- 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.
-
Biologics Process Validation Leader
4 days ago
1925 GlaxoSmithKline LLC Rockville, United States Full timeAre 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, yo ...
-
Biologics Process Validation Leader
2 weeks ago
GSK Rockville, United StatesAre 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, yo ...
-
Biologics Virus Clearance Validation Leader
2 weeks ago
GSK Rockville, United StatesAre you energized by a scientific leadership role that allows you to enhance and improve processes across biologics manufacturing? If so, this Biologics Virus Clearance Validation Leader role could be an ideal opportunity to explore. · As a Biologics Virus Clearance Validation Le ...
-
Biologics Virus Clearance Validation Leader
2 weeks ago
GlaxoSmithKline Rockville, United StatesSite Name: USA - Maryland - Rockville · Posted Date: Apr 8 2024 · Are you energized by a scientific leadership role that allows you to enhance and improve processes across biologics manufacturing? If so, this Biologics Virus Clearance Validation Leader role could be an ideal oppo ...
-
Biologics Virus Clearance Validation Leader
3 days ago
Glaxosmithkline Rockville, United StatesSite Name: USA - Maryland - RockvillePosted Date: Apr 8 2024Are you energized by a scientific leadership role that allows you to enhance and improve processes across biologics manufacturing? If so, this Biologics Virus Clearance Validation Leader role could be an ideal opportunit ...
-
Security Assistant, Richard Montgomery Hs, 8hrs
3 weeks ago
Montgomery County Public Schools Rockville, United States**Security Assistant, Richard Montgomery HS, 8hrs / 10mos, Ad Closes ** · **MCPS Official Job Description** · **SUMMARY DESCRIPTION**: · Positions in this class are assigned to the local school to assist the administration maintain a safe and secure learning environment for the s ...
-
Security Assistant, Richard Montgomery Hs, 8hr
3 weeks ago
Montgomery County Public Schools Rockville, United States**Security Assistant, Richard Montgomery HS, 8hr / 10mos, Ad Closes ** · **MCPS Official Job Description** · **SUMMARY DESCRIPTION**: · Positions in this class are assigned to the local school to assist the administration maintain a safe and secure learning environment for the sc ...
-
Honda Apprentice Technician
3 weeks ago
Hersons Honda Rockville, United States**Apprentice Technician** · Herson's Auto Group is hiring, and we want to talk to you · **BENEFITS** · - HealthCare Plan · - Dental Plan · - 401 (k) w/ Company Match · - Health Savings Plan · - Growth Opportunities · - Career & Factory Training · **RESPONSIBILITIES**: · - Examine ...
-
Risk Adjustment Manager
3 weeks ago
Mid-Atlantic Permanente Medical Group PC Rockville, United StatesMid-Atlantic Permanente Medical Group is comprised of more than 1,700 Permanente physicians and nearly 300 staff professionals who come together to make a positive impact on the health and lives of more than 800,000 members in Virginia, Maryland, and the District of Columbia. · R ...
-
Economic Development Specialist
3 weeks ago
MONTGOMERY COUNTY ECONOMIC DEVELOPMENT CORPORATION Rockville, United StatesThe **Economic Development Specialist (Life Sciences) **is an exempt, full-time position and serves as a key member of the MCEDC's business development team. This position will perform increasingly responsible work to attract and retain life sciences companies in Montgomery Count ...
-
Field Auto Adjuster
2 weeks ago
Allstate Rockville, United StatesThe world isn't standing still, and neither is Allstate. We're moving quickly, looking across our businesses and brands and taking bold steps to better serve customers' evolving needs. That's why now is an exciting time to join our team. You'll have opportunities to take risks, c ...
-
Clinical Project Leader
4 days ago
Champions Oncology Inc. Rockville, United States**Title**:Clinical Project Leader · **Reporting Location**: ROCKVILLE, MD** · **Primary Objectives**:The Clinical Project Leader (CPL) serves as the primary point of contact for Champions vast portfolio of client sponsors regarding Champions aspects of sponsors clinical trial exe ...
-
Maryland State Automotive Inspector
1 week ago
HERSON'S KIA Rockville, United States**Maryland State Automotive Inspector** · This is more than a job, it's a career opportunity. We promote from within, so join our team and start your career today Plus, we are offering a **$1,000 signing bonus** · **BENEFITS** · - HealthCare Plan · - Dental Plan · - 401 (k) w/ Co ...
-
Wheel Repair Technician
1 week ago
WheelsOnsite Rockville, United States**Hiring Immediately** · **Position Location**: · Our technicians conveniently recondition wheels wherever our customers are (their shop, home, or workplace) all while the wheel remains mounted to the vehicle. · The wheel repair technician hired for this position will service our ...
-
HR Representative
6 days ago
Rockville Housing Enterprises Rockville, United StatesThe Human Resources Representative (HRP) position is responsible for aligning business objectives and HR functions to deliver value-added service to management and employees in designated business units. The HRP develops human resources solutions and supports business units on hu ...
-
Student Engagement Associate
1 week ago
Future Link Rockville, United StatesAre you a self-starter ready to assist motivated young adults to succeed in post-secondary education and the workforce? Want to contribute to a mission-minded nonprofit team that transforms lives? · **Responsibilities**: · **1. Seminar Leader** · - Provide leadership and logistic ...
-
Nurse Practitioner
1 day ago
Ikon Health Montgomery County, MD, United States**About Ikon Health** · Ikon Health is a premier leader in providing primary care house-calls to the homebound throughout Montgomery, Howard and Prince George's Counties, MD. Our goal is to provide high quality medical care to the homebound geriatric community, ensuring they have ...
-
Affiliate Relations Specialist
2 weeks ago
NEA Member Benefits Gaithersburg, United States**POSITION FUNCTION AND PURPOSE** · **SPECIFIC DUTIES AND RESPONSIBILITIES** · - Develop and manage assigned territory and achieve annual goals. · - Develop and leverage relationships with key affiliate stakeholders. · - Educate members, affiliate leaders and staff about NEA MB p ...
-
Laborer
2 weeks ago
1-800-GOT-JUNK? Gaithersburg, United States1-800-GOT-JUNK? is looking for happy, reliable, and physically fit individuals to join our growing team We make the ordinary business of junk removal exceptional We are proud to be the leaders of our industry, and we recognize that every member of our team is a vital contributor ...
-
Water Technologies Technician
2 weeks ago
Boland Trane Associates Inc & Boland Trane Services Inc Gaithersburg, United StatesJoin the industry leader** BOLAND** provides clients with sustainable and energy efficient solutions for commercial, institutional and industrial buildings in the Washington, DC / Baltimore metropolitan area. We allow building occupants and owners to do what they do best - focus ...
Biologics Process Validation Leader - Rockville, United States - GlaxoSmithKline
Description
Site Name:
Rockville Biopharm
Posted Date:
Apr 8 2024
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:
Preferred Qualifications:
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.
