GSK

Scientific Leader, Sterile Product Formulation

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Posted
October 27 2020
Ref
268834
Organization Type
Pharma
As an experienced formulation scientist with strong background in classic Pharmaceutical Chemistry, you will have the opportunity to utilize your skills in executing and guiding pre-formulation and formulation of small molecules from pre-candidate selection to Phase I and beyond. You will have the opportunity to use creative thinking to drive drug development of a variety of sterile product dosage forms at GSK's Sterile Products Centre of Excellence in Collegeville, PA.

Key Responsibilities:
  • Identify gaps (e.g. physical & chemical instability, local tolerability, solubility) in early development of candidate selection, and proactively advise modality-based pre-formulation activities to ensure robust candidate selections, in collaboration with discovery chemistry, automation and developability groups in matrix set-up.
  • Handle formulation design and execute them from pre-clinical to clinical phases, with greater emphasis on pre-formulation aspects to get it right at first time as much possible.
  • Interface and contribute to CMC miles stone and provide scientific data-based risk identification for early and late stage sterile projects.
  • Liaise with early stage DMPK and Safety groups to troubleshoot solubility, stability and local tolerability related issues with early stage drug candidates.
  • Review form and version screen data package and judge / identify potential polymorphs/metastability issues in context of sterile formulation processes lyophilization, milling, autoclave. etc, and advise on suitability of selected form and version for proposed drug product modality.
  • Collaborate with API and material characterization groups to understand the polymorphism landscape and be vigilant about its impact on drug product development.
  • Work closely with sterile pilot plant for GLP and clinical manufacturing and define processes that are compatible with Sterile Pilot Plant expectations and norms, including authoring batch records drafting and ensuring successful clinical supply manufacturing.
  • Contribute to regulatory document review and writings.
  • Communicate results to line management as well as to broader Pharm. Dev. stakeholders.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • PhD in Physical Pharmacy/Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences, Materials Science, or related discipline with at least 2 years of post-PhD experience.
  • Experience in solution equilibria, pH Solubility, aggregation and modelling
  • Experience in pH Stability, rate profiling, degradation kinetic, understanding of degradation pathways.
  • Experience in knowledge of polymorphism, phase mapping / characterization, thermodynamic profiling e.g. free energy vs. temperature profiling.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Experience in sterile product requirements and unit operation e.g. aseptic filtration, lyophilization, wet bead milling, primary container closer selection.
  • An individual with experience in pre-formulation and with line of sight to develop sterile formulation of various modality, including solution, lyophilized and nanosuspension. A strong understanding of physicochemical properties of drugs and its implications on drug product development.
  • Ability to apply scientific fundamentals in routine troubleshooting with sense of urgency.
  • Agility to develop new skills in depth.
  • Knowledge of regulatory requirements for sterile products.


Why GSK?

Our values and expectationsare 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:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.


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.

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