein therapeutics. Knowledge and/or experience in analytical comparability, forced degradation and design of experiments for the understanding of structure function relationships Experience of regulatory requirements as applied to QbD (quality by design) and CQA, and phase-appropriate analytical strategies. Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
Experience in leading identification and life cycle management of CQA from early development through commercial launch, and developing risk based, phase-appropriate analytical strategies. Experience in design and execution of structure function relationship studies including in vitro and in vivo studies linking product quality attributes to biological activities as a part of the CQA identification and analytical control strategy development The ability to learn and apply CQA principles from monoclonal antibodies to novel modalities and remain current on scientific advances in CQA and QbD. Experience in leading multidisciplinary teams or projects, driving milestone and project progression in dynamic and challenging environment. Demonstrated ability to influence stakeholders without direct line authority Capability to efficiently prioritize and manage simultaneous deliveries to multiple projects, Excellent leadership, communication, and interpersonal skills Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
PhD in Analytical Chemistry, Biochemistry, Biology, or related scientific field with greater than 8 years' experience in biopharmaceutical development. Experience in the identification and life cycle management of critical quality attributes (CQA) for protein therapeutics. Knowledge and/or experience in analytical methodologies used to characterize physiochemical properties, immunochemical and biological activity of protein therapeutics. Knowledge and/or experience in analytical comparability, forced degradation and design of experiments for the understanding of structure function relationships Experience of regulatory requirements as applied to QbD (quality by design) and CQA, and phase-appropriate analytical strategies. Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
Experience in leading identification and life cycle management of CQA from early development through commercial launch, and developing risk based, phase-appropriate analytical strategies. Experience in design and execution of structure function relationship studies including in vitro and in vivo studies linking product quality attributes to biological activities as a part of the CQA identification and analytical control strategy development The ability to learn and apply CQA principles from monoclonal antibodies to novel modalities and remain current on scientific advances in CQA and QbD. Experience in leading multidisciplinary teams or projects, driving milestone and project progression in dynamic and challenging environment. Demonstrated ability to influence stakeholders without direct line authority Capability to efficiently prioritize and manage simultaneous deliveries to multiple projects, Excellent leadership, communication, and interpersonal skills Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
Salary Range:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
