Laboratory Management, Downstream Process Development

King of Prussia, Pennsylvania
Closing date
Jan 28, 2022

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Pharmaceutical, Laboratory, Supply Chain, Quality Assurance
Organization Type
Jobseeker Type
We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us! Click to know more about GSK Biopharm. #GSKBiopharm_Development Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Senior Scientist, Laboratory Management, Biopharm Downstream Process Development role could be an exciting opportunity to explore. 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. 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. Within Biopharm Process Development, the Downstream Process Development (DPD) department is responsible for the development of purification processes for the manufacture of GSK's Biopharm assets. The Department is also responsible for the scale-up and tech transfer of the processes to manufacturing facilities all over the world. Our aim is to integrate innovative process platforms, automation and advanced data analytics into the downstream process development workflow. In our mission, we follow the science and are committed to the design, development, and transfer of the most robust, well-understood, and well-characterized downstream manufacturing processes and platforms that will ensure quality and reliable supply of medicines for the patient. To deliver on our mission, we rely on a robust infrastructure of modern laboratories, equipment, and safe lab practices critical to the generation of scientific process knowledge, supporting the biopharm development portfolio. As a Laboratory Management Senior Scientist in Downstream Process Development (DPD), you will be responsible for managing department adherence to all GSK global laboratory and Environment, Health and Safety (EHS) standards and for coordinating all activities and budgets necessary to maintaining our adherence excellent. This role will interface above department to central teams and across site to peer safety and operation compliance managers to ensure consistency in our program and initiatives. You will also be the primary interface between department and EHS functions to assure proper and timely execution of capital projects, EHS suggestions, actions resulting from any safety incidents, and other EHS compliance initiatives. Finally, you will own and be ultimately responsible for laboratory equipment maintenance programs and service activities. Through your leadership, you will support the efficient operation, utilization, and improvement of our laboratory spaces and footprint. Although predominantly lab-based, the role involves verbal and written communication and requires good organization. Both individual and team working are required and therefore the role will suit a scientist with good interpersonal skills, self-motivation and an open mindset. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Own the department safety standards, specifications, auditable compliance framework, and adherence to all GSK global laboratory and EHS standards. Lead the yearly safety trainings & new employee safety training, standard work, and laboratory operation management. Organize and participate lab and office inspection to maintain audit readiness. Support EHS and other audit readiness of DPD labs. Promote a strong and robust safety-minded culture. Create, Revise and / or update safety risk assessments for DPD lab activities. Support & facilitate investigations for near miss and safety incident. Summarize and communicate CAPA to all DPD in a mindset of continuous improvement. Ensure that the lab equipment and computers are maintained current, networked and protected in compliance with data integrity core principles. Support new equipment installation, relocation, and equipment removal (ESO). Ensure continued DCS integration of new assets (refrigerators, freezers, laboratory instruments), communicate current DSC way of working and ensure proper training. Develop an in-process material storage program for the department, ensuring the maintenance of updated inventory records of critical materials. Support freezer monitoring and communicate way of working for responding to alarms notifications. Ensure yearly freezer cleanouts and updated inventory records. Stay abreast of new process lab technologies, propose improved ways of working and new ideas for equipment platform in the lab. Define and communicate ways of working and guidance/protocols for commonly used DPD equipment/instruments. Maintain capital equipment request timeline, list of equipment & propose prioritization. Provide feedback and support DPD lab renovation projects. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's or Master's degree (Chemical Engineering, Biochemistry, Chemistry or Biology, equivalent Life Science degree) with 5+ years of relevant experience. Experience working with R&D laboratory safety guidance and policies. Experience in laboratory operation management. Experience working with biopharm mechanical, electrical, instrumentation, computer and process equipment. Preferred Qualifications: If you have the following characteristics, it would be a plus: Demonstrated effective management of significant capital and ownership of systems subject to audits from oversight groups. Demonstrated capability of leading matrix teams with excellent communication and influencing abilities at all levels. Previous laboratory experience in biopharm process development. Leadership skills that enable the introduction of new ways of working and accelerated change management. Proven capability to lead and motivate matrix teams (multi-disciplinary & cross-departmental) to deliver business solutions and benefits. Demonstrate initiative, creative, and analytical problem solving skills - ability to use and interpret data to drive decision making at both tactical and strategic level. Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant 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. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK GSKBiopharm_Development 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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.

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