- Uses regulatory guidance and industry best practice, and scientific and technical experience, to develop innovative approaches to process or viral clearance validation.
- Plans, executes and reports process or viral clearance validation studies through process sciences, CROs, internal NPI or commercial DS sites or strategic CDMOs.
- Authors regulatory submissions, responds to health authority information requests and presents at pre-approval & cGMP inspections as necessary.
- Participates in deviation, change & continuous improvement evaluations in support of continued lifecycle verification.
- Participates in the development & implementation of new process and analytical manufacturing technologies in support of biologics DS processes.
- Manages CRO or CDMO contracts, and the effective management of expenditure and effort in support of process or viral clearance validation studies.
- Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate.
- Provides technical leadership and establishes key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and also with R&D.
- BSc in Scientific Discipline
- Minimum 5 years' demonstrated experience in the Pharmaceutical Industry in leading the technical aspects of the product lifecycle, including technical risk assessments, product control strategies, bench, pilot & commercial scale validation studies, QbD, PPQ, CPV and change control.
- Experienced in process validation at commercial scale and bench scale.
- Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
- Excellent problem solver and ability to think and work creatively.
- Demonstrated knowledge of Quality by Design and risk management approaches.
- Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.
- Broad and integrated knowledge that can impact project and workgroup direction. Working knowledge of regulatory requirements in the industry and drug development.
- Must have excellent verbal and written communication skills, and ability to influence, lead and drive change.
- Experience in program management, process validation, BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, change and deviation management), and knowledge management.
- Ability to support due diligences.
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Biologics Process Validation Leader - Rockville, United States - GSK
Description
Are you energized by a scientific leadership role that allows you to enhance and improve processes across biopharmaceutical manufacturing? If so, this Biologics Process Validation Leader role could be an ideal opportunity to explore.As a Biologics Process Validation Leader, you will be responsible for technical leadership of important programs of work to support lifecycle changes. The role provides leadership across process sciences, a CRO, an NPI or commercial site, or a CDMO to ensure that the studies are completed to the latest regulatory, cGMP requirements and time and cost. The Biologics Process Validation Leader is responsible for cell culture and purification process stretching studies, resin lifetime studies, buffer/solution hold time studies, at-scale membrane and resin lifetime verification studies, virus clearance studies, limit of in-vitro cell age studies, preparation for the regulatory files, PAI and support through the product lifecycle including knowledge management.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
If you have the following characteristics, it would be a plus:
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why Us?
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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.
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.
