BIOLOGICS DP LEADER

Description.
Site Name.
UK - County Durham - Barnard Castle, Italy - Parma Posted Date.
Dec Biologics DP Leader The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical / operational support to ensure that GSK Global Supply Chain (GSC) network, and site goals/objectives for life-saving medicines are achieved, through a focused strategy execution.
As the Biologics Drug Product Leader, you will be responsible for technical leadership for injectable drug products (both biologic and oligonucleotide) spanning new product introduction (NPI) to post-approval commercial supply across multiple manufacturing sites as appropriate while maintaining key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and also with R&D.
The Biologics Drug Product Lead is responsible for technology transfer, process validation, supports regulatory filing activities, preparation for PAI and technical support through the product lifecycle including knowledge management.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included.
We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will Be responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug product.
Technical Risk Assessment, Product Control Strategy, Stage 2 and Stage 3 (PPQ and CPV) Process Validation, Process Robustness Assessment, leads cross functional improvement projects, and change implementation impact assessments on CQAs/CPPs.
Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.
.
CAPAs or governance boards Lead the technology transfer from R&D and between manufacturing sites, internally and externally while ensuring QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialisation.
Provide technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
Respond to technical questions during regulatory submission and inspections.
Recommends Technical readiness to launch, including technical aspects of Transfer Acceptance Criteria are achieved.
Be 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.
Why you? Basic Qualifications & Skills.
We are looking for professionals with these required skills to achieve our goals.
BSc in Scientific Discipline (Scientific, Engineering, Technical) Experienced in late-stage process development or MSAT roles supporting industrialization & commercialization Experienced in technology transfer, with an understanding of the product development process, regulatory requirements for biopharmaceutical production.
Excellent problem solver and ability to think and work creatively.
Must have excellent verbal and written communication skills, and ability to influence, lead and drive change demonstrated through relevant work experiences.
Broad and integrated knowledge and experience that can impact project and workgroup direction.
Preferred Qualifications & Skills.
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply.
Post Graduate Degree (Scientific, Engineering, Technical) Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
Track record of improving products, processes and trouble-shooting, execution of technical activities including validation activities Demonstrated experience in the Pharmaceutical industry in leading the Technical aspects of Product Lifecycle Management.
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.
Closing Date for Applications – 17th January (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Why GSK? Uniting science, technology and talent to get ahead of disease together.
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 organisation where people can thrive.
We prevent and treat disease with vaccines, specialty and general medicines.
We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 place where people feel inspired, encouraged and challenged to be the best they can be.
A place where they can be themselves – feeling welcome, valued, and included.
Where they can keep growing and look after their wellbeing.
So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
As an Equal Opportunity Employer, we are open to all talent.
In the US, we also adhere to Affirmative Action principles.
This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles.
If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or .
The helpline is available from 8.
am to noon Monday to Friday, during bank holidays these times and days may vary.
Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels.
However, we have created a UK Recruitment FAQ guide.
Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive As you apply, we will ask you to share some personal information which is entirely voluntary.
We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions.
We would really appreciate it if you could take a few moments to complete it.
Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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.
Qualifications.
UNAVAILABLE Responsabilities.
UNAVAILABLE Skills.
UNAVAILABLE