- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Oct 5 2020
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 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.
The open position resides within Biopharm Product Sciences, a department under the larger Biopharm Process Development department. Biopharm Product Sciences focuses on developing world class patient-centric biopharmaceutical drug products and delivery devices through innovation, technology and strategic partnering. The successful candidate will focus on late stage CMC development of biopharm drug products through protein formulation and drug product process (fill-finish) development/characterization/validation activities.
Role responsibilities will include laboratory experimentation, analytical testing, and technical report authoring related to development of protein formulations and processes for drug product manufacturing. The position will include physicochemical and bioanalytical characterization of Biopharm compounds; crafting & execution of non-GMP stability studies to generate product and drug product manufacturing process knowledge, and interfacing with the quality organization to craft GMP stability protocols and assessing results to establish shelf-life; working with Device Engineering to coordinate introduction of delivery devices into drug product development, working closely with internal & external discovery and development support partners, as needed; maintaining accurate, complete laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques; and, will also require authoring and review of equipment procedures, technical reports, and regulatory documentation (e.g., IND/IMPD, BLA/MAA/JNDA, etc.).
This laboratory-based role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Designs and executes protocols related to area of expertise
- Executes a wide range of experiments and development studies independently based on a protocol
- Identifies and troubleshoots problems in the execution of experimental processes, technical studies, and tasks.
- Fully understands the rationale and hypotheses for experimental designs and/or has extensive theoretical understanding of a particular area of science.
- Develops understanding of regulatory requirements
- Comply with data integrity requirements
- Authoring of technical reports and sections of regulatory documentation
Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Bachelor's or Master's degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
- 2-5 years of laboratory-based experience
- Experience, knowledge and/or competencies in protein or peptide chemistry, formulation and drug delivery/device development, and drug product manufacturing principles
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Creative and motivated self-starter
- Strong organizational skills
- Maintains accurate, complete laboratory records
- Ability to work effectively in team and matrix environment
- Excellent verbal communication and technical writing skills
- Ability to maintain accurate complete laboratory records
- Experience with both conventional and alternative protein formulation and drug delivery/device approaches or experience in protein drug product manufacturing process (fill-finish) area.
- Experience using bioanalytical and/or biophysical techniques for critically assessing product characterization and product stability evaluation, including e.g., HPLC, capillary electrophoresis (cGE, cIEF), SEC, Spectroscopy (UV/VIS, fluorescence, or CD), & DSC.
- Regulatory documentation authoring experience (IND/IMPD, BLA/MAA, etc.).
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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