Are you energized by a scientific leadership role that allows you to enhance and improve processes across biopharmaceutical product development? If so, this Scientific Leader role could be an ideal opportunity to explore.
As a Scientific Leader, you will be responsible for leading internal and external development of recovery and purification processes for both early and late stage biopharmaceutical assets.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Agility to adapt to changes in the balance of internal and external portfolio. Must have significant expertise in protein purification and process development at bench-scale with experience in process scale-up, and a corresponding demonstrated record of achievement and broad integrated knowledge of the field.
Supporting internal/external manufacturing processes as a subject matter expert, including the authoring and review of externalized work packages and scope of work documentation.
National and international travel may be required to support technology transfer and manufacturing activities.
Involvement in the authorship and review of INDs/IMPDs and BLAs/MAAs for biopharmaceuticals; process characterization, validation and technology transfer for commercial manufacture, as well as process transfers to support manufacture for early- and late-stage clinical trials.
As a technical leader, using extensive technical knowledge and ability to turn concepts into manufacturing methods; interpreting complex data and information and making decisions and proposals that impact quality and cost.
Managing across multiple projects simultaneously, leading matrix teams, supervising, mentoring, and training staff members (group of 3-8 scientists).
We are looking for professionals with these required skills to achieve our goals:
PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry, or Biology, or other relevant discipline with 7 or more years industrial experience in therapeutic protein purification process development, or BS/MS graduate with equivalent experience.
Expertise in therapeutic protein purification, process development, scale-up, and technology transfer.
Demonstrated record of achievement and broad integrated knowledge of all aspects of the work.
Thorough knowledge of drug development and of regulatory requirements in the industry, including familiarity with cGMPs.
Experience contributing to CMC matrix project teams
If you have the following characteristics, it would be a plus:
Experience with both early and late phase development of purification processes, process scale-up, technology transfer (internal and to external CMO), process validation and BLA/MAA preparation for biopharmaceuticals.
Previous experience demonstrating strong business acumen in supporting external process development and manufacturing activities is strongly preferred.
Requires excellent oral and written communication skills to effectively deliver new medicines via internal and external CMC efforts.
Broad and integrated knowledge and experience that can impact project and work-group direction.
Demonstrated record of innovation and technology development. Knowledge of regulatory requirements for biopharmaceutical production, including principles of quality by design and virus clearance validation.
Experience with purification of protein products from both mammalian and microbial cell culture.
Involvement in external scientific and industrial community as demonstrated by a record of presentations, publications and participation in conferences.
Demonstrated ability to supervise and mentor others. Experience recruiting and training staff.
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:
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 HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. 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.
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.