Senior Scientist, Open to flexible working
GlaxoSmithKline 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 more, feel better and live longer.
Biopharm Process Development (BPD) is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life-cycle of asset development from Discovery through commercialization. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.
Biopharm Product Sciences & Device Engineering (BPS-DE) is a department within BPDS that designs, develops and delivers biologic drug products, manufacturing processes and devices via the integration and application of principles from basic sciences, pharmacy, engineering and technology.
The successful candidate will work closely with Biopharm Process Research (BPR) and Biopharm Medicine Discovery which are located within the state-of-the-art facilities at GSK Stevenage. BPR is a department within BPD that is dedicated to the identification of best-in-class, readily industrialised biopharmaceutical molecules, the development of commercial cell lines, and the development and transfer of processes to drug substance manufacturing facilities.
We are currently seeking a keen, dynamic and self-motivated Senior Scientist to join the BPS Early Development and Project Support Team. This team is dedicated to developing products and processes for toxicology and early phase clinical trials. As an experienced formulation scientist with strong background in bioanalytical and biophysical testing and characterization, you will have the opportunity to utilize your skills in devising, guiding, executing, analyzing, and interpreting pre-clinical formulation studies of BioPharm molecules. You will have the opportunity to use creative thinking to design non-GMP wet work and predictive modelling studies to drive a better understanding of pre-clinical molecules with respect to platform formulation, high concentration formulations, 'deviceability', and a molecule's chemical and physical stability during the manufacturing process and subsequent storage and handling.
Although predominantly lab-based, the role also involves important aspects of verbal and written communication and requires excellent organization skills, as well as a broader scientific knowledge. Both individual and team working are essential and therefore the role will suit a scientist with strong interpersonal skills, good abilities in data analytics and bioinformatics, and high self-motivation. Successful applicants will report to the BPS-DE team leader and will be an integral part of a high-performing and ambitious team. However, daily engagement with the BPR team and Discovery will be required to deliver the pipeline.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Identify potential gaps (e.g. biophysical & biochemical instability, solubility) in early development of candidate selection, and proactively advise modality-based pre-formulation activities to ensure robust candidate selections, in collaboration with BioPharm Discovery and Molecule Quality Analysis (MQA) groups in matrix role set-up.
- Design and execute pre-formulation scouting studies
- Working with key stakeholders, leverage predictive modelling approaches to drive a better understanding of pre-clinical molecules
- Specific responsibilities will be focused around laboratory experimentation and analytical testing of early phase formulations for a wide range of protein therapeutic assets
- Biophysical and bioanalytical characterization of native and modified biopharm compounds
- Design and execution of non-GMP stability protocols to test quality & stability of product formulations
- Working closely with internal & external development support partners, as needed
- Maintaining accurate, complete laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques; and involved in the preparation of development reports. Communicate results to line management as well as to broader BPD Stakeholders
The successful candidate will have experience and/or competencies related to:
- Protein and peptide chemistry
- Formulation and biophysical characterization of biopharm
- Bioanalytical techniques such as Differential Scanning Calorimetry/Fluorimetry, Viscometry, sub-visible particulate imaging
- Spectroscopic techniques such as FT-IR, Light Scattering (DLS, SLS, MALS), UV etc.
- Chromatography and electrophoretic techniques such as SEC-HPLC, c-IEF, iEX, HIC
We are looking for professionals with these required skills to achieve our goals:
- PhD or equivalent experience in Pharmaceutical science, Biology, Chemistry, Chemical Engineering, or related scientific discipline with 2-3 years of protein formulation and drug delivery development experience
- Experience with therapeutic protein and peptide chemistry and experience with formulation and biophysical characterization
- Experience with protein chromatography and electrophoretic techniques
- Experience with both conventional and alternative biopharmaceutical protein formulation, and drug product development
- Experience conducting DOE studies for formulation research activities and applying statistical interpretation to drive performance
If you have the following characteristics, it would be a plus :
- A strong understanding or working knowledge of Differential Scanning Calorimetry/Fluorimetry and Viscometry, sub-visible particulate imaging
- Good working knowledge of different spectroscopic techniques such as FT-IR, fluorescence, UV etc
- Quick adaptability in new scientific areas, working across teams and the use of shared lab instrumentation
- Experience of working with and leading matrix teams across time-bound multi-project work packages
- Strong attention to detail in experimental setup; excellent organizational and prioritization skills
- Ability to independently collate, analyse, interpret and draw conclusions from data
- Strong written and verbal communication skills
- Ability to independently design and execute work plans
- Experience and understanding of multiple bioanalytical techniques for product characterization and product stability evaluation, including analytical chromatography, capillary electrophoresis & surface plasmon resonance etc.
- Experience in working with in vivo/ in vitro models to critically assess formulation & delivery modalities.
- Experience in drug product manufacturing technology transfer to non-GMP and GMP drug product manufacturing would be beneficial.
- Creative and motivated self-starter, with excellent verbal and written communication skills, demonstrated ability to work independently and the ability to work effectively in team and matrix environments.
- Able to demonstrate the ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.
- Demonstrated effective interpersonal, communications and negotiation skills for a wide variety of audiences, including senior management
- Ability to handle large sets of data, including statistical analysis using software packages such as JMP/SIMCA/etc.
- Experience in liquid handling automation systems
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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